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
UCB (Euronext: UCB) and Dermira (Nasdaq: DERM) have said they expect to file for regulatory approval later this year of their anti-inflammatory drug following the latest positive clinical trial results. 19 January 2017
Dr Nicola Davies reports on what the US Food and Drug Administration (FDA) is doing to promote female participation in clinical trials. 19 January 2017
The opportunities created, and necessary standards needed, by biosimilar drugs in order to deliver sustainable cancer care are outlined in a position paper from the European Society for Medical Oncology (ESMO). 18 January 2017
The boss of one of the world’s biggest pharma companies has defended the industry after President-elect Donald Trump’s share-denting comments in a press conference last week. 18 January 2017
Boehringer Ingelheim is the latest to announce that its biosimilar to AbbVie’s (NYSE: ABBV) blockbuster drug Humira (adalimumab), BI 695501, has been accepted for regulatory review by the European Medicines Agency and the US Food and Drug Administration. 18 January 2017
French pharma major Sanofi has received marketing authorization in Europe for its diabetes therapy Suliqua, known as Soliqua in the USA. 18 January 2017
The US Food and Drug Administration has granted a Rare Pediatric Disease (RPD) designation for TXA127 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic skin disorder. 18 January 2017
The US Food and Drug Administration today announced the issue of new draft guidance on medical product communications, with FDA Commissioner Robert Califf saying that the agency is aware of a high level of interest about its views on such matters. 18 January 2017
A drug that's commonly used to treat high blood pressure is being repurposed for a rare tissue cancer in Europe. The medication, named propranolol, was recently granted Orphan Drug Designation by the European Commission (EC). 18 January 2017
More than 20 pharma companies have given their backing to C/Can 2025: City Cancer Challenge, a new initiative launched at the World Economic Forum’s (WEC) Annual Meeting in Davos, Switzerland, on Tuesday. 17 January 2017
Collaborations with other companies, academia and catapults are increasingly central to the discovery and development of new medicines, says a new report on UK pharma. 17 January 2017
Dr Sam Samaratunga, a GP and life sciences lawyer with Keystone Law, looks at the proposed changes to arrangements for evaluating and funding drugs and other health technologies appraised through NICE’s Technology Appraisal (TA) and Highly Specialized Technologies (HST) programs. 17 January 2017
The United States Supreme Court has agreed to hear a case that will determine whether companies that develop biosimilar versions of biologics must wait six months before launching them in the USA. 16 January 2017
The US Food and Drug Administration has published draft guidance relating to the 180-day exclusivity for generic drug product provisions as the agency seeks to establish its current approach to this topic. 16 January 2017
A new report published by the Organization for Economic Cooperation and Development has warned of pressures in public health spending, blaming pricing policies in the pharmaceutical and medical device industries. 16 January 2017
An independent report has underlined just how important the contribution is of some of the pharmaceutical industry’s biggest companies to Europe’s economy. 16 January 2017
US Biotechnology Innovation Organization (BIO) president and chief executive Jim Greenwood participated in economic development meetings with top Indian government officials, including Prime Minister Narendra Modi, while attending the Vibrant Gujarat Global Summit 2017 last week. 16 January 2017
As the pace picks up after the festive break and the realities of our respective New Year’s resolutions settle on us, Australian trade group AusBiotech says it is starting the year with a renewed focus on leadership in policy and a resolution to continue committed advocacy for innovation in life sciences. 16 January 2017
US pharmaceutical companies Eli Lilly and Incyte have announced that the US Food and Drug Administration has extended by three months the action date for its review of their rheumatoid arthritis candidate baricitinib. 16 January 2017
On January 17, Health Ministers from Organization for Economic Cooperation and Development (OECD) countries will gather in Paris to discuss how healthcare systems can reform to better deal with the challenges and to realize the opportunities of tomorrow. 16 January 2017