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 Senate’s Special Committee on Aging has published a damning report on pharma companies’ manipulation of loopholes in the system so they can raise prices of off-patent drugs massively. 22 December 2016
Fresh from its decision to intervene over the price of the multi-indication cancer drug Opdivo (nivolumab), the Japanese government has unveiled new plans to reduce the cost of health care. 21 December 2016
Translating bold campaign trail claims of “repeal and replace” into legislative action can often be challenging with any established bill, let alone one as complex as the Affordable Care Act (ACA). 21 December 2016
Sweeping changes are afoot at India's Health Ministry to encourage innovation in the pharmaceutical sector and to ensure speedier approvals for conducting medical research, reports The Pharma Letter's India correspondent. 21 December 2016
The European Commission (EC) has authorized the extension of the label for all metformin-containing products for all metformin-containing products for the treatment of type 2 diabetes. 21 December 2016
What more does pharma and biotech know now about the implications of Brexit six months after the UK population voted to leave the European Union? 19 December 2016
The US Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. 19 December 2016
Merck & Co has received approval in Japan for its immuno-oncology drug Keytruda (pembrolizumab) to treat certain patients with PD-L1-positive unresectable advanced/recurrent non-small cell lung cancer (NSCLC) in the first and second-line treatment settings. 19 December 2016
The European Commission has approved an expanded indication for Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine) for active immunization against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age. 19 December 2016
Bangladeshi generic drugs company Beximco Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a generic equivalent of Glucophage XR tablets (metformin hydrochloride). 19 December 2016
Based on a US Food and Drug Administration review of a large clinical trial that FDA required the drug companies to conduct, the agency has determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. 19 December 2016
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Vemlidy (tenofovir alafenamide) 25mg, a once-daily treatment for suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function. 19 December 2016
The proposed new measures of the Ministry of Health prove to be disastrous for both the right of Greek patients to unhindered and fair access to the necessary treatments and for public health and the viability of the pharmaceutical industry. 19 December 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for marketing authorization at its December 2016 meeting. 17 December 2016
Agios Pharmaceuticals saw its shares drop 20% to $44.74 today, after it announced that development of its second pyruvate kinase-R (PKR) activator, AG-519, was to be discontinued. 16 December 2016
The publication of a second draft recommendation not recommending use of Takeda’s Adcetris (brentuximab vedotin) in relapsed or refractory Hodgkin lymphoma (R/R HL) on the National Health Service (NHS), has prompted fresh criticism from the Japanese drugmaker. 16 December 2016
Mylan on Friday announced the US launch of the authorized generic for EpiPen (epinephrine injection, USP) Auto-Injector at a wholesale acquisition cost (WAC) of $300 per epinephrine injection, USP two-pack. 16 December 2016
The UK’s Competition and Markets Authority (CMA) has accused generic drugmaker Actavis UK of breaking competition law by raising the price for hydrocortisone tablets paid by the National Health Service. 16 December 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