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
Johnson & Johnson (NYSE: JNJ) subsidiary Janssen has announced results from a Phase II study showing glycemic improvements in patients with type 1 diabetes (T1DM) who were treated with its SGLT2 inhibitor Invokana (canagliflozin). But in the same week the US Food and Drug Administration (FDA) upped its safety warnings on the drug. 15 June 2016
Leading Russian biotech firm Biocad has filed a petition to the New York Federal Court against Swiss pharma giant Roche, accusing the company of setting monopoly-low prices for its products in Russia, with the aim of ruining business of local competitors, reports The Pharma Letter’s local correspondent. 14 June 2016
French pharma major Sanofi has announced that two late-stage Phase III trials of its LixiLan diabetes drugs have met their primary endpoints. 14 June 2016
Immediate contingency plans should be put in place to safeguard the UK’s science and innovation sector in case Britain votes to leave the EU, a government report has said. 14 June 2016
USA-based Eleven Biotherapeutics, specialized in protein therapeutics to treat diseases of the eye, yesterday entered into an exclusive license agreement with Swiss pharma giant Roche 14 June 2016
Taiwanese drug developer TaiGen Biotechnology has received approval from the China Food and Drug Administration (CFDA) to market the oral formulation of its novel antibiotic, Taigexyn (nemonoxacin), in mainland China. 14 June 2016
In our weekly expert view piece, chief executive of the BioIndustry Association (BIA), Steve Bates, explains why he thinks it is vital the UK remains a part of the European Union. 14 June 2016
Research findings from specialists treating advanced lung cancer have today highlighted worrying concerns that UK patients are being denied the best possible chance of survival. 14 June 2016
The US Food and Drug Administration has granted Breakthrough Therapy designation for two investigational products for rare diseases from Shire. 13 June 2016
Drug pricing was on Wall Street’s mind again Friday, as Wells Fargo tapped Netherlands-incorporated Mylan as the next target for activists, reported Investor’s Business Daily. 13 June 2016
The US Food and Drug Administration has granted approval for privately-held PaxVax’ Vaxchora, a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. 13 June 2016
The Colombian Ministry of Health has announced that negotiations with Swiss pharma giant Novartis over the price of its cancer drug Glivec (imatinib) have failed, and that Health Minister Alejandro Gaviria will proceed with the formal declaration that a compulsory license for the patents on the drug is in the public interest. 13 June 2016
China Food and Drug Administration’s (CFDA) Minister Bi Jingquan and Bill & Melinda Gates Foundation co-chairman Bill Gates recently officially signed the Memorandum of Understanding on Strategic Cooperation between the CFDA of the People's Republic of China and the Gates Foundation. 13 June 2016
By Barbara Obstoj-Cardwell. Editor
Sarepta Therapeutics and top officials at the US Food and Drug Administration are working cooperatively to approve the Duchenne muscular dystrophy drug eteplirsen, wrote Adam Feuerstein on TheStreet blog. 12 June 2016
The European Ombudsman, Emily O'Reilly, has welcomed increased transparency in the clinical testing of Humira (adalimumab), one of the world’s biggest selling drugs, following her inquiry into the publication of clinical study reports. 10 June 2016
The Indian Pharmacopeia Commission (IPC) has released the national reference standards, specifically referred as the Indian Pharmacopoeia Reference Substances (IPRS Vaccines), the first such initiative to be undertaken of its kind. 9 June 2016
New Zealand’s Pharmaceutical Management Agency, PHARMAC, today announced funding of six new treatments across important areas of health, including major advancements in the treatment of hepatitis C. 9 June 2016
Trade group AusBiotech said today it has provided a submission in response to the Australin Productivity Commission’s Intellectual Property (IP) Arrangements Draft Report, disagreeing with numerous recommendations in regard to patents and data protection. 9 June 2016
There is an urgent need for renewal of Written Confirmation (WCs) issued by the Drug Controller General of India (DCGI) for active pharmaceutical ingredient (API) exporters to the European Union, according to Brand India Pharma. 9 June 2016