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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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North Carolina, USA-based vTv Therapeutics has announced that screening has been reinitiated in the company’s CATT1 Phase III trial investigating cadisegliatin as an adjunctive treatment of type 1 diabetes (T1D). 21 May 2025
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Welcome to The Pharma Letter’s real-time coverage of the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3 in Chicago. This feed will deliver concise updates as they happen—check back here regularly for headline trial results, regulatory milestones, practice updates and more. 21 May 2025
Pharmaceutical
UK-based PureTech Health delivered a late-breaking, oral presentation at the 2025 American Thoracic Society (ATS) International Conference in San Francisco. 21 May 2025
Pharmaceutical
US biotech Tourmaline Bio has reported topline data from a Phase II trial of its lead asset, pacibekitug, in people with chronic kidney disease (CKD) and elevated inflammation levels associated with cardiovascular risk. 21 May 2025
Pharmaceutical
US biotech company SparX Biopharmaceutical has signed a research agreement with Mitsubishi Tanabe Pharma America aimed at advancing a new antibody-drug conjugate (ADC) that targets a novel immune cell protein. 21 May 2025
Pharmaceutical
US healthcare giant Johnson & Johnson presented long-term findings from the 24-month open-label extension of the A DUE trial of Opsynvi (macitentan and tadalafil) in pulmonary arterial hypertension (PAH) during a late-breaking oral session at the American Thoracic Society (ATS) Conference. 21 May 2025
Pharmaceutical
A week after US President Donald Trump signed an executive order to bring back the Most Favored Nation (MFN) idea he introduced at the end of his first term, the US Department of Health and Human Services (HHS announced it is proceeding with implementing the order on prescription drug pricing. 20 May 2025
Pharmaceutical
German drugmaker Grünenthal has named Maren Thurow as its new vice president and head of global communications, stepping into the role at a time of significant business expansion and leadership change. She succeeds Florian Dieckmann, who had led the company’s communications function since 2021. 20 May 2025
Pharmaceutical
Australia’s digital health sector is poised for steady expansion, with the market forecast to grow at a compound annual growth rate of around 8% through 2034, according to research from data and analytics group GlobalData. 20 May 2025
Pharmaceutical
Cambridge, USA-based Apnimed today announced positive top-line results from its pivotal Phase III SynAIRgy clinical trial evaluating the efficacy and safety of its lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) in adults living with mild, moderate and severe OSA, and across all weight classes. 20 May 2025
Pharmaceutical
Major progress has been made in delivering a more efficient and adaptable regulatory framework for clinical trials, and Lawrence Tallon, chief executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reflected on International Clinical Trials Day. 20 May 2025
Pharmaceutical
German drugmaker Boehringer Ingelheim has released full Phase III results for its experimental lung disease drug nerandomilast, showing it met primary endpoints in both idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
However, while the data were enough to support regulatory filings, analysts remain cautious, viewing the treatment as a marginal improvement over current options. 20 May 2025
Pharmaceutical
Marking International Clinical Trials Day, we bring you a special Q&A with Andrea Manfrin, Deputy Director of Clinical Trials from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). 20 May 2025
Pharmaceutical
A US district court judge has found that the Department of Health and Human Services (HHS) must preapprove the use of 340B rebate models before they can be implemented. 19 May 2025
Pharmaceutical
USA-based rare disease company Applied Therapeutics saw its shares rise nearly 23% to $0.60 on Friday, ahead of a planned presentation on its lead candidate, govorestat, at the Peripheral Nerve Society (PNS) 2025 Annual Meeting, being held May 17-20 in Edinburgh, Scotland. 19 May 2025
Pharmaceutical
A federal judge in Rhode Island has issued a sweeping order preventing the Trump administration from cutting $11 billion in public health grants, a move that preserves critical funding for 23 states and the District of Columbia as legal proceedings continue. 19 May 2025
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released new data that sheds light on why patients in some European countries wait significantly longer than others for access to innovative medicines. 19 May 2025
Pharmaceutical
The European Medicines Agency’s (EMA) Emergency Task Force (EFT) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant LP.8.1 for the 2025/2026 vaccination campaign. 19 May 2025
Pharmaceutical
Vaccines Europe’s response to the Call for Evidence on the European Centre for Disease Prevention and Control evaluation Vaccines Europe (VE) welcomes the evaluation of the European Centre for Disease Prevention and Control (ECDC). 19 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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