Regulation
Refine Search
Biotechnology
US pharma major AbbVie announced it plan to acquire Capstan Therapeutics, along with its autoimmune disease candidate CPTX2309, for up to $2.1 billion. Organon posted disappointing mid-stage trial results for its investigational endometriosis pain drug, OG-6219. Also of note last week, the US Food and drug Administration (FDA) granted accelerated approval for Regeneron’s multiple myeloma drug Lynozyfic. 6 July 2025
Pharmaceutical
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins. 4 July 2025
Biosimilars
Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd has announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for Vevzuo and Evfraxy biosimilars of denosumab, originated by Amgen. 4 July 2025
Biotechnology
The US Food and Drug Administration has granted accelerated approval to sunvozertinib (trade name Zegfrovy) from Dizal (Jiangsu) Pharmaceutical for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). 3 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has provided an update on the risk of myocarditis after receiving an mRNA COVID-19 vaccine, noting the risk is higher in young men. 3 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval for Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti CD38 monoclonal antibody. 3 July 2025
Pharmaceutical
A federal judge has blocked the US Department of Health and Human Services from moving forward with a major workforce reduction and agency overhaul, finding that the changes may violate federal law and cause lasting disruption. 2 July 2025
Biotechnology
US pharma giant Merck & Co today revealed that the US Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental Biologics License Application (sBLA) to update the US product label for Winrevair (sotatercept-csrk) based on the Phase III ZENITH trial. 2 July 2025
Pharmaceutical
Alnylam Pharmaceuticals has won European Commission approval for Amvuttra (vutrisiran) to treat transthyretin amyloidosis with cardiomyopathy (ATTR-CM), positioning the drug as a likely challenger to entrenched therapies in a market expected to see rapid evolution. 2 July 2025
Biotechnology
US biotech Jazz Pharmaceuticals yesterday announced that the European Commission (EC) has granted conditional marketing authorization for Ziihera (zanidatamab), a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, with the news edging its shares up 3.1% to $109.44. 2 July 2025
Pharmaceutical
Artificial Intelligence (AI) is reshaping pharmacovigilance, promising faster detection of safety signals hidden within mountains of adverse event (AE) data. However, as the US Food and Drug Administration (FDA) sharpens its focus on transparency, credibility, and real-world monitoring, the days of relying on opaque algorithms are numbered. In this article, we explore why sponsors and safety teams must rethink their approach to AE prediction to ensure the very tools designed to protect patients don’t become risks themselves. 2 July 2025
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
Canadian clinical-stage biotech Zymeworks today announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab (trade name Ziihera) for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). 30 May 2025
Pharmaceutical
A typical advertisement for a prescription drug airs on television. The visuals are lively and upbeat; the people are smiling and confident. But the viewer walks away with no clear understanding of what the drug treats. Within moments, the ad is forgotten. 30 May 2025
Pharmaceutical
Industry stakeholders have urged the European Medicines Agency to sharpen its guidance on decentralized clinical trials, calling for more practical detail in a key international framework on good clinical practice. 30 May 2025
Pharmaceutical
Swiss eye care specialist Alcon yesterday revealed the US Food and Drug Administration (FDA) has approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512.The new pushed the firm’s shares up 2.5% to 72.32 francs this morning. 30 May 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has identified a potential path forward for elamipretide for the treatment of Barth syndrome, Stealth BioTherapeutics revealed today. 29 May 2025
Biotechnology
The European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 29 May 2025
Biotechnology
Japan’s Daiichi Sankyo and partner Merck & Co today revealed that the Biologics License Application (BLA) seeking accelerated approval in the USA for patritumab deruxtecan (HER3-DXd) has been withdrawn. 29 May 2025
Biotechnology
Texas, USA-based clinical-stage biopharma Savara on Tuesday announced that the company received a refuse to file (RTF) letter from the US Food and Drug Administration (FDA) for the biologics license application (BLA) of Molbreevi (molgramostim) as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis (PAP), with the news sending its shares plunging 32% to $1.94. 28 May 2025
Biotechnology
In a policy shift that breaks with the previous administration's broad vaccination campaign, US health authorities have removed the COVID-19 vaccine from the routine immunization schedule for healthy children and healthy pregnant women. 28 May 2025
Biotechnology
US late-stage biotech Rocket Pharmaceuticals saw its shares plummet as much as 64% to $2.25 in pre-market activity today, after it announced an update related to a trial of RP-A501, its investigational gene therapy for Danon disease, which resulted in a patient death. 27 May 2025
Biosimilars
Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd , today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its Yesintek, a biosimilar of ustekinumab, which is marketed under the trade name Stelara by us healthcare giant Johnson & Johnson (NYSE: JNJ) . 27 May 2025
Pharmaceutical
Japanese drugmaker Eisai today announced that the in-house-discovered and developed orexin receptor antagonist Dayvigo (lemborexant) has been approved in China for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Eisai plans to launch this medicine in China in the second quarter of fiscal year 2025. 27 May 2025
Biotechnology
Japanese drugmaker Otsuka Pharmaceutical today announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with immunoglobulin A nephropathy (IgAN). 26 May 2025
Biosimilars
The Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. 26 May 2025
Biotechnology
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on May 22 to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the USA beginning in the fall of 2025. 26 May 2025
Biotechnology
Last week saw Novavax receive full approval from the US Food and Drug Administration (FDA) for its COVID-19 vaccine, but with post-market requirements. Swiss gene-editing company CRISPR Therapeutics linked up with Sirius Therapeutics to develop siRNA therapeutics, notably the latter’s SRSD107 in cardiovascular indications. The FDA last week announced a new executive order aiming to provide a pathway for prescription drugs from Canada, Also of note, Gilead Sciences released positive results for its Trodelvy ASCENT-03 study in metastatic triple negative breast cancer (mTNBC). 25 May 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its May 2025 meeting. Final approvals from the European Commission are now expected in the third quarter of this year. 23 May 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) today revealed it has approved Akantior (polihexanide) to treat acanthamoeba keratitis (AK). 23 May 2025
Pharmaceutical
Swiss biopharma Relief Therapeutics closed Thursday’s trading 50% higher. 23 May 2025
Biotechnology
UK pharma major GSK yesterday announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 23 May 2025
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze