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
On May 30, 2017 (tomorrow), trade talks will resume for the India-EFTA (European Free Trade Association) free trade agreement (FTA) in Liechtenstein, between India and the EFTA countries of Switzerland, Norway, Iceland and Liechtenstein. 29 May 2017
The US Food and Drug Administration has approved the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. 27 May 2017
The National Institute for Health and Care Excellence (NICE), in its final decision has recommended Afinitor (everolimus) for the treatment of well- or moderately-differentiated unresectable or metastatic neuroendocrine tumors (NETs) of pancreatic origin in adults with progressive disease. 27 May 2017
The US Food and Drug Administration on May 26 issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for SUN-101/eFlow (glycopyrrolate). 27 May 2017
On the occasion of the World Clinical Trials Day last week, the Hellenic Association of Pharmaceutical Industries (SFEE) held an event to raise awareness of the crucial role of clinical studies both for patients and for the economy, as well as to warn against the imminent threat posed to clinical research in the country by the implementation of new measures. 26 May 2017
Even as India’s National Pharmaceutical Pricing Authority (NPPA) has fixed the prices of 31 more drug formulations, in yet another crackdown on prices, India's premier policy formulating agency Niti Aayog has proposed a change in the manner the government should identify drugs to be brought under price control. 26 May 2017
The European Medicines Agency has granted "PRIME eligibility" for Myrcludex B, a first in class entry inhibitor for hepatitis Delta (D) virus. 26 May 2017
The US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended approval of the proposed epoetin alfa biosimilar across all indications by a vote of 14 to one. 26 May 2017
Global drugmakers operating in Russia have called on the country’s government to impose a ban on the registration of generics before the expiration of the patent protection of original drugs. 25 May 2017
USA-based Puma Biotechnology took its share price rise for the week to nearly 100% after the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted 12 to four to recommend approval of neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer. 25 May 2017
The European Commission has granted a standard marketing authorization for Fampyra (prolonged-release fampridine tablets) for walking improvement in people with multiple sclerosis (MS). 25 May 2017
The US Food and Drug Administration accepted a supplemental Biologics License Application (sBLA) that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC), or liver cancer, after prior treatment with sorafenib (Bayer’s Nexavar). 25 May 2017
The member states of the World Health Organization (WHO) have elected Tedros Adhanom Ghebreyesus (pictured above) as the agency’s new director-general. 24 May 2017
America’s Merck & Co has received yet another US FDA approval, the second in as many weeks, for its immuno-oncology drug Keytruda (pembrolizumab). 24 May 2017
The European Union commitment to ensuring equity of access to healthcare is challenged by the limited financial capacity of governments to cover growing demand for healthcare services. Generic and biosimilar medicines provide the greatest opportunity to improve access to safe and effective medicines through efficient medicines policies. 23 May 2017
Portugal's largest drugmaker Bial and Japanese pharma major Eisai have announced approval from the European Medicines Agency to market Zebinix (eslicarbazepine acetate) as a monotherapy to treat epilepsy. 23 May 2017
The US Food and Drug Administration has approved Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX). 23 May 2017
Shares in USA-based Puma Biotechnology closed 39% higher on Monday at $52.60 as investors sought to predict the position a US Food and Drug Administration (FDA) advisory panel would adopt on neratinib. 23 May 2017