Pharma back in hot seat as 2020 presidential election gets into gear

September 26, 2019 As the first Democratic presidential debates kicked off in June, candidates took numerous shots at drugmakers in an early sign the industry will face plenty of tough questions throughout the 2020 cycle.  The candidates blasted corporate power in the U.S. in general — and pharma in particular, using words like “corruption” and … Read more

Former Pfizer site in Puerto Rico picked up by medical marijuana producer

September 24, 2019 Vireo Health says it has leased a 40,000 square foot former Pfizer site in Cruce Dávila Business Park, in Barceloneta, Puerto Rico to house its cultivation and processing operations.  “We are thrilled to expand into the Commonwealth of Puerto Rico, one of the largest pharmaceutical hubs in the world,” Vireo CEO Kyle … Read more

Abbott launches 3-minute, in-office A1c blood test for diagnosing diabetes

September 19, 2019 The company describes the assay as the first and only rapid test cleared by the FDA for use in diagnosing diabetes or for monitoring a person’s risk for developing the condition in the future.  The Afinion HbA1c Dx test is now available for use on Abbott’s Afinion 2 and AS100 analyzers. “In … Read more

How a long-known biomarker backs BioNTech’s antibody for pancreatic cancer

September 12, 2019 The team found that blocking CA19-9 could serve as a therapeutic strategy to prevent the progression from chronic pancreatitis to pancreatic cancer.  The findings were just published in the journal Science, but they have already been translated into an antibody drug acquired by BioNTech called MVT-5873. The CA19-9 antibody is already in … Read more

FDA sets novel device approval record for 2018, outlines new criteria for 510(k) clearances

September 05, 2019 In 2018, the FDA greenlit 106 new devices — including premarket approvals and panel-track supplements; de novo and breakthrough 510(k) clearances; and humanitarian device exemptions — beating out 2017’s 40-year record of 98 devices.  Some of these include the world’s smallest mechanical heart valve, developed by Abbott and St. Jude Medical for … Read more

U.K. calls for globally organized incentives for antibiotic R&D

September 03, 2019 In recent years, the U.K. has tried to establish itself at the forefront of global efforts to address the problem of antimicrobial resistance (AMR) through activities including an earlier five-year strategy and the commissioning of an independent review.  Now, the U.K. has set out its hopes for the next five (5) and … Read more