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
Ireland-incorporated drugmaker Allergan finished Tuesday’s trading 3% up at $216.19 as markets and analysts reacted to drug price rises which the company limited to single figures – but only just. 4 January 2017
Russian drugmakers will be allowed to produce one drug under different brand names, which should help to accelerate the process of import substitution in the industry, according to a recent decision of the Russian government. 3 January 2017
China's first oral antiviral drug, dubbed danoprevir (ASC08), for treating hepatitis C virus (HCV) has been accepted for review by the Chinese Food and Drug Administration (CFDA). 1 January 2017
The US Food and Drug Administration has issued a Refusal to File letter for Xaracoll (bupivacaine HCl collagen-matrix implants), a product candidate for the treatment of postsurgical pain. 30 December 2016
The UK’s system for assessing the cost-effectiveness of medicines has long been criticized and the latest to slam the negations between drugmakers and the National Health Service (NHS) is AstraZeneca chief executive Pascal Soriot. 30 December 2016
Shares of US antibiotics developer Cempra (Nasdaq: CEMP) slumped 53.4% to $2.85 in early trading this morning, following news late Thursday of a significant delay in the development of its pneumonia drug candidate. 29 December 2016
Our quarterly Special Report from experts at QuintilesIMS provides scientific and practical insights on Post Authorization Safety Studies based on the first three years since implementation of the new European Union legislation, offering forecasts for likely advances in 2017. 29 December 2016
The National Institute for Health and Care Excellence (NICE) has published draft guidance not recommending Kadcyla (trastuzumab emtansine), a breast cancer drug currently available through the UK’s Cancer Drugs Fund (CDF). 29 December 2016
Russian President Vladimir Putin was told on a visit to Biocad, one of the country’s leading biotech companies, that the quality of Russia's research and development (R&D) and manufacturing meant it could “absolutely compete with foreign counterparts” in the pharmaceutical industry. 28 December 2016
Seattle Genetics has revealed receipt of a notice from the US Food and Drug Administration that a clinical hold or partial clinical hold has been placed on several early stage trials. 28 December 2016
The US Food and Drug Administration has approved Adynovate (antihemophilic Factor [recombinant], PEGylated), an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, in pediatric patients under 12 years of age. 28 December 2016
The US Food and Drug Administration has approved Spinraza (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. 27 December 2016
China-based vaccines developer Sinovac Biotech (Nasdaq: SVA) responded to a recent report regarding the allegations raised in a research report by Geoinvesting. 23 December 2016
Aerie Pharmaceuticals today revealed that the manufacturing line related to its glaucoma treatment Rhopressa (netarsudil ophthalmic solution) will not be ready in time for pre-approval inspection by the Food and Drug Administration. 23 December 2016
Following the Colombian Ministry of Health’s recent decision to lower the price of its cancer drug Glivec/Gleevec (imatinib), Swiss pharma giant Novartis has advised The Pharma Letter that it proposes to take action. 23 December 2016
Belgian biopharma firm TiGenix has submitted its responses to the European Medicines Agency's (EMA) day 120 list of questions for Cx601, its lead product candidate being developed for complex perianal fistulas in Crohn's disease. 23 December 2016
The UK’s National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of Otezla (apremilast). 22 December 2016
The price of Swiss pharma giant Novartis’ cancer drug Glivec/Gleevec (imatinib) will now be 44% lower in Colombia than previously, the country’s health authorities have decided. 22 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