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
Roche has received approval from the European Commission for Gazyvaro (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance in people with follicular lymphoma. 17 June 2016
The National Institute for Health and Care Excellence (NICE) has recommended the combination therapy of Opdivo (nivolumab) + Yervoy (ipilimumab), both drugs from US pharma major Bristol-Myers Squibb, to treat National Health Service patients with advanced skin cancer. 17 June 2016
The National Institute for Health and Care Excellence (NICE) has said it will not be able to recommend Orkambi (lumacaftor-ivacaftor) from US drugmaker Vertex Pharmaceuticals for treating cystic fibrosis. 17 June 2016
Netherlands-headquartered independent drugmaker Norgine has received approval from the Dutch Ministry of Health for the reimbursement of Xifaxan 550 (rifaximin-α 550mg) in hepatic encephalopathy (HE). 16 June 2016
The National Institute for Health and Care Excellence (NICE) has today published draft guidance on Cotellic (cobimetinib) with Zelboraf (vemurafenib) for a type of advanced skin cancer. 16 June 2016
The National Pharmaceutical Pricing Authority (NPPA) in India has taken action against major drug firms for not registering their products on the online database Integrated Pharmaceutical Database Management System. 16 June 2016
The US Senate Judiciary Committee introduced new legislation Tuesday, aimed at countering the growing issue of rising prescription drug prices in the USA and anti-competitive moves by pharmaceutical companies to delay lower-priced generic competition from entering the market. 15 June 2016
Johnson & Johnson (NYSE: JNJ) subsidiary Janssen has announced results from a Phase II study showing glycemic improvements in patients with type 1 diabetes (T1DM) who were treated with its SGLT2 inhibitor Invokana (canagliflozin). But in the same week the US Food and Drug Administration (FDA) upped its safety warnings on the drug. 15 June 2016
Leading Russian biotech firm Biocad has filed a petition to the New York Federal Court against Swiss pharma giant Roche, accusing the company of setting monopoly-low prices for its products in Russia, with the aim of ruining business of local competitors, reports The Pharma Letter’s local correspondent. 14 June 2016
French pharma major Sanofi has announced that two late-stage Phase III trials of its LixiLan diabetes drugs have met their primary endpoints. 14 June 2016
Immediate contingency plans should be put in place to safeguard the UK’s science and innovation sector in case Britain votes to leave the EU, a government report has said. 14 June 2016
USA-based Eleven Biotherapeutics, specialized in protein therapeutics to treat diseases of the eye, yesterday entered into an exclusive license agreement with Swiss pharma giant Roche 14 June 2016
Taiwanese drug developer TaiGen Biotechnology has received approval from the China Food and Drug Administration (CFDA) to market the oral formulation of its novel antibiotic, Taigexyn (nemonoxacin), in mainland China. 14 June 2016
In our weekly expert view piece, chief executive of the BioIndustry Association (BIA), Steve Bates, explains why he thinks it is vital the UK remains a part of the European Union. 14 June 2016
Research findings from specialists treating advanced lung cancer have today highlighted worrying concerns that UK patients are being denied the best possible chance of survival. 14 June 2016
The US Food and Drug Administration has granted Breakthrough Therapy designation for two investigational products for rare diseases from Shire. 13 June 2016
Drug pricing was on Wall Street’s mind again Friday, as Wells Fargo tapped Netherlands-incorporated Mylan as the next target for activists, reported Investor’s Business Daily. 13 June 2016
The US Food and Drug Administration has granted approval for privately-held PaxVax’ Vaxchora, a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. 13 June 2016
The Colombian Ministry of Health has announced that negotiations with Swiss pharma giant Novartis over the price of its cancer drug Glivec (imatinib) have failed, and that Health Minister Alejandro Gaviria will proceed with the formal declaration that a compulsory license for the patents on the drug is in the public interest. 13 June 2016
China Food and Drug Administration’s (CFDA) Minister Bi Jingquan and Bill & Melinda Gates Foundation co-chairman Bill Gates recently officially signed the Memorandum of Understanding on Strategic Cooperation between the CFDA of the People's Republic of China and the Gates Foundation. 13 June 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