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
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 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
Shares in Indian drugmaker Natco Pharma were 13% down on Monday after the company provided an update on the US Food and Drug Administration inspection of its manufacturing facilities. 29 March 2016
The outgoing chief executive of under-siege Canadian drugmaker Valeant Pharmaceuticals will be grilled by a US Senate panel over rising drug prices. 29 March 2016
GlaxoSmithKline revealed this morning that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted approval for Nucala (mepolizumab). 29 March 2016
Alexion Pharmaceuticals said on Monday that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Kanuma (sebelipase alfa) for the treatment of patients of all ages in Japan with lysosomal acid lipase deficiency (LAL-D). 29 March 2016
In our weekly expert view piece, Mark De Simone, chief executive of Aegate, a company which operates a highly secure real-time system to verify the authenticity of medicines, examines the recently published Falsified Medicines Directive (FMD). 28 March 2016
Earlier this month, the China Food and Drug Administration (CFDA) formally launched a new classification system for chemical drugs, with the release of the Reform Scheme of the Classification System for Registration of Chemical Drugs. 28 March 2016
In 2015, the US Food and Drug Administration set a new record for the number of drugs approved in one year, with 56 drugs getting the green light from the federal agency. 28 March 2016
The US Food and Drug Administration has approved Cinqair (reslizumab) Injection, an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype. 24 March 2016
The Russian Parliament (State Duma) will consider a draft of a new federal law that will establish a state monopoly on the production of drugs in Russia, reports The Pharma Letter’s local correspondent. 24 March 2016
The US Food and Drug Administration (FDA) has approved Eli Lilly’s monoclonal antibody Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis, it has been announced. 23 March 2016
Anglo-Swedish pharma firm AstraZeneca has reported disappointing top-line results from the Socrates trial testing the efficacy of Brilinta (ticagrelor) tablets to prevent strokes. 23 March 2016
In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the US Food and Drug Administration yesterday announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. 23 March 2016
US pharma firm Vertex has slammed the UK cost watchdog, the National Institute for Health and Care Excellence (NICE), for its failure to recommend the company’s treatment for cystic fibrosis. 23 March 2016
In the next five years, where is China’s pharma industry heading to? How should pharma companies allocate their resources to ensure the reward? The answers lie in the recently released guidance for the pharma industry five-year development from China’s top authority – the State Council, reports The Pharma Letter’s local correspondent Wang Fangqing. 22 March 2016
The US subsidiary of Japanese pharma major Eisai has agreed to revise the joint promotion agreement with Switzerland’s Helsinn Healthcare for their chemotherapy-induced nausea and vomiting (CINV) franchise. 22 March 2016
Australian regulator the Therapeutics Goods Administration (TGA) has been closely monitoring reports of adverse events following immunization with Bexsero meningococcal B vaccine, specifically those relating to fever in infants and children. 22 March 2016
Rebuilding customer trust in pharma was the key theme underpinning the eyeforpharma conference in Barcelona last week, where key decision-makers gathered to share their ideas and experience. 22 March 2016
In our weekly expert view piece, Pam Taak, senior associate in the Life Sciences & Healthcare practice of Norton Rose Fulbright LLP, examines the implications of changes to the patent protection and enforcement landscape in Europe. 22 March 2016