Drug Company Admits Using Fake Data
Fibrogen used false data for its anemia pill. In other news, a lot of money is sloshing around the drug and medical device industries.
Stat:
Fibrogen Admits False Safety Data For Anemia Pill Shared With FDA, Investors
Fibrogen acknowledged Tuesday that the company has been touting false heart-safety data for its experimental anemia pill for at least two years — a shocking revelation that raises even more questions about the drug’s approvability. Shares of Fibrogen fell 27% to $25 in Tuesday’s after-hours trading session as investors questioned the credibility of the company’s management team and mulled the ramifications of revised heart-safety data that may no longer be strong enough to pass muster with the Food and Drug Administration. (Feuerstein, 4/6)
Axios:
LumiraDx, COVID Test Startup, In $5 Million SPAC Deal
LumiraDx, a British diagnostics startup that makes COVID-19 tests, has agreed to merge with special purpose acquisition company (SPAC) CA Healthcare Acquisition Corp. in a deal valued at $5 million, the companies announced Tuesday. LumiraDx has also secured a $300 million loan from BioPharma Credit and another $100 million from Capital One Financial, per the statement. (4/7)
Stat:
Biotech VCs Have More Money Than Ever To Invest. What Could Go Wrong?
There’s more money sloshing around in biotech than ever before. Over the past year, several trends have converged to create a historic financing environment for startups, full of what industry insiders call “dry powder.” Experts say this kind of environment could be great for the industry as a whole, allowing startups to raise more money and move much faster. But venture capitalists also told STAT that increased interest in biopharma companies means competition for investment has become unusually fierce. (Sheridan, 4/7)
Stat:
Medical Device Firms’ Payments To Doctors Outstrip Those From Pharma
The medical device industry gave doctors consulting fees, lunches, lodging, and other incentive payments worth $904 million between 2014 and 2017, per a new study — more than $80 million more than the pharmaceutical industry lavished on physicians over the same time period. Experts told STAT that the findings, published Monday in Health Affairs, raise new questions about the industry’s influence on physician behavior — particularly since the medical device industry pulls in far less in revenue than the pharmaceutical industry. (Diaz, 4/6)
In biotech industry news —
Modern Healthcare:
Biosimilars Need A Policy Boost, Experts Say
Physicians and patients are warming up to biosimilars but policy tweaks are needed to boost utilization, industry observers said. Around three-quarters of physicians see biosimilars as equally safe and effective as their corresponding biologic and 71% of patients are willing to take them with a doctor's recommendation, according to a new NORC at the University of Chicago survey of more than 1,200 physicians and patients. But the therapies' adoption has been slowed by price manipulation and patent litigation. (Kacik, 4/6)
Stat:
Akili’s Therapeutic Game Will Be Tested As A Treatment For Covid ‘Brain Fog’
Akili, which made history last summer by earning regulatory clearance for the first video-game based therapy, now plans to test if its software can help adults suffering from Covid “brain fog.” Two randomized remote studies, one conducted by Weill Cornell Medicine and New York-Presbyterian Hospital and the other by Vanderbilt University Medical Center, will assess whether AKL-T01, the treatment that Akili commercially markets for ADHD as EndeavorRx, can help improve cognition symptoms in Covid survivors. (Aguilar, 4/7)
Boston Globe:
MIT Scientists Launch Initiative To Solve Biotech’s ‘Missing Women’ Problem
A group of prominent MIT scientists that formed to address gender inequities in the biotech industry released a report Tuesday that says male faculty at the school start companies at a higher rate than their female peers, and proposes a way to help close the gap. The report ― which comes after two years of research by the Boston Biotech Working Group ― outlines a plan, called the Future Founders Initiative, that calls for collaborations between the university, venture capital firms, and faculty. (Anissa Gardizy, 4/6)