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
Prices for drugs from low and middle-priced segments of the Russian market may increase significantly this year, due to plans of the government to change the scheme of pricing for such categories of drugs, starting from January 1, 2018, reports The Pharma Letter’s local correspondent. 19 May 2017
Typically, when the US Food and Drug Administration approves an expansion of the indication for a drug, it means that additional clinical data have shown the drug can safely and effectively treat patient populations other than those for which it was originally intended. 19 May 2017
Major drug makers in India are in a soup. It is not just the US Food and Drug Administration that is cracking the whip given its three-fold increase in scrutiny of pharma units, the National Pharmaceutical Pricing Authority (NPPA) has issued ‘show cause’ notices to 67 drug companies for introducing certain new brands without price approval, reports The Pharma Letter’s India correspondent. 18 May 2017
The Association of the British Pharmaceutical Industry (ABPI), the trade group representing the UK’s pharma sector, has praised parts of the manifestos proposed by Labour, the Liberal Democrats and the Conservatives. 18 May 2017
Russia may be faced with a shortage of drugs in the future, due to the forthcoming transition to a new system of drug labeling that may lead to huge interruption in medicines supplies to the country. 18 May 2017
Shares in USA-based Concert Pharmaceuticals dropped 10% before rallying slightly, as stockholders learned the company’s clinical trial into hair loss candidate CTP-543 has been put on hold by the US Food and Drug Administration. 18 May 2017
Some of the world’s largest funders of medical research and international non-governmental organizations (NGOs) today agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly. 18 May 2017
By expanding the approved use of Kalydeco (ivacaftor) in cystic fibrosis (CF), the US Food and Drug Administration (FDA) has tripled the number of rare gene mutations that the drug can now treat. 18 May 2017
US healthcare giant Johnson & Johnson’s pharma unit Janssen expects more than 10 of its new ‘blockbuster’ products to be launched or filed for regulatory approval by 2021. 17 May 2017
Days after revealing a potential half-billion dollar collaboration in hemophilia with Pfizer, US gene editing specialist Sangamo Therapeutics announced that the US regulator has granted Fast Track designation to SB-525. 17 May 2017
US regulators have granted Priority Review designation to copanlisib, a non-Hodgkin lymphoma candidate under development by Germany's largest drugmaker Bayer. 17 May 2017
The US Food and Drug Administration says that canagliflozin, marketed by Johnson & Johnson as Invokana, causes an increased risk of leg and foot amputations. 17 May 2017
Taiwan’s Pharmadax has received approval from the US Food and Drug Administration (FDA) to market a generic equivalent of the anti-psychotic drug Seroquel XR (quetiapine fumarate) at five different strengths. 16 May 2017
American lawmakers are reintroducing a bill that would limit the ability of pharmaceutical companies to raise drug prices, with tougher language to prevent medium-term hikes. 16 May 2017
In non-small cell lung cancer (NSCLC) that has already formed metastases, the suitable treatment depends, among other factors, on the genes that are activated in the tumor cells and whether mutations have occurred that make certain treatments ineffective. 16 May 2017
South African drugmaker Aspen Pharma has confirmed that the European Commission has opened proceedings to investigate certain actions of Aspen Holdings and certain of its European subsidiaries. 16 May 2017
European politicians have lent voice to calls for more funding to treat and prevent drug-resistant tuberculosis (TB), at an event organized by charities fighting the disease. 15 May 2017
Research published in the Journal of the American Medical Association (JAMA) has found that a third of drugs approved by US regulators are subsequently flagged for a safety event. 15 May 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