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
Sanofi today announced that Jevtana (cabazitaxel) has been recommended for use in combination with prednisone or prednisolone as a treatment option for metastatic hormone-relapsed prostate cancer (mHRPC) in England. 25 May 2016
The Association of the British Pharmaceutical Industry (ABPI) has highlighted how patients in the UK would miss out on ground-breaking clinical trials by voting to leave the European Union. 25 May 2016
Canadians face wait times of about 449 days in order to get access to new, potentially lifesaving medicines in public drug plans, according to a new IMS Health Canada report commissioned by Innovative Medicines Canada. 25 May 2016
The National Institute for Health and Clinical Excellence (NICE), the medicines cost-effectiveness watchdog for England and Wales, has today published final guidance recommending three drugs for treating type 2 diabetes. 25 May 2016
The US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) yesterday voted 16-0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes. 25 May 2016
The US Food and Drug Administration has approved the first seasonal influenza vaccine that offers four-strain flu protection for people four years and older, it has been announced. 24 May 2016
According to the European Medicines Agency, adaptive pathways aim to improve timely access to new medicines “primarily in areas of high medical need.” The eligible products would be put on the market earlier for small subsets of patients and their use would gradually be expanded based on additional data generated. 24 May 2016
The European Commission (EC) has granted conditional approval for US healthcare giant Johnson & Johnson subsidiary Janssen Biotech’s single agent Darzalex (daratumumab), it has been announced. 24 May 2016
Sandoz, Swiss pharma giant Novartis' generics and biosimilars business, says that the European Medicines Agency has accepted its Marketing Authorization Application for a biosimilar to Roche's blockbuster drug MabThera (rituximab). 24 May 2016
South Korea-based Samsung Bioepis revealed today that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for SB2, a biosimilar candidate referencing Remicade (infliximab). 24 May 2016
US pharma major Pfizer has announced that the black triangle safety warning for its smoking cessation drug Champix (varenicline) has been removed in the UK. 23 May 2016
Japanese drugmaker Teijin Pharma has received approval from the Ministry of Health, Labour and Welfare in its home country for Feburic (febuxostat) as an indication for hyperuricemia caused by cancer chemotherapy. 23 May 2016
The 2016 European Society of Cardiology (ESC) guidelines on acute and chronic heart failure strongly recommend treating iron deficiency with Ferinject (ferric carboxymaltose), a drug marketed by Vifor Pharma, part of Switzerland-based Galenica Group. 23 May 2016
A US Food and Drug Administration (FDA) advisory panel briefing document has questioned the effectiveness of IDegLira, Novo Nordisk’s insulin degludec (IDeg) Tresiba and liraglutide (Victoza) treatment for type 2 diabetes mellitus (T2DM). 23 May 2016
A decision by the US Food and Drug Administration to revoke designation of a drug (or a biological product) as an orphan drug is a rare event, notes Kurt Karst writing on US law firm Hyman, Phelps & McNamara’s FDA Law Blog. 23 May 2016
Regulatory bodies in India and Japan will work together more closely, both countries vowed at a meeting of politicians and government officials. 23 May 2016
The Russian national Parliament (State Duma) has put forward an initiative to provide financial support to domestic and multinational pharmaceutical producers (operating their plants in Russia), that will freeze the prices for their drugs for the period up to three years. 21 May 2016
Entresto (sacubitril/valsartan), from Swiss pharma giant Novartis, has been given a Class I recommendation, the strongest endorsement, from professional bodies in the USA and EU. 21 May 2016
US-based Ariad Pharmaceuticals will pocket $25 million in second quarter net product revenue related to cumulative shipments of its leukemia treatment Iclusig (ponatinib) to France, following talks with the French health authorities. 20 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