Latest Pharma and Biotech News
Pharmaceutical
11 April 2025 The US Centers for Medicare & Medicaid Services (CMS) has announced action intended to preserve the core mission of the Medicaid program against a wider backdrop of wider cost-cutting under the regime of President Donald Trump.
Today's issue
Refine Search
Biotechnology
US mRNA specialist Moderna has announced that the German Standing Committee on Vaccination (STIKO) has issued a recommendation for mRESVIA, the company’s RSV vaccine available in a pre-filled syringe (PFS). 11 April 2025
Pharmaceutical
Speculation about the US Administration’s views on the Pharmaceutical Benefits Scheme (PBS) has reconfirmed the sanctity of the PBS as the cornerstone of Australia’s healthcare system, the domestic pharma trade group stressed. 11 April 2025
Biotechnology
Johnson & Johnson has announced new data from an analysis modelling long-term progression free survival (PFS) in transplant eligible (TE) and transplant ineligible (TIE) newly diagnosed multiple myeloma (NDMM) patients given Darzalex (daratumumab)-subcutaneous (SC) therapy alongside bortezomib, lenalidomide and dexamethasone (VRd). 11 April 2025
Biotechnology
US biotech giant Amgen today announced a significant breakthrough with its global Phase III DeLLphi-304 clinical trial evaluating Imdelltra (tarlatamab-dlle). 11 April 2025
Pharmaceutical
The obesity drug market has experienced a seismic shift in recent years, with Novo Nordisk's Wegovy (semaglutide) and Eli Lilly's Mounjaro (tirzepatide) revolutionizing the way the condition is treated. 11 April 2025
Pharmaceutical
Indian drugmaker Sun Pharmaceutical shares were buzzing in trade on the last trading day of the week to April 11, rising as much as 5%. 11 April 2025
Pharmaceutical
The US Centers for Medicare & Medicaid Services (CMS) has announced action intended to preserve the core mission of the Medicaid program against a wider backdrop of wider cost-cutting under the regime of President Donald Trump. 11 April 2025
Pharmaceutical
US biopharma company Palatin Technologies is at risk of being removed from the NYSE American exchange after failing to meet minimum stockholders' equity requirements. 11 April 2025
Biotechnology
US biotech Oncolytics Biotech has entered into a funding agreement with institutional investor Alumni Capital, providing access to up to $20 million in equity financing over the next 15 months. 11 April 2025
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s Truqap (capivasertib) with fulvestrant as an option for around 1,100 adults with hormone receptor (HR)-positive HER2-negative breast cancer that has certain genetic mutations and has spread. 11 April 2025
Biotechnology
Australian biotech Opthea is cutting around two-thirds of its workforce, as the company moves to curb spending following the collapse of its lead program for age-related macular degeneration (AMD). 11 April 2025
Pharmaceutical
Swiss pharma giant Novartis has announced a planned $23 billion investment over five years in US-based infrastructure, ensuring all key Novartis medicines for US patients will be made in the USA. 11 April 2025
Pharmaceutical
US biotech Imbria Pharmaceuticals has raised $57.5 million in a series B financing round to fund a new mid-stage trial of its only pipeline drug, ninerafaxstat, for a form of heart muscle disease with limited treatment options. 11 April 2025
Biotechnology
Late Thursday, the US Food and Drug Administration revealed it is taking a ground-breaking step to advance public health by replacing animal testing in the development of monoclonal antibody (MAb) therapies and other drugs with more effective, human-relevant methods. 11 April 2025
Biotechnology
US biotech Atossa Therapeutics has entered into a research collaboration with China-backed Nona Biosciences, aiming to identify next-generation antibody therapies for breast cancer using Nona’s proprietary platform technology. 10 April 2025
Biotechnology
US clinical-stage biotech Imbria Pharmaceuticals, which is focused on cardiometabolic diseases with high unmet need, says it has closed a $57.5 million Seres B financing. 10 April 2025
Pharmaceutical
Pain is good. Or finding non-opioid ways to manage it is good, if Latigo Biotherapeutics’ $150 million March fundraise is anything to go by. 10 April 2025
Biotechnology
US biotech ImmunityBio has secured $75 million through a direct offering with a single institutional investor, according to a statement released Tuesday. 10 April 2025
Pharmaceutical
The UK’s National Institute of Health and Care Excellence (NICE) has recommended erdafitinib, trade name Balversa and manufactured by Johnson & Johnson, for some adult patients in England. 10 April 2025
All news
Biotechnology
February 20, 2025
New Jersey, USA-based Imunon announced new translational data from the Phase II OVATION 2 Study of IMNN-001, an interleukin-12 (IL-12) DNA-based immunotherapy in development for the treatment of newly diagnosed advanced ovarian cancer. The firm’s shares edged up 3.3% to $0.90 on the news, although they fell back by close of trading 20 February 2025
Pharmaceutical
In a U-turn for the UK health technology assessor, the National Institute for Health and Care Excellence (NICE) has today approved Fintepla (fenfluramine) for the treatment of Lennox-Gastaut syndrome (LGS) in patients from two years of age. 20 February 2025
Pharmaceutical
Privately-held Ventus Therapeutics, a biopharma with two novel small-molecule programs entering Phase II development for immunology, inflammation, and neurology disorders, has appointed Mona Kotecha as chief medical officer (CMO). 19 February 2025
Biotechnology
Germany-based Bayer’s wholly-owned gene therapy company AskBio today announced that its investigational gene therapy AB-1005 for the treatment of Parkinson’s disease (PD) has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the US Food and Drug Administration (FDA). 19 February 2025
Biosimilars
Icelandic biosimilar company Alvotech and Israeli drugmaker Teva Pharmaceuticals have announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to Eylea (aflibercept). 19 February 2025
Pharmaceutical
Australia’s Recce Pharmaceuticals has announced positive data from a Phase II trial evaluating RECCE 327 Topical Gel (R327G) for the treatment of acute bacterial skin and skin structure infections (ABSSSI), with the news pushing the firm’s shares up around 9%. 19 February 2025
Biotechnology
Boston, USA-based biotech Solid Biosciences saw its shares rocket 36% to $5.48 yesterday, after the precision genetic medicines for neuromuscular and cardiac diseases company announced positive initial data from the Phase I/II INSPIRE DUCHENNE trial evaluating SGT-003. 19 February 2025
Pharmaceutical
US biotech Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP). 19 February 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to Dutch clinical-stage drug developer Merus for its petosemtamab. 19 February 2025
Pharmaceutical
Danish pharma major Novo Nordisk has sued KBP Biosciences and its founder and executive chairman, Huang Zhenhua, for $830 million in an application to the Singapore International Commercial Court. 19 February 2025
Biotechnology
US clinical-stage biotech Septerna yesterday announced its decision to discontinue the Phase I single- and multiple-ascending dose (SAD/MAD) clinical trial of SEP-786 in healthy volunteers. SEP-786 is an oral small molecule agonist of the parathyroid hormone 1 receptor (PTH1R) being developed for the treatment of hypoparathyroidism. 19 February 2025
Biotechnology
Barcelona, Spain-based biotech Ona Therapeutics today announced key leadership appointments to support its rapid growth and pipeline advancement. 19 February 2025
Pharmaceutical
Nura Bio, a US biopharma developing neuroprotective, small molecule therapies for the treatment of debilitating neurological diseases, has announced the appointments of Lahar Mehta as chief medical officer and Scott Greenberg as chief business officer. 18 February 2025
Pharmaceutical
Israel-based clinical-stage company Purple Biotech today announced it is advancing into a Phase II study with NT219 in patients with recurrent/metastatic squamous cell carcinoma. of the head and neck (R/M SCCHN), with the news pushing its shares up as much as 10% to 6.50 shekels. 18 February 2025
Biotechnology
Epitopea, an Anglo-Canadian company developing accessible, off-the-shelf RNA-based immunotherapies for cancer, has announced a license and research collaboration deal with US pharma giant Merck & Co to identify Cryptigen tumor-specific antigens (TSAs) in an undisclosed solid tumor. 18 February 2025
Pharmaceutical
Germany’s Merck KGaA has appointed three new members to its executive board, which it says is a natural evolution in the company’s leadership as it continues to implement its growth strategy. 18 February 2025
Biotechnology
Swiss dermatology company Galderma has announced two European approvals for Nemluvio (nemolizumab) to treat both atopic dermatitis and prurigo nodularis. 18 February 2025
Pharmaceutical
US pharma giant Merck & Co today announced that the European Commission (EC) has conditionally approved two indications for Welireg (belzutifan), its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. 18 February 2025
Pharmaceutical
Stoke Therapeutics’ stock climbed 8% early Tuesday, after the company and Biogen today announced a collaboration to develop and commercialize a treatment for Dravet Syndrome, a severe form of epilepsy that starts in childhood. 18 February 2025
Biotechnology
California-based Arcus Biosciences, a biopharma developing differentiated molecules and combination therapies for people with cancer, has presented new data for casdatifan, a HIF-2a inhibitor with best-in-class potential, in metastatic kidney cancer. 18 February 2025
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze