Latest Pharma and Biotech News
Biotechnology
31 March 2025 US pharma major Eli Lilly has unveiled new Phase II data showing that its RNA-based therapy lepodisiran produced significant and lasting reductions in levels of lipoprotein(a), a known genetic risk factor for cardiovascular disease.
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Pharmaceutical
UK-based AI-first development company Isomorphic Labs revealed that it has raised $600 Million in its first external funding round. 1 April 2025
Pharmaceutical
Nuage Therapeutics, a Barcelona-based firm specializing in precision therapies for cancer, has appointed Stuart Hughes as chief executive and Vanessa Malier as chair of the board. Mr Hughes succeeds founding CEO Judit Anido, who will assist during the leadership transition. 1 April 2025
Biotechnology
US oncology biotech Inspirna is winding down after a decade of operations, according to a LinkedIn post from chief executive Usman Azam. 1 April 2025
Pharmaceutical
Positive results from the PURSUIT Phase IIb trial of AstraZeneca’s AZD0780 have shown a statistically significant low-density lipoprotein cholesterol (LDL-C) reduction when administered on top of standard-of-care statin therapy, as compared with placebo. 1 April 2025
Pharmaceutical
New data from Israel-based generics giant Teva Pharmaceutical Industries show favorable patient and healthcare provider experiences with TEV-‘749, a long-acting injectable formulation of olanzapine. 1 April 2025
Biosimilars
China's Bio-Thera Solutions has entered into an exclusive commercialization agreement with India's Dr Reddy's Laboratories for two proposed biosimilars referencing Stelara (ustekinumab) and Simponi (golimumab). 1 April 2025
Biotechnology
Eisai and Biogen today provided an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab – trade name Leqembi - as a treatment for early AD (mild cognitive impairment and mild dementia due to Alzheimer’s disease (AD)) by the European Commission (EC). 1 April 2025
Pharmaceutical
Merck & Co -as announced the first presentation of full results from the Phase III ZENITH trial of Winrevair (sotatercept-csrk) compared to placebo in adults with pulmonary arterial hypertension World Health Organization functional class (FC) III or IV at high risk of mortality who were on maximum tolerated background PAH therapy. 1 April 2025
Pharmaceutical
Japanese drugmaker Nxera Pharma today announced two new appointments to its leadership team: Kiyoshi Kaneko, is appointed as chief commercial officer (CCO), and Mariko Nakafuji is promoted into the role of chief legal officer (CLO). 1 April 2025
Pharmaceutical
Eli Lilly is advancing its ambitions in cardiometabolic medicine with new mid-stage data showing that solbinsiran, an RNA interference therapy targeting ANGPTL3, can meaningfully reduce key lipid markers in patients with mixed dyslipidemia. 1 April 2025
Pharmaceutical
The European Commission (EC) has issued a decision amending the marketing authorization for Abrysvo, US pharma giant Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age. 1 April 2025
Biotechnology
Japanese drugmaker Ono Pharmaceutical today revealed that it has entered into a drug discovery collaboration agreement with fellow Japan-based Reborna Biosciences to generate ribonucleic acid (RNA)-targeting novel small molecule in the field of central nervous system. 31 March 2025
Biotechnology
US pharma major Eli Lilly has unveiled new Phase II data showing that its RNA-based therapy lepodisiran produced significant and lasting reductions in levels of lipoprotein(a), a known genetic risk factor for cardiovascular disease. 31 March 2025
Biotechnology
Australian medicines regulator, the Therapeutic Goods Administration (TGA), has granted approval for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to prevent lower respiratory tract disease caused by RSV infection in adults aged 60 years and older. 31 March 2025
Pharmaceutical
Japanese drugmaker Chugai Pharmaceutical has obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for Evrysdi Tablets 5mg, a new formulation of the spinal muscular atrophy (SMA) treatment risdiplam. 31 March 2025
Biotechnology
AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved in the USA for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). 31 March 2025
Biotechnology
Cambridge, USA-based Anthos Therapeutics presented two new analyses from its landmark AZALEA-TIMI 71 study at the American College of Cardiology Annual Scientific Session (ACC.25) demonstrating the novel Factor XI inhibitor abelacimab significantly reduced bleeding in patients regardless of age or bleeding risk. 31 March 2025
Pharmaceutical
Novartis announced late Friday that the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy. 31 March 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors. 31 March 2025
Generics
The Danish Medicines Agency's new analysis shows that generic prescribing will not necessarily lead to financial savings or increased patient safety. 31 March 2025
All news
Pharmaceutical
With shortages of its blockbuster obesity now declared resolved in the USA, Denmark’s Novo Nordisk is moving to make the drug more widely available. 6 March 2025
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
UK-based Trimtech Therapeutics, a biotech harnessing targeted protein degradation (TPD) for neurodegenerative diseases, has announced the closing of its $31 million seed funding round. 5 March 2025
Pharmaceutical
Ireland-headquartered Jazz Pharmaceuticals has entered into a definitive agreement to acquire US biopharma company Chimerix for $8.55 per share in cash, representing a total consideration of around $935 million. The news sent Chimerix’ shares rocketing almost 70% to $8.40. 5 March 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis submitted by Swiss pharma giant Roche. 5 March 2025
Biotechnology
The board of directors at immunology-focused biopharma Acelyrin has found that an unsolicited takeover bid from Concentra Biosciences is an inferior proposal to the planned merger with Alumis. 5 March 2025
Pharmaceutical
Pliant Therapeutics has scrapped its Phase IIb Beacon-IPF trial for bexotegrast in idiopathic pulmonary fibrosis (IPF), after data monitors noted higher adverse events for the treatment group. 5 March 2025
Pharmaceutical
The Department of Government Efficiency (DOGE), led by Tesla chief executive Elon Musk, has terminated leases for 30 US Food and Drug Administration facilities across the USA. 5 March 2025
Biotechnology
IN8bio has unveiled a new T cell engager (TCE) platform, marking its first major push into autoimmune disease. 5 March 2025
Pharmaceutical
German life science giant Bayer has reported 2024 group revenue of 47.6 billion euros ($51.5 billion), down 2.2% from the previous year. Core earnings per share fell 21% to 5.05 euros, while EBITDA before special items declined 13.5% to 10.1 billion euros. 5 March 2025
Pharmaceutical
The combined use of two well-known active substances can fight leukemic cells and limit their spread. This is the result of a study conducted by the Karl Landsteiner University of Health Sciences (KL Krems) and recently published in the journal Cancer Letters. 5 March 2025
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
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