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
Japanese drugmaker Chugai Pharmaceutical has received approval for an additional indication of its cancer drug Xeloda (capecitabine) in Japan. 26 August 2016
Medicines regulator Health Canada has issued a warning to healthcare professionals on the potential hepatoxicity of Revolade (eltrombopag), a thrombopoietin receptor agonist. 26 August 2016
NICE, the medicines cost-effectiveness watchdog for England and Wales, has issued an updated guideline recommending the use of Esmya (ulipristal acetate 5mg), up to four courses, as first-line treatment for patients presenting with heavy menstrual bleeding and uterine fibroids 3cm or more in diameter. 26 August 2016
Netherlands-based generics major Mylan and Indian drugmaker Biocon have had their regulatory submission for a trastuzumab biosimilar accepted by the European Medicines Agency (EMA). 25 August 2016
Mylan today announced it is taking immediate action to further enhance access to EpiPen (epinephrine) Auto-Injector by expanding already existing programs in recognition of those patients who are facing the burden of higher out-of-pocket costs. 25 August 2016
The Food and Drug Administration has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for Parsabiv (etelcalcetide), a potential treatment for secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. 25 August 2016
Republican Iowa Senator Chuck Grassley has asked the manufacturer of the EpiPen, used for emergency treatment for life-threatening allergic reactions, to explain a steep price increase in the product in recent years. 24 August 2016
Final guidance from the UK's National Institute for Health and Care Excellence (NICE) has recommended Lonsurf (trifluridine/tipiracil), within its marketing authorization, as an option for treating metastatic colorectal cancer, in adults who have had previous treatment. 24 August 2016
The UK’s National Institute for Health and Care Excellence (NICE) has today issued final guidance recommending two drugs for routine use within the National Health Service, both of which were previously available on the now being reformed Cancer Drugs Fund (CDF). 24 August 2016
German pharma major Bayer has announced that its drug Eylea (aflibercept) has been recommended as a cost-effective treatment by the National Institute for Health and Care Excellence (NICE) for visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO). 24 August 2016
US drugmaker AbbVie has received a positive scientific opinion through the UK’s Early Access to Medicines Scheme (EAMS) for venetoclax, a treatment for Chronic Lymphocytic Leukemia (CLL). 23 August 2016
Janssen has submitted an application to the European Medicines Agency to broaden the existing marketing authorization for its immunotherapy Darzalex (daratumumab) to include treatment of adult patients with relapsed multiple myeloma who have received one or more lines of therapy. 23 August 2016
US drugmaker Hemispherx Biopharma has received approval for commercial sale of rintatolimod (US trade name: Ampligen) in the Argentine Republic for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). 23 August 2016
USA-based Puma Biotechnology says that its Marketing Authorization Application (MAA) for neratinib has been validated by the European Medicines Agency (EMA). 23 August 2016
Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. 23 August 2016
The European Commission has granted marketing authorization for US biotech giant Gilead Sciences’ once-daily Truvada (emtricitabine/tenofovir) in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP. 22 August 2016
AstraZeneca and Eli Lilly have received US Food and Drug Administration fast-track designation for the development program in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial. 22 August 2016
The National Agency for Health Vigilance (ANVISA), the medicines regulator in Brazil, has increased the list of health products which, because of lower risk, are subject to less rigorous rules to obtain the renewal of country registration. 22 August 2016
French pharma major Sanofi says it has submitted updated information on the pen delivery device as part of the New Drug Application (NDA) for iGlarLixi. 22 August 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