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
Republicans have taken the chance to aim further criticism at the Affordable Care Act (ACA) amid US Senate proposals to repeal and replace the act. 23 June 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five new medicines, a biosimilar and two generics for approval at its June meeting. 23 June 2017
The US Food and Drug Administration has granted drugmaker Novartis approval to market Tafinlar and Mekinist as a combination therapy for patients with metastatic non-small cell lung cancer with BRAF V600E mutation. 23 June 2017
Haegarda, a therapy for hereditary angioedema (HAE) from biotech firm CSL Behring, has been approved by the US Food and Drug Administration. 23 June 2017
Shares in Danish CNS specialist Lundbeck have fallen 4% on the news that the company, together with development partner Takeda Pharmaceutical, has not succeeded in adding new data to the label for depression therapy Trintellix. 23 June 2017
The US Food and Drug Administration yesterday approved Rituxan Hycela, the combination of Genentech’s Rituxan (rituximab) and Halozyme’s hyaluronidase human Enhanze technology for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. 23 June 2017
The UK's medicines regulator has given a positive scientific opinion to Santhera Pharmaceuticals’ therapy Raxone, through the country’s Early Access to Medicines Scheme (EAMS). 22 June 2017
The European Medicines Agency has agreed to review London-listed Shire's application for approval to market Veyvondi as a treatment for von Willebrand Disease (VWD), the most common inherited bleeding disorder. 22 June 2017
The New York Times published an analysis of a draft Trump executive order on prescription pricing and innovation. US advocacy group consumer rights Public Citizen reviewed portions of the order text in cooperation with the Times. 22 June 2017
Anthem is pulling out of health insurance exchanges in Wisconsin and Indiana, a decision cheered by Republicans as another harbinger of doom for Obamacare. 22 June 2017
One interesting corollary of Amazon’s recent acquisition of Whole Foods was the effect on pharmacies, which shed about $10 billion in share price value, according to UBS. 22 June 2017
Citing the saving of $1.67 trillion that competition from generics has brought to the US health care system in the last decade, Food and Drug Administration (FDA) Commissioner Scott Gottlieb has voiced his support for more of these copycat drugs to reach market sooner. 21 June 2017
Shares in Ireland-headquartered Shire are up more than 2% in London, on news that the rare disease specialist has finally received US Food and Drug Administration approval for its long-acting attention deficit hyperactivity disorder (ADHD) therapy. 21 June 2017
A group of the three biggest state rheumatology organizations have joined a new coalition of provider and patient groups concerned about the role of pharmacy benefit managers (PBMs) in driving up drug costs. 21 June 2017
Ten leading pharmaceutical companies in Canada have agreed to disclose payments made in exchange for services or to fund charitable, educational and scientific activities. 21 June 2017
Brexit, political instability, economic uncertainty, an aging population increasingly suffering from chronic conditions, a cost-effectiveness watchdog looking to save every penny possible when paying for new medicines and a National Health Service (NHS) reportedly facing its worst crisis in generations – the challenges facing the UK health sector appear almost insurmountable. 21 June 2017
The US Food and Drug Administration’s Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) has invited PharmaMar (MC: PHM) to participate in this ODAC, giving a presentation to provide background information on Zepsyre. 20 June 2017
Increased scrutiny around the pricing of medicines is starting to have an impact on drug sales growth, according to Evaluate’s latest World Preview report. 20 June 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