PERTH, Australia – Biopharma stakeholders are furious about the consultation process the Australian government has pursued with its review of the country’s National Medicines Policy, and they are asking the government to hold off on making any changes until after the federal election that is scheduled for May.
PERTH, Australia – Biopharma stakeholders are furious about the consultation process the Australian government has pursued with its review of the country’s National Medicines Policy, and they are asking the government to hold off on making any changes until after the federal election that is scheduled for May.
Three companies from the pharmaceutical and med-tech sectors are among this year’s most influential innovators, according to the newest edition of Clarivate plc’s Top 100 Global Innovators 2022. The pharmaceutical companies that were found to be the most innovative in the top 100 list are Johnson & Johnson, of New Brunswick, N.J., and Roche AG, of Basel, Switzerland. Royal Philips NV, of Amsterdam, was found to be the most innovative med-tech company in the top 100.
LONDON – The team that opened up the market for anti-vascular endothelial growth factor (VEGF) drugs in the treatment of eye diseases has formed a new company, Eyebio Ltd., with the aim of developing a new generation of ocular therapies. David Guyer and Anthony Adamis, founders of Eyetech Pharmaceuticals Inc., which brought Macugen (pegaptanib sodium) through to FDA approval in December 2004, set up Eyebio in August last year, with seed funding from SV Health Investors.
The FDA’s device center reported the addition of four device types to the ranks of class II devices, including one each for de novo petitions by Apple Inc., of Cupertino, Calif., and Roche Molecular Systems Inc., of Pleasanton, Calif.
While last week’s marathon Oncologic Drugs Advisory Committee meeting to consider accelerated approvals for cancer drugs that didn’t demonstrate effectiveness in confirmatory trials was a good step forward, oncologists need the FDA to do more to ensure drug labeling truly reflects the benefit of the product.
In the final part of its three-day meeting on accelerated approvals granted to anti-PD-1/PD-L1 antibodies, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously to continue the accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) as a therapy for patients with advanced hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (Nexavar, Bayer AG).
If the FDA follows the advice of its Oncologic Drugs Advisory Committee (ODAC), both Keytruda and Tecentriq will remain on the U.S. market, for the time being, with accelerated approval as first-line treatments for certain patients with advanced or metastatic urothelial carcinoma. The committee voted 5-3 April 28 to recommend continuing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) and 10-1 for maintaining the accelerated approval of the Roche Group’s Tecentriq (atezolizumab) until the final data come in from a confirmatory trial that’s expected to be completed next year.
In a virtual meeting fraught with technical difficulties, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 7-2 April 27 that the accelerated approval for Tecentriq (atezolizumab) in combination with nab-paclitaxel as a treatment for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) in adults with PD-L1+ tumors should continue as additional trials are conducted or completed.
As part of a U.S. FDA evaluation of confirmatory trials for anti-PD-1/PD-L1 antibodies, the agency’s Oncologic Drugs Advisory Committee (ODAC) is being asked this week to consider whether three blockbuster biologics should continue to be available for certain cancer indications for which they received accelerated approval. At question is whether the data from the confirmatory trials for the Roche Group’s Tecentriq (atezolizumab), Merck & Co. Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb Co.’s Opdivo (nivolumab) has proved sufficient benefit in particular indications and, if not, whether alternative or ongoing trials could do so.
