October 24, 2019 “The current wording of the draft guidance…provides FDA with so much flexibility to deviate from these processes and standards that they are rendered meaningless,” writes AdvaMed Senior Executive Vice President for Technology and Regulatory Affairs Janet Trunzo. The group seeks revisions that address “this shortcoming” and align with least burdensome principles. AdvaMed … Read more
October 22, 2019 Regulation is complex, to say the least; however, U.S. and European biotech companies know China is an increasingly important area not just to sell medicines, but to discover and develop them as well. China, too, has been making a big push in the direction of innovation, and is looking to spend considerable … Read more
October 17, 2019 Summers’ team collaborated with scientists at Merck Research Laboratories to develop a technique for lowering the amount of ceramides in the body. They accomplished that by shutting down an enzyme called dihydroceramide desaturase 1 (DES1). That, in turn, shifted two hydrogen atoms from ceramide, crippling the fatty lipid. When the researchers made … Read more
October 15, 2019 Swiss authorities arrested Xue in May and are keeping him in custody while they mull the extradition request, Reuters reported. He is fighting extradition and considered a potential flight risk, according to a Swiss Federal Criminal Court Verdict. Xue’s sister, Yu Xue, worked at GSK’s R&D unit in Pennsylvania from 2006 to 2016, … Read more
October 10, 2019 Scientists at Columbia University hope to change that, using another emerging field of science: synthetic biology. A team at Columbia Engineering and the University’s Irving Medical Center are engineering bacteria that can deliver immunotherapy drugs straight to solid tumors. In mice, the strain of bacteria that the researchers made was able to … Read more
October 08, 2019 In a campaign, which began in July, for an unnamed PCSK9 inhibitor, for instance, thousands of cardiologists’ offices in Semcasting’s Wi-Fi “Smart Zones” will send messages to waiting room patients. People who log into the Wi-Fi network — and opt in for ads — to browse the web, read news or even … Read more
October 03, 2019 The goal is to produce a rapid, inexpensive and simple-to-perform diagnostic tool that could help physicians identify the disease, track a patient’s progression and monitor responses to treatment. The researchers’ preliminary results have highlighted potential signals related to MS, which researchers believe may be linked to changes in the gut microbiome. They … Read more
October 01, 2019 In a wide-ranging face-to-face with reporters in July, Trump said the White House was considering an order creating a “favored-nation” clause for drugs sold to the U.S. government, which would essentially secure the lowest possible prices on the market — or so he says. While it is not yet clear what the … Read more
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
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