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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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Biotechnology
Flagship Pioneering-founded genome engineering biotech Tessera Therapeutics today announced an investment of up to $50 million from the Bill & Melinda Gates Foundation to develop curative, globally accessible in vivo genetic therapies for sickle cell disease. 18 December 2024
Biotechnology
Swiss immune-oncology specialist Anaveon has appointed Richard Sachse as its chief medical officer (CMO) effective February 1, 2025. 18 December 2024
Biosimilars
The US Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Johnson & Johnson’s Stelara, from South Korea’s Celltrion. 18 December 2024
Biotechnology
San Francisco-based Indapta Therapeutics, a privately held start-up developing next-generation cell therapies, has raised $22.5 million in a new financing round. The firm raised over $50 million in series A funding in 2022. 18 December 2024
Pharmaceutical
The Egyptian Drug Authority has approved EVA Pharma's insulin glargine injection, marking a significant milestone in its collaboration with US pharma major Eli Lilly. 18 December 2024
Biotechnology
US pharma giant Merck & Co has announced the discontinuation of the clinical development programs for vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody. 18 December 2024
Biotechnology
Eylea HD (aflibercept) developers Regeneron Pharmaceuticals and Bayer have announced positive Phase III results, from the QUASAR study. 18 December 2024
Biotechnology
French CNS specialist Theranexus saw its shares leap more than 34% to 0.65 euros as it revealed a license and supply agreement with Exeltis to commercialize TX01, its novel formulation of a compound already approved in the indication for the treatment of rare neurological diseases. 18 December 2024
Pharmaceutical
ENA Respiratory, an Australian pharma developing innate immune modulators to prevent complications associated with respiratory viral infections in at-risk populations, has announced the publication of results of its Phase IIa study with its liquid formulation of INNA-051 in ERJ Open Research. 18 December 2024
Pharmaceutical
In significant efforts to strengthen public health and improve vaccine access in Africa, the US International Development Finance Corporation, the African Development Bank and the International Finance Corporation (IFC) have jointly announced a $45 million financing package for VaxSen, a subsidiary of Senegal’s Institut Pasteur de Dakar (IPD). 18 December 2024
Pharmaceutical
US pharma giant Pfizer has provided its full-year 2025 guidance and reaffirmed its October 29, 2024 full-year 2024 guidance, which was largely in line with expectations but still pushed its shares up 4.7% to $26.43 by close of trading on Tuesday. 18 December 2024
Biosimilars
South Korea has emerged as a global leader in the biopharmaceutical industry, driven by its advanced clinical research infrastructure and government support. 18 December 2024
Biotechnology
China's drug regulator has approved clinical trials for an experimental mpox vaccine developed by Sinopharm, marking a significant step in the country’s efforts to offer an alternative jab. 17 December 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy, said Gilead Sciences. 17 December 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), Merck & Co’s prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. 17 December 2024
Generics
Venture capital firm BC Partners has entered into an agreement under which the private equity business at Goldman Sachs Alternatives will acquire a majority stake in Netherlands-based Synthon, from funds advised by BC Partners. 17 December 2024
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has licensed an indication extension to Blincyto (blinatumomab) to treat adults with Philadelphia chromosome negative CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL) in the consolidation phase. 17 December 2024
Biotechnology
Sanofi and Teva Pharmaceutical have announced that the Phase IIb RELIEVE UCCD study met its primary endpoints. 17 December 2024
Biotechnology
Danish vaccine maker Bavarian Nordic has signed a licensing and manufacturing agreement with the Serum Institute of India (SII) to expand production capacity for its mpox vaccine Jynneos. 17 December 2024
Pharmaceutical
In a review of the condition and associated drug development opportunities, GlobalData describes chronic hand eczema (CHE) as a persistent, inflammatory skin disorder characterized by redness and itching, significantly reducing quality of life (QoL). 17 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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