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.
Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex, provides an Expert View. 29 February 2024
US gastroenterology specialist Ironwood Pharmaceuticals saw its shares plunge more than 30% to $10.50 in pre-market activity today, after it announced what it called ‘positive’ top-line results from its pivotal Phase III STARS trial. 29 February 2024
Indian drugmakers plan to accelerate their expansion in the Russian pharmaceutical market this year, which will be achieved by the building of several large-scale manufacturing facilities within the territory of the country, reports The Pharma Letter’s local correspondent. 29 February 2024
Last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorization for Nezglyal (leriglitazone) following a re-examination of the filing. 29 February 2024
Shares in New Jersey, USA-based Palatin Technologies fell over a third on Wednesday, after a key Phase III trial missed its efficacy goals. 29 February 2024
Australian medicines regulator the Therapeutic Goods Administration (TGA) has begun a targeted consultation process as part of a proposal to change the Therapeutic Goods Regulations 1990 to remove all medicines containing glucagon-like-peptide-1 (GLP-1) receptor agonist analogues (GLP-1 RAs), including semaglutide-like medicines, from the pharmacist extemporaneous compounding exemptions. 29 February 2024
Process changes for the assessment of established medicines have been published by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), in new guidance which will come into effect on Friday March1, 2024. 29 February 2024
USA-based rare disease Applied Therapeutics today announced that the US Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) for govorestat (AT-007) for the treatment of classic galactosemia 28 February 2024
Riding high after a high-profile victory over erstwhile US President Donald Trump, New York Attorney General Letitia James has set her sights on another emotive issue - the safety of certain medicines given to children. 28 February 2024
Indian drugmaker Cipla Limited says it has received approval from the Central Drugs Standard Control Organization (CDSCO) to market the novel antibiotic Zemdri (plazomicin) in India. 28 February 2024
Belgium’s largest drugmaker UCB today reported earnings results for the full year ended December 31, 2023 with a downturn on sales and earnings, but demonstrating significant achievements and sending its shares up 3.5% to 100.50 euros. 28 February 2024
Shares of biotech FibroGen leapt 14.6% to $2.12 by close of trading Tuesday, after it announced a deal with UK pharma major AstraZeneca for roxadustat would be terminated. 28 February 2024
French ophthalmology company Nicox has announced it will replace its chief executive, Andreas Segerros, with current chief business officer Gavin Spencer. 28 February 2024
In the USA, there is growing resistance to a bid from the White House to exercise so-called march-in rights, a process whereby the federal government requires patent holders to agree to a licence. 27 February 2024
Antiviral specialist Gilead Sciences has announced a new approval from the US Food and Drug Administration, for Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). 27 February 2024
USA-based Pelage Pharmaceuticals, a clinical-stage regenerative medicine company developing treatments for hair loss, has closed a $16.75 million Series A financing. 27 February 2024
The US Food and Drug Administration (FDA) has approved the marketing application for Exblifep (cefepime/enmetazobactam), submitted by Franco-German firm Allecra Therapeutics. 27 February 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.