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
As of today, December 1, Australians will pay no more than A$38.30 ($28.37) for a medicine to treat thyroid cancer that would cost a patient A$117,000 without subsidized access through the Pharmaceutical Benefits Scheme (PBS). 1 December 2016
The National Institute for Health and Care Excellence (NICE) has recommended a new treatment mepolizumab, in draft guidance for adults with severe asthma, reversing a negative earlier decision. 1 December 2016
US President-elect Donald Trump has chosen a fierce critic of the Affordable Care Act and a proponent of overhauling the nation’s entitlement programs, to lead the Department of Health and Human Services. 30 November 2016
In an expert view piece, Ramon Mohanlal, chief medical officer at BeyondSpring, tackles the issue which threatens to undermine the entire drugmaking cycle. 29 November 2016
The US Food and Drug Administration (FDA) has accepted for priority review a biologics license application (BLA) for what could be the first treatment indicated for patients with metastatic Merkel cell carcinoma (MCC). 29 November 2016
Shares of US biotech firm Amicus Therapeutics were down 24.28% at $6.30 in pre-market trading this morning, after the company late yesterday revealed that the US Food and Drug Administration has declined to allow accelerated approval for its lead Fabry disease drug. 29 November 2016
US drug developer PhaseRx saw its shares leap 106.7% to $2.34 after it revealed it had been awarded orphan status for its lead candidate in the USA. 29 November 2016
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the three main economic objectives of a strategy on what more can be done to support growth, reinforce economic convergence, create jobs and strengthen social fairness in European Union (EU) countries. 28 November 2016
Trade group Medicines for Europe, which represents the generics and biosimilars sector, has taken issue with the report ‘Health at a Glance 2016’ launched yesterday prepared by the Organization for Economic Co-operation and Development (OECD) for the European Commission. 28 November 2016
Santen Pharmaceutical has announced the top-line results of its SAKURA (Sirolimus study Assessing double-masKed Uveitis tReAtment) global clinical development program. 28 November 2016
Executives at Vifor Pharma, a company of the Swiss Galenica group, have welcomed the US Food and Drug Administration’s (FDA) approval of a supplemental New Drug Application (sNDA) for Veltassa (patiromer) for oral suspension, with important updates to the product labeling label. 28 November 2016
A Marketing Authorization Application (MAA) to the European Medicines Agency, seeking approval for a candidate shingles vaccine, for the prevention of herpes zoster (shingles) in people aged 50 years or over, has been submitted. 26 November 2016
Following swiftly on a US regulatory filing, US healthcare giant Johnson & Johnson (NYSE: JNJ) has now applying to get clearance for its blockbuster-potential plaque psoriasis drug. 25 November 2016
Adding to US approval early last year for their combination diabetes product, German family-owned drug major Boehringer Ingelheim and USA-based Eli Lilly have received clearance to market it in Europe. 25 November 2016
In a further move to enhance quality, safety and efficacy of medicines globally, there was a positive move today with the news that Japan has now joined the effort. 25 November 2016
The Belgian Competition Authority (BCA) has confirmed that it is inspecting several companies involved in the wholesale distribution of pharmaceutical and para-pharmaceuticals products to pharmacies. 25 November 2016
The Russian government has designed new restrictions for the participation of foreign drugmakers in state tenders for the purchase of drugs for state needs, reports The Pharma Letter’s local correspondent. 25 November 2016
In another reversal of a negative cancer drug opinion from the cost-effectiveness watchdog for England and Wales based on the drug manufacturer’s agreement on a price discount, the agency has said that a new drug for the treatment of leukemia can be used routinely on the National Health Service. 25 November 2016