Latest Pharma and Biotech News
Biotechnology
19 May 2025 Adopting a platform approach to designing new therapies will speed the delivery of innovative genomic treatments to patients—but only if developers, regulators, and manufacturers work together to evolve the current drug development paradigm, writes Vanessa Almendro, vice president of science and technology and head of innovation at Danaher Corporation, in an Expert View piece.
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Biotechnology
Genmab posted a 19% rise in revenue to $715 million for the first quarter of 2025, driven by higher royalties and increasing sales of its lymphoma therapy Epkinly (epcoritamab). Earnings before interest and taxes rose to $188 million, up from $116 million a year earlier. 9 May 2025
Pharmaceutical
UK pharma major GSK has unveiled full Phase III data showing its experimental drug linerixibat significantly reduced itching in people with primary biliary cholangitis (PBC), a rare autoimmune liver disorder. The results were presented at this year’s European Association for the Study of the Liver (EASL) meeting. 9 May 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy, Boston, said USA-based. Verastem Oncology, whose shares rose 3.7% to $6.94 on the news. 9 May 2025
Biotechnology
US regenerative medicine firm Forever Labs has formally spun out SuperShot as a standalone business, a move the company says will allow both entities to sharpen their focus on growth and innovation. 8 May 2025
Pharmaceutical
US non-profit the Gates Foundation has pledged to spend more than $200 billion over the next two decades, doubling its giving to date, and bringing forward its planned closure to 2045. The decision marks a seismic shift in the organization’s philanthropic approach. 8 May 2025
Pharmaceutical
Merck KGaA led the way in pharmaceutical M&A in April. The German company announced a $3.9 billion deal to buy the US drug developer SpringWorks Therapeutics in the month's biggest buy, with Swiss firm Novartis the only other established big pharma name to acquire a company, though a host of further deals were done. 8 May 2025
Biotechnology
The European Commission (EC) has approved a Marketing Authorization (MA) for Tremfya (guselkumab) to treat adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. 8 May 2025
Pharmaceutical
Following a European Union-wide review of available data on finasteride and dutasteride medicines, the European Medicines Agency’s (EMA) safety committee (PRAC) has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1mg and 5mg tablets but concluded that the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses. 8 May 2025
Biotechnology
Sino-American biotech BeiGene today announced that the European Commission has approved Tevimbra (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC). 8 May 2025
Biotechnology
Massachusetts-based PAQ Therapeutics, a biotech developing KRAS degraders for cancers lacking effective treatment options, has completed a $39 million Series B funding round. 8 May 2025
Pharmaceutical
Japanese drugmaker Takeda posted revenue of 4.58 trillion yen ($31.7 billion) for the fiscal year ended March 31, up 7.5% on a reported basis, while core operating profit rose 10% to $8 billion. Earnings per share slipped 26% to $0.45 as net profit fell to $748 million. 8 May 2025
Pharmaceutical
As the US government, under President Donald Trump, is on the verge of announcing significant new tariffs on pharmaceutical imports, Indian drug-maker stocks continue to take a hammering on the bourses. 8 May 2025
Pharmaceutical
This week on The Pharma Letter Podcast, we are joined by Tony Clarke, senior VP of IT digital operations at ICON. 8 May 2025
Pharmaceutical
UK-based specialty pharma business Kelso Pharma has appointed Bee Koen Low as its first chief operating officer (COO). 8 May 2025
Biotechnology
Privately-held Italian firm Sibylla Biotech today announced the appointment of Dieter Weinand as chairman of its board of directors. 8 May 2025
Pharmaceutical
US antivirals giant Gilead Sciences yesterday announced a substantial investment plan, noting that it is committed to advancing world-class science and driving innovation - with the USA at the heart of its operations. Today, the firm’s US R&D and manufacturing footprint is its largest globally. 8 May 2025
Biotechnology
The American medicines regulator will convene its vaccine advisory committee on May 22 to weigh in on which strains should be used for the next round of COVID-19 booster shots, amid heightened interest in the new administration’s stance toward vaccines. 8 May 2025
Pharmaceutical
Japanese drugmaker Shionogi is to scale up its pipeline and global ambitions with a deal worth more than $1 billion, buying the pharmaceutical operations of Japan Tobacco, including its US subsidiary Akros Pharma. 8 May 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) yesterday approved Tepezza (teprotumumab (Tepezza). 8 May 2025
Pharmaceutical
Pharmaceutical and Research Manufacturers of America (PhRMA) yesterday submitted comments to the US Department of Commerce on its Section 232 investigation of pharmaceuticals and pharmaceutical ingredients imported to the USA. 8 May 2025
All news
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
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
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
Biotechnology
GSK’s biologic therapy Nucala (mepolizumab) has demonstrated a consistent reduction in exacerbation rates among patients with eosinophilic chronic obstructive pulmonary disease (COPD), regardless of their history of severe events. 19 May 2025
Biotechnology
Japanese drugmaker Chugai Pharmaceutical today announced that it obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo intravitreal injection 120mg/mL (aricimab genetical recombination), for an additional indication of the treatment of choroidal neovascularization associated with angioid streaks. Vabysmo is the first approved drug in Japan for the treatment of this disease. 19 May 2025
Biotechnology
After a prolonged wait, American company Novavax has received full approval from the US regulator for its protein-based COVID-19 vaccine, Nuvaxovid (COVID-19 vaccine, adjuvanted). 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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