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Bayer’s USA-based subsidiary Vividion Therapeutics has taken over full development and commercialization rights for VVD-214, a clinical-stage Werner helicase (WRN) inhibitor originally discovered under a research collaboration with Roche. 5 June 2025
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The US Food and Drug Administration (FDA) has notified KalVista Pharmaceutical that it will not meet the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for sebetralstat, the company’s investigational oral on-demand treatment for hereditary angioedema (HAE). 14 June 2025
Pharmaceutical
The International Finance Facility for Immunization (IFFIm) has announced the settlement of its £300 million ($407 million), three-year 4.25% fixed-rate bond that was announced on June 3. 14 June 2025
Biotechnology
The Food and Drug Administration approved US pharma giant Merck & Co’s mega-blockbuster cancer drug Keytruda (pembrolizumab) for a new indication. 13 June 2025
Biotechnology
US mRNA specialist Moderna today announced that the US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), the company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease. 13 June 2025
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for second-line multiple myeloma treatment of adults who are refractory to or intolerant of lenalidomide. 13 June 2025
Pharmaceutical
Novartis has unveiled further data for Fabhalta (iptacopan), reinforcing its position in the paroxysmal nocturnal hemoglobinuria (PNH) market and adding momentum to the oral drug’s expanding presence across rare blood and kidney disorders. 13 June 2025
Pharmaceutical
The American medicines regulator has approved Zusduri (mitomycin), a hydrogel-based treatment developed by US biotech UroGen Pharma, for adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). 13 June 2025
Biotechnology
COVID success story BioNTech is to buy fellow German mRNA company CureVac. 12 June 2025
Generics
Russian drugmaker Axelpharm has managed to lift the ban on the launch of osimertinib - a drug, which is used in the treatment of lung cancer - in the domestic market, reports The Pharma Letter’s local correspondent. 12 June 2025
Latest In Brief for Roche
Biotechnology
South Korea’s LigaChem Biosciences has signed two antibody licensing agreements with US biotech NovaRock Biotherapeutics, reports Korea Biomedical Review. 12 June 2025
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COVID success story BioNTech is to buy fellow German mRNA company CureVac. 12 June 2025
16 May 2025
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