16 October 2024 US pharma major Eli Lilly has announced a strategic collaboration with two UK government departments and the devolved nations to tackle significant population health challenges, including exploring new models to better care for people living with obesity.
Swedish biotech Sobi has announced positive results from the AVA-PED-301 study, evaluating the efficacy and safety of Doptelet (avatrombopag). 25 March 2024
The US Food and Drug Administration (FDA) has approved Opsynvi (macitentan and tadalafil), a single-tablet combination of an endothelin receptor antagonist (ERA), and a phosphodiesterase 5 (PDE5) inhibitor. 25 March 2024
At its March management board meeting, the European Medicines Agency adopted the EMA’s annual report for 2023, noting that, in 2023, Agency recommended 77 medicines for marketing authorization for human use, 39 of which had a new active substance, and adopted the EMA’s annual report for 2023. 23 March 2024
Oslo, Norway-based Photocure said today that it has received notice from medicines regulator Health Canada approving the product monograph for its Cysview (hexaminolevulinate hydrochloride). 22 March 2024
US clinical-stage company OKYO Pharma’s shares rose 5.7% to $1.86 pre-market today, as it announced additional key findings from analyses of the clinical data set from the 240 patient Phase II, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with dry eye disease (DED). 22 March 2024
Validating Novo Nordisk’s decision to research the cardiovascular impact of Wegovy (semaglutide), US authorities have said Medicare patients with heart problems can now receive the drug. 22 March 2024
Swiss rare disease specialist Relief Therapeutics today announced it has granted an exclusive license to Eton Pharmaceuticals or the commercialization of GOLIKE family of products in the USA. 22 March 2024
Japanese drugmaker Otsuka Pharmaceutical and the US unit of Denmark’s Lundbeck have presented new post hoc pooled analyses of two pivotal Phase III trials evaluating the safety and efficacy of Rexulti (brexpiprazole) in patients with agitation associated with dementia due to Alzheimer's disease. 22 March 2024
Yesterday, the US Food and Drug Administration (FDA) approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular dystrophy (DMD) in patients six years of age and older. 22 March 2024
UK pharma major AstraZeneca today released results from the FLAURA2 Phase III trial that showed its Tagrisso (osimertinib) with the addition of chemotherapy provided a clinically-meaningful and consistent benefit in subsequent outcomes after disease progression in patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). 21 March 2024
Seelos Therapeutics, a company working on therapies for amyotrophic lateral sclerosis (ALS) and other central nervous system disorders (CNS) has been struck by a trial failure. 21 March 2024
Since Swiss pharma giant Roche’s Zelboraf (vemurafenib) gained US Food and drug Administration (FDA) approval in 2011, significant strides have been made in BRAF-targeted cancer therapies, underscoring the significance of combating BRAF mutations in melanoma. 21 March 2024
A statement from the Centers for Disease Control and Prevention (CDC) in the USA raises concerns about the spread of measles, a public health issue which has affected multiple countries in recent years. 20 March 2024
Italfarmaco has announced that results from its pivotal Phase III EPIDYS trial with givinostat in ambulant boys aged six years and older with Duchenne muscular dystrophy (DMD) have been published in The Lancet Neurology. 20 March 2024
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
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
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
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
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
The American Lung Association Research Institute has announced a $22 million research investment in 2024, marking one of the largest lung health research programs in the USA. 16 October 2024
US pharma major Eli Lilly has announced a strategic collaboration with two UK government departments and the devolved nations to tackle significant population health challenges, including exploring new models to better care for people living with obesity. 16 October 2024
TenNor Therapeutics, a Suzhou-based clinical-stage biotech company, has announced the initial closing of a series E financing round, raising over 300 million yuan ($41 million). 16 October 2024
Switzerland-based Novocure saw its shares rise 10% yesterday and leap a further 24% to $22.05 pre-market, after the company received a new US regulatory approval for its key product Optune Lua. 16 October 2024
Shares of Spanish drugmaker PharmaMar leapt more than 28% to 63.70 euros today, after it announced positive clinical trial findings for its combo lung cancer treatment, under development with USA-based Jazz Pharmaceuticals, which rose 4.2%. 15 October 2024
Novartis has discontinued an early Phase II trial of LTP001 in idiopathic pulmonary fibrosis (IPF). The company confirmed that the decision was not related to safety, with no issues emerging in the study. 15 October 2024
US pharma major Eli Lilly has announced plans to invest around 1.5 billion renminbi ($206 million) into expanding its manufacturing facility in Suzhou, China. 15 October 2024
Spanish dermatology specialist Almirall (BME: ALM) has announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole. 15 October 2024
French biopharma company Inventiva has announced financing of immediately 94.1 million euros ($103 million) and up to 348 million euros, subject to satisfaction of specified conditions. 15 October 2024
India's Central Drugs Standard Control Organization (CDSCO) has provided a favorable recommendation for its novel antibiotic Miqnaf (nafithromycin) discovered and developed for the treatment of community-acquired bacterial pneumonia (CABP) in adults. 14 October 2024
The Danish Medicines Council (Medicinrådet), responsible for evaluating and recommending new treatments for Denmark’s healthcare system, is facing a significant increase in processing times. 14 October 2024
The South African Health Products Regulatory Authority (SAHPRA) and the Australian Therapeutic Goods Administration (TGA) have signed a Memorandum of Understanding (MoU), which will strengthen collaboration between the two health product regulators. 14 October 2024
California-based AI company Suki has raised $70 million in new funding to accelerate the growth of its AI-powered voice solutions in healthcare. 11 October 2024
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Company Spotlight
Dewpoint is a biotech company pioneering the application of biomolecular condensate biology – the science studying the organization of biomolecules within membrane-less compartments – towards the development of a new generation of therapeutics to address diseases of high unmet need.