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.
The UK's National Institute for Health and Care Excellence (NICE) has decided not to recommend Xenpozyme (olipudase alfa) as a treatment for acid sphingomyelinase deficiency (ASMD; Niemann-Pick Disease) in people with type AB or type B. 5 March 2024
The Phase II KARDIA-2 study of zilebesiran, an investigational RNAi therapeutic in development for the treatment of hypertension (high blood pressure) - the leading cause of cardiovascular disease worldwide - met its primary endpoint. 5 March 2024
USA-based biopharma firm Paratek Pharmaceuticals has announced positive top-line efficacy data for Nuzyra (omadacycline) as post-exposure prophylaxis (PEP) in a non-human primate (NHP) model of inhalational anthrax. 5 March 2024
Danish diabetes and obesity specialist Novo Nordisk today announced positive headline results from the kidney outcomes trial FLOW, but its shares dipped 1.1% to 865 kroner. 5 March 2024
Beacon Therapeutics’ gene therapy AGTC-501 (laruparetigene zovaparvovec) is in the spotlight with encouraging interim results from SKYLINE trial in the retinitis pigmentosa (retinitis) market. 5 March 2024
All manufacturers participating in the first cycle of the US Medicare drug price negotiations have responded with counter offers, according to the US Department of Health and Human Services’ (HHS) Centers for Medicare and Medicaid Services (CMS). 5 March 2024
UK health technology assessor the National Institute for for Health and Care Excellence (NICE) today issued a final draft guidance recommending UK pharma major GSK’s Jemperli (dostarlimab) for a new indication. 5 March 2024
Announcing its financial results for 2023, diversified German drugmaker said it would delay a plan to break up the group for at least a couple of years. 5 March 2024
Danish CNS specialist Lundbeck will release clinical data from the AMULET Phase II, double-blind, randomized trial of Lu AF82422 in multiple system atrophy (MSA) at the InternaPional Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD 2024). 5 March 2024
The US Food and Drug Administration (FDA) has announced the availability of a final guidance for industry titled Clinical Pharmacology Considerations for Antibody-Drug Conjugates (ADCs), replacing the February 2022 draft guidance. 5 March 2024
Californian cardiovascular specialist Bitterroot Bio has entered into a partnership with Biotheus, a Chinese company working on antibodies. 4 March 2024
In another legal blow for opponents of the Inflation Reduction Act (IRA), a federal judge has now rejected a bid from AstraZeneca to prevent price negotiations on its diabetes med Farxiga (dapagliflozin). 4 March 2024
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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