FDA releases guidance on bioavailability and bioequivalence study samples
The FDA has released guidance on its compliance policy on reserve samples used in bioavailability and bioequivalence studies.
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Sanofi to acquire Principa Biopharma for $3.68 billion
Sanofi is set to acquire Principia Biopharma Inc. for a total aggregate equity value of $3.68 billion, at $100 per share.
Tradipitant may accelerate recovery from COVID-19 pneumonia, finds interim analysis
A preliminary analysis of data from the first COVID-19 pneumonia patients enrolled in the ODYSSEY trial revealed that tradipitant may expedite clinical improvement.
EMA accepts marketing application for Spinal Muscular Atrophy treatment
The European Medicines Agency (EMA) has accepted the marketing authorisation application for Evrysdi™ (risdiplam) as a treatment of spinal muscular atrophy (SMA).
Moderna to supply US with initial 100 million doses of COVID-19 vaccine
Moderna will supply the US with at least 100 million doses of mRNA-1273, its COVID-19 vaccine candidate currently in Phase III clinical trials.
Researchers find three drugs on market that induce side effects in C. elegans
A study has found that three prescription drugs on the market cause unexpected side effects in the C. elegans worm, meaning they could have unknown effects in humans.
AstraZeneca to supply Europe with up to 400 million doses of COVID-19 vaccine
An agreement between AstraZeneca and the European Commission means the company will supply up to 400 million doses of its AZD1222 COVID-19 vaccine.
Indian CMO market hotbed for private equity investment, says report
A report suggests that India’s CMO market has recently attracted investment from global private equity firms due to favourable government policies.
Severely ill COVID-19 patients treated with convalescent plasma therapy
Preliminary data from a study has shown that convalescent plasma therapy is safe and can combat COVID-19 in severely ill patients.
Phase III trial to study NT-300 as COVID-19 treatment initiated
A Phase III trial to investigate NT-300 (nitazoxanide extended-release tablets) as a treatment for mild or moderate COVID-19 has begun.
Bayer to acquire KaNDy Therapeutics with $425 million upfront payment
Bayer will acquire KaNDy Therapeutics Ltd for an upfront cost of $425 million to expand its drug development pipeline in women’s healthcare.
MHRA announces recall of Randox COVID-19 testing kits in UK
Randox is recalling COVID-19 testing kits in the UK as a precautionary measure as they do not meet the required safety standards, the MHRA has said.
COVID-19 vaccines to be monitored post-marketing by consortium in UK
The 'One Million Post-Authorisation Study' has been established to monitor the safety and effectiveness of COVID-19 vaccines in real-life conditions.
Joint working group to produce guidance on air cargo logistics for COVID-19 vaccines
The International Air Cargo Association and Pharma.Aero will form a joint working group to provide air cargo guidance to the logistics industry for the transportation of COVID-19 vaccines.
Russia grants regulatory approval to COVID-19 vaccine, according to report
A COVID-19 vaccine dubbed “Sputnik V” has been given regulatory approval in Russia, before completing its clinical trials.
