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 disconnect between the UK government’s target to make the country a world leader in the life sciences, and its failure to provide patients with the drugs that result from this science, has been underlined by a new report. 31 July 2017
US biotech firm Spark Therapeutics has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Luxturna, the proposed trade name for voretigene neparvovec, an investigational, one-time gene therapy for patients with vision loss due to Leber congenital amaurosis or retinitis pigmentosa caused by confirmed biallelic RPE65 mutations. 31 July 2017
Privately-held Italian biopharma company Dompé today revealed that the European Commission has granted a marketing authorization for Oxervate (cenegermin eye drops) for the treatment of moderate to severe neurotrophic keratitis. 31 July 2017
Whether the 16% hit that AstraZeneca’s share price took last week on the setback in its Mystic lung cancer trial was a market over-reaction or not, the damage will be hard to repair. 31 July 2017
The Irish Pharmaceutical Healthcare Association (IPHA) has welcomed the statement by the Health Service Executive (HSE) confirming that it will fund nine delayed medicines for prescribing to patients, but lambasts a “dysfunctional process.” 31 July 2017
In testimony presented to the U.S. House of Representatives’ Judiciary Committee Subcommittee on Regulatory Reform, Commerical and Antitrust Law, the USA’s Federal Trade Commission described its efforts to stop anticompetitive conduct in the pharmaceutical industry. 31 July 2017
Shares in Japan’s Kyowa Hakko Kirin are up nearly 4% following news that the company will proceed next month with its planned US regulatory submission for burosumab, a monoclonal antibody developed with Californian firm Ultragenyx Pharmaceutical. 31 July 2017
Australia’s Health Ministry says that Bristol-Myers Squibb’s Opdivo (nivolumab), a revolutionary new medicine for lung and renal cancer, has been listed on the Pharmaceutical Benefits Scheme (PBS). 31 July 2017
The total number of Abbreviated New Drug Applications (ANDAs) from the US Food and Drug Administration for Indian pharma firms rose to 129 this year, an increase of 45% from the number of 89 for the period of January-July of 2015. 31 July 2017
The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 12 to 1 that the safety data for Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted]) support licensure for immunization against hepatitis B infection in adults 18 years of age and older. 29 July 2017
Drugs will be the subject for total labeling in the Russian pharmaceutical market according to a recent draft law, which was submitted for the consideration of the national Parliament (State Duma) by the Russian national government, reports The Pharma Letter’s local correspondent. 29 July 2017
The European Commission has granted Maviret (glecaprevir/pibrentasvir) marketing authorization for chronic hepatitis C virus (HCV) in all major genotypes. 28 July 2017
Danish CNS specialist Lundbeck and Japan’s Otsuka Pharmaceutical have announced that Abilify Maintena (aripiprazole) for extended-release injectable suspension has been approved by the US Food and Drug Administration (FDA) for the maintenance monotherapy treatment of bipolar I disorder in adults. 28 July 2017
US biotech Gilead Sciences has received Marketing Authorization from the European Commission for a triple-combination therapy which could cure hepatitis C virus (HCV) patients who do not respond to direct-acting antiviral (DAA)-containing regimens. 28 July 2017
Donald Trump has suffered arguably his biggest setback as US President yet, with a humiliating defeat in his attempts to repeal Obamacare. 28 July 2017
The Australian government today announced another significant step to eliminate hepatitis C from Australia by subsidizing a new drug which can treat all forms of the disease with an expected success rate of 90%. 28 July 2017
The US non-profit Institute for Clinical and Economic Review (ICER) has released its preliminary list of prescription drug review topics for 2018. 28 July 2017
The European Commission has approved an update to the Victoza (liraglutide) label in the European Union that expands the indication to reflect both improving blood sugar and cardiovascular (CV) events as integral parts of type 2 diabetes treatment. 28 July 2017
In an increasingly attritional attempt to stay true to his campaign pledge of repealing and replacing his predecessor Barack Obama’s signature health policy, US President Donald Trump has suffered another setback. 27 July 2017
Ireland-incorporated Allergan said today that the National Institute of Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD), recommending that Truberzi (eluxadoline) be made available on the National Health Service for adults living with irritable bowel syndrome with diarrhea (IBS-D). 27 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