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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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Biotechnology
The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gamifant (emapalumab-Izsg), submitted by Swedish Orphan Biovitrum, the Nordic biotech also known as Sobi. 27 February 2025
Pharmaceutical
Privately-held French drugmaker Servier has announced the appointment of Nitza Thomasson as executive director, R&D Neurology. 27 February 2025
Pharmaceutical
Immuno-dermatology specialist Arcutis Biotherapeutics closed Wednesday’s trading 8% higher. 27 February 2025
Biosimilars
Johnson & Johnson has taken legal action against Samsung Bioepis, accusing the South Korean biotech of violating a settlement agreement by authorizing a third party to market a private-label biosimilar version of Stelara (ustekinumab). 27 February 2025
Pharmaceutical
A group representing compounding pharmacies has filed a lawsuit against the US Food and Drug Administration, arguing that the agency acted unlawfully when it removed Novo Nordisk’s semaglutide-based drugs Ozempic (semaglutide) and Wegovy (semaglutide) from the official shortage lst. 27 February 2025
Biotechnology
HBM Alpha Therapeutics has signed a collaboration and licensing agreement, granting an unnamed business partner exclusive rights outside China to develop and commercialize its antibody therapy for hormone-related disorders. 27 February 2025
Biotechnology
Enveda, a Colorado-based biotech, has received a $20 million investment from French pharma major Sanofi. 27 February 2025
Biotechnology
UCB exceeded market expectations in the fourth quarter of 2024, reporting revenue of 1.89 billion euros ($2.05 billion), an 8% increase compared to the same period last year. Core earnings per share (EPS) for the quarter reached 2.68 euros. 27 February 2025
Biotechnology
French immunotherapy company OSE Immunotherapeutics presented full efficacy and safety data from the induction period of the randomized, double-blind, placebo-controlled, Phase II CoTikiS study of lusvertikimab (OSE-127) at the 20th Congress of ECCO (European Crohn’s and Colitis Organization), demonstrating meaningful efficacy and a favorable safety profile in moderate to severe active ulcerative colitis (UC) patients. 27 February 2025
Generics
The 3rd Bioequivalence Conference, co-hosted by the International Generic and Biosimilar Medicines Association (IGBA) and Medicines for Europe, concluded yesterday in the Netherlands. 27 February 2025
Pharmaceutical
French biotech start-up studio Argobio and non-profit biomedical research center the Institut Pasteur have announced the launch of Enodia Therapeutics. 26 February 2025
Pharmaceutical
US pharma major Eli Lilly plans to bolster its domestic medicine production across therapeutic areas by building four new pharmaceutical manufacturing sites in the USA, involving new investment of $27 billion. 26 February 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. 26 February 2025
Pharmaceutical
Danish dermatology specialist LEO Pharma has announced results showing a strong performance in 2024, with both sales growth and adjusted earnings before interest, taxes, depreciation, and amortization (EBITDA) margin ahead of the initial outlook for the year. 26 February 2025
Biotechnology
California-based biotech Eikon Therapeutics today announced the initial closing of a $350.7 million Series D financing. Since its founding in 2019, Eikon Therapeutics has privately raised in excess of $1.1 billion to support its mission of developing new medicines to address grievous illnesses, the company noted. 26 February 2025
Biotechnology
Ligand Pharmaceuticals has entered into a royalty financing agreement with Castle Creek Biosciences, providing $75 million to support the Phase III clinical trial of D-Fi (FCX-007), an investigational gene therapy for dystrophic epidermolysis bullosa (DEB). 26 February 2025
Biotechnology
Shares of Sweden’s immune-oncology firm Alligator Bioscience were up almost 160% at 0.11 kronor by early afternoon today, after the company reported updated results from the Phase II OPTIMIZE-1 study evaluating mitazalimab. 26 February 2025
Biotechnology
Candel Therapeutics has released final data from a Phase II trial of its investigational immunotherapy, CAN-2409, in non-metastatic pancreatic ductal adenocarcinoma (PDAC), showing a notable survival benefit. 26 February 2025
Biotechnology
Swiss biotech company Idorsia has revised its collaboration terms with Viatris, reducing its financial commitment to the development of two late-stage drugs. In exchange, the company has accepted a significant reduction in future potential earnings. 26 February 2025
Biotechnology
Repare Therapeutics is set to cut approximately 75% of its workforce as part of a restructuring plan aimed at extending its cash reserves into mid-2027. 26 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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