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
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
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
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Pharmaceutical
Leading pharmaceutical associations in Russia have called on the government to postpone the introduction of new procurement rules that will give preference to drugs completely produced in Russia in state tenders. 5 March 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). 5 March 2025
Biosimilars
Swiss generics and biosimilars giant Sandoz today announced financial results for the full year 2024, showing that sales were $10.4 billion, up by 9% in constant currencies (+7% in $). 5 March 2025
Biotechnology
San Francisco-based 3T Biosciences, an immunotherapy company in the field of solid tumors and other immune-mediated diseases, has announced the promotion of Marvin Gee to chief research officer and the appointment of Barbara Sennino as senior vice president and head of early development. 4 March 2025
Pharmaceutical
Russia plans to increase procurements of drugs against rare diseases despite the current tough business environment and maintaining sanctions pressure, reports The Pharma Letter’s local correspondent. 4 March 2025
Generics
Czech Republic-based Zentiva Pharma, a generics and over-the-counter medicines company that is wholly-owned by private equity firm Advent International and was formerly a subsidiary of Sanofi , has announced a major UK launch. 4 March 2025
Biosimilars
South Korea-based Celltrion today announced that the US Food and Drug Administration (FDA) has approved Stoboclo and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Amgen’s Prolia and Xgeva brands respectively for all indications of the reference products. 4 March 2025
Biotechnology
Privately-held Cambridge, USA-based biotech Gensaic announced a potentially lucrative license and discovery collaboration with Denmark’s Novo Nordisk . 4 March 2025
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has published a special report on chronic obstructive pulmonary disease (COPD) therapies as part of the Centers for Medicare & Medicaid Services (CMS) public comment process on Medicare drug price negotiations. 4 March 2025
Pharmaceutical
US clinical-stage pharma company Protagonist Therapeutics and Japan’s Takeda have announced positive top-line results for the Phase III VERIFY study, in which phlebotomy-dependent patients with polycythemia vera (PV), a rare blood cancer, were randomized to treatment with either rusfertide or placebo, as an add-on to standard of care treatment. 4 March 2025
Pharmaceutical
Avecho Biotechnology has signed a ten-year development and licensing agreement with Sandoz for the commercial rights to its cannabidiol (CBD) capsule for insomnia in Australia. 4 March 2025
Pharmaceutical
The UK government has announced the appointment of Lawrence Tallon as the new chief executive (CEO) of the Medicines and Healthcare products Regulatory Agency (MHRA). 4 March 2025
Biotechnology
Japan’s Kyorin Pharmaceutical has entered into a global license agreement with Swiss pharma giant Novartis relating to KRP-M223 and its back-up compounds, which were discovered by the Tokyo-based firm. 4 March 2025
Pharmaceutical
The US Food and Drug Administration has issued new labeling changes for all approved testosterone replacement therapy products, removing a previous black box warning about cardiovascular risks while adding a new warning about increased blood pressure. 4 March 2025
Biotechnology
Roivant Sciences portfolio company Genevant Sciences and Canada’s Arbutus Biopharma yesterday filed five international lawsuits seeking to enforce patents protecting their innovative LNP technology against Moderna, and certain affiliates. 4 March 2025
Pharmaceutical
Genentech, part of the Roche group, has received a new approval from the US Food and Drug Administration for TNKase (tenecteplase). 4 March 2025
Pharmaceutical
Leading European venture capital firm Sofinnova Partners today announced it has raised 1.2 billion euros ($1.25 billion) across its platform of investment strategies over the past year, including more than 1 billion euros secured in the last quarter. 4 March 2025
Biotechnology
Frazier Life Sciences has launched Callio Therapeutics with $187 illion in series A funding to advance a HER2-targeted, dual-payload antibody-drug conjugate (ADC) into clinical trials. 4 March 2025
Pharmaceutical
Privately-held US drugmaker Protega Pharmaceuticals, which recently launched Roxybond (oxycodone hydrochloride), the first and only Food and Drug Administration (FDA)-approved abuse-deterrent immediate-release (IR) pain medication in the USA, is now collaborating with Wellgistics Health to support pharmacist education on abuse-deterrent pain management options and regulatory compliance as well as increase patient access to the drug for appropriately prescribed patients. 4 March 2025
Pharmaceutical
The Critical Medicines Alliance Strategic Report has been published in a bid to develop a coordinated, European industrial framework to prevent and mitigate shortages of crucial medical products. 3 March 2025
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