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 supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate), an investigational oral treatment for adult patients with moderately to severely active ulcerative colitis (UC), has been accepted for filing by the US Food and Drug Administration. 13 July 2017
US biotech major Gilead Sciences’ Marketing Authorization Application (MAA) for an investigational, once-daily single tablet regimen has been fully validated by the European Medicines Agency. 13 July 2017
Lawmakers in the USA should oppose two proposals being considered that would significantly expand the marketing of medications and medical devices in a way that would be extremely harmful to patients, consumer advocacy group Public Citizen told Representatives yesterday. 13 July 2017
The US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). 13 July 2017
The US non-profit Institute for Clinical and Economic Review (ICER) has released a Draft Evidence Report assessing the comparative clinical effectiveness and value of three poly ADP-ribose polymerase (PARP) inhibitors for treatment of ovarian cancer. 13 July 2017
Monday might have been a bad day for the biosimilar development partnership of Indian drugmaker Biocon and Netherlands-headquartered Mylan as a manufacturing setback held up its plans for the European market. 12 July 2017
As a result of lack of commercial interest, pharmaceutical companies operating in Brazil have withdrawn from the market old and cheap medications, some of them essential and without substitutes. 12 July 2017
What is claimed to be the world's first cell and gene therapy for degenerative arthritis has been approved by South Korea’s Ministry of Food and Drug Safety (MFDS). 12 July 2017
Californian biotech firm Amgen now has full marketing approval in the USA for Blincyto in a particular kind of acute lymphoblastic leukemia. 12 July 2017
As well as acting as the regulator to make sure therapies are safe and effective, the US Food and Drug Administration (FDA) is helping to bring precision medicine to people living with diseases that have specific genetic features. 12 July 2017
The US Food and Drug Administration (FDA) has changed its stance on a Fabry disease drug being developed by US biotech Amicus Therapeutics, paving the way for the company to submit a New Drug Application (NDA) later in 2017. 12 July 2017
The National Institute for Health and Care Excellence (NICE) today published guidance recommending approval of three drugs for the treatment of plaque psoriasis in children and young people. 12 July 2017
Ocular Therapeutix says it received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its resubmission of a New Drug Application (NDA) for Dextenza. 12 July 2017
Bristol-Myers Squibb has announced that the US Food and Drug Administration will review the company’s application to broaden the label for Sprycel. 12 July 2017
The US Food and Drug Administration (FDA) has accepted and filed the New Drug Administration (NDA) for abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, and granted it a Priority Review designation. 11 July 2017
Financial analyst Morningstar has expressed confidence in the strength of the US healthcare market, as “continued abatement of concerns over branded drug prices helps valuations.” 11 July 2017
USA-based Concert Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has lifted the clinical hold on its CTP-543 Phase IIa clinical trial for alopecia areata, a type of hair loss. 11 July 2017
Consumers and health professionals are advised that Danish diabetes care giant Novo Nordisk, in consultation with Australia’s Therapeutic Goods Administration (TGA), is recalling six batches of NovoPen Echo insulin cartridge holders after detecting that there is a risk that they may crack or break if exposed to chemicals in certain cleaning agents. 11 July 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