Friday, March 27, 2020

TSBP-Related Coronavirus Updates


On March 13, 2020, Governor Greg Abbott declared a state of disaster for all Texas Counties as a result of the COVID-19 (coronavirus) pandemic. In planning for the agency's response, the health and safety of the public and of our employees is of utmost concern.

The offices of the Texas State Board of Pharmacy are open and operational, and we will continue to perform the essential functions of our agency while providing the highest level of service possible. Please note that agency employees are working remotely and our physical office is not open for visitors. The best way to contact the office is by email. A list of agency emails can be found at www.pharmacy.texas.gov/contact.

Coronavirus (COVID-19) Update: FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients The following is attributed to FDA Commissioner Stephen M. Hahn, M.D.


The U.S. Food and Drug Administration took action to help increase the supply of ventilators, ventilator tubing connectors, and ventilator accessories, as well as filtering facepiece respirators (FFRs) due to shortages during COVID-19, as part of our commitment to ease burdens on the health care system during this pandemic.

The FDA issued an Emergency Use Authorization (EUA) to allow for the emergency use in healthcare settings of certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as “ventilators”), ventilator tubing connectors, and ventilator accessories that the FDA determines ...

President Trump plans to label different parts of the country as “high risk, medium, or low risk”


FDA fleshes out emergency guidance for coronavirus test developers


On Wednesday, the FDA held a webinar to flesh out its evolving policies, providing key insights on regulatory paths for molecular and serological diagnostic testing in commercial and state labs, and for commercial test products and devices.
READ MORE >

Kentucky hospital to furlough 300 employees in 'unprecedented times'

The furloughs impact about 25% of the hospital's workforce and will take place March 26.
READ MORE >

Roche pleads for global harmony as it supercharges production of Actemra, COVID-19 tests Tuesday, March 24, 2020

Roche pleads for global harmony as it supercharges production of Actemra, COVID-19 tests

Tuesday, March 24, 2020
China’s use of Roche's Actemra for some COVID-19 patients has put the arthritis drug in the spotlight and set it up for a surge in demand. Roche is trying to stay ahead of that curve by upping production, even as it tests it on COVID-19

FDA opens up Bellerophon's gas therapy for COVID-19, stock rockets

FDA opens up Bellerophon's gas therapy for COVID-19, stock rockets

Friday, March 20, 2020
Using a regulatory pathway that allows patients with life-threatening conditions to use unapproved therapies, the FDA has granted “emergency expanded access” to Bellerophon Therapeutics’ inhaled nitric oxide delivery system for treating the novel coronavirus.

Lilly slashes clinical trial activities in response to COVID-19

Lilly slashes clinical trial activities in response to COVID-19

Monday, March 23, 2020
Eli Lilly is slashing its clinical trial activities in response to the COVID-19 pandemic. With the novel coronavirus putting healthcare systems under tremendous strain, Lilly has decided to delay most trial starts and pause enrollment in most ongoing studies.

Gilead halts emergency access to COVID-19 contender remdesivir amid 'overwhelming demand' Monday, March 23, 2020

Gilead halts emergency access to COVID-19 contender remdesivir amid 'overwhelming demand'

Monday, March 23, 2020
Since the early days of the current coronavirus outbreak, Gilead Sciences’ experimental antiviral drug remdesivir has been hailed as a leading hope. That halo has apparently overwhelmed the Big Biotech, which has temporarily stopped granting patients emergency access to remdesivir due to an “exponential increase” in requests.

Coronavirus tracker: Merck to donate thousands of masks in NJ; White House prepping COVID-19 guidelines Thursday, March 26, 2020

Coronavirus tracker: Merck to donate thousands of masks in NJ; White House prepping COVID-19 guidelines

Thursday, March 26, 2020
With healthcare workers in the U.S. strapped for supplies amid the novel coronavirus outbreak, Merck & Co. is helping out with a donation of around 300,000 masks to the state of New Jersey. Meanwhile, the Trump administration is piecing together county-level guidelines to deal with the COVID-19 response.