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
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 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
According to the European Medicines Agency, adaptive pathways aim to improve timely access to new medicines “primarily in areas of high medical need.” The eligible products would be put on the market earlier for small subsets of patients and their use would gradually be expanded based on additional data generated. 24 May 2016
The European Commission (EC) has granted conditional approval for US healthcare giant Johnson & Johnson subsidiary Janssen Biotech’s single agent Darzalex (daratumumab), it has been announced. 24 May 2016
Sandoz, Swiss pharma giant Novartis' generics and biosimilars business, says that the European Medicines Agency has accepted its Marketing Authorization Application for a biosimilar to Roche's blockbuster drug MabThera (rituximab). 24 May 2016
South Korea-based Samsung Bioepis revealed today that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for SB2, a biosimilar candidate referencing Remicade (infliximab). 24 May 2016
US pharma major Pfizer has announced that the black triangle safety warning for its smoking cessation drug Champix (varenicline) has been removed in the UK. 23 May 2016
Japanese drugmaker Teijin Pharma has received approval from the Ministry of Health, Labour and Welfare in its home country for Feburic (febuxostat) as an indication for hyperuricemia caused by cancer chemotherapy. 23 May 2016
The 2016 European Society of Cardiology (ESC) guidelines on acute and chronic heart failure strongly recommend treating iron deficiency with Ferinject (ferric carboxymaltose), a drug marketed by Vifor Pharma, part of Switzerland-based Galenica Group. 23 May 2016
A US Food and Drug Administration (FDA) advisory panel briefing document has questioned the effectiveness of IDegLira, Novo Nordisk’s insulin degludec (IDeg) Tresiba and liraglutide (Victoza) treatment for type 2 diabetes mellitus (T2DM). 23 May 2016
A decision by the US Food and Drug Administration to revoke designation of a drug (or a biological product) as an orphan drug is a rare event, notes Kurt Karst writing on US law firm Hyman, Phelps & McNamara’s FDA Law Blog. 23 May 2016
Regulatory bodies in India and Japan will work together more closely, both countries vowed at a meeting of politicians and government officials. 23 May 2016
The Russian national Parliament (State Duma) has put forward an initiative to provide financial support to domestic and multinational pharmaceutical producers (operating their plants in Russia), that will freeze the prices for their drugs for the period up to three years. 21 May 2016
Entresto (sacubitril/valsartan), from Swiss pharma giant Novartis, has been given a Class I recommendation, the strongest endorsement, from professional bodies in the USA and EU. 21 May 2016
US-based Ariad Pharmaceuticals will pocket $25 million in second quarter net product revenue related to cumulative shipments of its leukemia treatment Iclusig (ponatinib) to France, following talks with the French health authorities. 20 May 2016
The US Food and Drug Administration is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. 20 May 2016
The National Institute for Health and Care Excellence (NICE) has today issued draft guidance not recommending Perjeta (pertuzumab), from Swiss pharma giant Roche, to treat HER2-positive breast cancer because it is uncertain how the responses to treatment seen in the clinical trials translate into long term benefits for patients. 20 May 2016
A UK government review warning of an ‘antibiotics apocalypse’ is recommending the introduction of incentives to encourage pharmaceutical companies to invest in research activity to find new drugs and treatments to tackle the ever-growing problem of antimicrobial resistance (AMR). 19 May 2016
The US Food and Drug Administration has granted accelerated approval to Tecentriq (atezolizumab injection) from Genentech, for the treatment of a specific type of bladder cancer. 19 May 2016
The US Food and Drug Administration has granted Priority Review to the supplemental Biologics License Application (sBLA) for Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) for to treat relapsed chronic lymphocytic leukemia (CLL) patients. 18 May 2016
Olmutinib (BI 1482694/HM61713) has been approved in South Korea for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). 18 May 2016