Pharmaceuticals, Biotechnology and Life Sciences
Akston Biosciences, Inc. a developer of new classes of biologic therapeutics, today announced positive data from the Phase II clinical trial of its second-generation SARS-CoV2 vaccine candidate, AKS-452.
Novavax Monday said that the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for its ‘ COVID-19 vaccine.
Sanofi will acquire Amunix for an upfront payment of approximately $1 billion and up to $225 million upon achievement of certain future development milestones. The acquisition supports Sanofi’s efforts to accelerate and expand its contributions to innovative medicines for oncology patients, with approximately 20 molecules currently in development.
Astra Zeneca said Tuesday that Ultomiris regulatory submission has been accepted under FDA Priority Review in the US for adults with generalised myasthenia gravis, based on positive Phase III trial in which Ultomiris significantly improved functional activities as measured by Myasthenia Gravis-Activities of Daily Living Profile.
Basilea Pharmaceutica’s license partner, Pfizer, has received a Drug Approval License from the National Medical Products Administration (NMPA) in China, for the oral formulation of its antifungal Cresemba® (isavuconazole).
— Post-hoc, interim analysis published in Circulation: Heart Failure evaluated patients who received continuous treatment with VYNDAQEL/VYNDAMAX compared to those…
Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets)…
EMA’s human medicines committee (CHMP) has recommended extending the indication of Kineret (anakinra) to include treatment of COVID-19 in adult patients with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure, as determined by blood levels of a protein called suPAR (soluble urokinase plasminogen activator receptor) of at least 6 ng per ml.
EMA’s CHMP advice states that PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) can be used for treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease
Molnupiravir is authorized in the United Kingdom as the first oral antiviral for the treatment of mild to moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness.