Industry Updates & Events

Industry Updates & Events

May 29, 2021
Bharat Biotech needs to give phase-3 efficacy data for WHO nod
  • Bharat Biotech said its emergency use listing (EUL) application had been submitted to WHO, Geneva, and regulatory approvals are expected between July and September.
  • Bharat Biotech will have to submit phase 3 clinical trial efficacy data of Covaxin before the decision.
July 6, 2021
Cipla enters into licensing pact with Eli Lilly for Baricitinib drug
  • Cipla signed a royalty-free, non-exclusive voluntary licensing agreement with US' Eli Lilly for the manufacture and commercialization of the drug Baricitinib for Covid-19 indication.
  • Baricitinib was issued a restricted emergency use approval.
June 29, 2021
Pharma Majors Collaborate for Clinical Trial of Investigational Oral Anti-Viral Drug Molnupiravir for COVID-19
  • Torrent Pharma has collaborated with Cipla, Dr. Reddy’s, Emcure and Sun Pharma for clinical trials of investigational oral anti-viral drug Molnupiravir for the treatment of mild COVID-19 in an outpatient setting in India.
  • According to SEC of CDSCO, Dr. Reddy’s will conduct the clinical trial using its product, and the other four pharma companies will be required to demonstrate equivalence of their product to the product used by Dr. Reddy’s in its clinical trial.
May 8, 2021
DCGI approves anti-COVID drug developed by DRDO for emergency use
  • India’s regulator has approved a new, oral Covid-19 drug that promises to reduce hospitalisation time and oxygen dependency.
  • The 2-deoxy-D-glucose (2-DG) drug developed by the Defence Research and Development Organisation has proved to be effective in three phases of trials on Covid-19 patients.
  • It is approved under EUA scheme.
June 22, 2021
AstraZeneca Covid vaccine linked to rare neurological disorder in India, UK
  • Indian and England patients which received AstraZeneca-Oxford Covid-19 vaccine had developed a rare neurological disorder called Guillain-Barre syndrome, reported in two separate studies.
  • In Guillain-Barre syndrome (GBS), the body's immune system mistakenly attacks part of its peripheral nervous system --the network of nerves located outside of the brain and spinal cord.
May 18, 2021
Quebec Announces Intention to Implement a Biosimilar Switching Policy
  • Quebec becomes the fourth province to implement a biosimilar switching policy under its public prescription drug insurance plan.
June 7, 2021
Pharmaceutical officials propose new USP harmonized chapter on visual inspections
  • Pharmaceutical industry officials have proposed the United States Pharmacopeia develop a new harmonized chapter on visual inspections of parenteral drugs that would address current testing gaps.
  • They recommend a harmonized compendial chapter which includes use of “universally available standards” to train inspectors, qualify the methods, and validate the results.
May 25, 2021
Roche’s Antibody Cocktail launched in India at Rs 59,750/dose
  • Roche India and Cipla launch Roche’s Antibody Cocktail (Casirivimab and Imdevimab) in India priced at Rs 59,750 per dose for the treatment of mild to moderate COVID-19 patients.
  • It is approved under EUA in India
June 29, 2021
Moderna becomes 4th COVID-19 vaccine to get approval for use in India: Reports
  • Cipla received Drugs Controller General of India's (DCGI) nod to import Moderna's COVID-19 vaccine for restricted emergency use.
  • The vaccine has been shown to be around 94% effective against COVID-19.
July 1, 2021
Zydus applies to the DCGI for EUA to launch ZyCoV-D, the world’s first Plasmid DNA vaccine for COVID-19
  • Zydus Cadila has requested emergency use approval for its ZyCoV-D three-dose Covid shot that is the world’s first Plasmid DNA vaccine.
  • Zydus claims its vaccine is 66.6 per cent effective against symptomatic Covid cases and 100 per cent for moderate disease.
June 29, 2021
Europe Union’s new move may hit India, South Africa’s patent waiver plan
  • European Union has drawn up a counter proposal which could ``undermine’’ India and South Africa’s proposed submission at the World Trade Organization seeking a waiver on intellectual property (IP) on Covid-19 drugs and vaccines.
  • If adopted at the WTO, the waiver would provide countries with critical policy space to address IP barriers to increase collaboration in research and development, manufacturing, scale-up, and hence boost supply of Covid-19 medicines and vaccines.
  • The EU proposal calls governments to ``facilitate the use of compulsory licensing within the WTO’s existing agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).