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 US Food and Drug Adminstration has approved Bristol-Myers Squibb’s Opdivo (nivolumab) as a treatment for patients with a rare blood cancer, marking the first approval of a PD-1 inhibitor in a hematological malignancy. 18 May 2016
Large innovative US pharmaceutical companies are expected to continue targeted acquisitions as the need for larger transactions has declined, according to Fitch Ratings. 18 May 2016
Valeant Pharmaceuticals has announced that it will make an enhanced rebate program available to reduce the price of Nitropress (nitroprusside) and Isuprel (isoproterenol) for all hospitals in the USA. 17 May 2016
US rare diseases focused biopharma company Catalyst Pharmaceuticals today announced that the company is reducing its workforce by approximately 30%. 17 May 2016
Switzerland-based Actelion has received European Commission marketing authorization for Uptravi (selexipag), its selective IP prostacyclin receptor agonist, as a long-term treatment of pulmonary arterial hypertension (PAH), in the European Union. 17 May 2016
Serious, sometimes life-threatening and fatal cases of diabetic ketoacidosis (DKA) have been reported in patients on sodium glucose co-transporter 2 (SGLT2) inhibitors for type 1 and type 2 diabetes, warns medicines regulator Health Canada. 17 May 2016
US Democrat presidential front runner Hillary Clinton just dipped her toe a little bit further into the waters of single-payer health care, prodded by her competitor for the Democratic presidential nomination, Senator Bernie Sanders, according to a posting on the website of the Pacific Research Institute think-tank. 17 May 2016
US Pharma major Bristol-Myers Squibb will not seek reimbursement for multiple myeloma drug Empliciti (elotuzumab) in the UK and the Republic of Ireland because the company cannot demonstrate cost-effectiveness, it has been revealed. 16 May 2016
BioIntegrator, a member of the Russian ChemRar group of companies, announced today the successful launch in Belorussia of Nescler, a unique oral formulation of fingolimod. 16 May 2016
Danish diabetes care giant Novo Nordisk said today it has submitted a Biologics License Application for the approval of long-acting factor IX, nonacog beta pegol to the US Food and Drug Administration. 16 May 2016
Medicines regulator Health Canada announced on Friday that the department will propose a regulatory amendment to allow access to diacetylmorphine under Health Canada's Special Access Program (SAP). 16 May 2016
According to estimates from Poland-based market research group PMR, Poland will be the most rapidly developing market in the area of generics in the next five years, given its traditionally unchangeable pro-generic policy and the generally attractive nature of the market, based on its affluence and size. 16 May 2016
The UK’s medicines cost-effectiveness watchdog the National Institute for Health and Clinical Excellence (NICE) has come in for a lot of criticism for negative decisions, particularly with regards to new cancer drugs, and last week’s rejection of Bristol-Myers Squibb’s Opdivo was no exception. 15 May 2016
A US drugmaker has joined the list of companies that have refused to supply the drugs that are used in the USA to implement capital punishment. Lethal injection has long been the most common form of execution in the USA. 14 May 2016
Eisai has received approval from the US Food and Drug Administration for Lenvima (lenvatinib mesylate), the company's multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an anti-angiogenic therapy. 14 May 2016
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), at its May meeting, adopted a summary report following the review of a meta-analysis of data from three observational studies, aiming to assess the risk of developing inhibitors (antibodies) against individual recombinant factor VIII products in previously untreated patients with severe hemophilia A. 13 May 2016
The European Commission has now approved Idelvion (coagulation Factor IX [recombinant], albumin fusion protein), from Australia’s CSL Limited, for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency). 13 May 2016
Nordic company Swedish Orphan Biovitrum and US biotech major Biogen have received European approval for their Alprolix (rFIXFc) extended half-life therapy for hemophilia B. 13 May 2016
The US companies represented by trade group Pharmaceutical Research and Manufacturers of America (PhRMA) invested an estimated $58.8 billion into research and development (R&D), according to the latest survey of its members. 13 May 2016
The first and only immuno-oncology combination therapy for the treatment of advanced melanoma has been approved by the European Commission. 12 May 2016