Latest Pharma and Biotech News
Pharmaceutical
16 April 2025 US President Donald Trump has passed an executive order that answers the pharmaceutical industry’s calls for the scrapping of the Inflation Reduction Act’s (IRA) ‘pill penalty’.
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Biotechnology
Dutch gene therapy company uniQure (Nasdaq: QURE) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AMT-130, sending the firm’s shares leaping more than 38% to $13.00 by close of trading on Thursday. 18 April 2025
Pharmaceutical
US President Donald Trump issued an executive order on April 15 listing several potential policy changes aimed at lowering US drug prices.
Responding to the announcement, Morningstar’s healthcare equity research director Karen Andersen gave her views on why this matters. 18 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) Injection 8mg, submitted by US biotech Regeneron Pharmaceuticals. 18 April 2025
Biotechnology
Australian clinical-stage biotech Neurizon Therapeutics, which is advancing innovative treatments for neurodegenerative diseases, has significantly strengthened its executive management team with three key appointments. 18 April 2025
Pharmaceutical
US biopharma company Galmed Pharmaceuticals has entered into a research collaboration with Virginia Commonwealth University to investigate its lead candidate Aramchol (arachidyl amido cholanoic acid) as a potential solution to drug resistance in gastrointestinal cancers. 17 April 2025
Biotechnology
BigHat Biosciences, a Californian biotech with a machine learning (ML)-guided antibody discovery and development platform, has announced a strategic collaboration with US pharma major Eli Lilly. 17 April 2025
Biotechnology
US cancer drug developer Werewolf Therapeutics today announced the appointment of Steven Bloom as chief business officer (CBOP. 17 April 2025
Pharmaceutical
Wall Street watched in awe as Eli Lilly made rampant gains in early trading Thursday. 17 April 2025
Biotechnology
Swiss pharma major Novartis has discontinued development of its experimental treatment QUC398 for knee osteoarthritis, ending hopes for a new therapy in the anti-ADAMTS-5 class. 17 April 2025
Pharmaceutical
Florida biopharma Ligand Pharmaceuticals subsidiary Pelthos Therapeutics is to merge with Channel Therapeutics, a developer of non-opioid pain treatments. 17 April 2025
Pharmaceutical
India’s Venus Remedies has secured Qualified Infectious Disease Product designation from the United States Food and Drug Administration for its investigational antibiotic VRP-034, a next-generation formulation of polymyxin B designed to reduce kidney toxicity. 17 April 2025
Biosimilars
Indian drugmaker Biocon subsidiary Biocon Biologics has announced a settlement and license agreement with the USA’s Regeneron that clears the way to commercialize Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept, in the USA. 17 April 2025
Biotechnology
Germany’s Evotec has unveiled a new strategy, and provided 2025 guidance—bolstered by strong results from the fourth-quarter of 2024. 17 April 2025
Biotechnology
Japanese drugmaker Chugai Pharmaceutical announced that results from the Phase III clinical trial (NIHONBASHI study) of anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo (faricimab) intravitreal injection 120mg/mL, for angioid streaks associated with neovascularization were presented at the 129th Annual Meeting of the Japanese Ophthalmological Society on April 17. 17 April 2025
Pharmaceutical
Switzerland-based Addex Therapeutics, a biopharma developing a portfolio of novel small molecule allosteric modulators for neurological disorders, has announced an update on its Phase II asset, ADX71149. 17 April 2025
Biotechnology
US gene therapy company bluebird bio announced that after three weeks of engagement, including a timeline extension, Ayrmid Pharma has not submitted a binding proposal to acquire bluebird and has not obtained necessary financing. 17 April 2025
Pharmaceutical
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD). 17 April 2025
Pharmaceutical
US biotech Wayfinder Biosciences has entered a research collaboration with Japanese drugmaker Daiichi Sankyo to develop small molecule therapies targeting RNA in neurodegenerative diseases. 16 April 2025
Biosimilars
China’s Chime Biologics has formed a strategic partnership with European biosimilars specialist Polpharma Biologics to support the end-to-end development and manufacture of a biosimilar product targeting the global market. 16 April 2025
Biotechnology
US biotech Myeloid Therapeutics has restructured its operations to concentrate on two cancer programs already in the clinic, a move that has resulted in staff reductions and an uncertain future for its early-stage research work. 16 April 2025
All news
Pharmaceutical
The US Food and Drug Administration (FDA) has issued several warning letters to pharmaceutical manufacturers in India and China, citing serious violations of current good manufacturing practice regulations. 7 February 2025
Biosimilars
Dr Reddy’s Laboratories has signed a licensing deal with Shanghai Henlius Biotech to develop and commercialize HLX15, a biosimilar of Johnson & Johnson’s Darzalex (daratumumab) for multiple myeloma. 7 February 2025
Pharmaceutical
Shares of rare disease drug developer X4 Pharmaceuticals took a battering after it said it will restructure its workforce and capital spending. 7 February 2025
Pharmaceutical
Karen Andersen, equity strategist at Morningstar, has issued an analysis of US pharma major Eli Lilly’s latest financial results, which were published yesterday. 7 February 2025
Pharmaceutical
Japan’s Mitsubishi Chemical Group has resolved, at a meeting of the board of directors held today, to transfer its consolidated subsidiary, Mitsubishi Tanabe Pharma (MTPC), which engages in the manufacturing and sales of pharmaceutical products, to K.K. BCJ-94, a special purpose company indirectly owned by Bain Capital for around 510 billion yen ($3.36 billion). 7 February 2025
Biotechnology
Alumis and Acelyrin have agreed to merge in an all-stock deal, creating a late-stage biopharmaceutical company focused on immune-mediated diseases. 7 February 2025
Biotechnology
Roche has reported positive results from its Phase III REGENCY trial of Gazyva (obinutuzumab) for the treatment of lupus nephritis, showing a statistically significant improvement in kidney function compared to standard therapy. 7 February 2025
Pharmaceutical
San Diegan biotech Viking Therapeutics has announced plans to initiate late-stage clinical trials for its obesity drug candidate VK2735 in the second quarter of 2025. 6 February 2025
Biotechnology
Bristol Myers Squibb reported stronger-than-expected earnings for the fourth quarter and full year of 2024, but rising generic competition and acquisition-related costs cloud the picture. 6 February 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis that was submitted by New Jersey, USA-based Insmed. 6 February 2025
Biotechnology
The 90 million euros ($94 million) raised by Orbis Medicines in a series A round was not January’s biggest venture investment by a long stretch. That honor belonged to the whopping $410 million netted by UK obesity group Verdiva Bio, but what Orbis’s VC round does show is the growing interest in macrocyclics as a drug class. 6 February 2025
Pharmaceutical
US pharma giant Pfizer today announced that Jeffrey Legos will join the company as chief oncology officer. 6 February 2025
Biotechnology
Shares in US retinal diseases specialist EyePoint Pharmaceuticals recovered from an early nosedive to close trading marginally higher on Wednesday. 6 February 2025
Pharmaceutical
Swiss drug developer Basilea Pharmaceutica reported that the sales of the antifungal Cresemba (isavuconazole) in Japan exceeded the threshold triggering the first sales milestone payment from its partner Asahi Kasei Pharma (AKP), amounting to around 1.2 million Swiss francs ($1.32 billion). 6 February 2025
Pharmaceutical
US pharma major Eli Lilly today announced its financial results for the fourth quarter of 2024 and detailed 2025 financial guidance, with the firm’s shares edging up 1.1% to $843.18. 6 February 2025
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca beat analyst expectations in presenting its impressive latest financial results. 6 February 2025
Biotechnology
California, USA-based rare disease company Ultragenyx Pharmaceutical yesterday released new data demonstrating treatment with UX111 (ABO-102) AAV gene therapy led to a statistically-significant improvement in the Bayley-III raw scores for the subdomains of cognition, receptive communication and expressive communication in patients with Sanfilippo syndrome type A (MPS IIIA) compared to natural history data from untreated patients. 6 February 2025
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER) yesterday posted its revised Evidence Report assessing the comparative clinical effectiveness and value of suzetrigine, from Vertex Pharmaceuticals, for the treatment of acute pain. 6 February 2025
Pharmaceutical
Kura Oncology and Japan’s Kyowa Kirin have announced that their menin inhibitor ziftomenib met the primary endpoint in a Phase II trial for relapsed or refractory acute myeloid leukemia (AML) 6 February 2025
Biotechnology
US clinical-stage biotech Qlaris Bio has announced positive top-line results from two U.S. Phase II clinical trials investigating QLS-111 in patients with primary open angle glaucoma (POAG) and ocular hypertension (OHT). 6 February 2025
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