Australian medicines regulator the Therapeutic Goods Administration (TGA) has published updated acceptable intake (AI) information for nitrosamine impurities in medicines consistent with recent EMA updated information- external site. 26 April 2024
With peptides, oligos and peptide conjugates continuing to attract drug developer interest and industry capacity in short supply, China’s WuXi AppTec says its Changzhou site has been approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). 19 April 2024
Japanese drugmaker Eisai has announced that the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for intravenous (IV) infusion has been launched in Japan. 17 April 2024
Japanese pharma major Shionogi has received approval of a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) for the treatment and post-exposure prophylaxis for influenza virus infection for pediatrics aged 5 to 15 April 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved the medicine Nulibry (fosdenopterin) to treat the genetic disease Molybdenum Cofactor Deficiency (MoCD) Type A. 9 April 2024
French pharma major Sanofi today announced the UK launch of Verorab (Sanofi Inactivated Rabies Vaccine) an inactivated rabies vaccine indicated for pre-exposure and post-exposure prophylaxis of rabies in all age groups. 5 April 2024
Japan’s Asahi Kasei Pharma has concluded an agreement with Swedish Orphan Biovitrum Japan Co regarding exclusive distribution rights in Japan for the additional indication of idiopathic thrombocytopenic purpura (immune thrombocytopenia) for Doptelet (avatrombopag maleate), a thrombopoietin receptor agonist. 2 April 2024
Earlier this week Merck & Co gained much awaited approval from the Food and Drug Administration for its pulmonary arterial hypertension (PAH) treatment Winrevair (sotatercept-csrk) injection. 30 March 2024
Germany’s Merck KGaA says it has expanded its M Lab Collaboration Center in Shanghai, the company’s largest in its global network of 10 interconnected labs. 29 March 2024
Eisai today announced that it has entered into an agreement to divest its Japanese rights for vertigo and equilibrium disturbance treatment Merislon (betahistine mesilate) and muscle relaxant Myonal (eperisone hydrochloride) to fellow Japan based Kaken Pharmaceutical. 29 March 2024
Swedish company InDex Pharmaceuticals have announced the departure of chief executive (CEO) Jenny Sundqvist and chief financial officer and deputy CEO Johan Giléus. 27 March 2024
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) today announced the new Quantitative Medicine (QM) Center of Excellence (CoE). 25 March 2024
Privately-held Austrian firm pharmaand (pharma&) has announced the presentation of new data from the randomized, Phase III company-sponsored ATHENA trial. 18 March 2024
Eris Lifesciences has announced the acquisition of fellow Indian company Biocon Biologics’ India branded formulation business for a consideration of rupees 1,242 crore (~$149 million). 16 March 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today (March 7) approved US drugmaker Marinus Pharmaceuticals’ Ztalmy (ganaxolone) as the first anti-seizure medication in the UK to treat cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD). 7 March 2024
US pharma company CymaBay Therapeutics today announced that the Marketing Authorization Application (MAA) for seladelpar, for the treatment of primary biliary cholangitis (PBC), has been validated and will be reviewed by the European Medicines Agency (EMA). 4 March 2024
Serum Institute of India (SII) aims to significantly boost supply of its human papillomavirus (HPV) vaccine as it gears up to provide its jabs to the government at cheaper rates for an immunization campaign this year against the cancer-causing virus, according to a Reuters report. 4 March 2024
Viking Therapeutics’ shares surged more than 80% pre-market on Monday, after it announced positive top-line results from the company's Phase II clinical trial of VK2735 as an obesity treatment. 27 February 2024
Japanese drugmaker Daiichi Sankyo said on Friday that it would invest about 1 billion euros ($1.07 billion) to expand a manufacturing site near Munich, Germany, to boost its work on precision cancer drugs, according to media reports. 20 February 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