Dive Brief: FDA awarded premarket approval to Terumo’s MicroVention subsidiary for a flow diversion system to treat wide-neck intracranial aneurysms of the carotid artery. The Flow-Redirection Endoluminal Device, or FRED, expands to a pre-determined diameter after implant to divert blood…
AstraZeneca kicks off 2020 with double win in US and China
AstraZeneca has started 2020 strongly, with the FDA granting a fast review for its big-selling Farxiga in heart failure and a key drug approval in China. AZ said the FDA has accepted a filing for Farxiga (dapagliflozin) to reduce risk…
Ebb Therapeutics Debuts First-of-its-Kind Wearable Technology at CES 2020 to Help Consumers Manage Sleeplessness
Created by a luminary sleep researcher and doctor, the intelligent device features novel cooling technology to calm “a racing mind” LAS VEGAS and PITTSBURGH, Jan. 4, 2020 /PRNewswire/ — Ebb Therapeutics is on a mission to make an impact in…
Novartis leads in new drug approvals; Vertex’s cystic fibrosis med holds highest sales potential
The US Food and Drug Administration’s (FDA) momentum of new drug approvals dropped marginally in 2019 — while 62 novel drugs were approved in 2018, 54 were approved in 2019. FDA’s Center for Drug Evaluation and Research (CDER) approved 48…
Charles River Laboratories Completes the Acquisition of HemaCare Corporation
WILMINGTON, Mass.–(BUSINESS WIRE)– Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it has completed the previously announced acquisition of HemaCare Corporation (OTCMKTS: HEMA) for approximately $380 million in cash, or $25.40 per HemaCare share. HemaCare will become part…
Boehringer cleared to manufacture BeiGene’s cancer drug for Chinese market
Boehringer Ingelheim is to manufacture the first biologic drug approved in China using a new regulatory system, designed to strengthen the country’s domestic pharma infrastructure. The German pharma successfully applied the Marketing Authorization Holder (MAH) system under China’s revised drug…
What Does 2020 Have in Store for the Life Sciences?
With the books being closed on 2019, it’s time to prognosticate about what the next year will hold in the biotech and pharmaceutical industry. And, to paraphrase a famous song from the 1980s, grab a set of shades, because the…
Washington State is latest to sue Janssen over opioid marketing
Washington State has become the latest to sue Johnson & Johnson over the way it marketed opioid painkillers, according to press reports. J&J supplies raw materials used to make opiates, and the state argues that the company used deceptive marketing…
Google Heath’s AI outperforms radiologists at breast cancer screening
An artificial intelligence (AI) system from Google Health can identify breast cancer more accurately than radiologists, according to research. The research conducted by experts from Google Health, Alphabet’s DeepMind unit, and UK and US universities and published in the scientific…
Gilead, Biogen, GSK, Pfizer and Others Increase List Prices of Some Drugs
Pharmaceutical companies kept their annual New Year’s Day traditions going with increases on the list price of drugs. According to an analysis conducted on Jan. 1, more than 250 drugs manufactured by different companies saw price increases. The analysis, conducted…
