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
US-based biotech firm Gilead Sciences has received notice that the European Medicines Agency (EMA) has validated and will review its Marketing Authorization Application for a new hepatology product. 20 January 2017
The US Food and Drug Administration on Thursday day approved Trulance (plecanatide) for the treatment of chronic idiopathic constipation (CIC) in adult patients. 20 January 2017
US pharma major Bristol-Myers Squibb was down 6.2% at $52.08 in after-hours trading on Thursday, after it revealed disappointing news on a proposed combination lung cancer drug. 20 January 2017
The trade group the Association for the British Pharmaceutical Industry has outlined its objections to new NICE/NHS England proposals on evaluating and funding new medicines. 20 January 2017
The US Food and Drug Administration (FDA) is weighing up potential changes to its advisory committees (ACs) and their role in making decisions on pharmaceutical and other products. 20 January 2017
Belgian drugmaker UCB has filed a supplemental New Drug Application (sNDA) with the US Food and Drug Administration to extend the label for epilepsy drug Briviact (brivaracetam). 20 January 2017
The US Food and Drug Administration has approved Vantrela ER (hydrocodone bitartrate) extended-release tablets [CII] formulated with Teva Pharmaceutical Industries’ (NYSE: TEVA) proprietary abuse deterrence technology. 19 January 2017
UCB (Euronext: UCB) and Dermira (Nasdaq: DERM) have said they expect to file for regulatory approval later this year of their anti-inflammatory drug following the latest positive clinical trial results. 19 January 2017
Dr Nicola Davies reports on what the US Food and Drug Administration (FDA) is doing to promote female participation in clinical trials. 19 January 2017
The opportunities created, and necessary standards needed, by biosimilar drugs in order to deliver sustainable cancer care are outlined in a position paper from the European Society for Medical Oncology (ESMO). 18 January 2017
The boss of one of the world’s biggest pharma companies has defended the industry after President-elect Donald Trump’s share-denting comments in a press conference last week. 18 January 2017
French pharma major Sanofi has received marketing authorization in Europe for its diabetes therapy Suliqua, known as Soliqua in the USA. 18 January 2017
Boehringer Ingelheim is the latest to announce that its biosimilar to AbbVie’s (NYSE: ABBV) blockbuster drug Humira (adalimumab), BI 695501, has been accepted for regulatory review by the European Medicines Agency and the US Food and Drug Administration. 18 January 2017
The US Food and Drug Administration has granted a Rare Pediatric Disease (RPD) designation for TXA127 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic skin disorder. 18 January 2017
The US Food and Drug Administration today announced the issue of new draft guidance on medical product communications, with FDA Commissioner Robert Califf saying that the agency is aware of a high level of interest about its views on such matters. 18 January 2017
A drug that's commonly used to treat high blood pressure is being repurposed for a rare tissue cancer in Europe. The medication, named propranolol, was recently granted Orphan Drug Designation by the European Commission (EC). 18 January 2017
More than 20 pharma companies have given their backing to C/Can 2025: City Cancer Challenge, a new initiative launched at the World Economic Forum’s (WEC) Annual Meeting in Davos, Switzerland, on Tuesday. 17 January 2017
Collaborations with other companies, academia and catapults are increasingly central to the discovery and development of new medicines, says a new report on UK pharma. 17 January 2017
Dr Sam Samaratunga, a GP and life sciences lawyer with Keystone Law, looks at the proposed changes to arrangements for evaluating and funding drugs and other health technologies appraised through NICE’s Technology Appraisal (TA) and Highly Specialized Technologies (HST) programs. 17 January 2017
The United States Supreme Court has agreed to hear a case that will determine whether companies that develop biosimilar versions of biologics must wait six months before launching them in the USA. 16 January 2017
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
Kezar Life Sciences has paused its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 7 October 2024