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
Falling stock markets, political uncertainty and continued global economic weakness all contributed to a mixed first half for the pharma and medtech industries, according to a new report. 17 August 2016
The Directorate General of Foreign Trade in India has laid down the conditions for import and export of human biological samples for commercial purposes recently. 17 August 2016
The US Food and Drug Administration (FDA) has granted esketamine, an investigational antidepressant medication, Breakthrough Therapy Designation for the treatment of major depressive disorder with imminent risk for suicide. 16 August 2016
Politically unaccountable groups, having their own agendas, should not be dictating the practice of medicine in the form of guidelines to be required by Medicare, states the Association of American Physicians and Surgeons (AAPS) in comments it submitted on Saturday (August 13) to the Centers for Medicare & Medicaid Services (CMS) on its proposed new regulation. 16 August 2016
A report on why UK cancer patients are missing out on drugs available elsewhere is ‘too simplistic’ in attributing the problem to failed negotiations with pharma companies, according to the Association of the British Pharmaceuticals Industry (ABPI). 15 August 2016
National health spending in the USA in June 2016 was 5.2% higher than in June 2015, totaling $3.36 trillion (seasonally adjusted annual rate). 15 August 2016
The European Medicines Agency has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), titled “Product- or population-specific considerations II: Biological medicinal products.” 15 August 2016
Much like a soccer player having to adapt his game when he goes to play in a different national league, pharma companies need a different approach to gaining regulatory approval and reimbursement in different major markets. 15 August 2016
British businesses and universities will have certainty over future funding and should continue to bid for competitive European Union funds while the UK remains a member of the European Union, ahead of leaving in the so-called ‘Brexit’ move following the referendum vote to leave, according to a government announcement on Saturday. 14 August 2016
The US Food and Drug Administration, with information received from the European Medicines Agency (EMA) and the French national medicines agency (ANSM), has completed a comprehensive review of safety information relevant to the investigational new drug BIA 10-2474 and the potential implications for related drugs under investigation in the USA. 12 August 2016
Endo International said today that, based on an August 11, 2016 discussion with the US Food and Drug Administration, the company has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for its opioid antagonist Opana ER without prejudice to re-filing. 12 August 2016
In Australia, product Information documents for US biotech major Amgen’s denosumab have been updated regarding the potential risk of QT interval prolongation associated with hypocalcemia. 12 August 2016
In draft guidance published today, Anglo-Swedish pharma major AstraZeneca’s Brilique (ticagrelor) has been recommended for National Health Service use by the medicines cost-effectiveness watchdog for England and Wales. 12 August 2016
NHS England has launched a 45-day public consultation on a proposed clinical commissioning policy for Pre-Exposure Prophylaxis (PrEP) for HIV. 11 August 2016
The US Food and Drug Administration (FDA) has created a model Drug Facts Label (DFL) to help drugmakers submit new drug applications for over-the-counter (OTD) versions of a drug that combats the effects of an opioid overdose. 11 August 2016
The US Food and Drug Administration (FDA) has granted Priority Review status to privately-held Marathon Pharmaceuticals’ investigational drug deflazacort for Duchenne Muscular Dystrophy (DMD). 11 August 2016
A European Medicines Agency (EMA) report on its adaptive pathways pilot fails to address concerns about how real world data can be used to draw reliable conclusions after drug approval, says Germany's Institute for Quality and Efficiency in Healthcare (IQWiG). 10 August 2016
Following a pre-planned interim analysis for MONARCH 2, an independent Data Monitoring Committee (DMC) recommended the study continue without modification as the interim efficacy criteria were not met, says US pharma major Eli Lilly. 10 August 2016
US specialty biotech group Heron Therapeutics says it has received US Food and Drug Administration approval for its Sustol (granisetron) extended-release injection. 10 August 2016
Canada’s Cardiome Pharma says that Xydalba (dalbavancin) has been approved by the European Medicines Agency for administration as a single, 30 minute, 1500mg infusion (three 500mg vials). 10 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