When it comes to leveling the playing field for foreign-based biopharma and medical device companies, China has made a lot of promises, but delivering on those promises is what matters. Throughout its annual assessment for Congress of China’s commitment to World Trade Organization principles, the U.S. Trade Representative (USTR) noted the many promises China has made over the years that have yet to be kept.
The U.S. FDA has granted IDE approval to the cardiac device startup Foldax Inc., to initiate clinical testing of its Tria mitral surgical heart valve. Patient enrollment is expected to begin in early 2021.
Researchers at the Georgia Institute of Technology see a future where long-lasting hydrogel injections replace eye drops and surgery in the management of glaucoma, the most common cause of irreversible blindness in the world. The treatment would be delivered every six months, in line with glaucoma patients’ regularly scheduled visits to the ophthalmologist.
Rayzebio Inc. has swiftly followed up its recent $45 million series A round with a $105 million series B round that attracted several top-tier crossover investors.
HONG KONG – New approaches to trials, digitalization and the effective use of advance technologies like artificial intelligence are reshaping how clinical trials are conducted, drugs are discovered, and new devices are developed, said participants at the Asia-focused Phar-East 2020 conference on Dec. 8.
Medtronic plc reported second quarter worldwide revenue of $7.647 billion, a decrease of 0.8% as reported and 1.5% on an organic basis. Analysts noted, however, that the figure beat the consensus of $7.08 billion. It also exceeded Wells Fargo’s $7.12 billion estimate. With the continued uncertainty related to the ongoing COVID-19 pandemic, the Dublin-based company did not provide formal annual or quarterly financial guidance. Still, the need for ventilators pushed the company ahead.
If the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services has its way, one of the casualties of the COVID-19 pandemic would be the in-person speaker programs many drug and device companies sponsor. The OIG issued a special fraud alert Nov. 16 questioning the need for such events in which health care professionals are often paid a hefty honorarium or fee to provide colleagues with information that’s readily available online and in the labeling of a drug or device.
Ocular Therapeutix Inc. and Affamed Therapeutics Ltd. entered a license and collaboration agreement to develop and commercialize Dextenza and OTX-TIC in greater China, South Korea and the Association of Southeast Asian Nations markets.
Teleflex Inc. reeled in $628.3 million in revenue in the third quarter, down 3.1% from the same period last year but ahead of the Street’s estimate of $619.4 million. Earnings per share also beat consensus, at $2.46 vs. $2.24. The release of the quarterly results dovetailed with Teleflex’s reveal of a definitive agreement to acquire hemostatic products company Z-Medica LLC for up to $525 million.
TORONTO – Whether it’s President Trump obtaining the drug Regeneron or COVID-19 test kits fast tracked in the U.S. and Canada, this has been the year of temporary emergency approvals for drugs and medical devices. What is sometimes overlooked are permanent programs like Canada’s Special Access Program and the U.S.’s Expanded Access Program, designed to provide therapeutics to patients who have exhausted every avenue for a cure or relief from a devastating disease.
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