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
Some of the world’s largest funders of medical research and international non-governmental organizations (NGOs) today agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly. 18 May 2017
By expanding the approved use of Kalydeco (ivacaftor) in cystic fibrosis (CF), the US Food and Drug Administration (FDA) has tripled the number of rare gene mutations that the drug can now treat. 18 May 2017
US healthcare giant Johnson & Johnson’s pharma unit Janssen expects more than 10 of its new ‘blockbuster’ products to be launched or filed for regulatory approval by 2021. 17 May 2017
Days after revealing a potential half-billion dollar collaboration in hemophilia with Pfizer, US gene editing specialist Sangamo Therapeutics announced that the US regulator has granted Fast Track designation to SB-525. 17 May 2017
US regulators have granted Priority Review designation to copanlisib, a non-Hodgkin lymphoma candidate under development by Germany's largest drugmaker Bayer. 17 May 2017
The US Food and Drug Administration says that canagliflozin, marketed by Johnson & Johnson as Invokana, causes an increased risk of leg and foot amputations. 17 May 2017
Taiwan’s Pharmadax has received approval from the US Food and Drug Administration (FDA) to market a generic equivalent of the anti-psychotic drug Seroquel XR (quetiapine fumarate) at five different strengths. 16 May 2017
American lawmakers are reintroducing a bill that would limit the ability of pharmaceutical companies to raise drug prices, with tougher language to prevent medium-term hikes. 16 May 2017
In non-small cell lung cancer (NSCLC) that has already formed metastases, the suitable treatment depends, among other factors, on the genes that are activated in the tumor cells and whether mutations have occurred that make certain treatments ineffective. 16 May 2017
South African drugmaker Aspen Pharma has confirmed that the European Commission has opened proceedings to investigate certain actions of Aspen Holdings and certain of its European subsidiaries. 16 May 2017
European politicians have lent voice to calls for more funding to treat and prevent drug-resistant tuberculosis (TB), at an event organized by charities fighting the disease. 15 May 2017
Research published in the Journal of the American Medical Association (JAMA) has found that a third of drugs approved by US regulators are subsequently flagged for a safety event. 15 May 2017
The USA’s Institute for Clinical and Economic Review (ICER), a non-profit organization, has released an Evidence Report assessing the comparative clinical effectiveness and value of dupilumab and crisaborole for the treatment of atopic dermatitis. 14 May 2017
The Food and Drug Administration has expanded a previously granted Breakthrough Therapy designation (BTD) for setmelanotide, a novel melanocortin-4 receptor (MC4R) agonist from Boston, USA-based biotech firm Rhythm Pharmaceuticals. 13 May 2017
The World Health Organization (WHO) has held a forum on the cost of medicines in a stated attempt to facilitate discussion leading to ‘fairer price setting and a system that is sustainable for health systems and for innovation’. 12 May 2017
A clinical trial has found that the oncology drug Avastin (bevacizumab) is about as effective as Eylea (aflibercept) in treating central retinal vein occlusion (CRVO), an eye condition. 11 May 2017
The National Institute for Health and Care Excellence (NICE) has issued a second Appraisal Consultation Document (ACD) not recommending the routine National Health Service use of Venclexta (venetoclax) for patients with certain types of difficult-to-treat relapsed and refractory chronic lymphocytic leukemia (CLL). 11 May 2017
The European Medicines Agency’s 2016 annual report published today focuses on the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and the safety monitoring of medicines in real life. 11 May 2017