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
Swissmedic has published amendments to regulations for drug manufacturers when highlighting changes to manuscripts of medicinal product information relating to their products. 14 December 2016
The European Commission has granted marketing authorization for Rekovelle (follitropin delta), a human recombinant follicle stimulating hormone (human rFSH), following a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October. 14 December 2016
The UK regulator has ruled on breaches of the Association of British Pharmaceutical Industry code of conduct by five separate pharma companies. 13 December 2016
The Russian Federal Antimonopoly Service (FAS) has designed a mechanism for the withdrawal of licenses on the production of drugs in Russia from their rightful owners, according to Igor Artemyev, head of the FAS. 13 December 2016
US pharma major Eli Lilly has moved to provide up to 40% discounts for US users of its insulin products from the start of 2017, as prices rise on the back of soaring insurance rates. 13 December 2016
Australian biotech firm CSL Limited has been announced as a co-investor in the government’s Biomedical Translation Fund, developed to stimulate investment in medical science in Australia. 13 December 2016
The Canadian government has announced new legislation aimed at tackling the growing problem of
opioid drug abuse, citing statistics that record numbers of Canadians have died from drug overdoses this year. 13 December 2016
The US Food and Drug Administration has approved Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. 13 December 2016
As a result of an updated review, the US Food and Drug Administration has concluded that use of the type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer. 13 December 2016
South Korea’s Celltrion Healthcare welcomes the publication of the latest position paper from the European Crohn’s and Colitis Organization (ECCO) on the use of biosimilars for inflammatory bowel disease (IBD). 12 December 2016
Rather like Kite’s registrational Zuma-1 trial of KTE-C19 in lymphoma, Novartis’ Eliana study has generated a fileable response rate. In the case of the Swiss firm’s rival CAR-T therapy, CTL019, this is in childhood leukemia patients, says EP Vantage, the editorial arm of the Evaluate group. 10 December 2016
The US Food and Drug Administration has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (MAb), and granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017. 10 December 2016
The European Commission has granted an additional indication for Lucentis (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD), or secondary to pathologic myopia (PM). 9 December 2016
Despite the uncertainty that loomed over the pharma and biotech sectors with unexpected outcomes from both the US presidential election and UK’s vote to leave the EU, 2017 may bring renewed energy to the industry with potential for more corporate activity and cash flow. 9 December 2016
A wide-ranging bill promising to fund biomedical research, establish a council to speed up the discovery, development, and delivery of innovative medicines and advance precision medicine, has been passed in the US Senate. 8 December 2016
Leading Indian drugmaker Sun Pharmaceutical Industries was trading 4.5% lower than it was at Tuesday’s close at a current 675.35 rupees after news that the US Food and Drug Administration (FDA) had raised further concerns about its Halol manufacturing plant in Gujarat. 8 December 2016
Following a positive recommendation in October from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the European Commission (EC) has now granted conditional marketing authorization for Venclyxto (venetoclax) monotherapy. 8 December 2016
The European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) for Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. 8 December 2016
Breakthrough immunotherapy Opdivo (nivolumab) has been approved in the European Union for the treatment of classical Hodgkin lymphoma (cHL), a rare and often-aggressive blood cancer. 7 December 2016
The UK’s Competition and Markets Authority (CMA) today announced that it has fined two compoanies nearly £90 million ($114.4 million) for charging excessive prices to the National Health Service (NHS) for an anti-epilepsy drug. 7 December 2016