German family-owned pharma major Boehringer Ingelheim’s attempt to block the Medicare Drug Price Negotiation Program was rejected by a federal judge. 5 July 2024
Mochida Pharmaceutical announced that it has submitted a New Drug Application to the China National Medical Products Administration (NMPA) for Epadel S (MND-21), a highly purified eicosapentaenoic acid (EPA). 4 July 2024
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has concluded its review of Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) and has recommended that the medicine’s marketing authorization be revoked 29 June 2024
US drugmaker Lexicon Pharmaceuticals today announced that, following multiple interactions with and recent feedback from the US Food and Drug Administration (FDA), it has resubmitted its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in people with type 1 diabetes and chronic kidney disease (CKD). 21 June 2024
The USA’s Biomedical Advanced Research and Development Authority (BARDA) has announced up to $500 million in Project NextGen funding to plan and execute multiple Phase IIb clinical trials evaluating novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19. 15 June 2024
Pfizer chief executive Albert Bourla said the pharma giant is pausing big acquisitions after spending $43 billion last year on buying Seagen, according to a Bloomberg report. 12 June 2024
German family-owned pharma major Boehringer Ingelheim’s new program to cap out-of-pocket costs at $35 per month for eligible patients for the company’s inhalers is now available. 1 June 2024
The US Food and Drug Administration (FDA) has approved Teva Pharmaceutical's Austedo XR (deutetrabenazine), as a one pill, once-daily treatment option, now with four new tablet strengths (30, 36, 42, 48 mg) indicated in adults for tardive dyskinesia (TD) and Huntington’s disease (HD) chorea. 30 May 2024
Negotiators of a proposed World Health Organization (WHO) pandemic accord have been unable to reach consensus ahead of a self-imposed deadline of next week’s World Health Assembly. 25 May 2024
Russia is experiencing a boom in demand and sales of antidepressants these days, according to recent statements by representatives of some leading local pharmacies and analysts. 21 May 2024
A Delaware, USA, federal jury on Friday said that AstraZeneca should pay $107.5 million in royalty damages for infringing a Pfizer-brand cancer treatment patent, with its cancer drug Tagrisso (osimertinib), according to IP Law360. 20 May 2024
This week, the US Centers for Medicare & Medicaid Services (CMS) announced it would hold off on a provision to rule RIN 0938-AU28 that would have required pharmaceutical manufacturers to stack discounts and rebates to report a best price for the Medicaid drug rebate program. 17 May 2024
Danish diabetes and obesity giant Novo Nordisk is planning to test whether its weight loss drugs, including semaglutide, marketed as Wegovy, can impact alcohol use in patients with liver disease, according to Bloomberg. 15 May 2024
Japanese drugmaker Eisai today announced it has received approval in China for the additional indication of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older. 13 May 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has now approved Pfizer’s Oxbryta (voxelotor) to be recommended for use on the National Health Service NHS to treat people with hemolytic anemia caused by sickle cell disease (SCD). 6 May 2024
Subsidies for Danish drugmaker giant Novo Nordisk’s diabetes drug Ozempic (semaglutide) will be restricted in its home country due to rising public spending on the blockbuster diabetes medicine, which is increasingly being used as a weight-loss treatment, according to a report from Bloomberg. 2 May 2024
As of May 1, Johnson & Johnson is updating its brand and uniting both its two business segments under the Johnson & Johnson brand name in the UK. 1 May 2024
US antivirals specialist Gilead Sciences announced that the US Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads. 27 April 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
Pfizer is to present initial findings from its CULTIVATE study of its sphingosine-1-phosphate (S1P) receptor modulator Velsipity (etrasimod) in Crohn’s disease (CD) at United European Gastroenterology Week 2024. 11 October 2024
Switzerland-based KeyBioscience and US pharma major Eli Lilly have agreed to extend their collaboration on the development of dual amylin calcitonin receptor agonists (DACRA), a new class of potential treatments for obesity and related disorders. 11 October 2024