Shares of Vaccinex Inc. fell to an all-time low on Sept. 22 after top-line results of the phase II trial, Signal, found its SEMA4D inhibitor, pepinemab, failed to improve measures of cognition in people with early manifest Huntington's disease following 18 months of treatment. Read More
Positive top-line data from Blueprint Medicines Corp.’s phase I and II trials of Ayvakit (avapritinib) for treating advanced systemic mastocytosis (SM) are pushing the company to submit an sNDA before 2020 ends. Read More
Early stage investment strategies and dealmaking in the age of COVID-19 became topics during the Biopharm America meeting, itself held virtually this year because of the pandemic. Kevin Johnson, partner and co-founder of European life sciences backer Medicxi, hailed an “unprecedented upswing” on the financial front. “There is no winter,” he said. “It’s amazing.” Read More
HONG KONG – Legend Biotech Corp. head Frank Fangliang Zhang has come under investigation by mainland Chinese law enforcement in relation to suspected violations of Chinese import and export regulations, the company said. Read More
Sessions at the European Society for Medical Oncology Virtual Congress, that has just concluded, provided an excellent opportunity for investors and analysts alike to familiarize themselves with the late-stage progress of new therapeutics aimed at improving cancer treatment. Overall, data presented at the meeting appear to have been positively received, a factor that has helped push up the value of the price-weighted BioWorld Cancer index this month. Read More
While the ultimate goal is increased diversity in clinical trials so as to improve health equity, a great start is making diversity a priority and a part of the research plan, Luther Clark, deputy chief patient officer at Merck & Co. Inc., said during an FDA Office of Minority Health and Health Equity webinar Sept. 22. Read More
The number of biopharma deals and mergers and acquisitions completed so far within the past three months are significantly down from each of the first two quarters of 2020. But despite slumping activity and uninspiring M&A values, the projected values of licensings, collaborations and joint ventures, at about $45.4 billion, has placed the nearly complete third quarter in line with the rest of the year. That is mainly due to July and August having two of the largest deals for the year. Together, they make up 27% of the money disclosed in the third quarter, although there is still a week and a half left in September. Read More
The U.S. FDA has posted another draft version of the intended use rule, this time with a fix for the so-called knowledge problem. This latest draft would eliminate mere knowledge of off-label use as a trigger for amendments to the product label, a provision the agency said in a Sept. 22 statement will “provide greater certainty and predictability for regulated parties.” Read More
BioWorld looks at translational medicine, including: Epigenetic resistance to PARP inhibitors; Arthritis is different disease with antibodies than without. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: New TGA service to ease the burden of biowaivers; FDA formalizes outside experts program; FDA unveils Digital Health Center of Excellence; FDA updates clinical trial guidance. Read More
New hires and promotions in the biopharma industry, including: Advanced Biodesign, Aziyo, Beyondspring, Decibel, ERS Genomics, Milestone, Ziopharm. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Basilea, Bayer, Blueprint, Cipla, Durect, Frequency, Gensight, GT, Jasper, Miceros, Novo Nordisk, Nucana, PDC*Line, Pulmatrix, Santhera, Sinovac, Sorrento, Vaccinex, Viralclear. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, BMS, Crispr, Emmetrope, Genocea, Knight, Lilly, Medeor, Mustang, Nicox, Ocumension, Redhill, Therapeuticsmd, UCB, Vertex. Read More
