The U.S. FDA’s 2018 program for voluntary malfunction summary reporting (VMSR) was intended to ease the burden for both industry and the agency regarding low-risk malfunctions associated with a limited set of device types. However, a new draft guidance on the subject drew criticism from two trade associations for being administratively cumbersome, suggesting the guidance will need considerable cleaning up before presentation in final form.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Merit Medical, Terumo Blood and Cell.
Chiesi Farmaceutici SpA scored U.S. FDA clearance of the enzyme replacement therapy (ERT) Lamzede (velmanase alfa-tycv) for non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and pediatric patients. An ultra-rare, progressive lysosomal storage disorder, AM is caused by deficiency in the enzyme alpha-mannosidase. Lamzede is the first ERT to win approval in the indication, characterized by an inability to properly break down certain groups of complex sugars in the body’s cells.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axcella, Entera, Kancera, Nymox, Ose, Pharming, Redhill.
The European Parliament (EP) has voted to affirm the proposal by the European Commission (EC) to extend the compliance timelines for the Medical Device Regulation (MDR) in an urgent vote that eliminated any chance of debate. The vote was a landslide, coming in at 564 votes in support and three nays.
The U.K. government recently released its first ever medical technology strategy which aims to accelerate access to innovative medical technologies in the NHS. Although it was welcomed by the industry, and questions remain as to whether it goes far enough to address some of the challenges to the adoption of medical devices, eyes are on its implementation and whether it will achieve its aims.
If the Feb. 16 hearing before the U.S. Senate Commerce Committee is anything to go by, it’s almost a given that the bipartisan Pharmacy Benefit Manager (PBM) Transparency Act will eventually be passed by the Senate. But its journey through the Republican-controlled House could be more uncertain in light of growing concerns about an “activist agenda” at the FTC.
The U.S. FDA granted Nanjing Iaso Biotherapeutics Co. Ltd. both regenerative medicine advanced therapy and fast track designations for its new drug, BCMA CAR T-cell therapy CT-103A (equecabtagene autoleucel), allowing it to speed up development and commercialization in the U.S. for the treatment of relapsed/refractory multiple myeloma.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lumendi, Perfuze, Saniva, Zephyrus.
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