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Tuesday, May 18, 2021

FDA Accepts Innovent, Eli Lilly Application for Sintilimab

 Innovent Biologics Inc. and Eli Lilly & Co. on Tuesday said the U.S. Food and Drug Administration accepted for review a biologics license application for sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

The companies said the FDA didn't identify any potential review issues and isn't currently planning to hold an advisory committee meeting to discuss the application, adding that the agency set a target action date in March 2022.

Indianapolis drugmaker Eli Lilly and Innovent, a Suzhou, China, pharmaceutical company, have been collaborating since March 2015. The filing marks the first U.S. regulatory submission of sintilimab, which the companies jointly developed and is marketed as Tyvyt in China.

https://www.marketscreener.com/quote/stock/INNOVENT-BIOLOGICS-INC-49476402/news/FDA-Accepts-Innovent-Eli-Lilly-Application-for-Sintilimab-33287702/

Spanish study: AstraZeneca vaccine followed by Pfizer dose is safe and effective

 A Spanish study on mixing COVID-19 vaccines has found that giving a dose of Pfizer's drug to people who already received a first shot of AstraZeneca vaccine is highly safe and effective, the researchers said on Tuesday.

The so-called Combivacs study, run by Spain's state-backed Carlos III Health Institute, found the immune response in people who received a Pfizer shot was between 30 and 40 times greater than in a control group who only had AstraZeneca dose.

Few serious side effects were reported among the 600 participants, the authors said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-Spanish-study-finds-AstraZeneca-vaccine-followed-by-Pfizer-dose-is-safe-and-effec-33287429/

China's Clover says its COVID-19 vaccine candidate shows immune response in mice

 Chinese biotechnology company Clover Biopharmaceuticals said on Tuesday the modified version of its COVID-19 vaccine candidate showed a strong immune response against the original strain of the virus and some variants during animal testing.

Clover said in a statement its vaccine candidate demonstrated a "neutralisation" against the South African, Brazilian and UK variants among mice.

The company is testing a COVID-19 vaccine candidate containing an adjuvant, typically designed to boost the efficacy of vaccines, from Dynavax Technologies Corp.

It had also been testing a candidate with an adjuvant from GlaxoSmithKline Plc, but ended the partnership in February after taking into account "scale-up manufacturing considerations."

Clover said it intends to continue evaluation of its remaining vaccine candidate and move into clinical trials in the second half of 2021 based on the data from the animal tests.

The company in February raised $230 million from investors, including Singapore's state investment firm Temasek Holdings to partly fund the development of its vaccine.

https://www.marketscreener.com/quote/stock/DYNAVAX-TECHNOLOGIES-CORP-19120561/news/Dynavax-Technologies-nbsp-China-s-Clover-says-its-COVID-19-vaccine-candidate-shows-immune-response-33284606/

Monday, May 17, 2021

Mental health services provider LifeStance Health Group files for $100 million IPO

 LifeStance Health Group, which provides outpatient mental health services, filed on Monday with the SEC to raise up to $100 million in an initial public offering.


LifeStance states that it has built one of the nation's largest outpatient mental health platforms based on number of clinicians and geographic scale, utilizing a tech-enabled in-person and virtual care delivery model. Its clinicians offer a comprehensive suite of mental health services, spanning psychiatric evaluations and treatment, psychological and neuropsychological testing, and individual, family, and group therapy.

The Scottsdale, AZ-based company was founded in 2017 and booked $447 million in revenue for the 12 months ended March 31, 2021. It plans to list on the Nasdaq under the symbol LFST. LifeStance Health Group filed confidentially on February 16, 2021. Morgan Stanley, Goldman Sachs, J.P. Morgan, and Jefferies are the joint bookrunners on the deal. No pricing terms were disclosed.

Spike Proteins of SARS-CoV-2 B.1.617, B.1.618 Variants IDd in India Partially Resist Vaccine-elicited, Therapeutic Monoclonal Antibodies

 Takuya Tada, Hao Zhou, 

Belinda M DcostaMarie I SamanovicMark J MulliganNathaniel R Landau

Anti-SARS-CoV-2 Antibodies Persist up to 13 Months, Reduce Risk of Reinfection

 Floriane Gallais, Pierre Gantner, Timothee Bruel, Aurelie Velay, Delphine Planas, Marie-Josee Wendling, Sophie Bayer, Morgane Solis, Elodie Laugel, Nathalie Reix, Anne Schneider, Ludovic Glady, Baptiste Panaget, Nicolas Collongues, Marialuisa Partisani, Jean-Marc Lessinger, Arnaud Fontanet, David Rey, Yves Hansmann, Laurence Kling-Pillitteri, Olivier Schwartz, Jerome De Seze, Nicolas Meyer, Maria Gonzalez, Catherine Schmidt-Mutter, Samira Fafi-Kremer

New OSHA Standards Coming for COVID-19. Better Late Than Never?

 On his first full day in office, President Joe Biden wasted no time in signaling a long-awaited shift for protecting workers during the pandemic, issuing an executive order that called for the Occupational Safety and Health Administration (OSHA) to enact emergency rules (called an emergency temporary standard or ETS) for the first time since 1983.

Under Trump, OSHA relied on general standards and did not invoke an ETS during the pandemic. Now, the agency is preparing to issue standards — OSHA sent draft standards to the Office of Management and Budget's Office of Information and Regulatory Affairs for review on April 26 — but it's unclear when it will happen.

"OSHA has been working diligently on its proposal and has taken the appropriate time to work with its science-agency partners, economic agencies, and others in the US government to get this proposed emergency standard right," said spokeswoman Kimberly Darby, who declined to estimate how long the review will take.

As health care unions and workers wait, here's what the rules might cover and why many believe the ETS is still relevant at this point in the pandemic.

What Could Be in the New Standard

OSHA posted updated guidance on protecting workers from COVID-19 in late January, including elements of effective workplace COVID-19 prevention programs and detailing key measures for limiting disease spread.

But the guidance isn't enforceable, and for now, the exact contents of the future ETS are "a pretty closely guarded secret," said James Brudney, JD, a professor at Fordham Law School in New York City and former chief counsel of the US Senate Subcommittee on Labor.

Generally, OSHA looks toward the scientific recommendations of the National Institute for Occupational Safety and Health (NIOSH), a division of the CDC that's responsible for conducting research and making recommendations on how to better protect people doing hazardous work, said Gregory Wagner, MD, a former NIOSH senior advisor now at the Harvard T.H. Chan School of Public Health, Boston, Massachusetts.

"OSHA takes the scientific recommendations of NIOSH and often incorporates them into the standard-setting process," Wagner said, "but they are not obligated to accept the recommendations from CDC."

OSHA could also base its standards on the ones of states such as Virginia, California, and Oregon, which have already issued their own standards. (Each of those states will be required to ensure that their regulations are at least as protective as the new federal rules.)

Health care workers and unions will be closely watching for specific requirements, especially related to respiratory protection after the CDC recently acknowledged aerosol inhalation as a major mode of transmission and said that only unvaccinated people have to wear masks in many public places. (In health care settings, masks are still required for everyone.)

"It is very important that the CDC further acknowledge the role of aerosol transmission," said former Obama administration Assistant Secretary of Labor David Michaels, PhD, MPH, now at the Milken Institute School of Public Health of George Washington University in Washington, DC. It's also important for OSHA to "encourage employers to examine and improve ventilation systems," he said.

Rules could address the mask issue by authorizing and/or encouraging employers to verify which employees are vaccinated and don't need to wear masks, Brudney said.

"Whether there will be rules that mandate all employers to seek such verification is a closer question," he said. "The federal government as an employer might be mandated to do so, but [the US Department of Labor] (or CDC) may decide that authorization and encouragement are better ways to secure widespread compliance with this workplace health-protection practice."

Some could be looking for strong antiretaliation protections, Brudney notes. There are different standards for whistle-blowing, he explains, as some laws and regulations protect employees who have a good faith belief that safety or health requirements are being violated, some require employees' beliefs to meet a test of objective reasonableness, and others only protect employees if they're correct that a violation has occurred.

The last type "would be chilling," he said. The first "is what you need with COVID, because as scientific consensus evolves in light of new information, what someone might think was reasonable 6 weeks ago might not seem so reasonable today."

Also, OSHA doesn't provide a way for individuals to pursue lawsuits themselves, Brudney points out. It is possible that new rules could force stronger internal governance within workplaces, for example by ensuring that employers establish health and safety committees that include worker members. These committees could report on compliance with PPE or other requirements such as available handwashing and disinfectant facilities. Such committees also could offer protection for workers who refuse to perform certain work when employers do not provide the required PPE or sanitary conditions.

Why a Standard Is Still Needed

For the US's largest labor union for registered nurses, the pending new rules are overdue but still not too late to be helpful.

"A strong ETS will save lives, both inside and outside our workplaces," National Nurses United President Deborah Burger, RN, said in an April 26 press release. "It is urgent that the Biden Administration complete its regulatory review with all deliberate speed. Lives hang in the balance."

Part of the delay could be the near certainty that the standards will be challenged in courts, experts said. Businesses and trade associations have sued California's OSHA office over its COVID-19 standards, and most of the standards issued in the '70s and '80s were stymied in court. But some say that shouldn't be a holdup.

"Lawsuits against health standards that aren't purely advisory pretty much come with the territory," Brudney said. "If the agency has done solid prep work, including reliance on its own scientific research and external studies, it should just be prepared to let its lawyers do their job."

While it may seem late, putting temporary standards in place now would allow for permanent standards by the end of the year. "Almost every public health expert is saying this is going to be with us for quite some time, so having a meaningful workplace standard that could carry you forward would be quite important," Brudney said.

Having standards "will make enforcement much more straightforward, and OSHA will be able to issue citations more easily and do it in a way that encourages others to follow the law," Michaels said. Standards also have an impact even when those who break the rules aren't punished, he said, as many employers want to be law-abiding.

Even though infection rates are slowing down as more people get vaccinated, more people are going back to work and need protections as society reopens. With "workplaces still driving transmission, the nation's workers desperately need more protection from this virus," Michaels said. "This is the most significant worker safety crisis since the founding of OSHA; it's certainly deserving of emergency standards."

https://www.medscape.com/viewarticle/951292