Latest Pharma and Biotech News
Biotechnology
3 July 2025 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.
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Pharmaceutical
This week, Dr Kimberly Smith, Senior Vice President, Chief Scientific Officer, Head of Research & Development at ViiV Healthcare, provides an Expert View on how, through a deep understanding of the HIV community, the company has led the way in changing the HIV treatment and prevention paradigm. 23 May 2025
Pharmaceutical
Verastem Oncology has unveiled updated early-stage data from its RAMP 205 trial in metastatic pancreatic cancer, bolstering its efforts to broaden use of its dual-drug regimen, Avmapki Fakzynja Co-Pack, beyond its recently approved indication in a rare form of ovarian cancer. 23 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
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that Filspari (sparsentan) can be used in the National Health Service (NHS) in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0g/day or more, or a urine protein-to-creatinine ratio of 0.75g/g or more. 23 May 2025
Pharmaceutical
Japanese drugmaker Astellas and US pharma giant Pfizer have announced longer-term follow-up results from an open-label extension of the Phase III ARCHES study. 23 May 2025
Pharmaceutical
Privately-held French drugmaker Servier and China-based BioNova Pharmaceuticals today announce that they have entered into a definitive agreement under which Servier will acquire BN104, a potential best-in-class menin inhibitor currently in Phase I/II development for the treatment of acute leukemias. 23 May 2025
Pharmaceutical
The oncology community’s biggest gathering returns to Chicago from May 30 to June 3, and all signs suggest the 2025 ASCO Annual Meeting will be a watershed moment. 23 May 2025
Pharmaceutical
USA-based nonprofit CureDuchenne has announced the appointment of Brenda Wong as its new chief medical advisor (CMA), effective January 5, 2026. 22 May 2025
Pharmaceutical
The US Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American patients, as part of its efforts to implement Executive Order Lowering Drug Prices by Once Again Putting Americans First. 22 May 2025
Pharmaceutical
USA-based UroGen Pharma, a biotech developing and commercializing innovative solutions that treat urothelial and specialty cancers, closed 45% lower Wednesday. 22 May 2025
Pharmaceutical
UK pharma major AstraZeneca is set to present data from more than 80 studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Spanning across 20 approved and investigational medicines, the presentations include two plenary sessions and a special late-breaking abstract. 22 May 2025
Pharmaceutical
Merck KGaA plans to move its investigational lupus drug enpatoran into late-stage development, after new Phase II data showed clinically meaningful improvement in skin manifestations of the disease among treated patients. 22 May 2025
Pharmaceutical
The US Food and Drug Administration (FDA) is set to sharply restrict vaccine availability to millions of Americans without a persuasive justification based in science. 22 May 2025
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca reports that it will have a historic presence at this year’s American Society of Cancer Oncology (ASCO) meeting across its expansive cancer portfolio. 21 May 2025
Pharmaceutical
The Dementia Discovery Fund (DDF) - managed by healthcare fund manager SV Health Investors - has announced the final closing of its second fund, DDF-2, with $269 million in commitments. 21 May 2025
Pharmaceutical
Earlier this month, the US Department of Health and Human Services (HHS) said it would require all future vaccines to undergo testing in placebo-controlled trials before being approved for use. 21 May 2025
Pharmaceutical
Pharmasyntez, one of Russia’s leading drugmakers, plans a significant expansion of its portfolio of innovative drugs in the short-term, according to recent statements, made by representatives of the company, reports The Pharma Letter’s local correspondent. 21 May 2025
Pharmaceutical
Swiss reproductive and women’s health medicines specialist ReproNovo today announced the successful closing of a $65 million Series A financing round, which will be used to advance its pipeline of multiple Phase II programs. 21 May 2025
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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
Pharmaceutical
Theratechnologies, a Canada-based biopharma, is to be acquired by CB Biotechnology, an affiliate of Future Pak, a privately-held contract manufacturer, packager and distributor of pharmaceutical and nutraceutical products. 4 July 2025
Pharmaceutical
Chinese biotech Brii Biosciences has licensed its experimental antibiotic BRII-693 to domestic pharma business Joincare Group for development and commercialization in China, as part of a technology transfer and exclusive licensing agreement announced on Wednesday. 4 July 2025
Pharmaceutical
US pharma major Eli Lilly today announced detailed results from QWINT-1, QWINT-3, and QWINT-4 Phase III clinical trials evaluating the safety and efficacy of investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes who used insulin for the first time, previously used daily basal insulin, and previously used daily basal insulin and mealtime insulin, respectively. 4 July 2025
Pharmaceutical
Pharmaceutical companies are heading toward a steep patent cliff that could strip more than $230 billion in US drug sales between 2025 and 2030, according to a new report from analytics firm GlobalData. The industry is preparing for a wave of revenue loss as leading drugs lose exclusivity and face generic and biosimilar competition. 4 July 2025
Pharmaceutical
A new company is responsible for Japanese promotional activities for Actair, Stallergenes Greer’s sublingual immunotherapy tablet for the treatment of patients suffering from house dust mite induced allergic rhinitis. 4 July 2025
Pharmaceutical
Multinational pharmaceutical companies (MNCs) are facing significant challenges in China's vaccine market, as regulatory scrutiny, domestic competition, and changing consumer behaviors disrupt a once-thriving sector. 4 July 2025
Pharmaceutical
In the high-stakes world of drug development, a pill is never just a pill. Every oral drug that reaches the market has passed through a tightly managed series of steps—none more critical, or more vulnerable, than tech transfer. 4 July 2025
Pharmaceutical
A new European Commission strategy promises to lift life sciences in the region out of a two-decade slump by tackling regulatory barriers, boosting clinical trials and supporting biotech innovation. The plan was unveiled in Brussels on July 2 and is being described by industry as a long-overdue course correction. 3 July 2025
Pharmaceutical
The UK government today launched its 10 Year Health Plan for the National Health Service (NHS), promising a "new era." A new network of neighborhood health hubs will be set up to shift care out of hospitals and into the community. 3 July 2025
Pharmaceutical
US-Japan venture capital firm AN Venture Partners has wrapped up its first fund at $200 million, marking one of the largest biotech funds focused on Japan to date. The new vehicle, called AN Venture Partners I, is backed by over 20 limited partners, including Japanese drugmakers Shionogi and Otsuka Pharmaceutical. 3 July 2025
Pharmaceutical
US women’s health focused drugmaker Organon yesterday revealed disappointing results from the Phase II ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint. 3 July 2025
Pharmaceutical
The chronic kidney disease (CKD) anemia market across the seven major markets (7MM) is forecast to grow at a compound annual growth rate (CAGR) of 1.7% from $4.4 billion in 2024 to $5.3 billion in 2034. 3 July 2025
Pharmaceutical
Australian neurodegenerative diseases specialist Neurizon Therapeutics has agreed an exclusive global license agreement with Elanco Animal Health and affiliates for monepantel, the active pharmaceutical ingredient in NUZ-001. 2 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
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
Pharmaceutical
Mitsubishi Tanabe Pharma Corporation is now under the ownership of US private investment firm Bain Capital Private Equity. 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
Mental health company atai Life Sciences was trading more than 31% higher during Tuesday morning’s trading in New York. 1 July 2025
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