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
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 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
US biopharmaceutical firm Elusys Therapeutics has received Food and Drug Administration approval for its Anthim (obiltoxaximab) injection for the treatment of inhalational anthrax. 22 March 2016
The UK cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has recommended abiraterone for some prostate cancer patients in a move described as “a big victory for men” by London-based charity The Institute of Cancer Research (ICR). 21 March 2016
German drug cost-effectiveness regulator the German Institute for Quality and Efficiency in Health Care (IQWiG) has released results of several recent reviews on cancer drugs, coming to various conclusions. 21 March 2016
Latest figures show that the Spanish pharmaceutical industry invested 382 million euros ($431 million) in contracts with the National Health system during 2014, maintaining once again its leading position in the private sector as far as public-private collaboration in Spain is concerned. 21 March 2016
Novartis says that the UK’s National Institute for Health and Care Excellence (NICE) has now recommend Entresto (sacubitril/valsartan) in its final draft guidance. 21 March 2016
In a surprise move last week, the charity Médecins Sans Frontières (MSF), for the first time ever, filed a ‘patent opposition’ in India, with the aim of preventing US pharma giant Pfizer from getting a patent on the pneumococcal conjugate vaccine (PCV13), sold under the Prevenar trade name. 20 March 2016
Shares of USA-based Eagle Pharmaceuticals slumped on Friday afternoon, after the Food and Drug Administration rejected its drug Kangio (bivalirudin injection). 19 March 2016
Following the announcement last week that it had been asked by the European Commission to start a review of the cancer medicine Zydelig (idelalisib), relating to concerns over serious adverse events in ongoing clinical trials, the European Medicines Agency’s today said its Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using to ensure that the drug continues to be used as safely as possible. 18 March 2016
The US Generic Pharmaceutical Association (GPhA) welcomed the holding of Senate Aging Committee discussions on Thursday over what it calls the ‘anti-competitive business practices’ of some brand manufacturers to stifle generics. 18 March 2016
The US Food and Drug Administration has granted Breakthrough Therapy designation to Swiss biotech firm Novimmune’s NI-0501 for the treatment of patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory disease, or with recurrent or progressive disease during conventional therapy. 18 March 2016
Allergan today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration seeking approval to market paclitaxel protein-bound particles for injectable suspension. 17 March 2016
The US Federal Trade Commission (FTC) has urged the Court of Appeals to correct four errors in a district court’s analysis of an alleged reverse-payment agreement involving UK pharma giant GlaxoSmithKline and generics firms Teva Pharmaceuticals and Anchen Pharmaceuticals. 17 March 2016
The UK government has committed to renegotiate its membership of the European Union and to giving the UK electorate the chance, in a referendum, to choose between the revised membership terms or “Brexit.” 17 March 2016
Alleged failures to follow regulations by US pharma company Orexigen Therapeutics in its trial of obesity drug Contrave must not “become a trend,” former US Food and Drug Administration (FDA) deputy commissioner Joshua Sharfstein told The Pharma Letter. 17 March 2016
The US Food and Drug Administration has approved Bayer's Kovaltry (octocog alfa; antihemophilic Factor [recombinant]), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. 17 March 2016
Drugs cost-effectiveness watchdog for England and Wales, the National Institute for Health and Care Excellence (NICE) has today issued draft guidance not recommending talimogene laherparepvec as an option for people with melanoma that has spread and can’t be surgically removed. 16 March 2016
Shares in biopharma company Celator Pharmaceuticals soared by more than 400% on Tuesday after announcing improved survival rates in a Phase III trial for Vyxeos, a drug treating acute myeloid leukemia (AML). 16 March 2016
Stephen Ubl, president and chief executive of the Pharmaceutical Research and Manufacturers of America (PhRMA), is optimistic that the association’s series of policy proposals can help to prompt a bright new period in drug discovery. 15 March 2016
The average price of brand-name drugs in the US rose by 16.2% in 2015, with the rise since 2011 now at 98.2%, according to pharmacy benefits manager Express Scripts. 15 March 2016