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Biogen
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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved US biotech Biogen’s Qalsody (tofersen) to treat adults with amyotrophic lateral sclerosis (ALS) caused by mutations in the SOD1 (an enzyme called superoxide dismutase 1) gene – a rare, inherited form of motor neurone disease (MND). 28 July 2025
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A California-based biotech company aiming to deliver a new class of RNA therapeutics.
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Sweden’s OncoZenge has chosen Meribel Pharma Solutions—formerly Recipharm—to be the contract development and manufacturing organization (CDMO) for its BupiZenge Phase III project. 21 July 2025
Biotechnology
Indian pharma major Sun Pharma reported positive top-line results from two late-stage studies of its psoriasis drug Ilumya (tildrakizumab), showing it helped reduce joint inflammation in people with active psoriatic arthritis. 21 July 2025
Pharmaceutical
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). 21 July 2025
Biotechnology
As of July 18, 2025, the Food and Drug Administration (FDA) said it has received three reports of fatal acute liver failure following treatment of patients with Sarepta Therapeutics’ AAVrh74 gene therapies that appear to have been caused by the gene therapy products as a result of acute liver failure. 19 July 2025
Biotechnology
The European Commission granted conditional marketing authorization for Ezmekly (mirdametinib) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric and adult patients with neurofibromatosis type 1 (NF1) aged two years and above. 19 July 2025
Pharmaceutical
Danish allergy immunotherapy specialist ALK has announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved EURneffy 2 mg for anaphylaxis treatment of adults and children (≥30 kg). 18 July 2025
Pharmaceutical
A major collaboration between the Allen Institute and the Aligning Science Across Parkinson’s (ASAP) initiative is set to transform neurodegenerative disease research by integrating Parkinson’s-specific brain cell data into the Allen Brain Cell (ABC) Atlas. The effort is expected to amplify understanding of the cellular mechanisms driving Parkinson’s and other related conditions, offering scientists a high-resolution view into previously inaccessible datasets. 17 July 2025
Biotechnology
US rare disease meds developer Sarepta Therapeutics late yesterday announced a strategic restructuring plan designed to prioritize high-value, high impact programs, meet its 2027 financial obligations, and support its long-term financial viability. 17 July 2025
Pharmaceutical
Swiss pharma giant Novartis this morning reported second quarter 2025 financial results, showing that net sales were $14.1 billion (+12%, +11% cc), with volume contributing 12 percentage points to growth. This was slightly better than the consensus estimate of $14.02 billion. 17 July 2025
Pharmaceutical
Bayer is giving chief executive Bill Anderson more time to deliver on his ambitious efforts to reshape the German group, extending his contract by three years to March 2029. The move signals strong support from the company’s supervisory board, which voted unanimously in favor of the renewal. 17 July 2025
Latest In Brief for Biogen
Pharmaceutical
Ireland-based biopharma Jazz Pharmaceuticals has been called out for a couple of indiscretions by The Prescription Medicines Code of Practice Authority (PMCPA), which was established by the Association of the British Pharmaceutical Industry (ABPI) to operate the ABPI Code of Practice for the Pharmaceutical Industry. 11 July 2025
Latest Relevant Ones To Watch News
Last week, a US Food and Drug Administration (FDA) advisory committee (AdCom) voted against approval of Danish drugmaker Lundbeck and Japan-based Otsuka’s Rexulti for post-traumatic stress disorder. France’s Sanofi announced it is expanding its respiratory vaccines pipeline with an up to $1.6 billion acquisition of UK biotech Vicebio. French biotech Abivax released new Phase III data on its investigational ulcerative colitis candidate obefazimod that saw its shares nearly quadruple. Also of note was the latest setback for Sarepta’s Duchenne muscular dystrophy drug Elevidys, when the European Medicines human health committee, the CHMP, declined partner Roche’s accelerated approval of the drug. 27 July 2025
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