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
On Thursday, The Pharma Letter reported that privately-held biotech startup Immunochina had become the latest Chinese venture to attract overseas investment as it raised 50 million renminbi ($7.5 million) in a funding round. 24 November 2017
Janssen-Cilag International, part of the US healthcare giant Johnson & Johnson, has announced that the European Commission (EC) has approved Tremfya (guselkumab) to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. 23 November 2017
The European Medicines Agency has launched a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorized or being studied in clinical trials in the European Economic Area (EEA). 23 November 2017
A new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) found that Canadian physicians overwhelmingly support distinguishable names for all biologics, including biosimilars. 23 November 2017
While many in the UK life sciences sector have looked on with concern as Brexit-backing Conservatives have pushed the nation towards exiting the European Union (EU) without even agreeing a deal with the trade bloc, the government’s promises over the past year for funding for science and health have been widely welcomed by the industry. 22 November 2017
The 1st Value Added Medicines conference organized by the Value Added Medicines Group, a sector group of the generics and biosimilars trade group Medicines for Europe, which took place today, November 22, gathered a wide range of experts in the healthcare community to raise awareness and foster debate on a common approach to present solutions for patient-centric innovation and better patient access to these medicines. 22 November 2017
A damning assessment of the cost-benefit of vesicular monoamine transporter-2 (VMAT2) inhibitors for management of tardive dyskinesia (TD) has been released by USA-based not-for-profit Institute for Clinical and Economic Review (ICER). 22 November 2017
US FDA commissioner Scott Gottlieb has announced new measures to promote the development of generic abuse-deterrent formulation opioids. 22 November 2017
The US Food and Drug Administration today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment and aimed at lessening the side effect burden of current treatments that combine three or four medicines. 22 November 2017
The US Food and Drug Administration has started including patent submission dates in the so-called Orange Book, the record of approved drug products. 22 November 2017
The long awaited European Medicines Agency relocation decision provides some certainty to the life sciences industry in an otherwise uncertain Brexit process, according to Helen Kimberley, a lawyer in Hogan Lovells' Commercial and Regulatory team, said. 21 November 2017
The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of adults with hereditary transthyretin-mediated ATTR amyloidosis (hATTR amyloidosis) with polyneuropathy. 21 November 2017
The US Food and Drug Administration is investigating serious adverse events involving Limbrel (flavocoxid), a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis, by Primus Pharmaceuticals. 21 November 2017
The Competition and Markets Authority, the UK’s primary competition and consumer authority, has provisionally found that Concordia abused a dominant position to overcharge the country’s National Health Service for an essential thyroid drug. 21 November 2017
The European Commission has given its backing to broaden the existing marketing authorization for Zytiga (abiraterone acetate) plus prednisone/prednisolone to include an earlier stage of metastatic prostate cancer than its current indications. 21 November 2017
European heads of state have chosen Amsterdam as the new home for the European Medicines Agency post-Brexit, simultaneously ending months of speculation and the hopes of 18 other nations bidding to host the prestigious organization. 21 November 2017
The International Society for Cellular Therapy has welcomed the US FDA’s newly-released comprehensive Regenerative Medicine Policy Framework. 20 November 2017
Samsung Bioepis has had its marketing authorization of Ontruzant, a biosimilar referencing Herceptin (trastuzumab), approved by the European Commission (EC). 20 November 2017
The US Food and Drug Administration has granted pediatric exclusivity for Adcirca (tadalafil) tablets through May 21, 2018, based on study results submitted by Eli Lilly in response to a written request by the FDA to investigate the use of tadalafil in pediatric patients with Duchenne muscular dystrophy. 20 November 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