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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Biotechnology
The Phase III KEYLYNK-006 trial evaluating Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, in combination with maintenance Lynparza (olaparib), a PARP inhibitor, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of certain patients with metastatic non-squamous non-small cell lung cancer (NSCLC). 22 March 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its March 2024 meeting. 22 March 2024
Pharmaceutical
This year could be a crucial one for Maat Pharma, a French microbiome company with a focus on cancer. 22 March 2024
Pharmaceutical
US clinical-stage company OKYO Pharma’s shares rose 5.7% to $1.86 pre-market today, as it announced additional key findings from analyses of the clinical data set from the 240 patient Phase II, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with dry eye disease (DED). 22 March 2024
Biotechnology
Guy Braunstein, who has served as Idorsia’s chief medical officer (CMO) since 2022, will retire at the end of this month. 22 March 2024
Pharmaceutical
Validating Novo Nordisk’s decision to research the cardiovascular impact of Wegovy (semaglutide), US authorities have said Medicare patients with heart problems can now receive the drug. 22 March 2024
Pharmaceutical
Swiss rare disease specialist Relief Therapeutics today announced it has granted an exclusive license to Eton Pharmaceuticals or the commercialization of GOLIKE family of products in the USA. 22 March 2024
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical and the US unit of Denmark’s Lundbeck have presented new post hoc pooled analyses of two pivotal Phase III trials evaluating the safety and efficacy of Rexulti (brexpiprazole) in patients with agitation associated with dementia due to Alzheimer's disease. 22 March 2024
Pharmaceutical
Yesterday, the US Food and Drug Administration (FDA) approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular dystrophy (DMD) in patients six years of age and older. 22 March 2024
Biotechnology
San Diego-based Mirador Therapeutics has announced its launch. 21 March 2024
Biotechnology
The biobanking market - valued at $60.74 billion in 2022 - is forecast to grow at a CAGR of 5.68%, reaching a market size of $89.41 billion by 2029. 21 March 2024
Biotechnology
Swiss pure-play dermatology category leader Galderma Group today announced the pricing of its Initial Public Offering (IPO) at 53 Swiss francs per share, at the top of the announced price range.
The shares will 21 March 2024
Pharmaceutical
UK pharma major AstraZeneca today released results from the FLAURA2 Phase III trial that showed its Tagrisso (osimertinib) with the addition of chemotherapy provided a clinically-meaningful and consistent benefit in subsequent outcomes after disease progression in patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). 21 March 2024
Biotechnology
Capstan Therapeutics, a company advancing in vivo reprogramming of cells through RNA delivery using targeted lipid nanoparticles, has become the latest San Diego biotech to announce a major fundraising. 21 March 2024
Pharmaceutical
Seelos Therapeutics, a company working on therapies for amyotrophic lateral sclerosis (ALS) and other central nervous system disorders (CNS) has been struck by a trial failure. 21 March 2024
Biotechnology
The European Commission (EC) has granted expanded approval for the cell therapy Abecma (idecabtagene vicleucel; ide-cel). 21 March 2024
Biotechnology
In Singapore, a modern manufacturing facility is to be built by Chinese contract research, development and manufacturing organization (CRDMO) WuXi Biologics. 21 March 2024
Biotechnology
Privately-held Californian firm Parvus Therapeutics has entered into an exclusive worldwide license collaboration and option agreement with US pharma major AbbVie. 21 March 2024
Biotechnology
Japanese drugmaker Chugai Pharmaceuticals today announced mixed results from the Phase III LUMINESCE study of Enspryng (satralizumab [genetical recombination]), created by Chugai, as an investigational treatment for generalized myasthenia gravis (gMG). 21 March 2024
Biotechnology
Another start-up has launched in the bustling biotech hub around Boston, USA, with $150 million in financing from investors including Novo Holdings. 21 March 2024
All news
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
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
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