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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
Once the hottest property in biotech, gene therapy company bluebird bio has been sold for less than $500 million after a long series of setbacks. 21 February 2025
Pharmaceutical
US drugmaker Cosette Pharmaceuticals has entered into a definitive agreement to acquire all the outstanding shares of Australia-based Mayne Pharma with the aim of expanding its health portfolio. 21 February 2025
Pharmaceutical
Privately-held Austria firm pharmaand GmbH (pharma&) today announced that the National Institute of Health and Care Excellence (NICE) has issued a positive recommendation for its Rubraca (rucaparib). 21 February 2025
Biotechnology
US healthcare giant Johnson & Johnson has announced data from the Phase III ASTRO study of Tremfya (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC). 21 February 2025
Pharmaceutical
Binnopharm Group, one of Russia’s leading drugmakers, which is controlled by the Russian financial conglomerate AFK Sistema, will begin selling two hormonal drugs in Russia in May 2025, and will consider localizing their production in the future, reports The Pharma Letter’s local correspondent. 21 February 2025
Pharmaceutical
US biopharma Incyte and privately-held AI-focused biotech Genesis Therapeutics have entered into a strategic collaboration focused on the research, discovery and development of novel small molecule medicines. 21 February 2025
Pharmaceutical
Just days after Robert F Kennedy Jr's (RFK Jr) nomination to lead the US Department of Health and Human Services (HHS) was approved by the Senate in a narrow vote, a new development has added to concerns about what his appointment could mean for the use of vaccines. 21 February 2025
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending the use Breyanzi (lisocabtagene maraleucel) for National Health Service (NHS) in England. 21 February 2025
Pharmaceutical
Gilead Sciences’ seladelpar has won conditional marketing authorization to treat primary biliary cholangitis (PBC) alongside ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. 21 February 2025
Biosimilars
South Korean biosimilars developer Celltrion late yesterday announced new post-hoc analyses of its pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC), at the 20th European Crohn’s and Colitis Organisation (ECCO) Congress, showcasing the treatment’s effectiveness across a range of key clinical outcomes in inflammatory bowel disease (IBD). 21 February 2025
Biotechnology
Japan's Ministry of Health, Labor and Welfare (MHLW) has granted manufacturing and marketing approval for Andembry (garadacimab) subcutaneous (SC) injection 200mg pens, developed by Australia’s CSL Limited and to be marketed by its CSL Behring unit. 21 February 2025
Biotechnology
French biotech tart-up EG 427 has successfully closed a 27 million-euro ($28.4 million) Series B financing round co-led by Andera Partners and Bpifrance - as part of the InnoBio investment strategy. 21 February 2025
Generics
New research shows that 46% of generic drugs from the European Union (EU) critical list of medicines are supplied by just one provider. 20 February 2025
Pharmaceutical
The pharmaceutical industry is preparing for ‘major disruptions’ following US President Donald Trump’s announcement on tariffs, says data and analytics firm GlobalData. 20 February 2025
Pharmaceutical
FibroGen today announced the sale of its China subsidiary to UK pharma major AstraZeneca for around $160 million, with the news sending the California-based company’s shares soaring 27% to $0.71. 20 February 2025
Biosimilars
South Korea-based Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars. 20 February 2025
Biotechnology
Japanese drugmaker Chugai Pharmaceutical today announced gaining regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq intravenous infusion (atezolizumab) for an additional indication of unresectable alveolar soft part sarcoma. 20 February 2025
Biotechnology
CSPC Megalith Biopharmaceutical has entered into a license agreement with Radiance Biopharma for the development and commercialization of SYS6005, a recombinant anti-human receptor tyrosine kinase-like orphan receptor 1 (ROR1) antibody-drug conjugate (ADC). 20 February 2025
Biosimilars
Formycon’s shares edged up 2.4% to 30.60 euros as it revealed it is presenting an overview of the comparative data of the ustekinumab biosimilar FYB202 at this year's Congress of the European Crohn's and Colitis Organization (ECCO), now taking place in Berlin, Germany. 20 February 2025
Biotechnology
Sweden’s BioArctic today revealed that the US Federal Trade Commission (FTC) has cleared the proposed deal with Bristol Myers Squibb to out-license to the US pharma major its pyroglutamate-amyloid-beta (PyroGlu-Aβ) antibody program. Closing of the agreement has been completed and BioArctic will receive an upfront payment of $100 million. 20 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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