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Pharma News – 20 February 2021 (Updates)

Lupin and Aurobindo Pharma initiates nationwide recall

medication pills isolated on yellow background

Pharma News – 20 February: The latest enforcement report of the USFDA[1] has led to the recall of certain medications by two major pharma companies. The companies involved are Lupin and Aurobindo Pharma.

Baltimore – based unit of Lupin Pharmaceuticals Inc. has been actively recalling an antiviral medication. This medication is called Oseltamivir Phosphate for Oral suspension and over 46,479 bottles are being recalled. The Hyderabad – based drug maker, Aurobindo Pharma, is also undertaking similar measures to recall Acetaminophen injection. Read more: Lupin and Aurobindo Pharma Recall certain medications

USFDA approves Lupin’s Posaconazole tablets

lupin pharma

On 17 February 2021, Lupin Limited announced the launch of Posaconazole delayed–release tablets in the United States. This tablet is marketed at the dose of 100 mg. This delayed–release tablet is the generic equivalent of Noxafil Delayed-release tablets, 100 mg. The latter is manufactured by Merck Sharp & Dohme Corp. Read more: USFDA approves Lupin’s Posaconazole tablets

GMP Violation by Alembic Pharma

Pharma News – 20 February

Pharma News – 20 February: At the beginning of February 2021, the US drug regulator issued “Form 483” to the Kharkhadi unit of Alembic Pharma. This is a sterile injectables manufacturing unit of the drug firm that is situated in Gujarat. The violations were related to quality control, cleanliness and size of the equipment, and inadequate sample collection procedures at the site. Read more GMP Violation by Alembic Pharma

The BioNTech / Pfizer COVID – 19 vaccines can be stored at – 25 to – 15 degrees Celsius for up to two weeks

medicine

On 19 February 2021, Pfizer announced that its COVID -19 vaccine could withstand warmer temperatures in pharmaceutical freezers and refrigerators. This jab can now be stored for up to 2 weeks at – 25 to – 15 degrees Celsius ( – 13 to 5 degrees Fahrenheit ). The company has contacted the USFDA[1] to seek this storage temperature approval. Know about The BioNTech/Pfizer COVID vaccines

5. Effectiveness of AstraZeneca’s COVID – 19 vaccine increases with a 3 months gap before the second dose :

Pharma News – 20 February: AstraZeneca and Oxford have claimed that their vaccine was more effective with a 3-month gap before the second dose. This was revealed in a peer–reviewed study in a medical journal (The Lancet on 19 February 2021).

medicine

The World Health Organization has also approved this vaccine for emergency use in the third week of February 2021. This, in turn, has paved the way for the distribution of this vaccine to developing countries through the COVAX program. Read more: AstraZeneca’s COVID–19 vaccine

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GMP Violation by Alembic Pharma

Violation of good manufacturing practices by sterile injectables unit of Alembic Pharma identified by USFDA

At the beginning of February 2021, the US drug regulator issued “Form 483” to the Kharkhadi unit of Alembic Pharma. This is a sterile injectables manufacturing unit of the drug firm that is situated in Gujarat.

Pharma News – 20 February

The form was issued after the unit was inspected by the USFDA[1] inspectors. These inspectors revealed that the unit violated the good manufacturing practices that must be observed during production. The violations were related to quality control, cleanliness and size of the equipment, and inadequate sample collection procedures at the site.

The US drug regulator has also reported that the quality control department of this unit “lacked the authority to investigate the errors that have occurred”. It further added that the company’s investigation on this matter was inadequate. This inadequacy was attributed to the fact that the company failed to address the testing of toxins in a particular batch of products.

GMP Violation

GMP Violation: What was the matter?

The company’s aseptic area was also deficient, and one of the GMP violation norms also mentions this. This difficulty in environmental monitoring increased the chances of product contamination in the unit. Other violations include the deficient procedures for the operation of the equipment in the unit. It stated that over 15 recorded failures were observed on a testing machine in one of the facility’s manufacturing lines. Apart from this, the equipment used in the manufacturing, processing, and packaging of drug products was also not of appropriate design or size. Furthermore, these were also not situated in suitable locations in the facility.

In response to these claims, the drug firm has announced that these observations were unrelated to the data integrity and only “procedural in nature”.

USFDA has issued 15 working days for the company to respond with a corrective and preparative action plan. This plan, if satisfactory, could pave the way for the clearance of the facility by the USFDA.

This manufacturing unit of Alembic Pharma in Gujarat is pivotal for the company as it caters to the international markets. Both US[2] and Europe receive products that are manufactured in this unit.

Abbreviation :

  • 1. United States Food and Drug Administration
  • 2. United States

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Pharma News February 2021 Updates

BioNTech ramps up production of its COVID – 19 vaccine to meet global demands :

Pharma News February 2021: The German biotechnology firm has recently announced that it would produce over two billion doses of its COVID – 19 vaccines in 2021. The company added that it plans to scale up its manufacturing capacities to meet the booming demand. It also stated that this was around 50 percent higher than the previously expected output that stood at 1.3 billion doses.

Image result for BioNTech

BioNTech and Pfizer have collaborated on the development of this mRNA vaccine. This vaccine is called BNT162b, and the vaccine shot depends on the messenger RNA[1] technology. The use of mRNA boosts the body’s immune system, which sped up the development process largely.

Clinical trials with over ten thousand participants have been conducted, and these showed that the vaccine has an efficacy rate of 95 %. The company has also revealed that this vaccine’s success rate in the vulnerable age groups lies at 94 %.

Image result for BioNTech

The company’s CEO[2] has also commented that this vaccine’s immunization effect would last for at least a year. Although this is not yet confirmed, research has been performed to estimate the recovered patients’ antibody levels. This was done to reveal the duration for which the natural protection would last. The results revealed that the recovered patients’ high antibody levels did not have a significant drop for quite some time. Per this, the company believes that this might be the same in the vaccinated individuals.

Several agreements have been signed to deliver millions of doses of this vaccine to various countries. An agreement has also been signed with the European Union for delivering 200 million doses. This is accompanied by an option for an additional 100 million doses.

The company also mentioned that Pfizer’s production facility processes in Puurs, Belgium, have been modified. This has helped bring the company back to the original schedule of vaccine dose delivery to the European Union.

Abbreviation : 1. Ribonucleic acid

  • Chief Executive Officer

2. Canadian pharma considers importing 50,000 doses of Covishield vaccine from India :

Pharma News February 2021: A private pharma company from Canada has recently contacted the Indian government to secure the Covishield vaccine doses. As per the Indian officials, this was a query and not a final deal.

Pharma News February 2021

The unidentified Canadian company discussed with the Indian government regarding the import of over 50,000 doses of the vaccine. This vaccine is developed by Oxford – AstraZeneca in the UK[1] and manufactured by Serum Institute of India under the Covishield brand.

The Canadian program has already ordered millions of doses of the vaccine from AstraZeneca. But owing to the lack of supplies, this company has decided to secure another consignment separately.

Canada has secured vaccine deals with Pfizer – BioNTech, Moderna, AstraZeneca, Sanofi and GlaxoSmithKline, Johnson & Johnson, and Novovax. These account for over 350 million doses of COVID – 19 vaccines in total.

Image result for covishiled

The vaccination program began in December 2020 in the country but has now come to a standstill due to a deficit of supplies. The program started after emergency authorization was given to Pfizer and Moderna vaccines. The recent lack of supplies was attributed to Pfizer delaying its supplies by ramping up its production plant in Belgium. Another important reason for this is the export controls placed on the vaccines manufactured in certain regions by the European Commission.

AstraZeneca has already sought out the Canadian public health authorities for its vaccine clearance. However, the region from where these will be sourced is yet to be revealed. The shipments from the European Union will be resuming soon. This belief is based on the fact that some shipments have already begun arriving in Canada.

On 2 February 2021, Canada agreed with Novovax to manufacture its vaccine. However, these vials are unlikely to be ready before the end of 2021.

Abbreviation : 1. United Kingdom

Pfizer withdraws the application for the emergency use authorization of its COVID -19 vaccine in India :

Pharma News February 2021: On 5 February 2021, Pfizer claimed that it has withdrawn the application for the EUA[1] of its COVID – 19 vaccine in India. This company was the first drugmaker to apply for the EUA of its vaccine to the DCGI[2]. The company held a meeting with India’s drug regulator on 3 February 2021 and finally made this decision.

Pharma News February 2021

The company stated that it would resubmit the application in the future after securing the Indian drugs regulator’s additional information. The company’s spokesperson stated that the company was committed to ensuring this vaccine’s use by the Indian government.

The CDSCO[3] expert committee announced that Pfizer did not produce any plan to generate safety and immunogenicity data in the Indian population. This was one reason behind the company’s decision to withdraw the application. Apart from this, CDSCO also revealed that it has been keeping an eye on the side effects reported abroad post-vaccination using Pfizer’s vaccine.

India started its mass vaccination program on 16 January 2021 following the approval of two COVID -19 vaccines in the country. This includes Covishield and Covaxin. Covishield is developed by Oxford University and locally produced by Serum Institute of India. Covaxin, on the other hand, is indigenously manufactured by Bharat Biotech.

Pharma News February 2021

Pfizer – BioNTech’s COVID -19 vaccine was first approved in the UK[4] on 2 December 2021 after approval from the MHRA[5]. The country has ordered over 40 million doses of this vaccine to vaccinate its 20 million population.

Following the UK, Bahrain approved the vaccine for emergency use after a thorough analysis of the available data.

Pfizer’s COVID – 19 vaccine must be stored at – 70 degrees Celsius. This extremely low temperature is needed as the vaccine uses synthetic mRNA to induce an immune response.

The company also announced on 2 February 2021 that it expects to generate around $15 billion from the sales of its vaccine. Pfizer currently plans to produce around 2 billion doses of this vaccine in 2021.

Abbreviation :

  • 1. Emergency Use Authorization
  • 2. Drugs Controller General of India
  • 3. Central Drugs Standard Control Organization
  • 4. United Kingdom
  • 5. Medicines and Healthcare Products Regulatory Agency

4. Central government committee approves the indigenous manufacture of Chlorantraniliprole by Natco Pharma :

Image result for natco pharma

Pharma News February 2021: Natco Pharma is a generic drugmaker that diversified into agrichemicals around two years ago in 2019. It recently announced that it has received approval for its application regarding Chlorantraniliprole ( CTPR ). This approval was received on 5 February 2021.

The Central Insecticide Board & Registration Committee approved the company’s application on 25 January 2021. This application was submitted to get registration for the indigenous manufacture of CTPR Technical 93.00 % w/w[1].

CTPR is a broad – spectrum insecticide that is used for better pest management in several crops. This product is the first key product of the company’s Crop Health Sciences Division. The company also claimed that it would be the first indigenous manufacturer to produce this technical product.

Image result for natco pharma

Natco also has pending litigation against FMC[2] corporation, a US chemical major company, for the declaration of freedom to use CTPR. It hopes to bring other CTPR based products to India at an affordable cost and ensure their accessibility to all farmers.

CTPR is an active ingredient of certain products manufactured by FMC corporation under the brands Coragen and Ferterra. As per FMC, the sales revenue of products containing CTPR in India is estimated to be around Rs. 1,540 crore in the year 2016.

Based on this data, Natco expects the current market size to be over Rs. 2,000 crore. During the company’s diversification, it invested over Rs. 100 crore to set up a manufacturing plant in Andhra Pradesh. This plant is involved in the making of agrichemical technical and formulation products.

Abbreviation :

  • 1. Weight by weight
  • 2. Food Machinery and Chemical Corporation

5. AstraZeneca receives DCGI’s approval for the use of its Dapagliflozin tablets in chronic kidney disease patients :

Pharma News February 2021: AstraZeneca announced that the DCGI[1] has given the go – ahead signal for its Dapagliflozin tablets, on 6 February 2021. This tablet was approved by the DCGI for the treatment of chronic kidney disease patients.

The company claimed that it has received the Import and Market permission in Form CT – 20 ( Subsequent New Drug Approval ). This approval was given for Dapagliflozin 10 mg tablets. Dapagliflozin is now approved for the treatment of patients with chronic kidney disease up to stage III. The company plans to launch this product into this new disease are soon and make it accessible to all the nephrologists in India.

This drug was initially approved by the DCGI for the treatment of patients suffering from heart failure with reduced ejection fraction. The company received this approval for this use in July 2020. Apart from this, Dapagliflozin is also used as a diabetic medication in India. It is widely used to lower blood sugar levels in adults with type II diabetes.

Abbreviation : 1. Drugs Controller General of India

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Pharma News – 20 January 2021

Leading drugmakers found in the new provisional list released by drug price watchdog of India :

NPPA[1], colloquially referred to as India’s drug price watchdog released the updated provisional list on 11 January 2021. This list details the “overcharging cases” (OC) under litigation. All the cases listed in this date back to 1997, which this watchdog was formed. Albeit being a regular occurrence, the new list baffled many. It included the names of some leading drug makers in India. This list encompassed pharma majors like Cipla, Lupin, Cadila, and Sun Pharma, among others accused of overcharging consumers.

The companies included in this list usually face penalties, which is the sum of the amount allegedly overcharged and the interest. According to this list, the total estimated overcharged amount minus the penalties already paid stands at Rs.6,550 crore. 

The penalty of Cipla is over Rs.3000 crore, while that of Sun Pharma is around Rs.250 crore. Ranbaxy, albeit merging with Sun Pharma in 2015, still has a penalty of Rs.400 crore left.

In 2013, two pharma companies alone contributed to around 50 percent of the total overcharged amount. These companies, namely Cipla and Ranbaxy, had a penalty of Rs.1382 crore and Rs.136.2 crore, respectively.

Based on the latest list, the overcharging penalty of Lupin stands around Rs.67 crore while that of GSK[2] totals Rs.3.42 crore. The total overcharging amount of Cadila is also revealed to be over Rs.34 crore.

The official website also uploaded an office memorandum accompanying this list. Through this, the NPPA announced that it would upload the provisional list of OC cases under litigation for companies to see their case’s status. It further added that the concerned companies might contact them in case of any discrepancies in this regard. It also reiterated that any modification in the list is only feasible if it provides substantial documentary evidence. This feedback is also requested to be submitted within 15 days. 

The NPPA has also explicitly stated that the interest amount had been updated up to 30.11.2020 wherever possible. It further revealed that any payment or part – payment made had been adjusted from the total amount. This can be observed by a variation in the date of updation of interest.

Abbreviation :

  • [1] – National Pharmaceutical Pricing Authority
  • [2] – GlaxoSmithKline

2. Oxford – AstraZeneca COVID-19 vaccine gets emergency approval in Pakistan :

On 16 January 2021, the DRAP[1] granted approval for Oxford’s emergency use – AstraZeneca’s COVID – 19 vaccine across the country. As per reports from the chief of the NCOC[2], the vaccine is expected to roll out by March 2021.

In the first phase of vaccination, the country plans to vaccinate health care workers and those aged 65 years and above.

Another government official also stated on 15 January 2021 that Pakistan had been in contact with China and other companies to purchase COVID – 19 vaccine. He further added that the government is looking forward to the results of the vaccine produced by the Chinese firm, Cansino. He asserted that this medicine would be registered with the DRAP for procurement if proven successful in the trials. Apart from this, he also stated that international coalition Covax had agreed to provide 50 million doses of free COVID – 19 vaccine to Pakistan.

The total number of COVID – 19 cases spiked to around 519,291 after 2,521 new cases were detected within the past 24 hours. During this period, 43 lives had succumbed to the disease bringing the total fatalities to around 10,951. A government official has also claimed that Pakistan plans to vaccinate at least 70 percent of its total population covering around 70 million citizens.

The NCOC is the country’s coronavirus control body headed by Asad Umar, the Minister for Planning.

Abbreviation :

  • [1] – Drug Regulatory Authority of Pakistan 
  • [2] – National Command and Operations Centre

3. Caplin Steriles enters into a partnership with JAMP Pharma to produce injectables for the Canadian market :

On 18 January 2021, Caplin Point announced the partnership of its subsidiary, Caplin Steriles, with JAMP Pharma. This collaboration was aimed to produce six injectables that are to be filed in Canada. As per reports, some of these injectables have already been filed in the USA[1].

The Chairman of Caplin Point Laboratories expressed his pleasure over this collaboration. He hoped to add more products in due course. He further added that the company has been proactive in expanding its market areas and targeting Canada as part of this approach.

Caplin Steriles Ltd is a sterile product manufacturing company approved by both the USFDA[2] and the EU – GMP [3]. The company has filed over 19 ANDA[4] In the US alone and currently possesses 11 FDA approvals at hand.

JAMP Pharma is also pleased with this collaboration and has expressed its intent to work with the company in the coming years.

Abbreviation :

  • [1] – United States of America
  • [2] – United States Food and Drug Administration
  • [3] – European Union – Good Manufacturing Practices
  • [4] – Abbreviated New Drug Application

4. Sinopharm’s COVID – 19 vaccine gets approved for emergency use in Pakistan :

On 15 January 2021, DRAP[1] granted emergency approval to use the COVID – 19 vaccine manufactured by Oxford – AstraZeneca. Following this, the regulatory body granted emergency use approval for the vaccine manufactured by the Chinese National Pharma group, Sinopharm. This was authorized on 18 January 2021.

The Registration Board of the regulatory body conducted a meeting on 18 January 2021. A spokesperson for the regulatory body stated that the EUA[2] of the vaccine was decided upon at this meeting. He further claimed that both the vaccines have been evaluated for their safety and granted EUA with certain conditions only. Adding on, he mentioned that the authorization would be reviewed quarterly. This review will be based on the data regarding the vaccines’ safety, efficacy, and quality.

The Beijing Institute of Biological Products developed this latest vaccine. It showed a 79.3 percent efficacy in the last – stage trials. The Chinese health regulators granted conditional approval of this vaccine in December 2020 for use in China. The two-dose effectiveness of this inactive vaccine is yet to be ascertained.

On 30 December 2020, the Pakistani government decided to procure 1.1 million doses of this vaccine. It further announced that around 500,000 health care workers would be given two doses, each with a margin spoilage of only 10 percent.

This vaccine can be stored at 2 to 8 degrees Celsius and has already been approved in the UAE[3] and Bahrain. 

The Phase-I clinical trial of this vaccine that was conducted in Karachi has reached the final stages with only 10 volunteers left out. This trial was carried out on 150 healthy volunteers at ICCBS[4] in collaboration with Indus Hospital.   

Another official has expressed his concern as he feels that the chances of getting the Oxford – AstraZeneca vaccine are bleak. He opined that this was due to India buying the research and manufacturing the vaccine. He further added that with India prioritizing its own population, the only chance of getting the vaccine was through Covax.

Covax is an alliance set up by the GAVI[5], CEPI[6], and WHO[7] in April 2020. This alliance pledged to provide free vaccines to around 20 percent of the population of around 190 countries. It is being speculated that the first consignment will be received by the start of the second quarter of 2021.

Abbreviation :

  • [1] – Drug Regulatory Authority of Pakistan
  • [2] – Emergency Use Approval 
  • [3] – United Arab Emirates
  • [4] – International Centre for Chemical and Biological Sciences
  • [5] – Global Alliance for Vaccines and Immunization
  • [6] – Coalition for Epidemic Preparedness Innovations
  • [7] – World Health Organization

5. Fosun Pharma in talks with the Chinese government to get emergency approval of BioNTech’s vaccine :

On 19 January 2021, Fosun Pharma began proactively working on getting emergency approval for BioNTech’s vaccine in Hong Kong. For this purpose, it began to communicate with Hong Kong’s regional government closely. 

A local committee of experts has also supported this by claiming that the approval would benefit more than risk. It announced this after reviewing the vaccine’s efficacy, safety, and quality on 19 January 2021.

The regional government had agreed to purchase 7.5 million doses of the mRNA COVID – 19 vaccine from Fosun Pharma on 11 December 2020. This vaccine is called BNT162b2 and was jointly developed by Fosun Pharma and BioNTech. Around 1 million doses of this vaccine are expected to be delivered by the first quarter of 2021. 

The government has also claimed that it plans to begin mass vaccination by February 2021. Hong Kong’s financial secretary believes that the economy will pick up in the second half of 2021.

As per Fosun Pharma, it will produce the vaccines in BioNTech’s factory in Europe. The company launched the phase II clinical trials of this vaccine on 24 November 2020. This was carried out in Taizhou and Lianshui. All the trial participants finished two doses and did not report any serious adverse effects as of 12 January 2021. The company does not plan to conduct phase III trials as the domestic epidemic has already been controlled. This is also because of the lack of a suitable environment for the trial.

The BioNTech vaccine is reported to be the first COVID – 19 vaccine to receive WHO’s[1] emergency approval on 31 December 2020. It has been approved for use in the UK[2], Bahrain, Canada, Saudi Arabia, Mexico, and the US[3].

Abbreviation :

  • [1] – World Health Organization
  • [2] – United Kingdom
  • [3] – United States

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Pharma News Update – 22 September 2020

1.Acella Pharma recalls thyroid medications owing to their sub-potent nature :

Pharma news – 22 September: Acella Pharmaceuticals is voluntarily recalling two lots of thyroid medications owing to potency issues. As the reports from the USFDA[1], the drugs being recalled are not strong enough and this has warranted the recall in the US.

Pharma news – 22 September

The recalled lots include one containing 15 mg NP Thyroid Tablets and the other containing 120 mg NP Thyroid Tablets. These products contain only around 87 % of the labeled amount of levothyroxine.

Pharma news – 22 September

Hypothyroidism or underactive thyroid is treated by using levothyroxine and liothyronine. Both these agents are called the active ingredients.

The FDA has announced that the symptoms of hypothyroidism return when sub potent drugs are used for treating underactive thyroid. The manifested symptoms include fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss and swelling of the thyroid among others.

Pharma news – 22 September

It further added that these drugs increase the risk of miscarriage and fetal hyperthyroidism when given to pregnant women. It also claimed that there is a serious risk of impairment to fetal neural and skeletal development when administered to newborn infants. Parallel to this, it induces toxic cardia manifestations like cardiac pain, palpitations and cardiac arrhythmias in elderly patients. These manifestations are also observed in those with underlying cardiac disease.

Till now, four reports of adverse effects have been received by the company. Medications that remain unaffected by this recall comprise those with “use by”, “discard after” or “expiration date” on or after December 2020.

The company is actively notifying its wholesalers to stop the distribution of these products. The same is also being done to the patients who are consuming these medications. However, patients are being requested to consult with their physicians before stopping the medication.

At the beginning of September 2020, around 483 lots of Nature-Thyroid and WP Thyroid were recalled by RLC labs. This was because these medications have as low as around 87 % of liothyronine or levothyroxine.

Abbreviations : 1. United States Food and Drug Administration

2.China raises the price of key starting materials used by the Pharma companies :

Pharma news – 22 September: In a recent tide of events, China has decided to hike the price of key staring materials (KSM) by 10 – 20 %. In contrast, the prices of active pharmaceutical ingredients (API) remain unchanged.

Pharma news – 22 September

This change will significantly impact the Indian pharma as it majorly depends on China for both APIs and KSMs. These ingredients are widely used for manufacturing antibiotics, steroids and other medicines.

The rise in the cost is expected to pressurize the domestic market over the next few months. This price hike is also expected to discourage the indigenous production of API in India. Subsequently, it might even make manufacturing units unviable and APIs less competitive against the Chinese products at the global level.

Recent estimates have claimed that China supplies around 70 – 80 % of the basic raw materials needed for making medicines in India. The API needed for the manufacture of the popular painkiller paracetamol is also imported from China.

Per the Pharma Industry associations, the prices of APIs in China have surged by 25 – 30 % in the past three to six months. China has also supplied around 68 % of the $3.5 billion worth APIs imported by India in 2018-19. These APIs were used to manufacture several essential medicines by Indian drugmakers.

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Pharma News Update – 17 September 2020

1.Aurobindo Pharma collaborates with BIRAC for the development of Covid-19 vaccine :

Pharma news – 17 September: On 15 September 2020, Aurobindo Pharma announced its collaboration with BIRAC[1], set up by the Department of Biotechnology. This tie-up was done to develop a Covid-19 vaccine in the country.

Pharma news – 17 September

The company has claimed that BIRAC supported it by assisting in the set-up of the ‘r-VSV vaccine’ manufacturing platform. It further added that it is working together with its subsidiary, Auro Vaccines for the development of the Covid-19. Auro Vaccines is a wholly-owned US[2] subsidiary of the drug firm. The drug firm has also claimed that the manufacturing plant will comply with global standards.

Pharma news – 17 September

Many Indian Pharma firms are also racing ahead to develop a potent Covid-19 vaccine. This includes Bharath Biotech, Serum Institute, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E.

Abbreviation : 1. Biotechnology Industry ResearchAssistance Council.

  • US – United States

2. Johnson & Johnson’s vaccine trial loses out on volunteers due to Oxford vaccine scare :

Pharma news – 17 September: The appearance of a serious illness in one of the volunteers enrolled for the Oxford vaccine trial has been creating chaos everywhere. This chaotic situation started on 6 September 2020 in the UK[1]. Following this, the trials were temporarily suspended but now these have resumed. Except for the US[2], other countries have already restarted their trials.

Pharma news – 17 September

This sudden scare has instilled fear in the minds of volunteers making them reluctant to go on with the trial. This has caused a few participants in Spain to drop out since 15 September 2020. Many, however, remained rational and enquired the researchers to provide additional information on the risks of the vaccine. Despite this fluctuation, the company has claimed that number of volunteers needed for the clinical trials is still sufficient.

Abbreviation : 1. United Kingdom

United States

3.Brinton Pharma gets Rs.10 crore debt funding from BlackSoil Capitals :

Pharma news – 17 September: Brinton Pharma has recently received the DCGI’s[1] approval for selling Favipiravir 400 mg in India. This medication is being launched under the brand name “Faviton”. This company has also raised around Rs.10 crores in debt funding from BlackSoil Capital.

Pharma news – 17 September

Favipiravir is an antiviral agent that is being used for the treatment of mild to moderate cases of Covid-19 in India. Brinton is the second country to launch the drug in India. Starting from May 2020, this drug was being exported to Nepal, Sri Lanka, China and Vietnam. This drug was made for Brinton pharma by its Hyderabad-based Optimus Pharma.

Pharma news – 17 September

The company is also manufacturing PPE[2] kits and RT-PCR[3] kits since the beginning of the pandemic. Despite being a seven-years-old company, Brinton Pharma’s response to the current pandemic was clearly impressive and this was appreciated by many in the field.

The drug firm’s investor BlackSoil Capital also praised the company. It claimed that the company was successful in increasing its revenue during the pandemic and also proved itself competent. It also added that Brinton Pharma is one of the few companies that have turned EBITDA[4] positive during the last few months. Apart from this, this investment is also expected to increase the market reach of the company and proliferate its business.

Abbreviation :  1. Drugs Controller General of India

2. Personal Protective Equipment

3. Reverse Transcriptase – Polymerase Chain Reaction

  • Earnings Before Investment, Taxes, Depreciation and Amortization

4. Experimental Covid-19 plasma therapy by Takeda Pharma to enter clinical trial :

Pharma news – 17 September: Takeda Pharmaceutical Co. and its partners are working on an experimental Covid-19 therapy blood plasma. This therapy is expected to undergo a late stage clinical trial after some delays.

Pharma news – 17 September

This study is sponsored by the NIAID[1] located in the United States. As per a posting found on the website of NIH[2], around 500 participants are to be recruited for this trial. The participants are expected to be from the United States, Britain, Denmark and Argentina.

The study is expected to begin in September 2020 albeit many speculating that it would begin in July 2020. It aims to compare the efficacy of the plasma product with that of Remdesivirand placebo.

This group is also known as the CoVIg-19 Plasma Alliance and includes Biotest AG, CSL Behring, Octapharma Plasma and Takeda Pharma. It is currently working on a hyperimmune globulin therapy obtained from convalescent plasma. The dose of the antibodies is standardized in this and there is no limitation especially with regard to the matching blood types.

The clinical supplies needed for this trial were given to the Takeda’s facility in the U.S State of Georgia and CSL Behring’s facility in Bern, Switzerland.

Abbreviation : 1. National Institute of Allergy and Infectious Diseases

  • National Institute of Health
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Pharma News Update – 13 September 2020

1.AstraZeneca resumes the clinical trials of its Covid-19 vaccine following approval from the MHRA :

Pharma news – 13 September: On 12 September 2020, Oxford University announced the resumption of its Covid-19 vaccine trials. This vaccine is being developed by the university in collaboration with AstraZeneca. The trials of this vaccine were recently suspended owing to an unexplained side-effect in one of the volunteers recruited for the study.

Pharma news – 13 September

An independent safety review committee and the UK[1] health regulator, MHRA[2] have given their approval for the restart of this trial. Following this, Oxford asserted the resumption of the trials in all the UK sites.

Pharma news – 13 September

The university has also added that such incidences cannot be turned a blind eye. This is due to a large number of participants enrolled in the study. A large number of volunteers in turn emphasizes the need to analyze the effects produced in each individual to assess the safety of the vaccine.  

News of this restart has been warmly welcomed by the British health secretary and the general public. The vaccine being developed by this collaboration is currently one among the top contenders in the global race for the Covid-19 vaccine.

Abbreviation : 1. United Kingdom

  • Medicines and Healthcare products Regulatory Agency

2. Serum Institute of India will resume clinical trials in India post approval from DCGI :

Pharma news – 13 September: Pharma major SII[1] has announced that the vaccine trials conducted in India will be resumed once the DCGI[2] gives the green signal. This was announced on 12 September 2020 hours after AstraZeneca resumed its Covid-19 vaccine trial.

On 6 September 2020, AstraZeneca temporarily suspended the clinical trials of its Covid-19 vaccine, AZD1222. This was due to an unexplained illness developed by one of the volunteers. Following this, the trials in USA[3], UK[4], Brazil and South Africa were also suspended.

Owing to these developments, the DCGI had asked the SII to temporarily stop recruiting volunteers for the Covid-19 vaccine until further notice. This meant that all the phase two and three trials conducted by the company will be paused for the time being.

On 2 August 2020, India’s top drug regulator permitted SII to conduct phase II/III clinical trials of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant). The trials were to be conducted at various sites in India to test the safety and immunogenicity of this vaccine.

This vaccine will be manufactured by SII. It was, however, developed by the technical collaboration with Oxford University and AstraZeneca.

As per reports, the trials of AZD1222 has resumed in the UK due to approval from the MHRA[5]. Following this, the DCGI has stated that the trial carried out by SII can be resumed following clearance from DSMB[6], UKand DSMB, India. The company also remains hopeful about this and plans to restart the trials at the earliest.

Abbreviation : 1. Serum Institute of India

2. Drugs Controller General of India

  • United States of America
  • United Kingdom
  • Medicines and Healthcare Regulatory Agency
  • Data and Safety Monitoring Board
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Pharma News

Pharma News Update – 10 September 2020

1.Cipla and Optimus Pharma receive permission to conduct phase 4 clinical trials for testing the efficacy of Favipiravir :

Pharma news – 10 September: Cipla and Optimus Pharma have recently submitted proposals for conducting phase 4 clinical trials of Favipiravir in India. These proposals were reviewed and approved by a Subject expert committee (SEC) on 2 September 2020. BDR Pharma has also submitted a similar proposal, but the SEC has requested a revised proposal from this company.

Pharma news – 10 September

The SEC advises DCGI[1] on applications seeking approvals for new drugs, vaccines and clinical trials for Covid-19.

Favipiravir is an antiviral drug that was developed in Japan and used for treating influenza patients. Currently, it is on the radar for treating Covid-19 along with the Ebola drug Remdesivir.

Pharma news – 10 September

As per CDSCO[2], the panel has asked the two companies to compare the results of phase 4 studies with the already available literature. This is believed to be useful in proving the efficacy of Favipiravir in Covid-19 patients.

The CDSCO is led by the DCGI and the DCGI has the authority to approve the trials.

In June 2020, Glenmark launched Favipiravir in the Indian market for the first time. This drug firm was also the first company to complete the phase 3 trials of Favipiravir.

The panel has also stated certain conditions that must be followed by the two companies. It has specifically asked the drug firms to call this a “Phase IV clinical trial” and not a “study”. This is to emphasize that the drug is already available in the market and is being used by the patients. The follow-up period is also set at 28 days instead of the usual 21 days. The clinical improvement of the patient and the safety of the drug will be the primary objectives of the trial. Secondary objectives are restricted to mortality, disease progression and viral clearance. These must be noted on 4, 7, 14 days or at hospital discharge.

Pharma news – 10 September

In July 2020, a clinical study of Avigan (Favipiravir) conducted on early state Covid-19 patients failed to show any significant effect. The Japanese university that conducted this study has also added that there was no remarkable difference in the effectiveness of the drug. This was deduced after comparing the effectiveness in patients who took the drug at the initial stages versus the ones who took it at a later stage. One professor has also claimed that Favipiravir has the tendency to reduce fever or eradicate the virus in Covid-19 patients. But this is not statistically significant as the study was conducted on a small group of 89 patients only.

Abbreviation : 1. Drugs Controller General of India

Central Drugs Standard Control Organization

2.Indian government announces all-clear for 3 drug cocktails that were banned as a part of the first crackdown :

Pharma news – 10 September: On 8 September 2020, the DCGI[1] announced the all-clear status of three drug cocktails that were banned in 2007. This was informed to the state-level health authorities and the Union Health Ministry by an official letter.

Pharma news – 10 September

As per the DTAB[2] panel conducted on 29 July 2020, three more FDCs[3] was considered rational from the 296 FDCs that were banned in 2007.         

The three FDCs include a hypertension medicine, a medicine for neuropathic pain, and one for nutritional deficiencies. The FDC of the hypertension medicine is Losartan, Atenolol and Hydrochlorthiazide. The FDC of the neuropathic pain drug cocktail contains duloxetine and methylcobalamine. And that of the one used for nutritional deficiencies comprises methylcobalamin, vitamin B6 and folic acid.

FDCs generally combine more than one drug in a single pill for ease of compliance. It is also done when the advantages of the combination surpass that of the single drug.

The 3 drug cocktails have been banned for around 13 years. The top manufacturers of these drugs are Sun Pharma, Torrent Pharma and Wockhardt.

These drugs were banned as part of the government’s first crackdown on 27 November 2007. However, this has been controversial as drugmakers had received a stay for this order from the Madras High court back then. This case is still ongoing in the Supreme court.

With this clearance, a total of around 86 FDCs have now been removed from the banned list and categorized as “rational”. An FDC is considered rational when the combination is proved to be more advantageous than the single-compound drug.

Abbreviation : 1. Drugs Controller General of India

2. Drugs Technical Advisory Board

  • Fixed-dose combinations

3. AstraZeneca temporarily pauses the clinical trials of its Covid-19 vaccine due to unexplained illness in a volunteer :

Pharma news – 10 September: On 8 September 2020, AstraZeneca announced its decision to “voluntarily pause” a randomized clinical trial of its Covid-19 vaccine. This was due to an unexplained illness developed in a volunteer post the trial.  

The spokesperson of the company has claimed that this was done to review the safety data of the vaccine by an independent committee. He further added that this measure is a routine activity that is taken whenever such a situation arises.

The drug firm is developing this vaccine together with Oxford University and is currently in the late-stage phase 3 trials. It had begun to recruit around 30,000 volunteers across dozens of sites in the US[1] alone on 31 August 2020.

The vaccine is called AZD1222 and is a weakened version of the common cold causing adenovirus. It codes for the spike protein that the novel coronavirus uses for invading host cells. Following vaccination, this protein is produced in the body. It then stimulates the immune system the coronavirus when the person gets infected later on.

Abbreviation : 1. United States

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Pharma News

Pharma News Update – 06 September 2020

1.Trump’s rush for vaccine conflicts with the interest of the pharma companies :

Pharma news – 6 September: The presidential election in the US[1] has been garnering the attention of the media especially due to Trump’s extravagant promises. The latest promise of the current president has created discord with the pharma companies. This promise assures the production of Covid-19 vaccines by October 2020.

Pharma news – 6 September

In response to this statement, many pharma companies have joined hands and come up with a decision. As per reports, many major pharma companies are opposing this and plan to release an official statement in September 2020. Some speculate that the announcement will be made by the second week of September 2020.

The representatives of these companies have claimed that the vaccine will be marketed only after all the safety protocols are completed. They further added that no unsatisfactory vaccine will be sent to the USFDA[2] for review. These statements were made to assure the public that potent vaccines of standard quality alone will be available in the market.

This joint pledge was supposedly signed by large manufacturers like Sanofi, Pfizer, Moderna, GlaxoSmithKline and Johnson & Johnson. Many believe this announcement was done to counteract the political pressure that was being exerted on the FDA.

Many in the US are actively criticizing the FDA for taking controversial decisions under political pressures. Despite these allegations, Trump has strongly accused the FDA of slowing down its work to damage his political career.

Pharma news – 6 September

Apart from this, the current president has also implemented the new Covid-19 testing guidance in the US. Per this, testing is unnecessary to patients who have been exposed to or have no symptoms of Covid-19. Around 33 states in the US have refused to acknowledge this guidance by the CDC[3] by recommending the people to test for Covid-19. While North Dakota is yet to decide on this matter, the other 16 states have refused to comment on it.

Abbreviation : 1. United States

  • United States Food and Drug Administration
  • US Centers for Disease Control and Prevention

2. BDR Pharma gears up for the launch of “BDFAVI” 400 mg in India :

Pharma News – 6 September: BDR Pharmaceuticals had earlier received the DCGI’s[1] approval to manufacture Favipiravir in India. Favipiravir is used to treat mild to moderate Covid-19 symptoms. The generic version launched by BDR Pharma is called “BDFAVI”.

Recently, the company has planned to launch 400 mg of BDFAVI in the market. This will be priced at Rs.990 for a strip of 10 tablets. The cost of 1 tablet is around Rs.99.

This increased dose is expected to satisfy the market demands and also aid in patient recovery. The company officials claim that higher dosages might smoothen the experience of the patients and their caregivers. They believe this could hasten the recovery process of  Covid-19 patients.

The company had launched 200 mg Favipiravir tablets in August 2020.

Abbreviation : 1. Drugs Controller General of India

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Pharma News

Pharma News Update –03 September 2020

1.Canada signs deal with Novovax and Johnson & Johnson to secure millions of doses of Covid-19 vaccine :

Pharma news – 3 September: On 31 August 2020, Canada signed two separate agreements with Novovax Inc and Johnson & Johnson. These were signed to secure millions of doses of the experimental Covid-19 vaccine of both the companies. The country had earlier secured deals with Pfizer Inc and Moderna Inc in the mid of August 2020.

Pharma news – 3 September

Talks with AstraZeneca to procure its potential vaccine and with Pfizer Inc to secure more doses are currently midway. The current population of Canada stands at around 38 million. The deals signed till now make the country eligible to secure around 88 million doses of the vaccine. These deals also have options to purchase further doses, which makes another 10 million doses as the country’s reserve if needed.

Pharma news – 3 September

The Prime Minister of Canada has also announced that around $96.7 million will be invested to build a biomanufacturing facility. This facility will be built in two years at the Human Health Therapeutics Research Centre in Montreal. The government plans to produce at least 2 million doses of vaccine per month from next year in this facility.

Pharma news – 3 September

Canada has recently nullified its contract with CanSino Biologics as the company lacked the authority to ship its vaccine. This was announced by Canada’s National Research Council in the last week of August 2020.

Novovax hopes to finalize an advance purchase agreement to supply the vaccine doses by the second quarter of 2021. The company has agreed to supply around 76 million doses of its experimental vaccine. Johnson & Johnson has also announced that it will supply around 38 million doses of its vaccine candidate to Canada. These vaccines will however only be supplied post licensure from Health Canada.

EU close to concluding preliminary talks with Novavax on COVID vaccine  supply - source

Apart from this, Canada has also been helpful to the small business owners during this pandemic. The government had come up with a program to provide loans up to C$40,000 to these owners. This program was to expire on 31 August 2020 but the government has now extended this to the end of October 2020.

2.Sanofi halts the International Phase 3 clinical trial of Kevzara drug due to inconclusive results :

Pharma news – 3 September: Sanofi has been actively conducting clinical tests of its Kevzara drug for serious Covid-19 cases. This drug has however given inconclusive results in phase 3 clinical trials. Owing to this inconspicuous outcome, the French pharma giant has decided to halt the trial.

As per the results, the drug failed to meet the primary and secondary evaluation criteria of the trial. This was reported following comparison with the placebo group comprising of established hospital care.

Pharma news – 3 September

The drug firm has clarified the clinical trial of Kevzara would no longer be conducted. It has also added that both the company and its American partner, Regeneron will adhere to this decision.

Since the outbreak of the Covid-19 pandemic in China last year, more than 800,000 loves have been lost. This has sparked a global race for vaccines and treatment.

Kevzara (sarilumab) is a medicine used in adults for the treatment of moderately to severely active rheumatoid arthritis.

3.Mankind Pharma ties up with DrOnA Health as part of its foray into telemedicine :

Pharma News – 3 September: Mankind Pharma has collaborated with DrOnA Health to help doctors interact with their patients through their own virtual clinics. DrOnA Health is a novel virtual consultation platform that is involved in telemedicine.

The drug firm recently conducted a survey with DrOnA to understand the patient’s preference of doctors for virtual consulting. Based on this survey, it was revealed that a majority of the patients’ preferred known doctors over new ones.

The app designed by the company focuses on this point and makes it easier for the patient to access the old doctor. The drug firm has announced that the app is conceptualized as the doctor’s own virtual clinic. The doctor can invite their old patients through the m-site link for appointment bookings. This process is completely hassle-free. The app is currently available on Apple-I store and android platforms.

Over 10,000 doctors are currently using this app and the patient’s privacy is also maintained in this app.

On the pharmaceutical forefront, the company is currently collaborating with Daewoong Pharma Co. for the phase-I trials of Niclosamide. This trial is being conducted for evaluating the efficacy of Niclosamide for treating Covid-19 in India. Around 1000 patients are recruited for this study and the results are expected in another 45 days.

The drug firm has also increased the production of its infertility drug dydrogesterone to thrice the initial value owing to increased demand. Dydrogesterone is the generic version of Abbott’s Duphaston tablets and it was launched in 2019.

Apart from this, a 500-scientist team has been set up by the company as a part of the R&D[1] infrastructure. This was done to identify potential therapies in chronic segments. The export of around 10-15 products manufactured by this company amount to roughly Rd.250 crores. The firm plans to increase this in the coming years.

Due to the current market situation, the company has no plans to accept an initial public offer for the coming 3 to 4 years. Reports have suggested that the company might grow by around 9 to 10 % in the current fiscal year, 2020.

Abbreviation : 1. Research and Development

4.USFDA issues warning to Mylan over failure to maintain quality standards in its Telangana plant :

Pharma news – 3 September: The USFDA[1] has warned Mylan NV for failure to adhere to the quality standards at one of its manufacturing facilities in India. The plant under the radar is in Pashamylaram, Telangana. It was inspected in February 2020. The reports of this inspection revealed that the plant had not taken precautionary measures to avoid solvent impurities. This was accompanied by the inadequate testing of raw materials.

On 2 September 2020, the FDA released the warning letter it had issued to the company in August 2020. As per this letter, the regulatory body has asked the company to hire a consultant to improve the manufacturing standards at the aforementioned plant.

The letter also emphasized that similar violations were observed at another facility in India in November 2019. Such repeated violations have put Mylan NV under the FDA’s radar.

Pharma news – 3 September

Mylan NV has however claimed that it had put additional controls and improvements in place in the facility in question months prior to the investigation. This was done to nullify the risk of product contamination. The drug firm has also claimed that it has been working intimately with the FDA since fall 2019 to investigate the risks associated with impurities.

The company has also announced that the active pharmaceutical ingredient was tested rigorously for impurities. These tests were conducted by the company and revealed the absence of nitrosamine and cross-contamination.

In July 2019, Bloomberg had reported that Mylan would join hands with Pfizer’s off patent drug unit Upjohn. This was expected to reshape the generic drugs industry and the merger was speculated to close by the end of 2020. This however lacks clarity as Mylan is yet to comment on this matter.

The FDA has also claimed that Mylan bought some of its solvents from a company that was banned from selling in the US[2]. It further added that despite the solvent passing the impurity test, the company used it for formulations intended for use in the US market.

Abbreviation : 1. United States Food and Drug Administration

2. United States