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
Rothschild Europe, a group affiliated with Rothschild family, has called on the Russian government, as well as Andrei Belousov, Russia’s Presidential Aide, to provide support and assistance to the Russian nano and pharmaceutical producer Rusnano and the US drug giant Pfizer in their development in the Russian pharmaceutical market. 25 January 2017
The Medical Technologies, Biotechnologies and Pharmaceuticals Industry Growth Centre – and trade group Medicines Australia, have signed a memorandum of understanding (MoU) to work collaboratively to boost the innovative pharmaceutical industry in Australia. 25 January 2017
Anticipating an early 2018 launch for Infacort (hydrocortisone), Diurnal Group has signed an agreement with two subsidiaries of UDG Healthcare to build up sales and medical infrastructure in the EU. 25 January 2017
Beximco Pharmaceuticals has entered into a collaboration with Malaysia’s BioCare Manufacturing, in what will be the Bangladeshi generics firm’s first overseas manufacturing deal. 25 January 2017
The US pharmaceutical industry has launched a new offensive in the ongoing battle for the hearts and minds of patients, policymakers and customers. 24 January 2017
AbbVie says its marketing authorization application (MAA) has been validated and is now under accelerated assessment by the European Medicines Agency for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of all major chronic hepatitis C virus (HCV) genotypes. 24 January 2017
Dutch supplier Bedrocan has become the world’s first producer of medicinal cannabis to be compliant with the European Medicines Agency’s good manufacturing practice (GMP) standards. 24 January 2017
USA-based biotech firm Ocular Therapeutix has confirmed that a New Drug Application (NDA) for Dextenza (dexamethasone) has been re-submitted to the US Food and Drug Administration. 24 January 2017
Medicines regulator Health Canada says its safety review of oral and injectable fluoroquinolones, a class of antibiotics, found that in rare cases some known side effects may be persistent or disabling. 24 January 2017
The UK Prime Minister has set out detailed plans for the country’s new industrial strategy for post-Brexit Britain, and the focus on science and innovation has been praised by figures from pharma and the research community. 23 January 2017
Bayer has announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review status to the company’s anticancer agent regorafenib, as a second-line treatment for liver cancer. 20 January 2017
Privately-held US pharma Kaléo has announced the relaunch date and details of an access program for its AUVI-Q (epinephrine injection, USP) auto-injector to treat life-threatening allergic reactions. 20 January 2017
US-based biotech firm Gilead Sciences has received notice that the European Medicines Agency (EMA) has validated and will review its Marketing Authorization Application for a new hepatology product. 20 January 2017
The US Food and Drug Administration on Thursday day approved Trulance (plecanatide) for the treatment of chronic idiopathic constipation (CIC) in adult patients. 20 January 2017
US pharma major Bristol-Myers Squibb was down 6.2% at $52.08 in after-hours trading on Thursday, after it revealed disappointing news on a proposed combination lung cancer drug. 20 January 2017
The trade group the Association for the British Pharmaceutical Industry has outlined its objections to new NICE/NHS England proposals on evaluating and funding new medicines. 20 January 2017
The US Food and Drug Administration (FDA) is weighing up potential changes to its advisory committees (ACs) and their role in making decisions on pharmaceutical and other products. 20 January 2017
Belgian drugmaker UCB has filed a supplemental New Drug Application (sNDA) with the US Food and Drug Administration to extend the label for epilepsy drug Briviact (brivaracetam). 20 January 2017
The US Food and Drug Administration has approved Vantrela ER (hydrocodone bitartrate) extended-release tablets [CII] formulated with Teva Pharmaceutical Industries’ (NYSE: TEVA) proprietary abuse deterrence technology. 19 January 2017