Latest Pharma and Biotech News
Pharmaceutical
5 June 2025 Bayer’s USA-based subsidiary Vividion Therapeutics has taken over full development and commercialization rights for VVD-214, a clinical-stage Werner helicase (WRN) inhibitor originally discovered under a research collaboration with Roche.
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Pharmaceutical
US drugmaker Vertex Pharmaceutical (Nasdaq: VRTX) has announced data across multiple studies demonstrating positive clinical and quality of life benefits of treatment with cystic fibrosis transmembrane conductance regulator (CFTR) modulators and, in particular, its Alyftrek (vanzacaftor/tezacaftor/deutivacaftor). 7 June 2025
Pharmaceutical
In Latin America, the average percentage of the public budget for health is 12.75%, half of what is allocated by the 38 countries that make up the Organization for Economic Cooperation and Development (OECD), which on average is 24.5%. 6 June 2025
Pharmaceutical
US cardiorenal-focussed drugmaker Ardelyx announced that Mike Kelliher, formerly executive vice president, corporate development and strategy, has been promoted to chief business officer, and James Brady has joined the company as chief human resources officer. 6 June 2025
Biotechnology
Sweden’s Sobi and US biopharma Apellis Pharmaceuticals have presented new data from the open-label period of the Phase III VALIANT study, investigating Aspaveli/Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). 6 June 2025
Biotechnology
Japan’s Otsuka today presented positive results from a pre-specified interim analysis of the Phase III VISIONARY study (NCT05248646) evaluating sibeprenlimab, for the treatment of immunoglobulin A nephropathy (IgAN) in adults. 6 June 2025
Biotechnology
China-based Kelun-Biotech Biopharmaceutical announced the placement of 5,918,000 H shares under its general mandate, representing approximately 2.54% of the enlarged share capital of the company post the placement. The shares were placed at HK$331.8 per share, raising net proceeds of around US$250 million. 6 June 2025
Biotechnology
The dynamics of the Friedreich's ataxia market are anticipated to change as companies across the globe work towards the development of new drug therapy options to treat this disease, according to a report from DelveInsight. 6 June 2025
Biotechnology
Texas-based ImmunoPrecise Antibodies, a leader in AI-driven biotherapeutics, closed 22% higher Thursday. 6 June 2025
Pharmaceutical
US biotech Trevi Therapeutics has raised around $115 million in a public stock offering, giving it fresh momentum to continue developing its investigational therapy Haduvio (nalbuphine) for chronic cough. 6 June 2025
Biotechnology
Genetic testing company 23andMe is preparing for a renewed auction of its assets after a federal judge agreed to reopen the sale process, following an eleventh hour bid from company co-founder Anne Wojcicki. 6 June 2025
Pharmaceutical
AstraZeneca has received European approval for a fixed-duration regimen of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, for adults newly diagnosed with chronic lymphocytic leukemia (CLL). 6 June 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the use of German pharma major Bayer’s Nubeqa (darolutamide) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). 6 June 2025
Biotechnology
US commercial-stage drugmaker Corcept Therapeutics has presented results from its DAZALS study of dazucorilant in patients with amyotrophic lateral sclerosis (ALS) at the European Network to Cure ALS (ENCALS) 2025 annual meeting. 6 June 2025
Biotechnology
US gene therapy company RegeNXBio yesterday announced new positive interim data from the Phase I/II AFFINITY DUCHENNE trial. Updates include positive functional, safety and biomarker data for RGX-202, RegeNXBio’s potential best-in-class, investigational gene therapy for Duchenne muscular dystrophy. 6 June 2025
Biotechnology
The New Drug Application (NDA) for the combination of fruquintinib and sintilimab for locally advanced or metastatic renal cell carcinoma patients who have failed prior treatment with one tyrosine kinase inhibitor (TKI) has been accepted for review by the China National Medical Products Administration (NMPA). 5 June 2025
Biotechnology
San Jose, USA-based biotech Allay Therapeutics today announced the completion of a $57.5 million Series D financing round with leading global investors. 5 June 2025
Biotechnology
German genetic medicine company ViGeneron has announced a rebrand to become VeonGen Therapeutics. 5 June 2025
Biotechnology
US rare disease meds developer Sarepta Therapeutics revealed that its rAAVrh74 viral vector used in the investigational gene therapy SRP-9003 (bidridistrogene xeboparvovec) for the treatment of limb-girdle muscular dystrophy type 2E/R4, has been granted platform technology designation by the US Food and Drug Administration. 5 June 2025
Biotechnology
AI-enabled biotech Juvenescence today announced the acquisition of Ro5 Inc, a proprietary AI drug discovery company. 5 June 2025
Biotechnology
US biopharma Cullinan Therapeutics has entered into an agreement with Genrix Bio for an all-indication, exclusive license to velinotamig, a BCMAxCD3 bispecific T-cell engager for everywhere outside Greater China. 5 June 2025
All news
Biotechnology
The market for Bavencio (avelumab), the checkpoint inhibitor co-developed by Pfizer and Merck KGaA, continues to grow as new indications drive demand. 11 March 2025
Biotechnology
Danish cancer specialist Genmab’s stock took a hit after US healthcare giant Johnson & Johnson opted not to license its HexaBody-CD38 (GEN301), despite its promising trial results. 11 March 2025
Biotechnology
US healthcare conglomerate Johnson & Johnson appears to have a promising IL-23-blocking oral peptide on its hands in the shape of icotrokinra. 11 March 2025
Generics
The US Food and Drug Administration (FDA) has approved the first generics of Xarelto (rivaroxaban), a cardio vascular drug developed by Germany’s Bayer and marketed in the USA by Johnson & Johnson. 11 March 2025
Pharmaceutical
CervoMed has announced encouraging findings from the first 16 weeks of the extension phase of its Phase IIb RewinD-LB study. 11 March 2025
Pharmaceutical
The Russian Ministry of Industry and Trade has developed criteria for including drugs in the list of strategically important medicines – a measure that will provide an opportunity for their manufacturers to apply for new government support measures, reports The Pharma Letter’s local correspondent. 11 March 2025
Biotechnology
Mineralys Therapeutics saw its stock rise by over 40% after reporting positive top-line results from two pivotal trials evaluating lorundrostat, a potentially new option for uncontrolled and resistant hypertension. 11 March 2025
Biotechnology
Sernova Biotherapeutics, a regenerative medicine company based in Canada and the USA, has announced the appointment of Pericles (Perry) Calias as chief development officer (CDO) and head of R&D. 11 March 2025
Pharmaceutical
An Expert View from Rob Abbott, chief executive and executive director of ISPOR — The Professional Society for Health Economics and Outcomes Research (HEOR), a nonprofit advancing HEOR excellence to improve decision-making for health globally. 10 March 2025
Biotechnology
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
Pharmaceutical
The US Food and Drug Administration has received a range of responses to its draft guidance on the Accelerated Approval pathway, with industry groups and advocacy organizations raising concerns about post-approval study requirements. 10 March 2025
Pharmaceutical
Trevi Therapeutics reported promising results from a mid-stage study of its experimental chronic cough treatment, Haduvio (nalbuphine extended-release). Shares in the company are trading around a third higher following the announcement. 10 March 2025
Pharmaceutical
Danish diabetes and obesity giant Novo Nordisk today announced headline results from REDEFINE 2, a Phase III trial in the global REDEFINE program. 10 March 2025
Biotechnology
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
Biotechnology
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
Pharmaceutical
Thought leaders from pharma are among the authors of a column tackling one of society’s toughest questions - what we should do to solve society’s obesity epidemic. 10 March 2025
Biotechnology
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
Biotechnology
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
Biosimilars
US pharma major Bristol Myers Squibb has announced positive data from the pivotal Phase III POETYK PsA-2 trial evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). 10 March 2025
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