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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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
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
All news
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
Pharmaceutical
The Irish Pharmaceutical Healthcare Association (IPHA) has published a position paper on the 2025 Programme for Government Commitments calling for faster and fairer access to medicines. 3 March 2025
Pharmaceutical
In a partnership marking AbbVie’s entrance into the weight management field, the US pharma major has signed a licensing deal with Denmark’s Gubra to develop GUB014295, a potential best-in-class, long-acting amylin analog for the treatment of obesity. 3 March 2025
Pharmaceutical
BridgeBio Oncology Therapeutics (BBOT), a company advancing small molecule therapeutics targeting RAS and PI3Ka malignancies, and Helix Acquisition Corp II , a special purpose acquisition company (SPAC) sponsored by affiliates of Cormorant Asset Management, have agreed to merge. 3 March 2025
Pharmaceutical
US oncology-focused Nuvation Bio today announced non-dilutive financings of up to $250 million with Sagard Healthcare Partners (Sagard), with the news pushing its shares up 6.6% to $2.10 in pre-market activity. 3 March 2025
Pharmaceutical
USA/China-based SciClone Pharmaceuticals has entered into a license agreement with Japan’s Eisai for the latter’s fibroblast growth factor (FGF) receptor selective tyrosine kinase inhibitor tasurgratinib succinate (code named E7090). 3 March 2025
Biotechnology
Boston, USA-based biotech Praxis Precision Medicines has provided an update on the interim analysis for Study 1 of the Essential3 program of ulixacaltamide in essential tremor (ET), sending the firm’s shares tumbling more than 40% to $38.60 on Friday. 3 March 2025
Biotechnology
Amgen and AstraZeneca have announced full results from the Phase III, registrational WAYPOINT trial showing that Tezspire (tezepelumab-ekko) significantly reduced nasal polyp severity, the need for surgery and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]). 3 March 2025
Biotechnology
The Therapeutic Goods Administration (TGA) of Australia has declined the approval of Leqembi (lecanemab) as a treatment for early Alzheimer’s disease (AD). 3 March 2025
Biotechnology
New positive data from Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored Phase III OUtMATCH study, which provide further evidence supporting the role of Xolair (omalizumab) for the treatment of one or more food allergies, have been released by Swiss pharma giant Roche. 3 March 2025
Generics
Even as the spectre of tariffs looms over the pharmaceutical trade between India and the USA, presenting a complex scenario with potential repercussions for both regions, its implementation would necessitate a rapid recalibration of supply chains and pricing strategies, reports The Pharma Letter’s India correspondent. 3 March 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Anktiva (nogapendekin alfa inbakicept-pmln) and CAR-NK (PD-L1 t-haNK) for the reversal of lymphopenia in patients receiving standard-of-care chemotherapy/radiotherapy and in multiply relapsed locally advanced or metastatic pancreatic cancer. 3 March 2025
Pharmaceutical
UK-based specialty drugmaker Kelso Pharma has appointed experienced pharma executive, Giovanni Mauri, as general manager at Velit Biopharma, the Italian-based pharma business that was acquired by Kelso in November 2023. 3 March 2025
Pharmaceutical
Among significant research news last week, US CNS specialist Axsome Therapeutics released new Phase III data on its recently US Food and Drug Administration (FDA)-approved migraine drug Symbravo, and the UK’s AstraZeneca announced positive Phase III trial results for its breast cancer candidate camizestrant. US biotech giant Amgen revealed it is pressing ahead with its $200 million investment in Indian technology center. US pharma major Eli Lilly attracted attention with its licensing deal for Organovo’s FXR program and announcing the release of new dosages and prices for its blockbuster obesity drug Zepbound. 2 March 2025
Pharmaceutical
Massachusetts, USA-based start-up Magnet Biomedicine, which is advancing molecular glue discovery with rational selection and design, has announced a collaboration and license agreement with pharma major Eli Lilly & Co to discover, develop, and commercialize molecular glue therapeutics in oncology. 1 March 2025
Biotechnology
The US President Donald Trump began his second term with a series of directives targeting the US National Institutes of Health (NIH), creating uncertainty around NIH grant funding for biopharmaceutical drug development. 1 March 2025
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