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
Merck & Co has received approval in Japan for its immuno-oncology drug Keytruda (pembrolizumab) to treat certain patients with PD-L1-positive unresectable advanced/recurrent non-small cell lung cancer (NSCLC) in the first and second-line treatment settings. 19 December 2016
The European Commission has approved an expanded indication for Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine) for active immunization against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age. 19 December 2016
Bangladeshi generic drugs company Beximco Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a generic equivalent of Glucophage XR tablets (metformin hydrochloride). 19 December 2016
Based on a US Food and Drug Administration review of a large clinical trial that FDA required the drug companies to conduct, the agency has determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. 19 December 2016
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Vemlidy (tenofovir alafenamide) 25mg, a once-daily treatment for suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function. 19 December 2016
The proposed new measures of the Ministry of Health prove to be disastrous for both the right of Greek patients to unhindered and fair access to the necessary treatments and for public health and the viability of the pharmaceutical industry. 19 December 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for marketing authorization at its December 2016 meeting. 17 December 2016
Agios Pharmaceuticals saw its shares drop 20% to $44.74 today, after it announced that development of its second pyruvate kinase-R (PKR) activator, AG-519, was to be discontinued. 16 December 2016
The publication of a second draft recommendation not recommending use of Takeda’s Adcetris (brentuximab vedotin) in relapsed or refractory Hodgkin lymphoma (R/R HL) on the National Health Service (NHS), has prompted fresh criticism from the Japanese drugmaker. 16 December 2016
Mylan on Friday announced the US launch of the authorized generic for EpiPen (epinephrine injection, USP) Auto-Injector at a wholesale acquisition cost (WAC) of $300 per epinephrine injection, USP two-pack. 16 December 2016
The UK’s Competition and Markets Authority (CMA) has accused generic drugmaker Actavis UK of breaking competition law by raising the price for hydrocortisone tablets paid by the National Health Service. 16 December 2016
The prices of prescription branded drugs widely used by older Americans rose by an average of 15.5% in 2015, some 130 times above inflation, according to a new report. 15 December 2016
The National Institute for Health and Care Excellence (NICE) has published draft guidance not recommending Japanese drugmaker Takeda’s Adcetris (brentuximab vedotin) to treat some patients with Hodgkin’s lymphoma on the National Health Service (NHS). 15 December 2016
New Zealand’s Pharmaceutical Management Agency PHARMAC consulted on a proposal to list ranibizumab (Lucentis) and aflibercept (Eylea) in Section H of the Pharmaceutical Schedule from November 1, 2016 for the second and third line treatment (respectively) of wet age-related macular degeneration (wAMD). 15 December 2016
The US Department of Justice (DoJ) has announced two former senior generic pharmaceutical executives have been charged over price-fixing of generic medicines. 15 December 2016
GlaxoSmithKline has submitted a regulatory application to the Japanese Ministry of Health, Labor and Welfare (MHLW) for belimumab, in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who have an inadequate response to standard therapy. 15 December 2016
New York Mayor Bill de Blasio has announced $500 million in funding in a bid to establish the city as a leader in life sciences innovation and research and development (R&D). 14 December 2016
USA-based Intercept Pharmaceuticals has won conditional marketing authorization from the European Commission for its liver disease drug Ocaliva (obeticholic acid). 14 December 2016
The 2017 Finance Bill, recently approved by the Republic of Italy's Senate, includes important provisions favoring biosimilar medicines, a significant landmark that will increase competition among biotech drug companies. 14 December 2016