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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
British artificial intelligence specialist BenevolentAI has announced the return of its founder, Ken Mulvany, as executive chairman. 18 October 2024
Pharmaceutical
Gan & Lee Pharmaceuticals as reported that its three investigational drugs - GZR18, GZR4, and GZR101 - achieved positive results in Phase II diabetes trials. 17 October 2024
Pharmaceutical
The rocky road goes on for Intercept Pharmaceuticals with its primary biliary cholangitis (PBC) candidate Ocaliva (obeticholic acid). 17 October 2024
Pharmaceutical
A new group of British Members of Parliament (MPs) and peers have written to the Chancellor urging her to protect and promote the UK’s world-leading life sciences sector in the government's first Budget, due on October 30. 17 October 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has updated the US label for French pharma major Sanofi’s Flublok (Influenza Vaccine) to include data from a new safety study involving pregnant women. 17 October 2024
Pharmaceutical
Chengdu Baiyu Pharmaceutical yesterday announced that it has entered into an exclusive license agreement with Swiss pharma giant Novartis for a small molecule anti-tumor asset. 17 October 2024
Biotechnology
RNA specialist Wave Life Sciences has been told by Takeda that the Japanese drugmaker is to bring to an end the last facet of a collaboration and license agreement that the companies signed in 2018. 17 October 2024
Biotechnology
Australia’s Therapeutic Goods Administration (TGA) yesterday revealed is has made the decision not to register Leqembi (lecanemab) for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer's disease and mild Alzheimer's dementia (early Alzheimer’s disease). 17 October 2024
Biotechnology
The chronic obstructive pulmonary disease (COPD) market in the seven major markets (7MM) is set to grow from $11.5 billion in 2023 to $30.8 billion in 2033, driven by the launch of the first biologic for COPD and other pioneering pipeline agents. 17 October 2024
Biotechnology
Shares of US protein-based vaccine maker Novavax closed down 19.4% at $10.15 yesterday having dropped as much as 24%, on the news of a setback for its investigational application for a covid vaccine. 17 October 2024
Biotechnology
A new clinical trial sponsored by the National Institutes of Health (NIH) has shown that the Jynneos (MVA-BN) vaccine is safe for adolescents and generates an antibody response similar to that in adults. 17 October 2024
Pharmaceutical
Shionogi has announced new data at IDWeek 2024 from PROVE (Retrospective Cefiderocol Chart Review), the largest global real-world evidence study of Fetroja/Fetcroja (cefiderocol), an innovative siderophore cephalosporin. 17 October 2024
Biotechnology
US RNA medicines biotech Wave Life Sciences yesterday announced positive proof-of-mechanism data from the ongoing Phase Ib/IIa RestorAATion-2 study of WVE-006 in alpha-1 antitrypsin deficiency (AATD) 17 October 2024
Generics
The US Food and Drug Administration (FDA) yesterday published the guidance for industry, “Requests for Reconsideration at the Division Level Under GDUFA.” 17 October 2024
Pharmaceutical
Sanofi has entered into an agreement with Orano Med, a subsidiary of the Orano Group, to advance the development of radioligand therapies for rare cancers. 17 October 2024
Biotechnology
UK-based Cellular Origins and Fresenius Kabi—an operating company of Germany’s Fresenius—have signed a development agreement to combine their expertise in cell and gene therapies (CGTs). 16 October 2024
Biotechnology
Where once the state of play in the cell and gene therapy space was mostly limited to hope and hype around what might be to come, this is increasingly being replaced by action, on-market therapies and genuine expectation of reaching patients—provided companies can avoid some of the sector’s notorious pitfalls. 16 October 2024
Pharmaceutical
ViiV Healthcare, the specialist HIV company majority owned by GSK, today announced the presentation of new real-world evidence and implementation data showing the effectiveness, adherence, and quality-of-life improvement of Apretude (cabotegravir long-acting (CAB LA)) for HIV pre-exposure prophylaxis (PrEP). 16 October 2024
Pharmaceutical
Jaguar Health today announced the US launch of Gelclair, the only Food and Drug Administration (FDA)-approved mucoadhesive on the market indicated for the management of pain caused by oral mucositis 16 October 2024
Pharmaceutical
Netherlands-based life sciences venture capital firm Forbion has raised more than 2 billion euros ($2.2 billion) across its two newest funds. 16 October 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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