7 March 2025 Marty Makary, nominated by Donald Trump to lead the Food and Drug Administration (FDA), has faced rigorous Senate scrutiny over recent agency job cuts and the abrupt cancellation of a flu vaccine advisory meeting.
Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, has launched with the support of a $15 million financing. 11 October 2024
German cancer specialist Immatics has announced the pricing of its $150 million public offering, with Jefferies, BofA Securities, and Leerink acting as joint book runners. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
Gene therapy start-up GEMMA Biotherapeutics (GEMMABio) has announced a significant partnership with Brazil's Fiocruz, a key supplier for the Brazilian Ministry of Health. 10 October 2024
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
Calluna Pharma, a biotech focused on treating inflammatory and fibrotic diseases, has appointed Mark Gaffney as its new chief executive. 9 October 2024
Cambridge, USA-based City Therapeutics has announced its launch with a vision to lead the future of RNA interference (RNAi)-based medicine. 9 October 2024
AstraZeneca and Ionis’ Wainzua (eplontersen) has been approved in the European Union (EU) for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy, commonly referred to as hATTR-PN or ATTRv-PN. 10 March 2025
Finnish drugmaker Orion Corporation has announced that it is establishing a new research and development (R&D) center in Cambridge, UK, during 2025 to accelerate its global growth strategy and the development of innovative medicines. 10 March 2025
Shares of German biotech BioNTech dipped 2.5% to $105.86 today, after it reported financial results for the three months and full year ended December 31, 2024, and provided an update on its corporate progress. 10 March 2025
Indian drug major Sun Pharmaceutical Industries has entered an agreement with Checkpoint Therapeutics to acquire the US immunotherapy and targeted oncology company, with the news sending the latter’s shares rocketing more than 65% to $4.06 this morning. 10 March 2025
The US Food and Drug Administration (FDA) has approved the biologics license application (BLA) for Encelto (revakinagene taroretcel-lwey; NT-501) for the treatment of macular telangiectasia type 2 (MacTel), submitted by privately-held US biotech Neurotech Pharmaceuticals. 10 March 2025
Positive results from the ADEPT Phase II/III study indicate that Dupixent (dupilumab) may be effective in treating moderate-to-severe bullous pemphigoid (BP). The findings were presented at the 2025 American Academy of Dermatology Annual Meeting. 10 March 2025
US biotech Amgen and Japanese partner Kyowa Kirin announced new results from the ongoing ROCKET Phase III clinical trial program evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in moderate to severe atopic dermatitis (AD). 10 March 2025
Nona Biosciences has introduced Hu-mAtrIx, an AI-assisted drug discovery platform designed to accelerate the identification and development of antibody-based therapies. 7 March 2025
US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). 7 March 2025
US clinical stage biotech Rapport Therapeutics has announced the appointment of Dr Jeffrey Sevigny as chief medical officer (CMO), effective immediately. 7 March 2025
A recent study by TEConomy Partners, commissioned by industry group PhRMA, has revealed that biopharmaceutical company-sponsored trials generated over $62 billion in economic activity in the USA in 2023. 7 March 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Lazcluze (lazertinib) for adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has undergone specific changes in a gene called epidermal growth factor receptor (EGFR). 7 March 2025
A treatment combining AstraZeneca’s immunotherapy Imfinzi (durvalumab) with chemotherapy has significantly reduced the risk of cancer recurrence in patients with early-stage stomach and gastroesophageal junction cancers, according to results from the MATTERHORN Phase III trial. 7 March 2025
Tenaya Therapeutics, a clinical-stage biotechnology company based in South San Francisco, has announced plans to raise approximately $52.5 million through a public offering. 6 March 2025
The US Patent Trial and Appeal Board handed a massive victory to Pfizer and BioNTech on Wednesday, as it invalidated two of Moderna patents covering its Spikevax COVID-19 vaccine, which the challengers stand accused of infringing, according to media reports. 6 March 2025
In what is seen as an unusual decision, the UK’s National Institute for Health and Care Excellence (NICE) says it will convene a third appraisal committee meeting as part of its ongoing evaluation of Leqembi (lecanemab), the drug’s developers, Eisai and Biogen announced today. 6 March 2025
French biopharmaceutical Osivax, which is developing vaccines to provide broad-spectrum protection against highly mutating respiratory viruses, has announced the successful first close of its Series B financing, raising 10 million euros ($10.05 million) from new and existing investors. 6 March 2025
CordenPharma has unveiled plans for a strategic investment exceeding 1 billion euros ($1.1 billion) to enhance its peptide development and manufacturing capabilities. 6 March 2025
Israel-based Pluri, a biotech using its platform for cell-based solutions to create a collaborative network of ventures, was trading 4% higher Wednesday lunchtime. 5 March 2025