The US Food and Drug Administration has cautioned against altering the dosing regimen for Covid-19 vaccines launched on the US market, saying that any changes not supported by clinical trial data would be “concerning.” The agency specifically warned against using a single dose regimen and/or administering less than the dose studied in clinical trials.
Angelini Pharma of Italy has agreed to spend up to $960 million to acquire a two-year old Swiss company with rights to an antiepileptic drug for the treatment of partial-onset seizures. The target company, Arvelle Therapeutics GmbH, was launched in 2019 with start-up capital of $207.5 in order to bring the antiepileptic, cenobamate, to the European market.
The UK has approved a second vaccine to prevent Covid-19 paving the way for a stepped up campaign to immunise the population just as hospitals across the country face a sharp rise in admissions from the pandemic. The vaccine, AZD1222, was developed by Oxford University and AstraZeneca Plc and received an emergency authorisation on 30 December – a little more than four weeks after a vaccine from Pfizer Inc and BioNTech was given clearance.
Twist Bioscience Corp has announced plans to offer a new control that could be used to alter protocols for tests currently in use to diagnose SARS-CoV-2 in order to detect a variant strain of the virus in circulation in the UK and other countries. In a statement issued on 23 December, the company said the new synthetic RNA control should be available by 15 January 2021.
A Phase 3 study of a prospective asthma treatment failed to meet its primary endpoint even though a registration trial for the same drug had positive results. The developers, Amgen Inc and AstraZeneca Plc, said the discrepancy may be due to the design of the failed study, but a further analysis of the data is ongoing.
The US Food and Drug Administration has placed a clinical hold on uniQure NV’s gene therapy programme in haemophilia B following a possibly related serious adverse event, the company announced on 21 December. The hold affects the company’s pivotal Phase 3 study called HOPE-B which recently reported positive initial data at the annual meeting of the American Society of Hematology (ASH).
The Covid-19 vaccine developed by BioNTech SE in partnership with Pfizer Inc received a conditional marketing authorisation in the EU on 21 December – only hours after having been given a positive opinion by the European Medicines Agency.
Japan-based Sosei Group Corp has entered a global collaboration and licencing agreement with GlaxoSmithKline Plc to discover small molecule agonists of a G protein-coupled receptor (GPCR) associated with inflammatory bowel disease and other gastrointestinal immune disorders. It will use technology developed by Heptares Therapeutics, a UK company it acquired in 2015. The deal is the newest collaboration for Sosei, which is using the Heptares’ structure-based drug design platform to grow its business.
The US Food and Drug Administration has issued an emergency use authorisation to Moderna Inc for a vaccine for Covid-19 following trial data showing it was 94.1% effective in preventing the disease. The decision comes just a week after the agency issued an emergency authorisation for a vaccine developed by BioNTech SE and its partner Pfizer Inc. Both vaccines are based on messenger RNA (mRNA), a technology never before used in a human vaccine. The two vaccines work by instructing cells in the body to make copies of the SARS-CoV-2 spike protein.
Gilead Sciences Inc and Galapagos NV have dropped plans to make a new submission in the US for their small molecule drug Jyseleca (filgotinib) in rheumatoid arthritis (RA) following a meeting with the Food and Drug Administration. The parties discussed the points raised in the agency’s complete response letter in August in which it refused to approve the drug because of concerns about its benefit/risk profile at a dose of 200 mg.