Indian government ceases exports of Ipca (hydroxychloroquine)
India has stopped exporting the malaria drug Ipca (hydroxychloroquine), despite the FDA lifting its ban on imports due to its potential as a coronavirus treatment.
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India has stopped exporting the malaria drug Ipca (hydroxychloroquine), despite the FDA lifting its ban on imports due to its potential as a coronavirus treatment.
Gilead Sciences say they are confident they can maintain an expedited regulatory review timeline for remdesivir as a treatment for COVID-19 without Orphan Drug Designation (ODD).
Positive topline results have been announced from a Phase II trial of VENCLEXTA® (venetoclax) in combination with azacitidine in patients with acute myeloid leukaemia (AML).
Boehringer Ingelheim and Eli Lilly have received a complete response letter from the US FDA for their sNDA of empagliflozin 2.5mg, an insulin adjunct.
Specially designed for R&D laboratories, Telstar's LyoQuest Arctic is a bench-top environmentally friendly lab freeze dryer. Unlike conventional freeze dryers using HFC cooling gases, the Lyoquest Arctic reduces the GWP impact more than 1,000-fold.
Due to the COVID-19 outbreak, India has decided to invest $1.3 billion into its internal drug manufacturing capabilities, says a new report.
Having become aware of insulin shortages in pharmacies, the company has stated that its products are not backordered and should be available for delivery by wholesalers.
A Phase Ib trial for the study of the oral formulation for Amphotericin B has met its primary endpoints, demonstrating safety in patients.
Windlas Healthcare Private Ltd has been sent a warning letter by the FDA for violations of current good manufacturing practice regulations.
A Class 4 falsified medicines directive (FMD) has been issued by the MHRA because medicines may have left the legal supply chain to be reintroduced later through HMS Wholesale Limited.
The US FDA will now approve biosimilars via a new regulatory pathway to help grow the competition between biologic products.
The producers of hydroxychloroquine have stated they will donate 130 million doses if the drug is approved as a treatment for the COVID-19 coronavirus.
Researchers have developed a new technology that could provide real-time analysis of patient samples during clinical trials to reveal the best cancer treatment regimens.
In the UK, the CMA has announced it will establish a taskforce to handle businesses that exploit the COVID-19 outbreak and inflate drug prices.
The first regulatory approval for Cabenuva (cabotegravir and rilpivirine) has been granted by Health Canada, in conjunction with use of Vocabria.