SEC

More in SEC

• SEC to meet again to decide on full market nod for Covaxin, Covishield

  "The data is huge which has to be reviewed and it needs a considerable amount of time. The SEC will meet in the next 1-2 days to finish the review," the same person said.

  

• Bharat Biotech asked to conduct Phase III trials for its intranasal vaccine

  The company had also sought approval from the SEC to use its intranasal vaccine as a booster dose, to which the SEC asked the company to submit a revised protocol. The company plans to administer its nasal vaccine as a booster dose for those who have received two shots of a Covid-19 vaccine.

  

• No robust trial data, government rejects SII and Bio E’s proposals on booster jabs

  An expert panel of the health ministry has turned down separate proposals from Serum Institute of India (SII) and Biological E on booster jabs, citing a lack of robust trial data.

  

• Panel seeks extra data on Merck's Covid drug

  "After deliberation, the committee recommended that the firms submit subgroup analysis along with the packaging insert, fact sheet indicating its use, risk mitigation plan," they said.

  

• Expert panel asks drug cos to submit subgroup data on Molnupiravir

  Molnupiravir is the first oral antiviral approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of mild-to-moderate Covid-19 in adults.

  

• Govt panel to review EUA application for generic Covid-19 pill

  The subject expert committee (SEC) under India's drug regulator is expected to review the EUA applications of drug companies seeking approval for Merck’s antiviral pill, Molnupiravir, on Thursday.

  

• SEC set to review Covaxin trial data for use in children

  Bharat Biotech has completed the Phase 2/3 trials of COVID-19 vaccine Covaxin for use in children under 18 years of age.

  

• Phase-3 trials to begin on two-dose regimen

  In a meeting held last month, the Subject Expert Committee (SEC), which advises the drug regulator-granted permission to the company for conducting Phase III trials on its vaccine.

  

• Dr Reddy’s tanks 10% on news of US legal action

  The stock crashed after the company informed the bourses that it has been subpoenaed by the US markets regulator Securities and Exchange Commission (SEC) on July 6 for documents pertaining to certain Commonwealth of Independent States (CIS) countries.

  

• Zydus’ vaccine for kids above 12 to come up for approval this week

  The drug regulator will consider emergency use approval for Covid vaccines developed by Zydus Cadila for children above 12 this week. The regulator's subject expert committee (SEC) will examine data submitted by Cadila, reports Sushmi Dey.

  

• Glenmark to conduct Phase III trial nasal spray meant to treat Covid-19

  ​Glenmark has joined hands with the Canadian company named Sanotize. The nasal spray works by killing the virus largely in the upper airways, preventing it from spreading to the lungs.