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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
Neurocrine Biosciences has secured US Food and Drug Administration approval for Crenessity (crinecerfont). 17 December 2024
Pharmaceutical
Belgian drugmaker UCB today announced the ORCHESTRA proof-of-concept study of minzasolmin - an investigational, oral small molecule, alpha-synuclein misfolding inhibitor - developed in partnership with Novartis for early Parkinson’s disease, did not meet its primary and secondary clinical endpoints. 17 December 2024
Biotechnology
Shares in US biopharma Viridian Therapeutics shot up by 21% on Monday. 17 December 2024
Biotechnology
Cell therapy specialist Candid Therapeutics has entered a strategic collaboration with Shanghai-based EpimAb Biotherapeutics to discover and develop new T-Cell engager (TCE) candidates. 17 December 2024
Biotechnology
US antivirals giant Gilead Sciences today revealed it has entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets with Californian biotech Terray Therapeutics. 17 December 2024
Biotechnology
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for a fixed combination of Rybrevant (amivantamab) and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations. 17 December 2024
Pharmaceutical
Japanese drugmaker Kyorin Pharmaceutical has entered into a licensee agreement with Bayer for the novel obstructive sleep apnea (OSA) treatment BAY2925976 and its backup compound discovered by the German pharma major. 17 December 2024
Biotechnology
US health technology assessor the Institute for Clinical and Economic Review (ICER) as released a Final Evidence Report assessing the comparative clinical effectiveness of French drugmaker Pierre Fabre’s tabelecleucel (tab-cel) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). 17 December 2024
Generics
Swiss generic and biosimilar medicines major Sandoz today announced a number of steps to resolve the US Generic Drug Antitrust Class Action Litigation. 17 December 2024
Pharmaceutical
Eli Lilly and Innovent Biologics have announced a distribution and promotion agreement for Jaypirca in China. 16 December 2024
Pharmaceutical
Swedish biotech company Inify Laboratories has raised approximately 135 million kroner ($12.3 million) through a private placement, supporting a planned expansion into the UK. 16 December 2024
Pharmaceutical
Japan’s largest drugmaker, Takeda Pharmaceuticals, announced it is working with the European Medicines Agency (EMA) to voluntarily withdraw the marketing authorization of Alofisel (darvadstrocel), a treatment for complex perianal fistulas in patients with Crohn’s disease, in the European Union (EU). 16 December 2024
Biotechnology
Dewpoint Therapeutics and ConcertAI have announced the first phase of their translational oncology partnership, aligned around the former company's latest drug candidate, DPTX3186. 16 December 2024
Biotechnology
Chinese biotech RemeGen has presented results from a Phase III trial of disitamab vedotin, a HER2-targeted antibody-drug conjugate (ADC), at the San Antonio Breast Cancer Symposium. 16 December 2024
Biotechnology
Switzerland’s Galderma has won US Food and Drug Administration (FDA) approval for the use of Nemluvio (nemolizumab) for patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD), alongside topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI), when the disease is not adequately controlled with topical prescription therapies. 16 December 2024
Pharmaceutical
The schizophrenia market across the seven major markets is poised to grow at a compound annual growth rate (CAGR) of 7.4% from $8.4 billion in 2021 to $17.0 billion in 2031, driven by the anticipated introduction of 11 late-stage pipeline products during the forecast period. 16 December 2024
Biotechnology
Bicycle Therapeutics, a UK-headquartered pharma company developing a new class of therapeutics based on its proprietary bicyclic peptide technology, closed a third lower on Friday. 16 December 2024
Pharmaceutical
Denmark-based diabetes and obesity giant Novo Nordisk says it plans to invest 8.5 billion Danish kroner ($1.2 billion) to establish a completely new production facility in Odense, Denmark. 16 December 2024
Pharmaceutical
UK-based PureTech Health has announced positive results from ELEVATE IPF, a Phase IIb trial of deupirfenidone (LYT-100) at two dose levels, three times a day (TID) over 26 weeks in patients with idiopathic pulmonary fibrosis (IPF). 16 December 2024
Biotechnology
In a filing with the US financial regulator, German mRNA specialist BioNTech has noted the lifting of a partial clinical hold on its PRESERVE-003 trial. 16 December 2024
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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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