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 US Food and Drug Administration (FDA) has warned Netherlands incorporated Mylan that unless it addresses manufacturing violations at its facility in Maharashtra, India, then the agency could withhold approval of any new applications or supplements listing the firm as a drug manufacturer. 12 April 2017
About a month ago, the Chinese Food and Drug Administration (CFDA) issued a draft proposal about easing the process for imported drugs to get into China, ie, ‘amended management for imported drugs registration.’ 12 April 2017
After Allergan chief executive Brent Saunders pledged to limit price increases to single digits, three pharmaceutical companies agreed to make the same commitment, according to Public Citizen. 12 April 2017
The US Food and Drug Administration has approved Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). 12 April 2017
New measures introduced by Romania’s Ministry of Health Order 269/2017 are to blame for medicines shortages, as these target all the medicines available in Romania with no time limit. 11 April 2017
The US Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) date of September 8, 2017 for its decision on the New Drug Application for Zerviate (cetirizine ophthalmic solution) 0.24%. 11 April 2017
In yet another negative decision of a new cancer drug, the medicines cost-effectiveness watchdog for England and Wales has issued new draft guidance that has also come in for criticism from the Institute for Cancer Research, though the latter sees a role for Pharma to reduce the cost of drug development. 11 April 2017
The European Medicines Agency’s management board has adopted a new policy on how the EMA handles allegations of improprieties received from external parties, it was announced today. 10 April 2017
The USA’s Institute for Clinical and Economic Review, (ICER), an independent not-for-profit organization, has released a Final Evidence Report and Meeting assessing the comparative clinical effectiveness and value of targeted immune modulators (TIMs) for treatment of moderately-to-severely active rheumatoid arthritis (RA). 10 April 2017
US Representatives David McKinley (Republican: West Virginia-1) and Peter Welch (Democrat: Vermont) last week introduced the Fair Access for Safe and Timely (FAST) Generics Act. 8 April 2017
Shares in US pharma giant Merck & Co slipped in the morning’s trading on news that the US Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the company’s Supplemental New Drug Applications for Januvia (sitagliptin) and its two Janumet (sitagliptin and metformin HCl) formulations. 7 April 2017
The US Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. 7 April 2017
The European Medicines Agency (EMA) has given Switzerland-based Actelion the OK to continue selling Uptravi (selexipag), after five patient deaths in France triggered a safety review. 7 April 2017
Ireland’s Health Service Executive (HSE) National Drugs Management Program (NDMP) and Neurology Program have introduced a national reimbursement scheme which will facilitate access for patients with multiple sclerosis (MS) to approved high cost treatments. 7 April 2017
For the last two years, the European Medicines Agency has carried out ‘single assessments’ of post-marketing safety reports which relate to products with the same active substance. 6 April 2017
Briviact (brivaracetam) has been accepted for use in Ireland as an add-on treatment for partial onset seizures (POS) with or without secondary generalized seizures in adults with epilepsy. 6 April 2017
The US Food and Drug Administration has granted Breakthrough Therapy designation status to evinacumab for the treatment of hypercholesterolemia in patients with homozygous familial hypercholesterolemia (HoFH). 6 April 2017
The Pacific Research Institute has criticized reimbursement practices in the UK, describing the country’s public health watchdog, the National Institute for Health and Care Excellence, as ‘a cautionary tale’ for the US healthcare system. 6 April 2017
Jordanian drugmaker Hikma Pharmaceuticals has reached a settlement with Jazz Pharmaceuticals that resolves patent litigation related to the Ireland-based company’s Xyrem (sodium oxybate) oral solution, 500mg/mL product. 6 April 2017
Lawmakers have confirmed that they will demand the relocation of the European Medicines Agency from its current base in London when the UK exits the EU. 6 April 2017