The European Commission’s Medical Device Coordination Group has posted several guidances for unique device identifiers (UDIs), the most recent of which is related to a company’s quality management system. While most regulators have developed policies related to UDIs, this MDCG guidance recommends that device makers formally incorporate those requirements into their QMS programs, and that notified bodies will examine the manufacturer’s compliance with these requirements during inspections.
LONDON – Birmingham University spinout 4D Biomaterials Ltd. has raised initial funding of £1.6 million (US$2.2 million) to commercialize a new shape-changing biopolymer for use in soft tissue repair.
Rapid changes, a traditionally conservative approach and a chronic lack of regulatory transparency could undo a lot of the progress that Japan has made in the past few years to speed up approvals and all but eliminate a punishing drug lag that, for decades, held back the development of the country’s biopharma sector.
Rapid changes, a traditionally conservative approach and a chronic lack of regulatory transparency could undo a lot of the progress that Japan has made in the past few years to speed up approvals and all but eliminate a punishing drug lag that, for decades, held back the development of the country’s biopharma sector.
While regulators and policymakers across the world are stressing the need for equitable access to COVID-19 vaccines, therapies and devices, their own policies and regulations may be getting in the way of that goal. The World Trade Organization (WTO) released a list of trade-related bottlenecks July 20 that are hindering access to pandemic-related medical products.
DUBLIN – Panakès Partners SGR SpA has raised €150 million (US$177 million) in a first close of its second fund and is looking to secure a final tally of €180 million by year-end. That would represent more than twice the size of its first fund of €80 million and reflects its move into therapeutics investing.
The M&As that are the current business model of the drug and device world are in for increased scrutiny under the executive order U.S. President Joe Biden signed July 9. Answering the administration’s call for a whole-of-government-approach to increasing competition in the U.S., the Department of Justice “will closely examine its antitrust guidelines and policy statements to better educate the public on its enforcement priorities, and it will heighten its efforts to prevent mergers that would result in excessive consolidations of purchasing power,” U.S. Attorney General Merrick Garland said.
DUBLIN – Having spent more than 150 years devoted to marketing tobacco, Philip Morris International Inc. is now embracing human health and wellness as part of what it calls a “beyond nicotine” strategy, under which it has tabled a £1.50 (US$2.07) per share offer for Vectura Group plc. The offer implies an enterprise value of £852 million or about $1.2 billion for Chippenham, U.K.-based Vectura, which majors in formulation and device development for inhaled drugs.
As the first flagship action of Europe’s plan to beat cancer, the European Commission launched its Cancer Knowledge Center June 30. The new online platform will map the latest evidence on cancer, provide health care guidelines and quality assurance schemes, and monitor and project trends in cancer incidence and mortality across the EU, where cancer is the No. 1 killer for people younger than 65.
A not-unexpected complete response letter (CRL) for Nexobrid, being developed by Mediwound Ltd., delayed the therapy’s approval and knocked the company’s share values backward. Nexobrid, proteolytic enzymes enriched in bromelain for treating for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns, had a June 29 PDUFA date.
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