FDA hands Boehringer and Lilly complete response letter for insulin adjunct
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.
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Telstar develops a new laboratory freeze dryer operating with natural gases
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.
India to set up $1.3bn pharma manufacturing fund, says report
Due to the COVID-19 outbreak, India has decided to invest $1.3 billion into its internal drug manufacturing capabilities, says a new report.
COVID-19 update: Eli Lilly assures security of insulin supply
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.
Phase Ib study for oral Amphotericin B meets primary endpoints
A Phase Ib trial for the study of the oral formulation for Amphotericin B has met its primary endpoints, demonstrating safety in patients.
Indian drug manufacturing facility issued FDA warning letter
Windlas Healthcare Private Ltd has been sent a warning letter by the FDA for violations of current good manufacturing practice regulations.
MHRA issues FMD over HMS Wholesale Limited products
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.
FDA transitions to new regulatory pathway for biosimilars
The US FDA will now approve biosimilars via a new regulatory pathway to help grow the competition between biologic products.
Anti-malarial drugs donated to aid fight against COVID-19
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.
Mass cytometry could reveal best cancer drug regimens for clinical trials
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.
CMA launches COVID-19 taskforce to combat drug price hikes
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.
Cabenuva (cabotegravir and rilpivirine) granted approval by Health Canada
The first regulatory approval for Cabenuva (cabotegravir and rilpivirine) has been granted by Health Canada, in conjunction with use of Vocabria.
UK bans parallel exporting of crucial medicines to help COVID-19 patients
The UK government has announced that the parallel export of certain essential medicines is banned, to preserve drugs for the treatment of coronavirus patients.
Novartis recalls Sandimmune and Neoral over risk of poisoning
The company is recalling 100mg blister packages of both Sandimmune and Neoral due to their packaging not being child-resistant, a fault that could result in infants being poisoned.
Researchers to trial SNG001 therapeutic in COVID-19 patients
Hospitalised patients in the UK will inhale the interferon beta 1a (IFN-β) formulation or a placebo to see if SNG001 is effective against the COVID-19 coronavirus.
