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
The European Medicines Agency started a review of the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation. This is being done in cooperation with the European Commission and the Member States of the European Union. 27 May 2016
The European Medicines Agency has recommended the granting of marketing authorizations in the European Union for two new combination therapies against chronic (long-term) hepatitis C virus (HCV) infection, Epclusa (sofosbuvir/velpatasvir) and Zepatier (grazoprevir/elbasvir). 27 May 2016
AstraZeneca today announced that the US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application for sodium zirconium cyclosilicate (ZS-9). 27 May 2016
The US Food and Drug Administration has approved Afstyla (antihemophilic Factor [recombinant], single chain), a novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A from CSL Behring. 27 May 2016
The pharmaceutical industry in Italy is set to decline from $21.3 billion in 2016 to $18.6 billion by 2020, at a negative compound annual growth rate of 3.3%, primarily due to the country's struggling economy. 27 May 2016
Adoption of the European Parliament’s report on the Single Market Strategy in Plenary has been applauded by Medicines for Europe, which represents generic and biosimilar medicines producers in Europe. 26 May 2016
The National Institute for Health and Care Excellence (NICE) has today published draft guidance that does not recommend approval for use in the National Health Service of US pharma major Eli Lilly’s Portrazza (necitumumab) for treating lung cancer. 26 May 2016
The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) yesterday recommended the approval of the New Drug Application (for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. 26 May 2016
US biopharma Intercept Pharmaceuticals is due to find out on Friday whether its liver disease drug Ocaliva (obeticholic acid) receives approval from the Food and Drug Administration (FDA). 25 May 2016
Sarepta Therapeutics today announced that the US Food and Drug Administration has notified the company that it is continuing its review and internal discussions related to the pending New Drug Application for eteplirsen. 25 May 2016
The Transatlantic Trade and Investment Partnership (TTIP) could increase the annual value of European Union (EU) pharma exports by 9 billion euros ($10.03 billion) by slashing trade barriers, a study suggests. 25 May 2016
Sanofi today announced that Jevtana (cabazitaxel) has been recommended for use in combination with prednisone or prednisolone as a treatment option for metastatic hormone-relapsed prostate cancer (mHRPC) in England. 25 May 2016
The Association of the British Pharmaceutical Industry (ABPI) has highlighted how patients in the UK would miss out on ground-breaking clinical trials by voting to leave the European Union. 25 May 2016
Canadians face wait times of about 449 days in order to get access to new, potentially lifesaving medicines in public drug plans, according to a new IMS Health Canada report commissioned by Innovative Medicines Canada. 25 May 2016
The National Institute for Health and Clinical Excellence (NICE), the medicines cost-effectiveness watchdog for England and Wales, has today published final guidance recommending three drugs for treating type 2 diabetes. 25 May 2016
The US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) yesterday voted 16-0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes. 25 May 2016
The US Food and Drug Administration has approved the first seasonal influenza vaccine that offers four-strain flu protection for people four years and older, it has been announced. 24 May 2016