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
Republicans in the US Congress went into last month’s vote to repeal and replace the Affordable Care Act with guidance from President Trump, effectively: ‘Vote yes or you’re stuck with Obamacare.’ 5 April 2017
APAC Biotech has been granted with a commercial license by India’s Central Drugs Standard Control Organization (CDSCO) to market product, Apcedene, a dendritic cell-based autologous Immuno-oncology product for four cancer indications. 5 April 2017
The US Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) to extend the use of Opdivo (nivolumab). 5 April 2017
Trade group AusBiotech has made a submission endorsing proposed changes to improved access options for unapproved therapeutic goods in Australia, which are intended to reduce time and administrative burden and greatly improve efficiencies for applicants. 5 April 2017
The Commonwealth Scientific and Industrial Research Organisation (CSIRO), an Australian government agency responsible for scientific research, is calling for: “action now to establish an ecosystem that will support the growth and innovation of the MTP sector in Australia.” 4 April 2017
Amgen has filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration and an application for a variation to the marketing authorization to the European Medicines Agency (EMA) for Xgeva (denosumab). 4 April 2017
Mallinckrodt has reached an agreement in principle with the US Drug Enforcement Administration (DEA) and the US Attorneys' Offices (USAOs) for the Eastern District of Michigan and the Northern District of New York regarding controlled substances. 4 April 2017
The US Food and Drug Administration has approved Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease, Teva Pharmaceutical has announced. 4 April 2017
Sanofi Pasteur has agreed to pay $19,868,194 to resolve claims that it incorrectly calculated drug prices and thereby overcharged the US Department of Veterans Affairs (VA) for drugs under two contracts between 2002 and 2011, the Department of Justice revealed yesterday. 4 April 2017
Ireland-headquartered Shire has announced that its partner in Japan, Shionogi , has received the approval of the Japanese Ministry of Health, Labor and Welfare to manufacture and market Intuniv (guanfacine hydrochloride prolonged release). 4 April 2017
Global drugmakers operating in Russia will be obliged to transfer information on the price of their drugs to a single information system operated by the Russian Federal Tax Service, as part of the new state strategy for drugs’ labeling in the Russian pharmaceutical market, reports The Pharma Letter’s local correspondent. 4 April 2017
Further lots have been added to the EpiPen (epinephrine) Auto-Injector devices being recalled because it is feared that they might not work. 3 April 2017
Swiss pharma giant Novartis has received EU approval for its combination therapy of Tafinlar (dabrafenib) and Mekinist (trametinib) in non-small cell lung cancer (NSCLC). 3 April 2017
A completed rolling submission has been filed with the US Food and Drug Administration (FDA) of the Biologics License Application (BLA) for axicabtagene ciloleucel. 3 April 2017
Privately-held Swiss biotech AB2 Bio has received Breakthrough Therapy Designation from the US Food and Drug Administration for its autoinflammatory candidate IL-18BP (tadekinig alfa). 3 April 2017
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for a first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, Ibrance (palbociclib). 3 April 2017
Most of the headline grabbing news last week focussed on approvals of new medicines and some exciting clinical trial results. Among these were the approvals of Roche’s Ocrevus for multiple sclerosis, Tesaro’s Zejula for treatment of recurrent ovarian cancer and Sanofi’s Dupixent for atopic dermatitis. Also stirring interest was clinical data on Vertex’ combination of tezacaftor and ivacaftor. 2 April 2017
The chief executive for the UK and Ireland at German pharma major Bayer is spending 30% of his time working on issues related to Brexit, he said this week. 1 April 2017
In a new snapshot survey of leading pharmaceutical businesses in the UK, companies have said that changes to the way the National Institute for Health and Care Excellence (NICE) and NHS England (NHSE) assess new medicines coming in to effect today (April 1, 2017), will decrease access to the latest treatments, with new medicines for cancer set to be impacted the most. 1 April 2017
Jubilant Democrats may have to put the champagne cork back in the bottle - the Affordable Care Act (ACA) may not be out of the woods just yet. 31 March 2017