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
Women’s health specialist Mithra has received a Marketing Authorization (MA) for the commercialization of Tibelia (tibolone), a generic version of Livial, in France. 30 May 2017
TaiGen Biotechnology has submitted a new drug application (NDA) for the intravenous formulation of Taigexyn (nemonoxacin) to the China Food and Drug Administration (CFDA). 30 May 2017
Switzerland’s medicines regulator has released its annual report, noting that regulatory approval was granted for more than 40 innovative medicinal products last year, with 99% of applications completed on schedule. 30 May 2017
Indian drugmaker Glenmark Pharmaceuticals has received final approval from the US Food and Drug Administration for its generic nebivolol product. 30 May 2017
The National Institute for Health and Care Excellence (NICE) has recommended Keytruda (pembrolizumab) for inclusion in the UK’s Cancer Drugs Fund (CDF) as the first immunotherapy for a specific population of previously untreated metastatic non-small-cell lung cancer (NSCLC). 30 May 2017
The USA’s new Food and Drug Administration Commissioner Scott Gottlieb was in the hot seat last week to defend President Donald Trump's budget plan to the House of Representatives appropriations subcommittee. 30 May 2017
South Africa’s Aspen Pharmacare has entered into a memorandum of understanding (MoU) has been concluded between Aspen’s Russian business and the Vladivostok Far Eastern Federal University (FEFU). 30 May 2017
On May 30, 2017 (tomorrow), trade talks will resume for the India-EFTA (European Free Trade Association) free trade agreement (FTA) in Liechtenstein, between India and the EFTA countries of Switzerland, Norway, Iceland and Liechtenstein. 29 May 2017
The US Food and Drug Administration has approved the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. 27 May 2017
The National Institute for Health and Care Excellence (NICE), in its final decision has recommended Afinitor (everolimus) for the treatment of well- or moderately-differentiated unresectable or metastatic neuroendocrine tumors (NETs) of pancreatic origin in adults with progressive disease. 27 May 2017
The US Food and Drug Administration on May 26 issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for SUN-101/eFlow (glycopyrrolate). 27 May 2017
On the occasion of the World Clinical Trials Day last week, the Hellenic Association of Pharmaceutical Industries (SFEE) held an event to raise awareness of the crucial role of clinical studies both for patients and for the economy, as well as to warn against the imminent threat posed to clinical research in the country by the implementation of new measures. 26 May 2017
Even as India’s National Pharmaceutical Pricing Authority (NPPA) has fixed the prices of 31 more drug formulations, in yet another crackdown on prices, India's premier policy formulating agency Niti Aayog has proposed a change in the manner the government should identify drugs to be brought under price control. 26 May 2017
The European Medicines Agency has granted "PRIME eligibility" for Myrcludex B, a first in class entry inhibitor for hepatitis Delta (D) virus. 26 May 2017
The US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended approval of the proposed epoetin alfa biosimilar across all indications by a vote of 14 to one. 26 May 2017
Global drugmakers operating in Russia have called on the country’s government to impose a ban on the registration of generics before the expiration of the patent protection of original drugs. 25 May 2017
USA-based Puma Biotechnology took its share price rise for the week to nearly 100% after the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted 12 to four to recommend approval of neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer. 25 May 2017
The European Commission has granted a standard marketing authorization for Fampyra (prolonged-release fampridine tablets) for walking improvement in people with multiple sclerosis (MS). 25 May 2017
The US Food and Drug Administration accepted a supplemental Biologics License Application (sBLA) that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC), or liver cancer, after prior treatment with sorafenib (Bayer’s Nexavar). 25 May 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