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
After a number of media leaks regarding the European Medicines Agency’s view of the rival member states’ bids, the agency has published its assessment in full. 4 October 2017
Market activity on Wednesday underlined the importance of a US Food and Drug Administration (FDA) approval of a generic drug from Mylan. 4 October 2017
It has not been an uneventful reign for Guido Rasi as executive director of the European Medicines Agency (EMA) since he took over in November 2011, with first his appointment called into question in a saga that saw him stripped of the role and then reinstated, and now the agency facing a disruptive move from its London home due to Brexit. 4 October 2017
Trade group AusBiotech has released its annual report, showcasing the accomplishments of the Australian biopharmaceutical sector and lobbying for the preservation of tax incentives for research and development. 3 October 2017
The US Food and Drug Administration’s recent approval of the first gene therapy in the USA, Novartis’ (NOVN: VX) Kymriah1 (tisagenlecleucel), has understandably sparked much attention, writes Dr Nicola Davies in her monthly FDA Blog for The Pharma Letter. 3 October 2017
An analysis from the investment research firm Zacks has considered the impact that US President Donald Trump’s proposed tax reforms could have on large-cap pharma companies based in the USA. 2 October 2017
The European Commission has approved the marketing authorization of lutetium (177Lu) oxodotreotide (Lutathera) for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. 2 October 2017
Anger has been stirred up by a Journal of the American Medical Association (JAMA) article on the estimated research and development (R&D) spending for developing a cancer drug that potentially makes a mockery of previous claims from pharma on how much the process costs. 2 October 2017
The commitment to transparency, contribution to the sustainability of the healthcare system and investment in research and development are the three pillars on which the social commitment of the innovative pharmaceutical industry in Spain is based, according to the local trade group. 2 October 2017
Last week saw AbbVie entering a patent settlement with Amgen relating to the latter’s biosimilar version of blockbuster drug Humira. US Food and Drug Administration acceptance for review of Eisai’s cancer drug Lenvima in a new indication, and FDA approval for Eli Lilly’s new breast cancer drug Verzenio also figured in the news. Also attracting attention was news on the failure of Axovant Sciences’ Alzheimer’s disease candidate intepirdine. 1 October 2017
US Health and Human Services Secretary Tom Price sent this letter to President Donald Trump as he resigned Friday in the midst of a scandal over his use of private planes, racking up bills estimated at nearly a million dollar in taxpayer-funded travel since taking office in February, according CNN. 30 September 2017
Science writer David Levine provides the latest quarterly Special Report piece, looking at the drug prices in one therapy area that are getting on people's nerves so much that they might prompt drastic action from the White House to bring down the cost of medicines across the board. 29 September 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has endorsed an update of the European Union label with immediate effect for Tresiba (insulin degludec) to include results from the DEVOTE trial on severe hypoglycemia. 29 September 2017
A new analysis from QuintilesIMS, which draws on the Medicines Use and Spending in the U.S. — A Review of 2016 and Outlook to 2021 report and the Outlook for Global Medicines Through 2021: Balancing Cost and Value, takes an in-depth look at the true drivers of US medicine spending. 29 September 2017
Before Bioverativ found a way to extend the half life of recombinant factor therapies, hemophilia patients required a transfusion as often as every other day, resulting in higher bleed frequency and associated morbidity. 29 September 2017
A group representing the industry that supplies more than 60% of Europe’s medicines has hit out at the low prices being paid for these drugs. 29 September 2017
Shares of US pharma major Eli Lilly were barely moved yesterday even though the company received approval from the US Food and Drug Administration for Verzenio (abemaciclib), under the agency’s Breakthrough and Priority Review designation programs. 29 September 2017
Rare diseases had long been ignored in China until very recently. In May, China’s Food and Drug Administration (CFDA) drafted a policy to accelerate the approval process for innovative medical devices and drugs, including those for rare diseases, reports The Pharma Letter’s local correspondent Wang Fangqing. 29 September 2017
As advancements in cancer therapies have been making headlines in recent years, cancer drug prices have significantly increased. The remaining question is, what are the economic impacts of the differentiations in cost of Food and Drug Administration-approved drugs and the purchasing power of individuals around the world? 29 September 2017
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Imbruvica (ibrutinib), within its marketing authorization, for use on the Cancer Drugs Fund (CDF) as an option for treating Waldenström’s macroglobulinemia (WM) in adults who have had at least one prior therapy, only if the conditions in the managed access agreement for ibrutinib are followed. 28 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