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 granted Toca 511 & Toca FC Breakthrough Therapy designation for the treatment of patients with recurrent high grade glioma (HGG). 23 February 2017
The chief executive of German pharma major Bayer (BAYN: DE) did not hold back in expressing his views on the year’s politics developments as he presented his company’s annual results for the first time. 23 February 2017
Australian biotech companies might not have Brexit or an unpredictable new President to worry about, but they are being caused uncertainty by a troubling tax issue. 23 February 2017
Swiss pharmaceutical firm Dipharma has announced that the European Medicines Agency has validated its Marketing Authorization application for Disanit. 23 February 2017
Truxima (biosimilar rituximab) has been approved by the European Medicines Agency for use in all indications of the reference product Mabthera, the blockbuster monoclonal antibody developed by Roche. 22 February 2017
China's Food and Drug Administration has announced that two five-year plans (2016-2020) on food and drug safety were issued by the State Council on February 21. 22 February 2017
Amphastar Pharmaceuticals revealed it had received a complete response letter (CRL) from the US Food and Drug Administration regarding its opioid overdose drug. 22 February 2017
US RNA-based drug developer Sarepta Therapeutics says it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV). 22 February 2017
A Biologics License Application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted Priority Review by the US Food and Drug Administration. 22 February 2017
Trade group Medicines for Europe says it welcomes the approval by the European Parliament of the European Union and Canada Comprehensive Economic and Trade Agreement (CETA) that can be an opportunity for medicine manufacturers in the two regions. 22 February 2017
UK Medicines cost-effectiveness watchdog The National Institute for Health and Care Excellence (NICE) has today published draft guidance that does not recommend cabozantinib for previously treated advanced renal cell carcinoma. 21 February 2017
Swiss pharmaceutical giant Roche has been granted conditional approval from the European Medicines Agency (EMA) for its lung cancer therapy Alecensa (alectinib). 21 February 2017
In Russia, the vast majority of pharmaceutical sales are attributed to imported drugs, something that President Vladimir Putin’s “Pharma 2020” project - an initiative to stimulate local pharmaceutical development and manufacturing - aims to change. 20 February 2017
Chugai Pharmaceutical has filed a new drug application to the Ministry of Health, Labor and Welfare (MHLW), for engineered anti PD-L1 monoclonal antibody atezolizumab (genetic recombinant) for the treatment of unresectable advanced or recurrent non-small cell lung cancer (NSCLC). 20 February 2017
Rare and specialty diseases specialist Mereo BioPharma Group was trading 2% higher on Monday lunchtime at £2.90 after more positive news on an asset which it acquired from Swiss pharma major Novartis in 2015. 20 February 2017
Momenta Pharmaceuticals announced that Sandoz’s contracted fill/finish manufacturing partner has received a US Food and Drug Administration warning letter. 20 February 2017
While developments at the USA’s White House were much in focus politically last week, the heat was off the Pharma sector, at least for the time being. Last week’s news for sector centered more on clinical trials results, drug approvals and some financial reports. 19 February 2017
Children with asthma in the USA aged six years and above can receive the Boehringer Ingelheim treatment Spiriva (tiotropium) Respimat, as opposed to those aged at least 12 years as was previously the case. 17 February 2017
Health Canada has granted a Notice of Compliance (NOC) for Odefsey (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) tablets as a complete regimen for the treatment of adults with HIV-1 infection. 17 February 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