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 US Food and Drug Administration has approved biotech major Amgen’s supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab). 2 September 2016
The National Institute for Health and Care Excellence has today issued draft final guidance recommending German pharma major Bayer’s Xofigo (radium-223 dichloride) as an option for treating prostate cancer, reversing an earlier decision not to back the drug. 2 September 2016
Canada is experiencing a growing number of opioid overdoses and deaths across the country, and days such as the International Overdose Awareness Day are bringing needed attention to this crisis. 1 September 2016
Amidst concerns about death and overdose risks from narcotic painkillers taken with certain antianxiety or sedative drugs, the US Food and Drug Administration has issued a strong “Boxed Warning” of combination usage. 1 September 2016
The European Commission has approved US pharma giant Pfizer’s Xalkori (crizotinib) for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC), the company revealed today. 31 August 2016
PHARMAC has made decisions to award the Zoladex brand of cancer drug goserelin Sole Subsidized Supply in the community and Hospital Supply Status in District Health Board hospitals and to apply reference pricing to leuprorelin (Eligard and Lucrin) in the community. 31 August 2016
Sandoz has received US Food and Drug Administration approval for Erelzi (etanercept-szzs) for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA). 31 August 2016
In India, 33 drugs supplied to various government hospitals and stores in Arunachal Pradesh were found to be of sub-standard quality during laboratory tests. 30 August 2016
Although the performance and procedural goals for the sixth iteration of the US Prescription Drug User Fee Act (PDUFA) were laid out last month, pharmaceutical companies, including Anglo-Swedish AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the program from fiscal years 2018 through 2022. 30 August 2016
To push India into top five pharmaceutical innovation hubs by 2020 and establish global presence by launching one out of every five-10 drugs discovered in India at a global level, the government is preparing for multi-billion dollar investment with 50% public funding through its public private partnership (PPP) model to enhance innovation capability, a new study reveals. 30 August 2016
Mylan has said it will launch the first generic to EpiPen Auto-Injector (epinephrine injection, USP) at a list price of $300 per generic EpiPen two-pack carton. 29 August 2016
Bernstein analyst Tim Anderson and team wonder if Pfizer winning the bidding war for Medivation with its $14 billion offer (announced last Monday) is “something to be proud of,” reported Barron’s magazine. 28 August 2016
The Russian Federal Anti-Monopoly Service (FAS) has started investigations regarding the recent detection of a cartel in the Russian pharmaceutical market, which was created by some leading local drugmakers and global majors operating in the Russian market, according to press-service of the FAS, reports The Pharma Letter’s local correspondent. 26 August 2016
The Ministry of Health of Ukraine has officially approved the conduct of clinical trials of drugs imported to the country – the initiative that has long been lobbied by global pharmaceutical majors, operating in the country. 26 August 2016
Eisai today said that the anticancer agent Treakisym (bendamustine hydrochloride) for Injection 100mg been approved in Japan for an additional indication of chronic lymphocytic leukemia. 26 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