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Pharmaceutical
Vertex Pharmaceuticals today announced that the European Commission has granted approval for Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) for the treatment of people with cystic fibrosis (CF) ages six years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 1 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Unicycive Therapeutics’ New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, but still sending the California-based company's share shares nearly 5% higher to $5.00. in pre-market activity. 1 July 2025
Pharmaceutical
A Republican-backed amendment to the sweeping budget proposal championed by US president Donald Trump would sharply reduce Medicaid spending, targeting one of the core features of the Affordable Care Act. 1 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD)—including certain formulations of amphetamine and methylphenidate—to warn of the risk of weight loss and other adverse reactions in patients younger than six years. 1 July 2025
Pharmaceutical
Swedish biotech Camurus has secured EU marketing authorization for its once-monthly acromegaly therapy, Oczyesa (octreotide), marking a significant step forward in treatment convenience for patients living with the rare endocrine disorder. 1 July 2025
Pharmaceutical
As pressure builds around drug pricing and access, US trade group PhRMA is pushing back against criticism of pharmaceutical patents. In a recent blog post, the organization argued that intellectual property protections are essential to biopharmaceutical innovation and key to sustaining the American economy. 1 July 2025
Pharmaceutical
Chinese biopharma Hutchmed today announced that the New Drug Application (NDA) for the combination of Orpathys (savolitinib) and Tagrisso (osimertinib) has been granted approval by the China National Medical Products Administration (NMPA). 30 June 2025
Pharmaceutical
Japanese drugmaker Shionogi has filed a supplemental application in Japan to broaden the use of its oral antiviral Xocova (ensitrelvir), aiming to include children as young as six who weigh at least 20 kilograms. 30 June 2025
Biotechnology
The US Food and Drug Administration (FDA) has announced the elimination of the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR-T cell immunotherapies. 30 June 2025
Pharmaceutical
China’s National Medical Products Administration (NMPA) has approved Innovent Biologics’ mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, for chronic weight management in Chinese adults with overweight or obesity. 30 June 2025
Pharmaceutical
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) last week submitted comments in response to the Centers for Medicare & Medicaid Services (CMS) draft guidance for implementation of the prescription drug price-setting program established under the Inflation Reduction Act (IRA). 30 June 2025
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has appointed Bayer’s Stefan Oelrich as its new president, with Roche chief executive Teresa Graham and Almirall’s Carlos Gallardo taking on first and second vice president roles. 30 June 2025
Pharmaceutical
US biotech major Amgen, a late comer to the growing obesity treatment space, released new data showing that its MariTide reduced weight by 20%. In deal-making news last week, US drugmaker Amarin struck a deal with Italy’s Recordati for the marketing of its cardiovascular drug Vazkepa in 59 countries, mostly Europe. Also, USA-based Vor Bio signed an exclusive agreement to acquire to RemeGen’s myasthenia drug telitacicept. Also of note, the US Centers for Disease Control and Prevention CDC) new advisory committee, the ACIP, met last week to review a number of vaccines. 29 June 2025
article
Swedish Orphan Biovitrum, the Nordic biotech also known as Sobi on Frida,y announced that the US Food and Drug Administration (FDA) approved Gamifant (emapalumab-lzsg) for a new indication, edging the company’s shares up 2.4% to 284.60 kronor. 28 June 2025
Pharmaceutical
Despite calls for the meeting to be delayed, Wednesday’s meeting of the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) went ahead. 27 June 2025
Biotechnology
Italian drugmaker Philogen has announced its decision to voluntarily withdraw the application for marketing authorization to the European Medicines Agency (EMA) for Nidlegy(daromun), a biological investigational medicinal product which is intended to be used for the neoadjuvant treatment of adult patients with locally advanced fully resectable melanoma. 27 June 2025
Biosimilars
Indian drugmaker Biocon has announced that Health Canada has granted a Notice of Compliance for Yesafili (aflibercept), a biosimilar to Eylea (aflibercept) injection, in vial and prefilled syringe presentations, 2 mg/0.05 mL. 27 June 2025
Pharmaceutical
Japanese drugmaker Chugai Pharmaceutical today revealed that it has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW) for an additional indication of its anti-cancer agent/ALK inhibitor Alecensa (alectinib) for ALK fusion/rearrangement gene-positive unresectable advanced or recurrent solid tumors, including pediatric patients. 27 June 2025
Biotechnology
US pharma major Merck & Co has secured a key endorsement for its newly approved respiratory syncytial virus (RSV) prevention product, Enflonsia (clesrovimab), as a majority of an influential advisory panel voted to recommend its use in newborns ahead of the 2025-2026 RSV season. 27 June 2025
Biotechnology
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
Pharmaceutical
The US Food and Drug Administration (FDA) has notified Bayer that it has extended the review period for the New Drug Application (NDA) for elinzanetant, the first neurokinin 1 and neurokinin 3 receptor antagonist for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) due to menopause. 26 July 2025
Biotechnology
As if there had not been enough negative news regarding Elevidys (delandistrogene moxeparvovec) this month, there was more today from the European regulator. 25 July 2025
Pharmaceutical
The European Medicines’ (EMA) human medicines committee (CHMP) has recommended seven novel medicines for approval at its July 2025 meeting. 25 July 2025
Biotechnology
French drugmaker Ipsen announced that the European Commission (EC) has approved Cabometyx (cabozantinib) for adult patients with unresectable or metastatic, well differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues. 25 July 2025
Pharmaceutical
The Trump administration has asked the US Supreme Court to allow the National Institutes of Health (NIH) to resume canceling hundreds of research grants supporting work on health equity, racial disparities, and other diversity-related public health initiatives. 25 July 2025
Biotechnology
In an import contrast to events in the USA, UK pharma major GSK late Thursday announced the approval of Blenrep (belantamab mafodotin) by the European Commission. 25 July 2025
Biotechnology
Following the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on June 19, 2025, the European Commission has approved French pharma major Sanofi's (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. 25 July 2025
Generics
Hospitals are rationing cancer treatments. Pharmacies are scrambling to fill routine antibiotic prescriptions. And across the USA, patients are facing growing delays, substitutions, or outright denials of essential medicines, not because the drugs don’t exist, but because the supply chains behind them have buckled. 24 July 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved US pharma major AbbVie’s Elahere (mirvetuximab soravtansine) to treat adults with ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. 24 July 2025
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma today revealed that the US Food and Drug Administration (FDA) has approved Anzupgo (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. 24 July 2025
Biotechnology
Swiss pharma giant Roche has paused shipments of the gene therapy Elevidys (delandistrogene moxeparvovec) for new orders in certain countries outside the USA. 24 July 2025
Biotechnology
US biotech Avidity Biosciences’ stock rose 4% on Wednesday after the company announced that the US Food and Drug Administration (FDA) had granted Breakthrough Therapy designation to delpacibart zotadirsen (del-zota, formerly known as AOC 1044), the company’s investigational therapy for the treatment of people with Duchenne muscular dystrophy amenable to exon 44 skipping (DMD44). 24 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for GSK’s Blenrep (belantamab mafodotin-blmf) combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. 24 July 2025
Biotechnology
US healthcare giant Johnson & Johnson (NYSE: JNJ) has announced that the European Commission (EC) has approved a new indication and an indication extension for Darzalex (daratumumab) and Imbruvica (ibrutinib), respectively. 23 July 2025
Pharmaceutical
Privately-held Spanish CNS specialist Minoryx Therapeutics and Germany’s Neuraxpharm Group today announced that the marketing authorization application (MAA) for Minoryx’ lead candidate Nezglyal (leriglitazone) has been submitted to the European Medicines Agency (EMA) for the treatment of pediatric and adult male patients with cerebral adrenoleukodystrophy (cALD). 23 July 2025
Biotechnology
The European Commission has approved Swiss pharma giant Roche’s Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. 23 July 2025
Biotechnology
Patients in the UK will now be able to access advanced, personalized treatments prepared at the hospital or even in mobile units near their homes, thanks to a world-first regulatory shift. New legislation introduced by the country’s drug regulator allows hospitals and care centers to produce small or individual batches of cutting-edge therapies at the point of care. 23 July 2025
Biotechnology
French biotech ImCheck Therapeutics has announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A) monoclonal antibody designed to selectively activate γ9δ2 T cells, in acute myeloid leukemia (AML). 22 July 2025
Biotechnology
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
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