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 European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval at its July meeting, and rejected two. 22 July 2017
An inquiry has been launched by the House of Lords into a strategy promised to make the UK the best place in the world to invest in life sciences. 21 July 2017
US biotech Amgen has had its Biologics License Application (BLA) for the migraine treatment Aimovig (erenumab) accepted by the US Food and Drug Administration (FDA). 21 July 2017
Privately-held Italian company Dompé has had its marketing authorization application of cenegermin eye drops for the treatment of moderate to severe neurotrophic keratitis approved by the European Commission (EC). 21 July 2017
Swiss pharma group Vifor Pharma has received European marketing authorization for Veltassa a sodium-free potassium binder for the treatment of hyperkalemia in adult patients. The company filed for approval in April 2016. 21 July 2017
The US Food and Drug Administration (FDA) has granted tentative approval for Lusduna Nexvue (insulin glargine injection), a follow-on biologic basal insulin in a pre-filled dosing device. 21 July 2017
Yesterday’s announcement that the European Ombudsman Emily O’Reilly is instigating an inquiry into the European Medicines Agency’s pre-submission meetings with pharmaceutical companies regarding marketing authorization applications (MAAs) has prompted a response from trade group the European Federation of Pharmaceutical Industries and Associations (EFPIA). 21 July 2017
The New Drug Application (NDA) for Yonsa (abiraterone acetate) ultramicrosize tablets has been accepted for filing by the US Food and Drug Administration, says privately-held company Churchill Pharmaceuticals. 20 July 2017
Kyntheum (brodalumab), a new biologic medicine developed for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy, has been granted full marketing authorization in all 28 EU member countries plus Iceland, Liechtenstein and Norway. 20 July 2017
Israel’s Teva Pharmaceutical has received a positive recommendation for Cinqaero from the UK’s health technology assessor, the National Institute for Health and Care Excellence. 20 July 2017
European Ombudsman Emily O’ Reilly has written to Guido Rasi, executive director of the European Medicines Agency (EMA), to notify him of her inquiry into the regulator’s meetings with drug companies before they have submitted marketing authorization applications (MAAs). 20 July 2017
The pharmaceutical industry is one of the UK’s great success stories, writes Michael Jewell, healthcare partner at Cavendish Corporate Finance, in an Expert View piece on how the sector could see an increase in deal-making as Brexit looms. 20 July 2017
The USA-based not-for-profit Institute for Clinical and Economic Review (ICER) will develop a report assessing the comparative clinical effectiveness and value of chimeric antigen receptor T-cell (CAR-T) therapies for treatment of certain types of cancer. 20 July 2017
A pilot program’s progress in streamlining drug approvals for the China market has been described as ‘only the beginning’ of a scheme designed to give Chinese patients access to more drugs, more quickly and more affordably. 19 July 2017
The latest Republican attempts to replace or repeal the Affordable Care Act – former President Barack Obama’s signature policy that is nicknamed Obamacare – have gone the way of those before them, ending in failure. 19 July 2017
The surge in international companies wanting to partner in Korea reflects a flourishing South Korean pharma economy, which, in recent years, has become the third largest pharma region in Asia. 19 July 2017
UK medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) today published its updated clinical guideline on Parkinson's disease. 19 July 2017
The US Food and Drug Administration (FDA) has approved Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for re-treatment of adults with chronic hepatitis C virus (HCV). 19 July 2017
A white paper with input from a host of experts from big pharma has looked into the extent to which the US market is moving towards value-based contracts that reward manufacturers on outcomes rather than volume. 19 July 2017
Gedeon Richter has been granted marketing authorization from the European Commission for Reagila (cariprazine), a novel antipsychotic for the treatment of schizophrenia in adult patients. 19 July 2017