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
Stockholm-based biotech firm Swedish Orphan Biovitrum has received a positive recommendation from the UK’s health technology assessor for Xiapex. 30 June 2017
Novartis has successfully extended the marketable use of Zykadia in Europe, to include the first-line treatment of patients with ALK-positive advanced non-small cell lung cancer (NSCLC). 30 June 2017
Against a backdrop of ever-increasing requests for Orphan Drug designation in the USA, the Food and Drug Administration today unveiled a strategic plan to eliminate the agency’s existing backlog of requests and ensure continued timely response to all new requests for designation with firm deadlines. 29 June 2017
The National Institute for Health and Care Excellence (NICE) has today published draft guidance recommending Eli Lilly’s Olumiant (baricitinib) for some people with rheumatoid arthritis (RA). 29 June 2017
The European Commission today launched its new European Union action plan to tackle antimicrobial resistance (AMR) – a growing threat that is responsible for 25,000 deaths in the EU every year. 29 June 2017
UK pharma major GlaxoSmithKline has filed for US approval for an expanded indication of its an interleukin-5 (IL-5) antagonist for the treatment of a rare disease. 29 June 2017
Netherlands-headquartered independent drugmaker Norgine says the US Food and Drug Administration has accepted and will review the company’s regulatory submission for Plenvu. 29 June 2017
The US Federal Trade Commission is currently accepting public comments on an application by Grifols, a Spain-based manufacturer of plasma-derived drugs, to amend the terms of a manufacturing agreement that was part of a 2011 FTC-ordered divestiture. 29 June 2017
The US Institute for Clinical and Economic Review (ICER) has agreed to work closely with the Department of Veterans Affairs (VA) Pharmacy Benefits Management Services office (PBM) to support its use of ICER drug assessment reports in drug coverage and price negotiations with the pharmaceutical industry. 28 June 2017
The US Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. 28 June 2017
US Republican attempts to rush through US President Donald Trump’s beleaguered Obamacare replacement look likely to fail, as the Congressional Budget Office found the bill would deny millions of Americans coverage. 27 June 2017
The European Commission has approved Erelzi (biosimilar etanercept) for use in Europe for the treatment of multiple inflammatory diseases. 27 June 2017
Spain’s leading drugmaker Almirall has received European clearance to market Skilarence (dimethyl fumarate), a new oral formulation of a type of fumaric acid ester, for the treatment of patients with moderate-to-severe chronic plaque psoriasis. 27 June 2017
Health economists have given the UK an “amber warning” on the potential consequences of leaving the European Medicines Agency, in a new research paper. 27 June 2017
The European Commission has granted marketing authorization for Kevzara (sarilumab) in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis. 27 June 2017