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
Alliance Pharma has accepted a final increased cash offer from investment firm DBAY Advisors, valuing the UK-based pharmaceutical company at approximately £362 million ($468 million). 11 March 2025
Pharmaceutical
USA-based Endo Inc today announced it has entered into a definitive agreement to divest its international pharmaceuticals business, primarily operated through Canada-based specialty pharmaceutical company Paladin Pharma to Knight Therapeutics. 11 March 2025
Biotechnology
Privately-held Tenpoint Therapeutics, a UK-headquartered biotech focused on developing groundbreaking treatments to rejuvenate vision in the aging eye, has announced the appointment of Carol Kearney as chief commercial officer (CCO). 11 March 2025
Biotechnology
Shares of US biotech 2seventy Bio skyrocketed almost 76% to $4.92 today, as it agreed to a takeover bid from US pharma major Bristol Myers Squibb, which is looking to enhance its CAR T-cell therapy business. 11 March 2025
Pharmaceutical
A recent study published in Diabetes Technology & Therapeutics has demonstrated that the off-label use of semaglutide and tirzepatide leads to significant reductions in HbA1c levels and body weight among adults with type 1 diabetes (T1D). 11 March 2025
Biotechnology
Sino-American biopharma Ascentage Pharma has announced that olverembatinib has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), alongside low-intensity chemotherapy, for first-line treatment of newly-diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). 11 March 2025
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
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