Pharma news – 3 September 2020

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

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