The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
US biotech Emergent BioSolutions revealed it has secured approximately $400 million in orders in 2024 and 2025 associated with its vaccinia, smallpox and mpox product portfolio. 26 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja (leniolisib), from Netherlands-based Pharming. 26 September 2024
The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
Healthcare plan provider Centivo has raised $75 million in equity and debt financing to support its goal of offering affordable care to employees and their families. 25 September 2024
President Biden has said the USA will commit at least $500 million to support African countries in battling the ongoing mpox outbreak in Central and Eastern Africa. 25 September 2024
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
The US Food and Drug Administration yesterday granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. 24 March 2017
The US Food and Drug Administration approved Symproic (naldemedine) 0.2 mg tablets C-II as a once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. 24 March 2017
The International Society of Cellular Therapy (ISCT) believes that the massive and unprecedented budget cuts to US governmental scientific agencies including the (National Institutes of Health (NIH) and National Science Foundation (NSF) proposed by US President Donald Trump, if implemented, will have wide ranging and potentially life threaten in ramifications to science, clinical care and patients in the US and internationally. 24 March 2017
The European Medicines agency is expected to complete its review of brexpiprazole for use in schizophrenia, according to the drug’s developers. 23 March 2017
There was good news for US clinical-stage biotech Akashi Therapeutics yesterday, when it received permission to resume development of its Duchenne drug candidate. 23 March 2017
India’s Union Health Ministry plans to create a digital platform to track and regulate sale of quality drugs in the country, according to a posting on Brand India Pharma*. 23 March 2017
Key authorities, eminent lawyers and industry leaders this week discussed in London the proposals put forward by the European Commission to stimulate jobs and growth in the pharmaceutical sector in Europe at the Medicines for Europe 13th Legal Affairs Conference. 23 March 2017
US-based Boston Biomedical is making new senior appointments in oncology, as the company’s founder Chiang J. Li steps down from his role as chief executive. 23 March 2017
The application of cost-effectiveness criteria is a hallmark of the UK’s approach to health technology assessment, differentiating it from many other European countries. It’s an approach which raises ethical considerations around access to medical technology; which drugs we should fund and which diseases, which patients, we should treat. 22 March 2017
Ireland-headquartered Shire today announced that the US Food and Drug Administration has granted the company Fast Track designation for its rare disease candidate SHP655. 22 March 2017
In a U-turn by the US agency, the Food and Drug Administration on Tuesday approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. 22 March 2017
The Russian Federal Antimonopoly Service (FAS) is discussing with the government lifting of the "third extra" rule for public procurement of drugs, according to recent statements of Igor Artemyev, head of the FAS, reports The Pharma Letter’s local correspondent. 22 March 2017
Up to 10 domestic and leading global drugmakers operating in the Russian market are considering reducing prices for their drugs, and in particular those intended for the treatment of the most serious diseases, including HIV/AIDS, hepatitis C, tuberculosis and some others, reports The Pharma Letter’s local correspondent. 21 March 2017
Texan analgesia specialist Pain Therapeutics has announced positive regulatory guidance from a recent meeting with the US Food and Drug Administration, regarding lead candidate Remoxy (oxycodone). 21 March 2017
The US Food and Drug Administration under the US President's Emergency Plan for AIDS Relief (PEPFAR) has approved the New Drug Application for efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 400mg/300mg/300mg ("TLE400"). 21 March 2017
The US Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) date of August 24, 2017 for its decision on the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%. 21 March 2017
The Therapeutics Goods Administration (TGA) is investigating ways that it might provide support for small- and medium-enterprises (SMEs) in accessing regulatory guidance, and seeks feedback on the key themes that emerged in initial discussions with trade group AusBiotech and industry. 21 March 2017
USA-based Rich Pharmaceuticals has reached agreement with I Tech Health Corp to form a subsidiary and launch CannCodex to serve the medicinal cannabis industry as well as provide data and services to pharmaceutical companies worldwide. 21 March 2017
Multinational pharma companies have long been complaining that it takes too long to get their drugs into the Chinese market, reports The Pharma Letter’s local correspondent Wang Fangqing. 20 March 2017