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
Biogen courted controversy after announcing a price for its newest approved rare disease drug that would make it one of the most expensive in history, but trial data released by the Cambridge biotech on Friday indicates that the treatment is effective. 15 January 2017
In December, the UK pharmaceutical industry gave evidence to the Exiting the EU Committee where, though its trade body the Association of the British Pharmaceutical Industry (ABPI), it stated that in the opinion of the UK's £60 billion (~$74 billion) Life Sciences sector, a primary objective for government in Brexit negotiations should be to secure alignment and cooperation with EU medicines regulation. 14 January 2017
VivaGel (astodrimer sodium) has been designated a Qualified Infectious Disease Product and given Fast Track status by the US Food and Drug Administration. 13 January 2017
In an early benefit assessment the German Institute for Quality and Efficiency in Health Care (IQWiG) investigated whether crizotinib offers advantages for patients over the appropriate comparator therapies. 13 January 2017
There were two new developments in the backlash against Mylan’s US pricing policy for its EpiPen Auto-Injector (epinephrine injection, USP) this week. 13 January 2017
Heron Therapeutics has submitted a New Drug Application (NDA) for Cinvanti (HTX-019), for the prevention of chemotherapy-induced nausea and vomiting (CINV), to the US Food and Drug Administration. 13 January 2017
Even before the new US President has been inaugurated, the health care provision introduced to ensure affordable health care for millions of poorer Americans – and heavily criticized by Donald Trump during his election campaign – appears to be on its way out. 12 January 2017
Shares of US cancer drug developer Tesaro dipped 2.48% to $142.028 by mid-morning trading today, after the company revealed that the US regulator had rejected approval of its intravenous presentation of rolapitant. 12 January 2017
Japanese drugmaker Shionogi has announced positive top-line trial results for cefiderocol (S-649266), a novel siderophore cephalosporin in late-stage development, 12 January 2017
Afinitor (everolimus) has been recommended for use on the National Health Service (NHS) in England and Wales after Novartis agreed to reductions to its £32,076 ($39,165) annual treatment cost per patient. 12 January 2017
Ever since his surprise election win in November, what Donald Trump’s Presidency might mean for pharma has been the subject of plenty of guesswork. 11 January 2017
The European Commission has granted marketing authorization for Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents. 11 January 2017
Netherlands-incorporated generics major Mylan and Indian biotech Biocon are a step closer to gaining approval for a biosimilar version of Herceptin (trastuzumab) in the USA. 11 January 2017
Merck & Co today announced that the US Food and Drug Administration has accepted for review a supplemental Biologics License Application (sBLA) for its dual immuno-oncological/chemotherapeutic treatment candidate. 11 January 2017
The European Commission has granted marketing authorization for Fiasp (fast-acting insulin aspart for the treatment of diabetes in adults. 10 January 2017
Excitement at opportunities, dread and doubts over what exactly the presidency of Donald Trump will mean for pharma all feature in predictions for the industry in 2017 expressed by an expert panel brought together by a pharma events organiser. 10 January 2017
Shares in Egalet rose sharply as the company received US Food and Drug Administration approval for Arymo ER (morphine sulfate), a new long-acting opioid, before falling back as details of the label were released hours later. 10 January 2017
Dr Nicola Davies explores the market access steps taken by companies such as Takeda to make medicines available and affordable for high priority patient populations. 10 January 2017