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’s Health Service Executive (HSE) National Drugs Management Program (NDMP) and Neurology Program have introduced a national reimbursement scheme which will facilitate access for patients with multiple sclerosis (MS) to approved high cost treatments. 7 April 2017
For the last two years, the European Medicines Agency has carried out ‘single assessments’ of post-marketing safety reports which relate to products with the same active substance. 6 April 2017
Briviact (brivaracetam) has been accepted for use in Ireland as an add-on treatment for partial onset seizures (POS) with or without secondary generalized seizures in adults with epilepsy. 6 April 2017
The US Food and Drug Administration has granted Breakthrough Therapy designation status to evinacumab for the treatment of hypercholesterolemia in patients with homozygous familial hypercholesterolemia (HoFH). 6 April 2017
The Pacific Research Institute has criticized reimbursement practices in the UK, describing the country’s public health watchdog, the National Institute for Health and Care Excellence, as ‘a cautionary tale’ for the US healthcare system. 6 April 2017
Jordanian drugmaker Hikma Pharmaceuticals has reached a settlement with Jazz Pharmaceuticals that resolves patent litigation related to the Ireland-based company’s Xyrem (sodium oxybate) oral solution, 500mg/mL product. 6 April 2017
Lawmakers have confirmed that they will demand the relocation of the European Medicines Agency from its current base in London when the UK exits the EU. 6 April 2017
Republicans in the US Congress went into last month’s vote to repeal and replace the Affordable Care Act with guidance from President Trump, effectively: ‘Vote yes or you’re stuck with Obamacare.’ 5 April 2017
APAC Biotech has been granted with a commercial license by India’s Central Drugs Standard Control Organization (CDSCO) to market product, Apcedene, a dendritic cell-based autologous Immuno-oncology product for four cancer indications. 5 April 2017
The US Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) to extend the use of Opdivo (nivolumab). 5 April 2017
Trade group AusBiotech has made a submission endorsing proposed changes to improved access options for unapproved therapeutic goods in Australia, which are intended to reduce time and administrative burden and greatly improve efficiencies for applicants. 5 April 2017
The Commonwealth Scientific and Industrial Research Organisation (CSIRO), an Australian government agency responsible for scientific research, is calling for: “action now to establish an ecosystem that will support the growth and innovation of the MTP sector in Australia.” 4 April 2017
Amgen has filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration and an application for a variation to the marketing authorization to the European Medicines Agency (EMA) for Xgeva (denosumab). 4 April 2017
Mallinckrodt has reached an agreement in principle with the US Drug Enforcement Administration (DEA) and the US Attorneys' Offices (USAOs) for the Eastern District of Michigan and the Northern District of New York regarding controlled substances. 4 April 2017
The US Food and Drug Administration has approved Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease, Teva Pharmaceutical has announced. 4 April 2017
Sanofi Pasteur has agreed to pay $19,868,194 to resolve claims that it incorrectly calculated drug prices and thereby overcharged the US Department of Veterans Affairs (VA) for drugs under two contracts between 2002 and 2011, the Department of Justice revealed yesterday. 4 April 2017
Ireland-headquartered Shire has announced that its partner in Japan, Shionogi , has received the approval of the Japanese Ministry of Health, Labor and Welfare to manufacture and market Intuniv (guanfacine hydrochloride prolonged release). 4 April 2017
Global drugmakers operating in Russia will be obliged to transfer information on the price of their drugs to a single information system operated by the Russian Federal Tax Service, as part of the new state strategy for drugs’ labeling in the Russian pharmaceutical market, reports The Pharma Letter’s local correspondent. 4 April 2017
Further lots have been added to the EpiPen (epinephrine) Auto-Injector devices being recalled because it is feared that they might not work. 3 April 2017
Swiss pharma giant Novartis has received EU approval for its combination therapy of Tafinlar (dabrafenib) and Mekinist (trametinib) in non-small cell lung cancer (NSCLC). 3 April 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