Latest Pharma and Biotech News
Pharmaceutical
18 June 2025 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.
Today's issue
Refine Search
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
Zealand Pharma, a Danish firm focused on the discovery and development of innovative peptide-based medicines, has announced positive topline results from part two of a Phase Ib multiple ascending dose (MAD) trial investigating 28 weeks of treatment with dapiglutide, a long-acting GLP-1/GLP-2 receptor dual agonist. 20 June 2025
Pharmaceutical
Spanish plasma-derived medicines specialist Grifols announced that the positive Phase III study data on its fibrinogen concentrate, BT524, has been published in eClinicalMedicine, a peer-reviewed journal published by The Lancet Discovery Science Suite. 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
Biotechnology
A report published by the Cell & Gene Collective, based on the findings of an expert commission, has offered recommendations to ensure the UK’s leadership in cell and gene therapies (CGTs) and urgently remove barriers to their adoption. 19 June 2025
Biotechnology
Sanofi has signed a strategic agreement with health authorities in Abu Dhabi to accelerate vaccine development and manufacturing in the United Arab Emirates. 19 June 2025
Biotechnology
Symbiotic.blue, the UK’s newest Techbio company has launched to innovate a next-generation artificial intelligence-driven drug discovery (AIDD) platform by combining the power of generative AI with brain-inspired methodologies. 19 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
Spanish skincare specialist Almirall has promised a key contribution at the International Congress of Dermatology (ICD), currently taking place in Rome, Italy. 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
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has announced that Japanese drugmaker Eisai and US biotech Biogen Leqembi (lecanemab) has not been recommended for use in the National Health Service (NHS) in England. 19 June 2025
Pharmaceutical
Israel-based Medison, a creator of a first-of-its-kind unified global commercialization platform that accelerates the launch of breakthrough therapies, has announced two key additions to its global leadership team: Shay Tamari as chief business officer (CBO) and Tali Mirsky as chief legal and compliance officer (CLCO). 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
Scholar Rock has unveiled encouraging Phase II data for its experimental therapy apitegromab, showing the drug can reduce the amount of lean mass lost during weight reduction with Eli Lilly’s (NYSE: LLY) weight-loss drug Zepbound (tirzepatide). 19 June 2025
Pharmaceutical
Australian biotech PolyActiva has brought in seasoned pharma executive Jerry St Peter as chief executive, in a leadership shake-up timed with a fresh $25 million financing round and a push to commercialize its lead eye implant therapy in the USA. 19 June 2025
Pharmaceutical
US biotech Actio Biosciences has raised $66 million in a series B round topport its pipeline of genetically targeted therapies, with new funding led by Regeneron Ventures and repeat backing from Deerfield Management. 19 June 2025
Biotechnology
SunRock Biopharma has teamed up with China’s Escugen to co-develop SRB123, a first-in-class antibody-drug conjugate (ADC) targeting CCR9, an antigen which is tied to particularly hard-to-treat cancers, including pancreatic, ovarian and lung. 18 June 2025
All news
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
Biotechnology
Shares in Prime Medicine, a US biotech seeking to develop one-time curative genetic therapies, closed 16% lower Monday. 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
Biotechnology
German vaccine pioneer BioNTech today revealed that its UK subsidiary has signed a grant agreement with the UK government to broaden the company’s R&D activities for innovative medicines in the UK. 20 May 2025
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved UK pharma major GSK’s Blenrep (belantamab mafodotin) combination for the treatment of adults with relapsed or refractory multiple myeloma. 20 May 2025
Biotechnology
Anti–interleukin five (IL-5) biologics such as mepolizumab and benralizumab have shown significant efficacy in reducing moderate and severe exacerbations in both asthma and chronic obstructive pulmonary disease (COPD), according to new real-world data presented at the 2025 American Thoracic Society (ATS) International Conference. 20 May 2025
Biotechnology
US pharma major Pfizer is stepping up its presence in the high-stakes field of bispecific immuno-oncology with a licensing deal worth up to $6 billion for a Chinese-developed drug that targets two key cancer pathways. 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
Biotechnology
Swiss gene-editing specialist CRISPR Therapeutics and San Diego, USA-based Sirius Therapeutics, which is developing innovative small interfering RNA (siRNA) therapies, announced a strategic partnership to develop and commercialize siRNA therapies. 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
Biotechnology
Genetic medicines company Arbor Biotechnologies has announced the appointment of Don Haut as chief business officer. 19 May 2025
Biosimilars
Formycon and its commercialization partner Fresenius Kabi have announced that the US Food and Drug Administration (FDA) has designated FYB202/Otulfi (ustekinumab-aauz) as interchangeable with Johnson & Johnson’s (NYSE: JNJ) reference biologic Stelara (ustekinumab). 19 May 2025
Biotechnology
Cambridge, UK-based CellCentric today announced the completion of a $120 million Series C funding round. 19 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
Biotechnology
US human genetics biotech 23andMe today revealed it has entered into a definitive agreement for the sale of the company to Regeneron Pharmaceutical, whose shares climbed 2% following the announcement 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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze