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 Royal Decree Law 1090/2015 regulating clinical trials has allowed, since its coming into force last January 13, that the time needed to kick off a new clinical trial in Spain is reduced by more than a month (19%) in Spain, reported the trade group Farmaindustria. 25 October 2016
Inovio Pharmaceuticals saw its shares tank, after it announced that the US Food and Drug Administration has placed a clinical hold on its proposed Phase III clinical program for VGX-3100. 24 October 2016
Melinta Therapeutics has submitted New Drug Applications (NDAs) to the US Food and Drug Administration for approval of IV and oral Baxdela (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). 24 October 2016
GlaxoSmithKline has filed a Biologics License Application (BLA) to the US Food and Drug Administration for its shingles vaccine Shingrix. 24 October 2016
The new pricing Agreement between the Irish Pharmaceutical Healthcare Association (IPHA) and the State which was finalized in July, is on course to save the State over 140 million euros ($154 million) in its first year. 24 October 2016
An official from the Department of Drug and Cosmetics Registration of the China Food and Drug Administration (CFDA) was interviewed about “the issues on authenticity of clinical trial data in new drug registration applications,” reported by media. 24 October 2016
Medicinal product authorization holders are obliged to notify Switzerland’s regulatory authority, Swissmedic, of the companies involved in manufacturing and to have them approved. 24 October 2016
A new report published by the UK government today, puts forward a number of recommendations aimed at speeding up the process by which the NHS implements newly developed drugs and medical procedures. 24 October 2016
By Barbara Obstoj-Cardwell. Editor
PTC Therapeutics is having a tough time convincing regulators on both sides of the Atlantic Ocean to reconsider the marketing application for its Duchenne muscular dystrophy drug Translarna, wrote Adam Feuerstein on The Street. 23 October 2016
The US Food and Drug Administration on Friday approved pharma giant Merck & Co’s Biologics Licensing Application for Zinplava (bezlotoxumab) Injection 25mg/mL. 22 October 2016
The US Food and Drug Administration approved a supplemental New Drug Application (sNDA) to update the US product labeling for Xtandi (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study. 22 October 2016
Cuba and the USA on Thursday signed an agreement to cooperate on cancer research as part of a visit to the island nation by US Secretary of Health and Human Services Sylvia Burwell. 21 October 2016
As of October 20, the European Medicines Agency has given open access to clinical reports for new medicines for human use authorized in the European Union. 21 October 2016
The US Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application for SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease (HD). 21 October 2016
The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance which Bristol–Myers Squibb’s Opdivo (nivolumab) should be made available to people who have been previously treated for advanced renal cell cancer (RCC) – a type of kidney cancer. 21 October 2016
Gilead Sciences today announced positive top-line results from four international Phase III clinical studies of a three anti-virals combination for the treatment of hepatitis C. 20 October 2016
The US Food and Drug Administration has granted accelerated approval for pharma major Eli Lilly’s Lartruvo (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS), which are cancers that develop in muscles, fat, tendons or other soft tissues. 20 October 2016
The European Court of Justice has issued a ruling that strikes against fixed prices for prescription drugs in Germany. The specific case dealt with mail-order prescriptions from the Netherlands used to treat Parkinson's, reports Deutsche Welle. 20 October 2016
Celgene announced today that adult patients in England and Wales with chronic plaque psoriasis will now have access to oral Otezla (apremilast) following a positive final appraisal determination from the National Institute for Health and Care Excellence (NICE). 20 October 2016