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 Food and Drug Administration has approved Admelog (insulin lispro injection), the first follow-on (ie, a similar) insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. 12 December 2017
The US lobby group Pharmaceutical Research and Manufacturers of America (PhRMA) has initiated litigation in the US District Court for the Eastern District of California challenging SB 17, describing it as ‘an unprecedented and unconstitutional California law.’ 11 December 2017
A survey compiled by US consulting firm the Reputation Institute put Bayer in the top 10 of a list of the world’s most reputable pharma companies. 11 December 2017
The news early Friday morning that Britain and the European Union had finally agreed that enough progress has been made in the Brexit talks for the UK to leave the EU, to move on to more detailed trade agreement discussions, was broadly welcomed by the pharma and biotech industry. 8 December 2017
In a reversal of its earlier draft decision, the UK’s health technology assessor has provided final draft guidance recommending Eisai’s Kisplyx (lenvatinib), in combination with everolimus, as an option for treating kidney cancer. 8 December 2017
Seven months post-launch, the clear majority of US neurologists (n=103) have initiated at least one patient on Roche (ROG: SIX) subsidiary Genentech's Ocrevus (ocrelizumab), with the brand share being boosted by uptake in both relapsing remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) patients, new report shows. 8 December 2017
A report from advocacy group AARP - the American Association of Retired Persons - has found that retail prices for 768 prescription drugs commonly used by older adults increased by an average of 6.4% in 2015, despite a low inflation rate of 0.1% for the period. 7 December 2017
The Australian Competition and Consumer Commission (ACCC) has instituted proceedings in the Federal Court of Australia against the local consumer health subsidiaries of GlaxoSmithKline and Novartis, alleging they made false or misleading representations in the marketing of Voltaren Osteo Gel and Voltaren Emulgel pain relief products. 7 December 2017
The UK’s National Institute for Health and Care Excellence (NICE) has today published draft guidance on the following technology appraisals: 7 December 2017
The upward momentum seen in the pharma and biotech sectors during 2017 looks set to continue into 2018, with more novel medicines set to hit the market and investor support for the industry remaining strong. 7 December 2017
Following a positive advisory committee vote in October, the US Food and Drug Administration has now given its formal approval to allow the marketing of Ozempic (semaglutide injection) in the USA. 6 December 2017
Three months after the US FDA put a partial hold on three clinical trials investigating Opdivo combinations in multiple myeloma, the agency has given Bristol-Myers Squibb and its collaborators the all clear to continue two of the studies. 6 December 2017
British lawmakers have revealed details of a new industrial strategy for the life sciences sector, aimed at supporting economic development in the wake of Brexit. 6 December 2017
The British pharmaceutical industry’s leading trade group told a UK government committee this morning that it would favor “a pragmatic agreement” where parts of the European Medicines Agency would stay in London after Brexit. 5 December 2017
There was disappointing news today for Swiss pharma giants Novartis and Roche when the UK’s National Institute for Health and Care Excellence (NICE) published draft guidance on technology appraisals turning down drugs from the companies for regular use on the National Health Service (NHS). 5 December 2017
The US Food and Drug Administration has granted Amgen a label extension for Repatha, to include prevention of heart attacks and strokes. 4 December 2017
Canada has launched proposals to amend regulations covering patented medicines, saying it hopes to “better protect Canadian consumers from the high prices of patented drugs.” 4 December 2017
The Chinese Food and Drug Administration has approved Brintellix (vortioxetine) for the treatment of major depressive disorders (MDD) in that country. 4 December 2017
The European Medicines Agency today released highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) meeting that was held November 27-30, 2017. 1 December 2017
Speaking before a congressional committee in the US House of Representatives, FDA Commissioner Scott Gottlieb confirmed Thursday that his agency is honing in on new ways to approve certain drugs faster. 1 December 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