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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
European biotech argenx has secured European Commission approval for Vyvgart (efgartigimod alfa) in chronic inflammatory demyelinating polyneuropathy (CIDP), marking the first regulatory green light for a novel mechanism in this condition in over three decades. 23 June 2025
Biotechnology
The Alliance for Regeneration Medicine (ARM), a trade group that represents more than 400 members companies across 25 countries, including emerging and established biotech firms, has taken aim at the powers that be in US healthcare. 23 June 2025
Pharmaceutical
Notable research news last week included Sarepta Therapeutics reporting another death associated with a trial of its Duchenne muscular dystrophy drug Elevidys. On the M&A front, US pharma major Eli Lilly last Tuesday announced it is to acquire Verve Therapeutics for up to $1.3 billion, along with its VERVE-102. Regulatory news saw the US Food and Drug Administration (FDA) announce a new voucher program aimed at enhancing the health interests of Americans. The FDA also approved Incyte’s Monjuvi for relapsed or refractory follicular lymphoma (LF). 22 June 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Hetronifly (serplulimab) to treat adults with extensive-stage small cell lung cancer (ES-SCLC), which has not previously been treated, and has spread within the lungs or to other parts of the body. 21 June 2025
Pharmaceutical
Japan’s Ministry of Health, Labor and Welfare (MHLW) has accepted UK pharma major GSK’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to include adults aged 18 to 49 years at increased risk of severe RSV disease. 20 June 2025
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval at its June 2025 meeting. 20 June 2025
Biotechnology
Further expanding the indications for French pharma major Sanofi’s mega-blockbuster Dupixent (dupilumab), the US Food and Drug Administration (FDA) has approved the drug for the treatment of adult patients with bullous pemphigoid (BP). 20 June 2025
Pharmaceutical
Privately-held UK firm Cycle Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Harliku (nitisinone) tablets for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU). 20 June 2025
Pharmaceutical
Japanese drugmaker Mochida Pharmaceutical announced that Thien Thao Pharmaceutical Joint Stock Company, a partner of Meiji, has obtained approval to import and market Epadel S, a highly purified eicosapentaenoic acid (EPA) ethyl ester formulation sold by Mochida in Japan, for the treatment of hypertriglyceridemia in Vietnam. 20 June 2025
Pharmaceutical
A reshaped agenda for the Centers for Disease Control and Prevention’s vaccine advisory committee meeting on June 25–26 signals a departure from the initial vaccine slate. New appointees named by Health and Human Services Secretary Robert F. Kennedy Jr dismantled the previous committee structure two days after dismissing all 17 members. 20 June 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Gilead Sciences Yeztugo (lenacapavir) - the company’s injectable HIV-1 capsid inhibitor - as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. 19 June 2025
Biotechnology
The US Food and Drug Administration has approved US biotech Incyte’s Monjuvi (tafasitamab-cxix) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL). 19 June 2025
Biotechnology
The biopharmaceutical industry is grappling with a complex mid-year outlook in 2025, as accelerating innovation collides with mounting policy and market uncertainty. From US drug pricing reforms to global tariff tensions, sentiment has taken a hit - reflected in a 16% drop in industry optimism. 19 June 2025
Biotechnology
EY today released its 35th annual Biotech Beyond Borders Report. This finds that the biopharma industry is currently at an inflection point – grappling with a unique environment of macroeconomic uncertainty and constrained access to capital, including high interest rates, inflation, shifting regulatory policies and tariff turmoil. 18 June 2025
Pharmaceutical
The US Food and Drug Administration has announced the Commissioner’s National Priority Voucher (CNPV) program aimed at enhancing the health interests of Americans. 18 June 2025
Biotechnology
US biotech Dyne Therapeutics has revised its regulatory approach for DYNE-101, a treatment in development for myotonic dystrophy type 1 (DM1), after discussions with the American medicines regulator. 18 June 2025
Pharmaceutical
A controversial proposal to change the Inflation Reduction Act’s pricing framework for rare disease drugs has been dropped from the Senate’s reconciliation package, marking a win for patient advocacy groups that lobbied against it. The ORPHAN Cures Act, which sought to shield some rare disease drugs from Medicare price talks, was notably absent from the text released this week by the Senate Finance Committee. 18 June 2025
Generics
Medicines for Europe, a manufacturers of generic and biosimilar trade group, today presented five trade policy recommendations to strengthen global access to medicines and enhance the competitiveness of the off-patent pharmaceutical sector in a seminar with the European Commission and Member States representatives. 17 June 2025
Biotechnology
Australian biotech CSL has announced that the US Food and Drug Administration (FDA) has approved Andembry (garadacimab-gxii), the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. 17 June 2025
Pharmaceutical
French drug developer Averoa today announced that the European Commission (EC) has granted marketing authorization for Xoanacyl (ferric citrate coordination complex). 16 June 2025
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