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
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
Politicians and bureaucrats in London and Brussels might be squabbling over the terms of Brexit, but the borderless nature of science and health imperatives are remaining resilient to such squabbles, a funding award shows. 2 August 2017
Following yesterday’s news that the US Food and Drug Administration had granted breakthrough status to acalabrutinib, London-listed AstraZeneca has announced the drug has also been accepted for priority review by the American regulator. 2 August 2017
Realm Therapeutics has submitted for approval to launch a Phase II trial for PR013, a candidate treatment for allergic conjunctivitis, in the USA. 2 August 2017
Safety will be a major topic when the merits or otherwise of sirukumab injection, a drug from US healthcare giant Johnson & Johnson’s Janssen Biotech unit, is discussed by the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) on Wednesday. 1 August 2017
The enforcement of a much more stringent pricing revision policy in Japan, both for new products as well as off-patent brands, is behind the decline of the products currently on the market which are forecast to drop about 2% annually in sales through 2022, a new report shows. 1 August 2017
Following news last month that a US Food and Drug Administration (FDA) advisory panel had given its backing to a biosimilar version of Swiss pharma giant Roche’s big-selling cancer drug Herceptin (trastuzumab), a separate copycat version has moved closer to market. 1 August 2017
For the second time in two days, Anglo-Swedish pharma company AstraZeneca announced that the US Food and Drug Administration (FDA) had given Breakthrough Therapy Designation to one of its oncology medicines. 1 August 2017
US cancer drug developer Kite Pharma has become the first company to submit a Marketing Authorization Application (MAA) for a chimeric antigen receptor (CAR) T-cell therapy to the European Medicines Agency (EMA). 1 August 2017
In late June this year, the US Food and Drug Administration’s Commissioner Scott Gottlieb, issued a statement on the Drug Quality and Security Act (DQSA). The FDA’s commitment to upholding and following through on moves to protect the public from poorly compounded drugs shows that the Administration means business. 1 August 2017
MSD, the non-North America operating name of US pharma giant Merck & Co, has announced the availability of biosimilar Renflexis (infliximab) on the Australian Pharmaceutical Benefits Scheme (PBS) from August 1. 1 August 2017
The disconnect between the UK government’s target to make the country a world leader in the life sciences, and its failure to provide patients with the drugs that result from this science, has been underlined by a new report. 31 July 2017
US biotech firm Spark Therapeutics has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Luxturna, the proposed trade name for voretigene neparvovec, an investigational, one-time gene therapy for patients with vision loss due to Leber congenital amaurosis or retinitis pigmentosa caused by confirmed biallelic RPE65 mutations. 31 July 2017
Privately-held Italian biopharma company Dompé today revealed that the European Commission has granted a marketing authorization for Oxervate (cenegermin eye drops) for the treatment of moderate to severe neurotrophic keratitis. 31 July 2017
Whether the 16% hit that AstraZeneca’s share price took last week on the setback in its Mystic lung cancer trial was a market over-reaction or not, the damage will be hard to repair. 31 July 2017
The Irish Pharmaceutical Healthcare Association (IPHA) has welcomed the statement by the Health Service Executive (HSE) confirming that it will fund nine delayed medicines for prescribing to patients, but lambasts a “dysfunctional process.” 31 July 2017
In testimony presented to the U.S. House of Representatives’ Judiciary Committee Subcommittee on Regulatory Reform, Commerical and Antitrust Law, the USA’s Federal Trade Commission described its efforts to stop anticompetitive conduct in the pharmaceutical industry. 31 July 2017
Shares in Japan’s Kyowa Hakko Kirin are up nearly 4% following news that the company will proceed next month with its planned US regulatory submission for burosumab, a monoclonal antibody developed with Californian firm Ultragenyx Pharmaceutical. 31 July 2017
Australia’s Health Ministry says that Bristol-Myers Squibb’s Opdivo (nivolumab), a revolutionary new medicine for lung and renal cancer, has been listed on the Pharmaceutical Benefits Scheme (PBS). 31 July 2017