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Biocon Pharma receives ANDA approval for Mycophenolic acid
Drug Approval | December 03, 2021

Biocon Pharma receives ANDA approval for Mycophenolic acid

This further adds to Biocon’s portfolio of vertically integrated complex drug products


Serum seeks DCGI approval for booster dose in India
News | December 02, 2021

Serum seeks DCGI approval for booster dose in India

The UK’s Medicine and Healthcare products Regulatory Agency has already approved the booster dose of AstraZenenca’s Covid-19 vaccine, which is administered in India


Sai Life Sciences receive Certificate of Inspection from Japan PMDA
Biotech | December 02, 2021

Sai Life Sciences receive Certificate of Inspection from Japan PMDA

The company has also started working with a large pharma company on the API supply of a recently launched animal and human health product


Molnupiravir, a step closer to approval in the fight against Covid-19
News | December 02, 2021

Molnupiravir, a step closer to approval in the fight against Covid-19

The U.S. FDA advisory committee voted 13-10 in favour of the oral antiviral medicine


Sygnature Discovery appoints Louisa Jordison as Chief Financial Officer
Appointment | December 01, 2021

Sygnature Discovery appoints Louisa Jordison as Chief Financial Officer

She replaces Victoria Tabiner, who is stepping down after 10 years at Sygnature


U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib
Biotech | November 30, 2021

U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib

Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)


Daiichi Sankyo initiates Phase 3 trial for Destiny-Breast11 neoadjuvant therapy
Biotech | November 30, 2021

Daiichi Sankyo initiates Phase 3 trial for Destiny-Breast11 neoadjuvant therapy

Destiny-Breast11 will evaluate Enhertu as a monotherapy or Enhertu followed by paclitaxel, trastuzumab and pertuzumab


U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery
Drug Approval | November 30, 2021

U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery

It is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal


Merck and Ridgeback Biotherapeutics Covid-19 pill less effective
Biotech | November 28, 2021

Merck and Ridgeback Biotherapeutics Covid-19 pill less effective

Merck has shared these additional analyses with the FDA and they will be presented to the FDA’s Antimicrobial Drugs Advisory Committee on Nov. 30th


Baidu and Sanofi to collaborate for next-gen mRNA therapy and vaccines
Biotech | November 26, 2021

Baidu and Sanofi to collaborate for next-gen mRNA therapy and vaccines

This agreement marks a milestone for Baidu to use its strengths in computational biology to optimize mRNA vaccine and therapy designs