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
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
Pharmaceutical
Cardiorenal specialist scPharmaceuticals has won US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Furoscix (furosemide injection) to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD). 7 March 2025
Biotechnology
US clinical stage biotech Rapport Therapeutics has announced the appointment of Dr Jeffrey Sevigny as chief medical officer (CMO), effective immediately. 7 March 2025
Biotechnology
A recent study by TEConomy Partners, commissioned by industry group PhRMA, has revealed that biopharmaceutical company-sponsored trials generated over $62 billion in economic activity in the USA in 2023. 7 March 2025
Pharmaceutical
US healthcare giant Johnson & Johnson yesterday revealed that it has made the decision to discontinue the Phase III VENTURA development program evaluating aticaprant as an adjunctive treatment for major depressive disorder (aMDD) due to insufficient efficacy in the target patient population. 7 March 2025
Biotechnology
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Lazcluze (lazertinib) for adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has undergone specific changes in a gene called epidermal growth factor receptor (EGFR). 7 March 2025
Biotechnology
A treatment combining AstraZeneca’s immunotherapy Imfinzi (durvalumab) with chemotherapy has significantly reduced the risk of cancer recurrence in patients with early-stage stomach and gastroesophageal junction cancers, according to results from the MATTERHORN Phase III trial. 7 March 2025
Biotechnology
Tenaya Therapeutics, a clinical-stage biotechnology company based in South San Francisco, has announced plans to raise approximately $52.5 million through a public offering. 6 March 2025
Pharmaceutical
Private equity firms acquiring assets were among the most eye-catching deals in pharma M&A during February. 6 March 2025
Pharmaceutical
China’s Enhua Pharma has announced a $3.5 million investment in NeuroThree Therapeutics, a biotech firm specializing in treatments for central nervous system disorders. The investment secures a 10.4% stake in the company as part of its Pre-A funding round. 6 March 2025
Pharmaceutical
Privately-held US drugmaker Tris Pharma today announced positive top-line results from its ALLEVIATE-2 Phase III pivotal clinical trial evaluating cebranopadol, an investigational therapy, for the treatment of moderate-to-severe acute pain in patients following bunionectomy surgery. 6 March 2025
Pharmaceutical
USA-based Medicus Pharma has announced a positive-trending interim analysis for the SKNJCT-003 Phase II study, which aims to treat non-invasively basal cell carcinoma of the skin (BCC). 6 March 2025
Generics
Indian drugmaker Biocon’s Biocon Biologics unit and USA-based Civica Rx, a not-for-profit generic drug and pharmaceutical company, have announced a strategic collaboration agreement to expand access and affordability of Insulin Aspart in the USA, with the news sending Biocon’s shares up nearly 4% to 333 rupees. 6 March 2025
Pharmaceutical
ARS Pharmaceuticals’ shares closed up 3.4% at $10.87 yesterday, after the company announced that the US Food and Drug Administration (FDA) had approved neffy 1mg (epinephrine nasal spray) for a new indication. 6 March 2025
Pharmaceutical
Germany’s Merck KGaA returned to profitable growth in 2024 and delivered on its guidance for the year. 6 March 2025
Pharmaceutical
As the new White House seeks to push ahead with swingeing cuts to government spending, a federal judge in Massachusetts has thrown a wrench in the works. 6 March 2025
Pharmaceutical
Polish drugmaker Celon Pharma has announced positive results from a Phase II trial of CPL’36, an experimental oral treatment for levodopa-induced dyskinesia (LID) in Parkinson’s disease. 6 March 2025
Biotechnology
The US Patent Trial and Appeal Board handed a massive victory to Pfizer and BioNTech on Wednesday, as it invalidated two of Moderna patents covering its Spikevax COVID-19 vaccine, which the challengers stand accused of infringing, according to media reports. 6 March 2025
Biotechnology
German biotech major BioNTech has suffered a blow as it seeks to add new revenue streams beyond its COVID-19 vaccine, Comirnaty. 6 March 2025
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