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
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
Pharmaceutical
Belgian biotech Agomab Therapeutics has reported positive interim results from its Phase IIa STENOVA trial of AGMB-129, an oral gut-restricted small molecule ALK5 inhibitor in development for fibrostenosing Crohn’s disease. The analysis includes data from 44 patients who completed 12 weeks of treatment, with the study meeting both its primary and secondary endpoints. 10 March 2025
Pharmaceutical
US pharma giant Pfizer today announced that James List, has joined the company as chief internal medicine officer. 10 March 2025
Pharmaceutical
Novartis has reported new data showing that its investigational BTK inhibitor, remibrutinib, significantly improves sleep quality for patients with chronic spontaneous urticaria (CSU). The findings, from the Phase III REMIX-1 and REMIX-2 trials, were presented at the American Academy of Dermatology annual meeting in Orlando. 10 March 2025
Biotechnology
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
Biotechnology
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
Pharmaceutical
Valo Therapeutics says it has successfully secured a financing round of 19 million euros ($20.6 million), part of which was raised in Europe and part in Australia, to clinically develop its innovative immune therapy for cancer. 10 March 2025
Pharmaceutical
The Bulgarian Association of Research-Based Pharmaceutical Manufacturers, ARPharM, says it is following the discussion of the National Health Insurance Fund (NHIF) budget for 2025 with attention and concern. 10 March 2025
Pharmaceutical
Last week’s significant research news included positive new Phase III data on Tezspire in nasal polyps from Amgen and AstraZeneca. US pharma major AbbVie became the latest entrant to the weight management sector, striking a deal with Gubra for its obesity candidate GUB14295. On the M&A front, Ireland-headquartered Jazz Pharmaceuticals announced it is acquiring Chimerix for around $935 million to expand its oncology portfolio. USA-based scPharmaceuticals gained US Food and Administration (FDA) approval for its supplemental new drug application (sNDA) for Furoscix in chronic kidney disease (CKD). 9 March 2025
Biosimilars
On Friday, the US Food and Drug Administration (FDA) approved as the first interchangeable biosimilar to Swiss pharma giant Roche's
anti-IgE monoclonal antibody Xolair (omalizumab). 8 March 2025
Pharmaceutical
Following swiftly after US regulatory clearance for the same indication for Odactra tablet brand, Danish allergy expert ALK Abello its Acarizax announced that Health Canada has approved tablet for use in children, aged five to 11, with house dust mite (HDM) allergy. 8 March 2025
Biotechnology
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
Pharmaceutical
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. 7 March 2025
Generics
German generics and consumer healthcare major STADA Arzneimittel today released financial results, which the firm said continued its profitable growth journey in 2024 – supported by its strong commercial network in Europe, and complemented by a growing presence in the MENA, Eurasia and Asia-Pacific regions. 7 March 2025
Biotechnology
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
Pharmaceutical
French ophthalmic drug specialist Nicox has provided details of a poster presentation highlighting additional pre-planned analysis from the NCX 470 Mont Blanc Phase III clinical trial at the 2025 American Glaucoma Society (AGS) Annual Meeting. 7 March 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Alyftrek (triple combination medicine deutivacaftor/tezacaftor/vanzacaftor. 7 March 2025
All news
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
Biotechnology
German contract development and manufacturing specialist ProBioGen has named Alfred Merz as its new chief executive. He had been serving as chief operating officer and interim chief executive since joining the company in 2024 from Bayer (BAYN: DE).
Mr Merz brings more than 30 years of experience across major pharmaceutical companies, including Bayer and Novartis (NOVN: VX). At Bayer, he was senior vice president and head of product supply for medical devices. 31 March 2025
Biotechnology
Brii Biosciences has reported promising interim results from its Phase II ENSURE study of elebsiran, a hepatitis B therapeutic, in combination with pegylated interferon, reinforcing its strategy to identify patients more likely to benefit from curative therapies. 31 March 2025
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