December 21, 2021
Novavax vaccine get approvals and recommendations
Novavax Monday said that the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for its ‘ COVID-19 vaccine.
Pharmaceuticals, Biotechnology and Life Sciences
Category: Europe
December 21, 2021
Sanofi will acquire Amunix for an upfront payment of approximately $1 billion
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.
December 21, 2021
Ultomiris accepted under FDA Priority Review in the US for adults with generalised myasthenia gravis
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.
December 21, 2021
Pfizer get China approval for antifungal Cresemba
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).
December 17, 2021
EMA recommends approval for use of Kineret in COVID-19 to the European Commission
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.
December 15, 2021
Sartorius and HOF Sonderanlagenbau Partnership Creates Streamlined Offering of Freeze-Thaw Solutions for Biological Products
Sartoriusand HOF Sonderanlagenbau, announced a partnership today to integrate two HOF horizontal plate freeze-thaw units into Sartorius’ portfolio offering customers a full suite of compatible freeze-thaw equipment and consumables. This partnership will enable faster and easier implementation of robust frozen drug substance management platforms through improved validation and purchase support from a single supplier.
December 13, 2021
Dupixent significantly improved disease severity in a trial that met all endpoints
Positive Phase 3 results show adding Dupixent (dupilumab) to standard-of-care topical corticosteroids (TCS) significantly improved skin clearance and reduced overall disease severity and itch in infants and children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis.
December 13, 2021
Acacia Pharma completes its post-approval requirement clinical trial testing Barhemsys in individuals with severe renal impairment
Acacia Pharma Group has completed its post-approval requirement clinical trial investigating the effects of BARHEMSYS® (amisulpride injection) in individuals with severe renal impairment.
December 13, 2021
Study shows positive results for Roche’s Hemlibra in people with moderate or mild haemophilia A
Roche interim analysis of the phase III HAVEN 6 study, which show Hemlibra (emicizumab) demonstrated a favourable safety profile and effective bleed control in people with moderate or mild haemophilia A without factor VIII inhibitors.
December 13, 2021
Roche launches system to advance sequencing technologies
Roche has launched the AVENIO Edge System, a core component of Roche’s strategy to advance sequencing technologies. Built on best-in-class foundational capabilities to deliver a fully-automated, integrated sequencing solution.