US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration review. 8 July 2016
The US Food and Drug Administration has issued two draft guidance documents describing how the FDA would implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products. 8 July 2016
As European Union member states vie to get re-location of the European Medicines Agency to their country following the UK referendum vote to leave the EU, Spain being the latest to pitch its case, the EMA acknowledges the outcome and says it is now up to the UK government to decide how to act. 7 July 2016
Ireland-headquartered Shire has had its marketing authorization extended for its short bowel syndrome (SBS) treatment Revestive (teduglutide) by the European Commission to allow for use by pediatric patients. 7 July 2016
Following a Request for Proposals (RFP) for the supply of gonadotropin-releasing hormone analogues (GnRH analogues), issued in March 2016, New Zealand’s Pharmaceutical Management Agency, PHARMAC, has entered into a provisional agreement with AstraZeneca over a cancer drug. 7 July 2016
The National Institute for Health and Care Excellence (NICE) has today recommended National Health Service use of US pharma giant Pfizer’s Bosulif (bosutinib) for treating some people with chronic myeloid leukemia. 7 July 2016
The Spanish government has confirmed its interest in Spain hosting the European Medicines Agency (EMA) if it moves from its current UK base following the vote for Brexit in last month’s referendum. 6 July 2016
US-based specialty pharma company Insys Therapeutics has received US Food and Drug Administration (approval for its cannabis-derived drug Syndros. 6 July 2016
The European Commission (EC) has granted marketing authorization for Zinbryta (daclizumab) to treat adults with relapsing forms of multiple sclerosis (RMS). 6 July 2016
After listening to what New Zealanders had to say, the country’s Pharmaceutical Management Agency PHARMAC said today that it has changed the way it makes decisions - the most significant change to its decision making in its 23 year history. 6 July 2016
Russian pharmaceutical companies plan to significantly increase the volume of investments in the conduct of clinical trials of their drugs over the next few years, according to recent statements of drugmakers. 5 July 2016
The National Institute for Health and Care Excellence (NICE), has today issued draft guidance for the use of Opdivo (nivolumab) for previously treated advanced renal cell carcinoma in adults, saying it does not recommend this Bristol-Myers Squibb drug for this kidney cancer indication. 5 July 2016
Bial said today that its Ongentys (opicapone) for the treatment of adult Parkinson´s disease patients with motor fluctuations was approved by the European Commission. 5 July 2016
AbbVie’s Humira (adalimumab) has today received approval from the European Medicines Agency as the first and only biologic medicine authorized for patients with certain types of non-infectious uveitis, an inflammatory, painful eye condition that can lead to blindness. 5 July 2016
French pharma major Sanofi and US biotech firm Regeneron Pharmaceuticals have received Japanese approval for Praluent (alirocumab) to treat uncontrolled low-density lipoprotein (LDL) cholesterol, in certain patients with hypercholesterolemia at high cardiovascular risk. 5 July 2016
The German Institute for Quality and Efficiency in Health Care (IQWiG) assessed the added benefit of ticagrelor for patients with acute coronary syndrome already in 2011 in its very first dossier assessment, just after the Act on the Reform of the Market for Medicinal Products (AMNOG) had come into force. 5 July 2016
The European Medicines Agency today said it has concluded its second inquiry within the framework of its infringement procedure against Swiss pharma giant Roche. 4 July 2016
Daiichi Sankyo and Belgian drugmaker UCB today announced the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted approval for Vimpat (lacosamide). 4 July 2016
The US not-for-profit organization the Institute for Clinical and Economic Review (ICER) has posted a draft scoping document which will inform a report on drug therapies for treatment of relapsing-remitting multiple sclerosis (RRMS). 4 July 2016
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
The UK has launched a new Regulatory Innovation Office (RIO), with the goal of accelerating new technologies, particularly in sectors like biotech and healthcare, by reducing regulatory barriers. 9 October 2024
US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
Israel-based Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia (denosumab). 8 October 2024
UK-based ViiV Healthcare, the specialist HIV company majority-owned by GSK (LSE: GSK), with Pfizer and Shionogi as shareholders, has announced a milestone in its efforts to achieve widespread international access to its therapies. 7 October 2024
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024