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 has advised specialty drugmaker Egalet that it will not meet the previously announced October 14 prescription drug user fee act (PDUFA) date for the company’s Arymo ER (morphine sulfate). 14 October 2016
The US Food and Drug Administration has accepted for review the New Drug Application (NDA) from Sunovion Pharmaceuticals for SUN-101 (glycopyrrolate). 14 October 2016
The National Institute for Health and Care Excellence (NICE) has asked Bristol-Myers Squibb to set out a case for including its Opdivo (nivolumab) in the Cancer Drugs Fund (CDF). 14 October 2016
Allergan has received the Marketing Authorization for Belkyra (deoxycholic acid) after being granted approval by the Swedish Medical Products Agency (MPA). 13 October 2016
In draft guidance published today, the medicines cost effectiveness watchdog for England and Wales says that it does not recommend Imbruvica (ibrutinib) for treating some people with Waldenstrom’s macroglobulinemia – a rare type of slow growing non-Hodgkin’s lymphoma. 12 October 2016
The US Food and Drug Administration has approved privately-held US biotech Protein Sciences’ quadrivalent formulation of Flublok influenza vaccine, which protects against four strains of influenza, three of the same strains found in trivalent Flublok plus an additional B strain. 12 October 2016
Inpatient hospital drug costs increased more than 38% per admission between 2013 and 2015, according to a new report from the University of Chicago’s NORC, an independent research institution. 12 October 2016
According to a paper published in Alzheimer's Research & Therapy, prominent experts in the field of Alzheimer’s disease (AD) state that under current conditions, only a limited number of disease-modifying therapies have a chance to be approved and available to patients by 2025. 11 October 2016
The German Institute for Quality and Efficiency in Health Care (IQWiG) has reassessed whether AstraZeneca’s Onglyza (saxagliptin) and the combination drug Komboglyze (saxagliptin and metformin) have advantages or javascript:void(0);disadvantages in comparison with the appropriate comparator therapies for the patients. 11 October 2016
With around 75 agency representatives from 23 countries attending, the two-day summit is being held in Switzerland for the first time and organized by Swissmedic, the Swiss Agency for Therapeutic Products. 11 October 2016
The medicines cost-effectiveness watchdog for England and Wales has today published draft updated guidance recommending National Health Service use of US biotech firm Celgene’s Otezla (apremilast) for psoriatic arthritis. 11 October 2016
New Zealand’s Pharmaceutical Management Agency PHARMAC has reached agreement with the local subsidiary of UK pharma major GlaxoSmithKline for the funding of the HIV treatments, dolutegravir (Tivicay) and abacavir sulphate with lamivudine (Kivexa). 11 October 2016
NicOx has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding the New Drug Application (NDA) for AC-170, its novel, proprietary, cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis. 10 October 2016
On October 12, the European Parliament’s Environment, Public Health and Food Safety (ENVI) committee will consider the new draft report on medicines access. 10 October 2016
Sanofi and Regeneron last week reported some strong results for their atopic dermatitis drug candidate Dupixent at the European Academy of Dermatology and Venereology meeting in Vienna over the weekend. 9 October 2016
Mylan said on Friday that its subsidiary, Mylan Inc, has agreed to the terms of a $465 million settlement with the US Department of Justice and other government agencies. 8 October 2016
Danish diabetes care giant Novo Nordisk revealed on Friday that it has received a Complete Response Letter from the US Food and Drug Administration regarding the New Drug Application for faster-acting insulin aspart. 8 October 2016
The US Food and Drug Administration has approved Danish CNS specialist Lundbeck’s Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. 8 October 2016
At its October 6, 2016 meeting in London, the European Medicines Agency’s management board elected Grzegorz Cessak as vice chairman for a three-year period. Dr Cessak is president of Poland’s Office for registration of Medicinal Products, Medical Devices and Biocidal Products, a post he has held since July 2009. 8 October 2016
India’s biosimilars drug industry was worth close to $300 million in 2015, with domestic sales of nearly $250 million and the remainder in exports, and is expanding at a compound annual growth rate of 14%. 7 October 2016