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
Stephen Ubl, president and chief executive of Pharmaceutical Research and Manufacturers of America (PhRMA), is meeting with President Donald Trump on Tuesday morning. 31 January 2017
The European Commission has approved Votubia (everolimus) dispersible tablets as an adjunctive treatment for patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex (TSC). 31 January 2017
Mindful that the next two years will be massively important for the company and how closely pharma will be watching its progress, it is not surprising that Realm Therapeutics has been keen to let the world know its plans for 2017. 31 January 2017
Teva Pharmaceutical Industries has received US Food and Drug Administration approval for its own branded versions of two asthma treatments sold by UK pharma major GlaxoSmithKline. 31 January 2017
uniQure says that AMT-060, its proprietary, investigational gene therapy in patients with severe hemophilia B, has received Breakthrough Therapy designation by the US Food and Drug Administration. 30 January 2017
As of now, collaborations between healthcare professionals and pharma in Spain are to be published individually, following an update to Code of Good Practice on the pharmaceutical industry. 30 January 2017
Donald Trump’s warnings on drug prices and the tougher stance being taken by governments in Japan and Europe on paying for medicines make this a worrying time for pharma companies, as they nervously keep an eye on leaders’ pledges, policy changes and payer decisions in these mature markets. 30 January 2017
The pharmaceutical sector in India is set to gain rather than be impacted with the new US President Donald Trump's decision to reduce drug prices, given that the country's generic medicines are already affordable. 30 January 2017
The US Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Latuda (lurasidone HCI) for the treatment of schizophrenia in adolescents aged 13 to 17 years. 30 January 2017
In the run-up to last year’s referendum on the UK’s membership of the EU, commentators and analysts warned that the country’s healthcare and pharmaceutical industries would suffer should the country turn its back on Europe. 30 January 2017
Italian drugmaker Recordati has been granted marketing authorization by the European Medicines Agency for its orphan medicinal product Cystadrops (mercaptamine). 30 January 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its January meeting. 28 January 2017
According to a new evidence review, PB272 (neratinib), which is currently under review by the US Food and Drug Administration (FDA), will “...likely be approved for the extended adjuvant treatment of HER2-positive early stage breast cancer”. 27 January 2017
The UK’s health authority has issued guidance recommending Imbruvica (ibrutinib) for routine use in the country’s national healthcare provider, the National Health Service (NHS). 26 January 2017
The US Food and Drug Administration has granted six months of pediatric exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol. 26 January 2017
New Zealand’s Pharmaceutical Management Agency PHARMAC has announce the approval of an agreement to amend the contractual terms of listing for clostridium botulinum type A toxin (Botox (external link) ), inj 100 u vial in DHB hospitals. 26 January 2017
In final guidance issued today, the National Institute of Clinical Excellence (NICE) has approved Epclusa (sofosbuvir 400mg/velpatasvir 100mg), for the treatment of adults with chronic hepatitis C genotypes 1-6 infection. 25 January 2017
The healthcare sector in India catering to the unmet health needs of the society should be kept out of the purview of the Goods and Services Tax (GST) or else medical care would become expensive and unaffordable for the ordinary people. 25 January 2017