Monthly Update- pharma News June 2021

pharma News June 2021: Read what is happening in India and around the globe in the pharma industry.

AstraZeneca’s India vaccine partner seeking EU travel resolution:
28 June 2021

European Union’s vaccine passport program has allowed only people vaccinated with one of the four Western-made vaccines to travel within the bloc from 1 July 2021. This includes the COVID -19 vaccines made by AstraZeneca (Vaxzevria), Pfizer and BioNTech, Johnson & Johnson, and Moderna. It, however, doesn’t extend to Covishield, the Indian variant of the AstraZeneca vaccine made by the Serum Institute of India (SII). The company’s CEO has brought this issue to the notice of the higher-ups and hopes to resolve it soon in a diplomatic manner. ¹

Dr. Reddy’s rolls out the 2-DG drug for Covid treatment
pharma News June 2021: 29 June 2021

Dr. Reddy’s launched 2 – deoxy – D – Glucose (2 – DG) in the Indian market on 28 June 2021. This drug developed by the DRDO comes in the form of a sachet that must be dissolved in water before oral consumption. It is priced at INR 990 per sachet but will be offered to government institutions at subsidized rates. Dr. Reddy’s has announced that it will be sold to the private and government hospitals in the metro and tier – 1 cities in the initial weeks and then extend to the entire country. ²

Sanofi sells portfolio of regional consumer brands to Stada
28 June 2021

Sanofi has agreed to sell over 16 European consumer healthcare brands to the private-equity-owned Stada. This includes brands such as Mitosyl ointment, Silomat cough remedies, Frubisae nutritional supplements, among others. Both the companies have not disclosed the financial terms of this deal, but it is speculated that it would range from around 120 to 140 million euros ($144 to $168 million). Sanofi added that it struck this deal to streamline the company’s product portfolio. ³

IICT ties up with Nosch Labs for transfer of process knowhow to make anti-Covid drug 2-DG
29 June 2021

Nosch Labs has entered into a non – exclusive agreement with CSIR – IICT to transfer the process know-how for the synthesis of 2 – DG. The pharma company announced that the manufacturing would commence as soon as it receives the regulatory clearances from the DCGI. It also plans to make this COVID – 19 drug available at an affordable price.⁴

Covid: In a first, 5 Indian pharma majors join hands for Molnupiravir clinical trials
pharma News June 2021: 29 June 2021

Cipla Ltd., Dr. Reddy’s Laboratories, Torrent Ltd., Sun Pharma Ltd., and Emcure Pharma have joined together to conduct the clinical trials of Molnupiravir in India. The trial for this oral anti-viral drug will be conducted to treat mild COVID -19 patients in an outpatient setting. It is expected to take place between June 2021 and September 2021 in around 1200 patients. Per sources, the trial will be conducted using Dr. Reddy’s product, while the other four pharma companies will be required to show the equivalence of their product to Dr. Reddy’s product. The five companies had individually entered into an agreement with Merck Sharpe Dohme (MSK) in March – April 2021 for supplying Molnupiravir to India and 100 other countries. 5

AstraZeneca Pharma India moves Delhi High Court against NPPA demand notice
29 June 2021

AstraZeneca has filed a writ petition challenging a demand notice from the National Pharmaceutical Pricing Authority (NPPA) that alleged overpricing of the Tagrisso 80 mg tablets by the company. NPPA sent the notice of demand to AstraZeneca on 25 June 2021. It claimed that the company had overcharged about INR 157.38 crores between 8 March 2019 and 31 January 2021 regarding Tagrisso (Osimertinib) 80 mg tablets. Apart from this, it also ordered the company to deposit this amount within 30 days from the date of notice and added that the company was liable to pay interest that would be calculated till the date of actual payment. AstraZeneca filed the petition in Delhi High Court stating that the DPCO 2013 does not apply to Osimertinib as it is a patented drug and hopes to resolve it soon. ⁶

Cipla to Support Moderna for Covid vax to be donated to India:
29 June 2021

Cipla supports Moderna for the regulatory approval and import of its COVID – 19 vaccines to be donated to India. It, however, revealed that there is no agreement for the commercial supply of the vaccine at the moment. Moderna’s mRNA vaccine was granted restricted emergency use in India on 29 June 2021. This makes it the fourth COVID -19 jab to be approved in India after Covishield, Covaxin, and Sputnik V. ⁷

Pfizer, Moderna vaccines likely to provide protection against COVID-19 for years, says study
29 June 2021

A study published in the journal ‘Nature’ has stated that Pfizer and Moderna vaccines generate persistent immune responses that provide protection against coronavirus infection for years. It also revealed that people administered with these jabs do not require booster shots as long as the virus does not evolve beyond the current forms. Those who have gotten the jab after recovering from COVID – 19 infection may not need booster shots even if the virus evolves. The number of memory cells that detect the virus was not reduced even after 4 months of the mRNA vaccination, unlike those produced by other vaccines as they disappear in around four to six weeks. This study did not include Johnson & Johnson’s COVID – 19 vaccine in this study. ⁸

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AstraZeneca partners with Docon to digitalise 1,000 clinics across India
pharma News June 2021: 30 June 2021

AstraZeneca and Bengaluru – based Docon technologies have collaborated to digitalize over 1000 clinics across India. Docon will provide the Electronic Medical Record (EMR) system to the clinics to help the physicians access the patient’s clinical history. On-ground identification and support have been placed in around 30 cities to achieve this feat, and a pilot phase is also being conducted. For this phase, around 200 clinics in Tier I and II cities have been upgraded. Three-day in-clinic training for learning and adoption and a dedicated helpline for resolving technical queries have also been set up for this purpose. ⁹

Lupin gets USFDA nod for HIV drug under PEPFAR
30 June 2021

The USFDA has given the green signal for marketing Lupin’s HIV treatment medication in the American market. This approval comes under the US President’s Emergency Plan for AIDS Relief (PEPFAR). This medication includes Dolutregravir, Lamivudine, and Tenofovir Dosoproxil Fumarate (TLD) tablets (50 mg/ 300 mg/ 300mg), along with an antiretroviral fixed-dose combination (FDC). This tablet is preferred as the first-line treatment for HIV in adults and pediatric patients weighing at least 35 kg. TLD tablets will be manufactured in the company’s Nagpur – based facility. ¹⁰

Monthly Update- pharma News June 2021

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