Despite FDA’s Request, Company Says It Won’t Pull Premature Birth Drug
The FDA says evidence doesn't show that Makena is effective for its approved use, but AMAG Pharmaceuticals wants a hearing to review its rationale. Other companies in the news include Evotec, Eli Lilly, Disarm Therapeutics, AstraZeneca and more.
Stat:
AMAG Wants An FDA Hearing Rather Than Withdraw Its Premature Birth Drug
In a defiant move, AMAG Pharmaceuticals (AMAG) is refusing to voluntarily withdraw its controversial treatment for preventing premature births, despite a request to do so made earlier this month by the Food and Drug Administration. Instead, the drug maker is seeking a hearing to review the rationale given by the regulator for wanting its Makena medication pulled off the market. (Silverman, 10/16)
Reuters:
Evotec Secures Grant To Evaluate Antibody Drugs For COVID-19
German biotech company Evotec EVTG.DE said on Monday it had received a grant from the Bill & Melinda Gates Foundation to help identify and develop potential monoclonal antibody (mAbS) drugs for the prevention of severe COVID-19. Several drugmakers are testing antibody treatments for COVID-19 to help patients’ immune systems fight the coronavirus that causes the disease which has killed more than 1 million people worldwide. (10/19)
Boston Globe:
Disarm Therapeutics Bought By Lilly For $135 Million
Disarm Therapeutics, a Cambridge biotechnology firm working on new potential drugs for neurological diseases such as ALS and multiple sclerosis, will be bought by the pharmaceutical giant Eli Lilly and Company for $135 million up front. Under the deal announced Thursday, investors in the four-year-old, privately held biotech could reap up to $1.225 billion in additional payments, depending on how well Lilly does developing and marketing new medicines resulting from the acquisition. (Saltzman, 10/16)
Reuters:
AstraZeneca Wins Two Approval Recommendations From EU Agency
The European medicines watchdog has recommended approving AstraZeneca Plc's treatments for a form of heart failure and a lung disorder, the British drugmaker said on Monday. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approving Forxiga for treating a form of heart failure and Trixeo Aerosphere for a form of lung disorder known as “smoker’s lung”. (10/19)
In biotech news —
AP:
UK Space Agency Backs Medical Drone Delivery Project
A medical drone delivery service founded by trainee doctors that aims to transport coronavirus samples, test kits and protective equipment between hospitals has won the backing of Britain’s Space Agency. The start-up project can help free up healthcare staff, avoid courier waiting times and minimize the risk of virus transmission, authorities said Saturday. (10/17)
Modern Healthcare:
Artificial Intelligence Gets Real In The OR
Since the start of the year, some surgeons and residents at UC San Diego Health have had access to a new surgical resource: reams of video recordings of them performing operations, parsed by artificial intelligence. Video recordings of procedures are uploaded to the cloud for quick analysis. The five surgeons involved in the project and their residents then receive videos of their minimally invasive procedures, which are divided into critical steps with a dashboard that compares an operation against previous procedures. The system pixelates distinguishing features of patients and staff, such as faces and tattoos, to de-identify them. (Cohen, 10/17)
Stat:
How Biotechs Are Cramming Multiple Fundraising Rounds Into A Single Year
Historically, biotech startups have tried to bring in new money every eighteen months or so — ideally raising enough to keep them going for the next few years. But in the last year, that timeline has become noticeably compressed. Several companies have crammed multiple venture financings into a single year this year, and some have even managed to go public less than eighteen months after launch. (Sheridan, 10/19)
Stat:
The Two Months In 1980 That Shaped The Future Of Biotech
In the course of just under two months that started 40 years ago this week, five events occurred that shaped the biotechnology industry and bioscience research. Looking back on these seminal events is a reminder of the odd ways in which change happens. (Greely, 10/17)
