Latest Pharma and Biotech News
Pharmaceutical
4 April 2025 A planned autumn review of the UK’s 2024 Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) will be brought forward to report back in June, it has been announced.
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Hong Kong-based Ascletis Pharma announces today positive interim results from the first two cohorts of its randomized, double-blind, placebo-controlled Phase Ib multiple ascending dose (MAD) study, conducted in the USA, of ASC30 oral once-daily tablet in patients with obesity (body mass index (BMI): 30-40 kg/m2). 20 February 2025
Pharmaceutical
US CNS specialist Supernus Pharmaceuticals has announced that its Phase IIb study of SPN-820 in adults with treatment-resistant depression (TRD) did not demonstrate a statistically significant improvement on the primary endpoint. 20 February 2025
Pharmaceutical
Swiss drug developer Basilea Pharmaceutica yesterday announced its results for the financial year ended December 31, 2024. 20 February 2025
Biotechnology
Eleva, a German company developing difficult-to-produce biologics based on a breakthrough moss-based platform, has announced the appointment of Martin Bauer as its chief medical officer (CMO). 20 February 2025
Generics
The International Generic and Biosimilar Medicines Association (IGBA), in line with its goals of promoting the widest possible access to safe, effective, and quality-assured medicines and of promoting intellectual property (IP) regimes which foster innovation and allow the timely entry of generic and biosimilar medicines, has released its report called “GAMING THE SYSTEM - An overview of originator companies’ evergreening strategies used to hinder access to generic and biosimilar products”. 20 February 2025
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
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Pharmaceutical
al rule on April 4, that modernizes and improves Medicare Advantage (MA), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) programs.
New Medicare proposals will not cover obesity drugs
April 4, 2025 5 April 2025
Pharmaceutical
A planned autumn review of the UK’s 2024 Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) will be brought forward to report back in June, it has been announced. 4 April 2025
Pharmaceutical
US private equity firm Vance Street Capital has expanded its life sciences manufacturing platform with the acquisition of Irish contract manufacturer Zenith Adhesive Components, adding further technical capabilities and boosting regional reach. 4 April 2025
Pharmaceutical
Swedish biotech OncoZenge has expanded its regulatory team as it prepares for a Phase III trial of BupiZenge (bupivacaine), a non-opioid treatment for oral pain caused by cancer therapies. 4 April 2025
Pharmaceutical
US neuroscience-focused biopharma Neurocrine Biosciences today announced the appointment of Sanjay Keswani to the company's executive management team as chief medical officer (CMO) effective June 2, 2025. 4 April 2025
Biotechnology
Dark Blue Therapeutics, a UK discovery and development biotech developing precision oncology medicines, has announced the appointment of Edwin Moses as chairman. 4 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Uplizna (inebilizumab-cdon) as the first and only treatment for adults living with immunoglobulin G4-related disease (IgG4-RD), the drug’s developer, Amgen announced yesterday. 4 April 2025
Biotechnology
US biotech MoonLake Immunotherapeutics has entered into an agreement with Hercules Capital for up to $500 million in non-dilutive capital, of which $75 million drawn down at close and additional tranches will become available upon achievement of certain pre-specified milestones that are aligned with MoonLake’s strategy and funding needs. 4 April 2025
Biotechnology
Struggling US genomic medicines company Sangamo Therapeutics has been offered a lifeline via a licensing deal with pharma major Eli Lilly, sending its share up 24% to $0.77. 4 April 2025
Biosimilars
An Expert View from Dr Elena Wolff-Holz, global head of clinical development at Biocon Biologics, the biosimilar subsidiary of Biocon. 4 April 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Wainzua (eplontersen) to treat adults with polyneuropathy associated with hereditary transthyretin amyloidosis (ATTRv), which is a rare progressive condition that runs in families caused by a protein called transthyretin (TTR). 4 April 2025
Pharmaceutical
US biotech Aldeyra Therapeutics has received a Complete Response Letter from the US Food and Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) of its dry eye disease candidate reproxalap. 4 April 2025
Biotechnology
Swiss pharma giant Roche’s Genentech subsidiary has presented new data at the AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases in Vienna, Austria. 4 April 2025
Biotechnology
A new report from GlobalData has raised concerns over the effectiveness of mpox vaccines for people living with HIV. 4 April 2025
Biotechnology
UK pharma major AstraZeneca today reported extended approvals in Europe for two of its cancer drugs: Imfinzi (durvalumab) and Enhertu (trastuzumab deruxtecan). 4 April 2025
Biotechnology
US biotech Novavax is still waiting on a decision from the Food and Drug Administration over full approval of its protein-based COVID-19 vaccine, despite the agency having set an April 1 target date to complete its review. 4 April 2025
Biotechnology
US regenerative cell therapy specialist Neurona Therapeutics has announced the successful completion of an upsized and oversubscribed $102 million financing. 4 April 2025
Pharmaceutical
US pharma major Eli Lilly’s brand value has surged by 108% since entering the weight loss market in 2023, according to a new report from Brand Finance. 3 April 2025
Biotechnology
US biotech BioMarin Pharmaceutical yesterday revealed that the Phase III PEGASUS trial evaluating Palynziq (pegvaliase-pqpz) met its primary efficacy endpoint, demonstrating a statistically-significant lowering in blood phenylalanine( Phe) levels in adolescents aged 12-17 with phenylketonuria (PKU) compared to diet alone. 3 April 2025
Biotechnology
Sino-American biotech BeiGene today revealed it intends to discontinue its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody, as a potential treatment for lung cancer. 3 April 2025
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