Latest Pharma and Biotech News
Pharmaceutical
7 April 2025 Thousands of workers dismissed from the US Department of Health and Human Services this week may soon be reinstated, after health secretary Robert F Kennedy Jr admitted that a significant share of the job cuts were made in error.
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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
Pharmaceutical
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
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Pharmaceutical
The uveitis treatment market across seven major markets—the USA, France, Germany, Italy, Spain, the UK, and Japan—is projected to grow from $522 million in 2023 to $1.5 billion by 2033, according to a report from data analytics firm GlobalData. This marks an annual growth rate of nearly 11%. 8 April 2025
Pharmaceutical
In the USA, the layoffs at health agencies, proposed tariffs on imports and other disruptive policies under President Donald Trump have led some to express concern over a potential ‘brain drain’ impacting pharma and other industries. 8 April 2025
Biotechnology
Myricx Bio, a UK biotech focusing on the discovery and development of a novel class of payloads for antibody-drug conjugates (ADCs), is expanding its team. 8 April 2025
Biotechnology
Datroway (datopotamab deruxtecan) has been approved in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. 8 April 2025
Pharmaceutical
US biopharma Rhythm Pharmaceuticals has announced positive topline results from the pivotal Phase III TRANSCEND trial evaluating setmelanotide, a melanocortin-4 receptor (MC4R) agonist, for the treatment of acquired hypothalamic obesity. 8 April 2025
Pharmaceutical
Indian drugmaker Sun Pharmaceutical Industries revealed it has launched fexuprazan tablets 40mg in India under the brand name Fexuclue, which is a novel potassiumcompetitive acid blocker (PCAB) that is approved as a new treatment for adults with erosive esophagitis of all grades. 8 April 2025
Biotechnology
Following hot on the heels of Monday’s European Commission EC approval of an indication extension for Johnson & Johnson’s Darzalex (daratumumab) for the treatment of adult patients with newly diagnosed multiple myeloma, comes a second EC approval today – this time in lung cancer. 8 April 2025
Pharmaceutical
Ireland’s government remains confident in its ability to retain the country’s strategic position in pharmaceutical manufacturing, despite rising tensions between the European Union and the United States over trade policy. 8 April 2025
Pharmaceutical
At the recent AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Disease (PD), Cerevance announced that solengepras, a first-in-class G-protein coupled receptor 6 (GPR6) antagonist in development for early PD, failed to meet its primary endpoint in the Phase II ASCEND trial as a monotherapy. 8 April 2025
Pharmaceutical
US biotech company Vertex Pharmaceuticals has received European Commission approval to extend the use of its cystic fibrosis therapy, Kaftrio (ivacaftor/tezacaftor/elexacaftor), in combination with ivacaftor. 8 April 2025
article
Australia’s Therapeutics Goods Administration (TGA) has issued a safety notice on isotretinoin, originally sold as Roaccutane by Swiss pharma giant Roche. 8 April 2025
Pharmaceutical
The USA’s Centers for Medicare & Medicaid Services (CMS) yesterday released the Calendar Year (CY) 2026 Rate Announcement for the Medicare Advantage (MA) and Medicare Part D Prescription Drug Programs that finalizes the payment policies for these programs. 8 April 2025
Pharmaceutical
US biotech start-up RayThera has secured $110 million in series A financing to fund the early clinical development of its small molecule drug candidates in immunology. 8 April 2025
Pharmaceutical
The UK’s Prime Minister has announced action to accelerate the discovery of life-saving drugs, improve patient care and make Britain the best place in the world for medical research. 8 April 2025
Biosimilars
Israel-based Teva Pharmaceuticals industries today revealed two important updates reflecting its commitment to expanding access to both biosimilars and innovative medicines. 7 April 2025
Pharmaceutical
Alzheon, a privately-held clinical-stage biopharma company, presented promising Phase III APOLLOE4 trial results for ALZ-801 (valiltramiprosate) in treating mild cognitive impairment (MCI) in APOE4 homozygous patients at the AD/PD 2024 International Conference on Alzheimer’s and Parkinson’s Diseases (PD). 7 April 2025
Biotechnology
South Korean clinical-stage biotech ABL Bio on Sunday announced a worldwide licensing agreement enabling GSK to develop novel medicines for neurodegenerative diseases by utilizing ABL Bio's blood-brain barrier (BBB) shuttle platform, Grabody-B. 7 April 2025
Biotechnology
China-based biotech DualityBio has named Hua Mu as its global chief medical officer, as the company prepares to ramp up its international clinical development efforts and advance toward key capital market milestones. 7 April 2025
Biotechnology
US-listed biotech CASI Pharmaceuticals has received a revised proposal from its chairman and chief executive Wei-Wu He to acquire its business in China along with certain regional rights to pipeline drugs for $20 million. 7 April 2025
Biotechnology
Italy-based Angelini Ventures, the corporate venture arm of Angelini Industries, has named Regina Hodits as managing director as it looks to scale its biotech investment activities across Europe and North America. 7 April 2025
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