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 is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. 20 May 2016
The National Institute for Health and Care Excellence (NICE) has today issued draft guidance not recommending Perjeta (pertuzumab), from Swiss pharma giant Roche, to treat HER2-positive breast cancer because it is uncertain how the responses to treatment seen in the clinical trials translate into long term benefits for patients. 20 May 2016
A UK government review warning of an ‘antibiotics apocalypse’ is recommending the introduction of incentives to encourage pharmaceutical companies to invest in research activity to find new drugs and treatments to tackle the ever-growing problem of antimicrobial resistance (AMR). 19 May 2016
The US Food and Drug Administration has granted accelerated approval to Tecentriq (atezolizumab injection) from Genentech, for the treatment of a specific type of bladder cancer. 19 May 2016
The US Food and Drug Administration has granted Priority Review to the supplemental Biologics License Application (sBLA) for Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) for to treat relapsed chronic lymphocytic leukemia (CLL) patients. 18 May 2016
Olmutinib (BI 1482694/HM61713) has been approved in South Korea for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). 18 May 2016
The US Food and Drug Adminstration has approved Bristol-Myers Squibb’s Opdivo (nivolumab) as a treatment for patients with a rare blood cancer, marking the first approval of a PD-1 inhibitor in a hematological malignancy. 18 May 2016
Large innovative US pharmaceutical companies are expected to continue targeted acquisitions as the need for larger transactions has declined, according to Fitch Ratings. 18 May 2016
Valeant Pharmaceuticals has announced that it will make an enhanced rebate program available to reduce the price of Nitropress (nitroprusside) and Isuprel (isoproterenol) for all hospitals in the USA. 17 May 2016
US rare diseases focused biopharma company Catalyst Pharmaceuticals today announced that the company is reducing its workforce by approximately 30%. 17 May 2016
Switzerland-based Actelion has received European Commission marketing authorization for Uptravi (selexipag), its selective IP prostacyclin receptor agonist, as a long-term treatment of pulmonary arterial hypertension (PAH), in the European Union. 17 May 2016
Serious, sometimes life-threatening and fatal cases of diabetic ketoacidosis (DKA) have been reported in patients on sodium glucose co-transporter 2 (SGLT2) inhibitors for type 1 and type 2 diabetes, warns medicines regulator Health Canada. 17 May 2016
US Democrat presidential front runner Hillary Clinton just dipped her toe a little bit further into the waters of single-payer health care, prodded by her competitor for the Democratic presidential nomination, Senator Bernie Sanders, according to a posting on the website of the Pacific Research Institute think-tank. 17 May 2016
US Pharma major Bristol-Myers Squibb will not seek reimbursement for multiple myeloma drug Empliciti (elotuzumab) in the UK and the Republic of Ireland because the company cannot demonstrate cost-effectiveness, it has been revealed. 16 May 2016
BioIntegrator, a member of the Russian ChemRar group of companies, announced today the successful launch in Belorussia of Nescler, a unique oral formulation of fingolimod. 16 May 2016
Danish diabetes care giant Novo Nordisk said today it has submitted a Biologics License Application for the approval of long-acting factor IX, nonacog beta pegol to the US Food and Drug Administration. 16 May 2016
Medicines regulator Health Canada announced on Friday that the department will propose a regulatory amendment to allow access to diacetylmorphine under Health Canada's Special Access Program (SAP). 16 May 2016
According to estimates from Poland-based market research group PMR, Poland will be the most rapidly developing market in the area of generics in the next five years, given its traditionally unchangeable pro-generic policy and the generally attractive nature of the market, based on its affluence and size. 16 May 2016
The UK’s medicines cost-effectiveness watchdog the National Institute for Health and Clinical Excellence (NICE) has come in for a lot of criticism for negative decisions, particularly with regards to new cancer drugs, and last week’s rejection of Bristol-Myers Squibb’s Opdivo was no exception. 15 May 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