The Australian medicines regulator has updated its guidance on reporting obligations for pharmaceutical companies, mandating confidential reporting of all shortages. 2 May 2019
Gilead Sciences has won a positive reimbursement decision in Taiwan for its once-daily hepatitis B medicine Vemlidy (tenofovir alafenamide. The approval covers adults with compensated liver disease. 1 May 2019
US pharma giant Merck & Co, which is the USA’s sole supplier of measles, mumps and rubella (MMR) vaccine, has "taken steps to increase US supply" of the vaccine due to the current measles outbreak, according to a report from Seeking Alpha. 29 April 2019
Shield Therapeutics has broadened the Swiss label for Feraccru (ferric maltol) to include treatment of all adults with iron deficiency (ID), with or without anemia. The firm won European approval for this indication last year. 24 April 2019
California-based Satsuma Pharmaceuticals, which is developing STS101 (dihydroergotamine [DHE] nasal powder) for the acute treatment of migraine, today announced a $62 million Series B preferred stock financing. 24 April 2019
ADC Therapeutics has entered into a discovery collaboration and license agreement with Adagene, leveraging the latter’s SAFEbody technology to develop a novel antibody-drug conjugate against a solid tumor target. 24 April 2019
INSYS Therapeutics has appointed Andrew Long as chief executive, replacing Saeed Motahari, who the firm says has “mutually agreed” with the board to step down immediately. 16 April 2019
Rifaximin-a, in combination with lactulose, the standard of care treatment, resulted in significant reductions in both hepatic encephalopathy-related hospital admissions and length of hospital stay. 15 April 2019
Shanghai’s Luqa Pharmaceuticals has reached a deal with Spanish drugmaker Ferrer Internacional to develop and commercialize ozenoxacin in China and Hong Kong. 12 April 2019
Mallinckrodt has been awarded Australian approval for INOmax (nitric oxide) gas, for perioperative pulmonary hypertension in adults, in conjunction with cardiovascular surgery. 12 April 2019
UK-based Diurnal has agreed on a clinical and regulatory path for Chronocort (hydrocortisone) as a therapy for congenital adrenal hyperplasia (CAH) in Europe. 11 April 2019
Some seven years after a conditional approval, Pixuvri (pixantrone) is on the brink of gaining a full authorization in Europe as a single agent for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma. 9 April 2019
Gilead has applied to broaden the US label for Descovy (emtricitabine/tenofovir alafenamide) for pre-exposure prophylaxis (PrEP), to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV. 5 April 2019
The US Food and Drug Administration on Thursday issued a final guidance for industry entitled "REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary." 5 April 2019
The UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has provided a new guidance document covering the conduct of clinical trials in the event of the UK leaving the European Union without a negotiated trading agreement. 4 April 2019
Japanese drugmaker Sumitomo Dainippon Pharma today announced that on March 29 the company applied for a partial change in the marketing approval previously acquired in Japan for Rethio (thiotepa) 100mg for IV infusion. 3 April 2019
European firm Neuraxpharm has launched a new Polish subsidiary. The company wants to build its position as a CNS specialist in Poland, offering nutraceuticals, standard generics and added value medicines. 3 April 2019
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