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
The USA’s Acadia Pharmaceuticals received a significant boost last week, when a US Food and Drug Administration advisory panel voted to recommend approval of the company’s Nuplazid (pimavanserin) for psychosis associated with Parkinson’s disease, with its shares leaping 25% in pre-market trading the following day. 3 April 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines, including one advanced therapy medicinal product (ATMP), for approval at its March meeting. 2 April 2016
The US Generic Pharmaceutical Association (GPhA) and America’s Health Insurance Plans (AHIP) have filed an amicus brief urging the Supreme Court to preserve the inter partes review (IPR) process in promoting a competitive prescription drug market for consumers. 1 April 2016
US pharma major Bristol-Myers Squibb has had an application validated by the European Medicines Agency (EMA) to extend indications for Opdivo (nivolumab) to treat classical Hodgkin lymphoma (cHL) patients after prior therapies. 1 April 2016
The US Food and Drug Administration has approved new labeling for Mifeprex (mifepristone) allowing the abortion drug to be used through 70 days of pregnancy rather than the previous 49 days. 31 March 2016
US pharma company Radius Health has submitted a new drug application (NDA) for abaloparatide—SC, a once daily treatment for postmenopausal women with osteoporosis. 31 March 2016
The European Medicines Agency (EMA) has published today a report on its pilot on parallel scientific advice with health-technology-assessment (HTA) bodies that finished at the end of March 2016. 31 March 2016
Anglo-Swedish pharma major AstraZeneca has welcomed a new treatment guideline which recommends its Brilinta (ticagrelor) over clopidogrel in acute coronary syndrome (ACS). 31 March 2016
Privately-held UK manufacturer of plasma-derived protein therapies Bio Products Laboratory has been granted marketing approval by the European Medicines Agency for Coagadex (human coagulation factor X). 30 March 2016
The US Food and Drug Administration has issued a complete response letter (CRL) to OPKO Health’s (NYSE: OPK) New Drug Application (NDA) for Rayaldee (calcifediol) as a treatment for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. 30 March 2016
The benefits of using Nuplazid (pimavanserin) for psychosis associated with Parkinson’s disease outweigh the risks, according to a vote of the US Food and Drug Administration Psychopharmacologic Drugs Advisory Committee. 30 March 2016
The US Food and Drug Administration has issued a complete response letter (CRL) for the supplemental new drug application (sNDA) to include new data in the clinical trials section of the US label of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD). 30 March 2016
US Congress has written to the National Institutes of Health (NIH) questioning the price Americans are charged for the prostate cancer drug Xtandi (enzalutamide) by Japanese company Astellas Pharma. 30 March 2016
Italian CNS-focused drug developer Newron Pharmaceuticals and its partners Zambon and US WorldMeds have received a complete response letter from the US Food and Drug Administration relating to their Parkinson’s disease treatment Xadago (safinamide). 30 March 2016
Puma Biotechnology says that, following recent meetings with the Food and Drug Administration, the company now plans to submit its New Drug Application (NDA) for the approval of neratinib for the treatment of extended adjuvant breast cancer in mid-2016. 29 March 2016
US biotech firm Placon Therapeutics has been launched as an independent company. Placon was spun out from Blend Therapeutics (now Tarveda Therapeutics) to distinctly focus on a pipeline of innovative platinum-based assets. 29 March 2016