The stage is set for a showdown between the pharma industry and national governments and public health experts over which policy the EU should grasp, as it bids to create a pan-European incentive scheme that will encourage innovation and get more antibiotics through to market. At issue is a proposal supported by the industry, under which companies getting approval for a new antibiotic would be given a voucher allowing them to extend market exclusivity of any different drug of their choice for one year.
GSK plc has announced it has stopped early two pivotal phase III trials of its urinary tract infection drug, gepotidacin, for efficacy and is preparing regulatory filings for what could be the first new oral antibiotic for the disease in more than 20 years.
To jumpstart the development of much-needed antibiotics, the European Federation of Pharmaceutical Industries and Associations (EFPIA) released a new report Sept. 28 demonstrating the economic benefit of granting additional exclusivity for another drug as a way of incentivizing antibiotic R&D.
Spero Therapeutics Inc. has come out swinging after a U.S. FDA rejection for its oral antibiotic, tebipenem Hbr, picking up a potential $600 million licensing deal with pharma giant GSK plc after agreeing on a plan with the regulator to revive the drug.
Hot on the heels of a groundbreaking deal brokered by the U.K.’s NICE to finance an antibiotic with a subscription-style payment plan, three European life sciences companies have formed a joint venture (JV) to create next-generation antimicrobials and diagnostics to fight antimicrobial resistance.
Spero Therapeutics Inc.’s oral antibiotic, tebipenem Hbr, has been rejected by the U.S. FDA for adults with complicated urinary tract infection, after the regulator said a further trial is needed for approval.
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
Antibiotics drugs discovery, Ursula Theuretzbacher told the audience at the 2022 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), has more than one challenge to overcome.
The U.K. plan to fix the market failure in antibiotics has taken a significant step forward with the publication of guidance estimating the value of two drugs to the National Health Service.
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