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 pharmaceutical industry has signaled its support for severe limitations on the length of opioid prescriptions, saying it would be happy if the current 30-day maximum was reduced to just seven days. 28 September 2017
Cancer is on the rise in India. With 1 million people diagnosed with it every year, some 700,000 of them die, making it one of the leading causes of death in the country, reports The Pharma Letter’s India correspondent. 28 September 2017
The European Commission (EC) approval of a combination involving Kisqali (ribociclib) for a large breast cancer indication last month led a senior executive from Swiss pharma giant Novartis to proclaim that it proved the company’s ‘recognized leadership in cancer research’. 27 September 2017
European pharma/biotech groups today issued their views and aims to support European competitiveness in the biomedical sector, and to avoid unnecessary delays for patient access to such innovative medicines whilst ensuring patient and environmental safety. 27 September 2017
Markets reacted accordingly on Tuesday as PTC Therapeutics suffered the latest blow to its hopes to gain approval in the USA for Translarna (ataluren) as a treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). 27 September 2017
Danish diabetes care giant Novo Nordisk today announced that the China Food and Drug Administration (CFDA) has approved Tresiba (insulin degludec) for the treatment of diabetes in China, which it said has the world's highest number of adult diabetes patients. 27 September 2017
The Final Budget Outcome papers released today reveal the enormous efforts of the members of Medicines Australia to keep expenditure low on the Pharmaceutical Benefits Scheme (PBS) while providing Australians with incredible access to breakthrough medicines. 26 September 2017
As part of the ongoing Ease of Doing Export Business - Rapid Results Initiative (RRI), the Medicines Control Authority of Zimbabwe (MCAZ), through the Ministry of Health and Child Care recently reduced the cost of two permits that are essential for exporting pharmaceutical products, reports local newspaper The Herald. 26 September 2017
The China Food and Drug Administration (CFDA) has approved Sovaldi (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. 25 September 2017
The Russian government has prepared a bill simplifying the introduction of new drugs into the domestic pharmaceutical market, a spokesman of state press-service has said recently, reports The Pharma Letter’s local correspondent. 25 September 2017
As the largest pharma event in South Korea, the confidence amongst the attendees at the CPhI Korea meeting this year is a good indication of the industry’s overall health. 25 September 2017
The European Commission has granted a marketing authorization for Tecentriq (atezolizumab) as a monotherapy for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) after they have been previously treated with chemotherapy regardless of PD-L1 status. 25 September 2017
News last week attracted a great deal of comment included Neos Therapeutics gaining US Food and Drug Administration for its attention deficit hyperactivity disorder (ADHD) drug Adzenys. Also garnering attention were: Ultragenyx’ rival bid to acquire Dimension Therapeutics; supplemental approval for Ipsen’s Somatuline Depot; an FDA safety alert on Intercept Pharmaceuticals’ Ocaliva; and a Phase III success for Nabriva’s lefamulin 23 September 2017
The US Food and Drug Administration has issued a complete response letter (CRL) for the Biologics License Application (BLA) seeking approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis (RA). 23 September 2017
Steve Miller, chief medical officer at Express Scripts, the USA’s leading pharmacy benefit manager (PBM), has made a public push for reform of the way that drugs are paid for. 22 September 2017
American advocacy group Public Citizen is launching a legal bid to force a ruling on a petition it launched three years ago regarding the use of benzocaine in over-the-counter medicines. 22 September 2017
With the leading pair of immuno-oncology (I-O) agents Keytruda (pembrolizumab) and Opdivo (nivolumab) seemingly scoring new approvals by the month in major markets, it would be easy to ignore the importance of the latest nod for the latter drug in Japan. 22 September 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