21 July 2025 The Psychopharmacologic Drugs Advisory Committee (PDAC) of the US Food and Drug Administration (FDA) met to discuss the supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD).
Shares in Replimune Group, a US biotech developing novel oncolytic immunotherapies, went in freefall Tuesday, as the company announced a major setback. 22 July 2025
Neuraxpharm Group, a privately-held German specialty pharma focused on central nervous system (CNS) disorders, today announced the launch of a new affiliate, Neuraxpharm Australia, led by newly appointed head of commercial, Avendran Naidu, as the company continues to expand globally. 22 July 2025
US biotech iTeos Therapeutics yesterday announced that it has entered into a definitive merger agreement Concentra Biosciences, a vehicle controlled by hedge fund Tang Capital Partners, this year, which has already come to the rescue of five struggling biotechs. 22 July 2025
Ireland-based Alkermes has announced positive topline results from the randomized double-blind treatment period of the Vibrance-1 Phase II study evaluating alixorexton in patients with narcolepsy type 1 (NT1). 22 July 2025
French pharma major Sanofi today announced it has entered into an agreement to acquire Vicebio, a privately held biotechnology company headquartered in London, UK. 22 July 2025
Shares in Sarepta Therapeutics have slumped by more than a third since late last week amid new updates on its gene therapy development woes. 22 July 2025
The US regulator has tapped Stanford University physician-scientist and former biotech executive George Tidmarsh to serve as director of its Center for Drug Evaluation and Research, CDER, stepping into a pivotal leadership role during a time of significant internal reshuffling. 22 July 2025
Canadian biotech Eyam Health has entered a research alliance with Swiss-based nonprofit Medicines for Malaria Venture to explore monoclonal antibody-based therapies aimed at preventing malaria. 22 July 2025
Adding to the string of US and international drugmakers investment in US production investment following a call from President Donald Trump, AstraZeneca announces $50 billion of investment in the USA by 2030, building on America’s global leadership in medicines manufacturing and R&D. 22 July 2025
George Medicines, a UK biopharma focused on cardiometabolic diseases, has entered into an exclusive licensing and supply agreement with Azurity Pharmaceuticals. a privately-held US pharma. 21 July 2025
The European Commission has granted marketing authorization in the European Union (EU) for German pharma major Bayer’s Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT), for a third therapeutic indication. 21 July 2025
NodThera, a privately-held biotech working in chronic inflammatory diseases through selective modulation of the NLRP3 inflammasome, has announced the appointment of Jyothis George as chief medical officer (CMO), effective immediately. 21 July 2025
South Korea’s biosimilar drug developer Samsung Bioepis today released its Third Quarter 2025 Biosimilar Market Report, marking the tenth edition reviewing the situation in the USA. 21 July 2025
The US Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis, submitted by US pharma major Bristol Myers Squibb. 21 July 2025
US biotech major Biogen has announced that it intends to invest an additional $2 billion in its existing manufacturing footprint in North Carolina’s Research Triangle Park (RTP). 21 July 2025
Swiss pharma giant Roche today reported mixed results from late-stage trials for its experimental drug astegolimab, which is being developed to treat chronic obstructive pulmonary disease (COPD). 21 July 2025
The global market for preservative-free eye drops is on a growth trajectory, driven by rising awareness of the long-term risks of chemical preservatives and a surge in chronic eye conditions. 21 July 2025
Denmark-based allergy immunotherapy specialist ALK Abello today announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended the use of the company’s tree pollen tablet Itulazax for the treatment in adults. 21 July 2025
Shares in Replimune Group, a US biotech developing novel oncolytic immunotherapies, went in freefall Tuesday, as the company announced a major setback. 22 July 2025
Neuraxpharm Group, a privately-held German specialty pharma focused on central nervous system (CNS) disorders, today announced the launch of a new affiliate, Neuraxpharm Australia, led by newly appointed head of commercial, Avendran Naidu, as the company continues to expand globally. 22 July 2025
US biotech iTeos Therapeutics yesterday announced that it has entered into a definitive merger agreement Concentra Biosciences, a vehicle controlled by hedge fund Tang Capital Partners, this year, which has already come to the rescue of five struggling biotechs. 22 July 2025
Ireland-based Alkermes has announced positive topline results from the randomized double-blind treatment period of the Vibrance-1 Phase II study evaluating alixorexton in patients with narcolepsy type 1 (NT1). 22 July 2025
French pharma major Sanofi today announced it has entered into an agreement to acquire Vicebio, a privately held biotechnology company headquartered in London, UK. 22 July 2025
Shares in Sarepta Therapeutics have slumped by more than a third since late last week amid new updates on its gene therapy development woes. 22 July 2025
The US regulator has tapped Stanford University physician-scientist and former biotech executive George Tidmarsh to serve as director of its Center for Drug Evaluation and Research, CDER, stepping into a pivotal leadership role during a time of significant internal reshuffling. 22 July 2025
Canadian biotech Eyam Health has entered a research alliance with Swiss-based nonprofit Medicines for Malaria Venture to explore monoclonal antibody-based therapies aimed at preventing malaria. 22 July 2025
Adding to the string of US and international drugmakers investment in US production investment following a call from President Donald Trump, AstraZeneca announces $50 billion of investment in the USA by 2030, building on America’s global leadership in medicines manufacturing and R&D. 22 July 2025
George Medicines, a UK biopharma focused on cardiometabolic diseases, has entered into an exclusive licensing and supply agreement with Azurity Pharmaceuticals. a privately-held US pharma. 21 July 2025
The European Commission has granted marketing authorization in the European Union (EU) for German pharma major Bayer’s Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT), for a third therapeutic indication. 21 July 2025
NodThera, a privately-held biotech working in chronic inflammatory diseases through selective modulation of the NLRP3 inflammasome, has announced the appointment of Jyothis George as chief medical officer (CMO), effective immediately. 21 July 2025
South Korea’s biosimilar drug developer Samsung Bioepis today released its Third Quarter 2025 Biosimilar Market Report, marking the tenth edition reviewing the situation in the USA. 21 July 2025
The US Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis, submitted by US pharma major Bristol Myers Squibb. 21 July 2025
US biotech major Biogen has announced that it intends to invest an additional $2 billion in its existing manufacturing footprint in North Carolina’s Research Triangle Park (RTP). 21 July 2025
Swiss pharma giant Roche today reported mixed results from late-stage trials for its experimental drug astegolimab, which is being developed to treat chronic obstructive pulmonary disease (COPD). 21 July 2025
The global market for preservative-free eye drops is on a growth trajectory, driven by rising awareness of the long-term risks of chemical preservatives and a surge in chronic eye conditions. 21 July 2025
Denmark-based allergy immunotherapy specialist ALK Abello today announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended the use of the company’s tree pollen tablet Itulazax for the treatment in adults. 21 July 2025