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Saturday, January 7, 2023

Healthcare adds 55K jobs in December, totaling 580K new roles since 2021

 Healthcare employment rose by 54,700 jobs in December with new roles in ambulatory care and hospitals, representing the strongest month of industry job gains since September’s 60,100, according to the U.S. Bureau of Labor Statistics’ monthly report released Friday morning.

Ambulatory care services led the way with 29,900 new jobs, followed by hospitals adding 15,700 jobs and nursing and residential care facilities adding 9,100, according to BLS.

The sector’s monthly adds surpassed the roughly 46,000 tallied in October, the 45,000 gained in November and 2022’s monthly average of 49,000.

December’s numbers capped off a strong year for healthcare workforce recovery in the wake of the pandemic’s widespread flight.

Compared to December 2021, the ambulatory care, hospital and nursing and residential care subsectors added nearly 580,000 jobs. The year’s 49,000 average monthly job gain was also well above the average monthly gain of 9,000 from 2021.

“While this increase will eventually level off, healthcare has regained employment levels last seen pre-pandemic,” Michael Haas, healthcare senior analyst at consulting firm RSM US, told Fierce Healthcare.

Labor shortages have been a consistent sore spot for healthcare often cited as a primary factor in capacity issues and elevated expenses. Haas cited a Kaufman Hall report from mid-2022 outlining hospital labor expenses increasing from $4,009 in 2019 to $5,494 by March 2022—an increase accompanied by contract labor expenses that grew from 2% of total labor to 11%.

More recent industry reports and earnings statements from healthcare providers suggested that organizations were beginning to curtail their reliance on contract labor and, accordingly, see some early relief across their labor expenses. BLS’ latest report suggests that trend will continue into the early part of 2023, Haas said.

“With these stronger than expected healthcare employment numbers, organizations can start strategizing ways to end contracts with external staff and investing more time and resources with their internal employees to effectively provide quality care and reduce overall labor spending,” he said.

As a whole, the U.S. economy added 223,000 jobs in December and saw unemployment inch down to 3.5%.

https://www.fiercehealthcare.com/providers/bls-healthcare-adds-55k-jobs-december-totaling-580k-new-roles-2021

How FTC's noncompete agreements rule could impact healthcare

 Noncompete agreements have become so ubiquitous that a proposed rule published by the Federal Trade Commission (FTC) yesterday will affect almost all industries, experts say.

Healthcare will be no exception, Carrie Amezcua, an attorney with the law firm Buchanan Ingersoll & Rooney, told Fierce Healthcare. She said healthcare industry executives should keep a close eye on the debate about the rule.

The public has 60 days to submit comments before the FTC can make it final.

“It could still change—it could still be challenged actually—because it goes too far from what the FTC has the authority to do,” said Amezcua, who usually represents employers in disputes over noncompete agreements.

Backlash to the rule has already begun. In a statement, the U.S. Chamber of Commerce called the regulation "blatantly unlawful."

The rule falls under Section 5 of the FTC Act, which bans unfair methods of competition. So, not-for-profit healthcare systems would not be covered by the rule, said Amezcua.

“For physicians, if they are working directly for a hospital, and that hospital is a nonprofit, that hospital is not actually covered by the FTC act. So that hospital is not subject to this rule,” said Amezcua.

About 45% of primary care physicians employed by group practices are bound by noncompete agreements, according to one survey (PDF) by researchers from various universities. 

Amezcua added: “Insurers are not exempt from the FTC Act. They would be subject to this rule in its final form. And right now, it is written as a complete ban on noncompete agreements, post-employment. You could still have a noncompete during your employment. But you can’t have the provision that says you can't work for another company for two years after you leave.”

Once used to keep high-level executives and salespeople from running off to competitors with sensitive and proprietary company information and clients, the agreements have evolved to a point where many workers making minimum wage at fast food establishments aren’t able to change jobs because they’d signed a noncompete agreement.

The FTC said employees often agree under duress: Either sign or lose your job.

Elizabeth Wilkins, the FTC’s director of the office of policy planning, said in a statement that “the proposed rule would ensure that employers can’t exploit their outsized bargaining power to limit workers’ opportunities and stifle competition.”\

If enacted, the rule would boost wages by about $296 billion a year, according to the FTC.

Echoing Amezcua’s remarks about FTC overreach, Sean Heather, the Chamber's vice president for international regulatory affairs and antitrust, said in the statement that “Congress has never delegated the FTC anything close to the authority it would need to promulgate such a competition rule.”

Kristen Limarzi, a partner at Gibson, Dunn & Crutcher, was once a senior official in the antitrust division of the Department of Justice. Limarzi told Fierce Healthcare that she’s not convinced by the economic research the FTC used to justify the rule.

Limarzi said that “FTC Commissioner Christine Wilson argued in her dissent that the empirical evidence is more mixed and that studies show noncompete provisions can incentivize employer investment in things like worker training that ultimately benefits both employers and workers. The impact of a noncompete in any particular industry is likely quite fact specific. But the FTC rule would impose a nationwide ban.”

But Heather also said that “attempting to ban noncompete clauses in all employment circumstances overturns well-established state laws which have long governed their use and ignores the fact that, when appropriately used, noncompete agreements are an important tool in fostering innovation and preserving competition.”

However, evidence seems to be mounting that states will not side with the U.S. Chamber of Commerce when it comes to noncompete agreements, and in fact, might impose even more restrictions than the FTC rule would.

The proposed rule “is a floor and not a ceiling,” said Amezcua. “So, some states have even more restrictions right now, like California, on noncompete agreements. That would stay and be enforceable regardless of what the final rule says.”

North Dakota and Oklahoma also, in effect, ban noncompete agreements. Some states—such as Illinois, Colorado and New Jersey—have not out-and-out banned noncompete agreements yet have nonetheless made them much harder for employers to defend.

New Jersey legislators introduced a bill that caps noncompete agreements at a year post-termination and would make employers pay the former employee their full salary, including benefits, for that year unless the employee had been fired for misconduct.

In other words, everybody—not just the top executives making millions of dollars—would get a golden parachute, or at least be afforded a soft landing.

https://www.fiercehealthcare.com/payers/how-ftcs-noncompete-agreements-rule-might-affect-healthcare-industry

Chinese-made mRNA vaccine starts trial production

 China's CanSino Biologics Inc has entered "test production phase" for its COVID-19 mRNA booster vaccine, the company said in a post on its social media account late on Thursday.

The vaccine, known as CS-2034, targets new Omicron variants of the virus, which are responsible for the vast majority of infections that have swept across China since the country began dismantling strict COVID curbs last month.

Until now, China has relied on nine domestically-developed COVID vaccines approved for use, including inactivated vaccines, but none have been adapted to target the highly-transmissible Omicron variant and its offshoots that are currently in circulation.

The CanSino booster vaccine is one of China's first home-grown potential vaccines based on mRNA technology similar to that employed in vaccines produced internationally by Pfizer-BioNTech and Moderna.

On Thursday, CanSino also reported "positive" interim data from a mid-stage clinical trial in a filing to the Hong Kong stock exchange.

According to CanSino, the first phase of its mRNA vaccine production could produce 100 million doses.

https://www.yahoo.com/news/chinese-made-mrna-vaccine-starts-021142214.html

Friday, January 6, 2023

Aclaris Therapeutics Provides 2023 Outlook

 Aclaris Therapeutics Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today is providing a corporate outlook for 2023.

“2023 is setting up to be an incredibly exciting year for Aclaris with several important expected data read-outs for our two lead clinical programs, zunsemetinib (ATI-450) and ATI-1777,” stated Douglas Manion, M.D., Aclaris’ Chief Executive Officer and President. “In addition to these highly anticipated clinical milestones, we also are eager to progress the development of our earlier stage assets such as ATI-2138 for T cell mediated diseases and ATI-2231 for certain oncology indications,” continued Dr. Manion.  “Our research and development team also continues to identify and develop novel kinase drug candidates targeting areas of significant unmet need further bolstering our rich clinical development pipeline.”

Clinical Development Programs:

  • Zunsemetinib, an investigational oral small molecule MK2 inhibitor:
    Currently being developed as a potential treatment for immuno-inflammatory diseases
    • Rheumatoid Arthritis (ATI-450-RA-202): This Phase 2b dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses (20 mg and 50 mg twice daily) of zunsemetinib in combination with methotrexate in subjects with moderate to severe rheumatoid arthritis (RA) is ongoing. Aclaris expects topline data in the second half of 2023.
       
    • Hidradenitis Suppurativa (ATI-450-HS-201): This Phase 2a trial to investigate the efficacy, safety, tolerability, PK and PD of zunsemetinib (50 mg twice daily) over 12 weeks in subjects with moderate to severe hidradenitis suppurativa (HS) has completed enrollment with 95 patients randomized and is ongoing. Aclaris expects topline data in mid-first half of 2023.
       
    • Psoriatic Arthritis (ATI-450-PsA-201): This Phase 2a trial to investigate the efficacy, safety, tolerability, PK and PD of zunsemetinib (50 mg twice daily) in subjects with moderate to severe psoriatic arthritis (PsA) is ongoing. Aclaris expects topline data by year end 2023.
  • ATI-1777, an investigational topical “soft” Janus kinase (JAK) 1/3 inhibitor:
    Currently being developing as a potential treatment for moderate to severe atopic dermatitis (AD)
     
    • Atopic Dermatitis (ATI-1777-AD-202): This Phase 2b trial to determine the efficacy, safety, tolerability, and PK of multiple doses and application regimens of ATI-1777 in subjects with moderate to severe AD is ongoing. Aclaris expects topline data mid-year 2023.
  • ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor:
    Currently being developed as a potential treatment for T cell-mediated autoimmune diseases
    • Aclaris has selected ulcerative colitis as the intended first clinical development target for ATI-2138. Aclaris is also exploring additional indications that are relevant to the mechanism of action.
    • Aclaris initiated a Phase 1 MAD trial of ATI-2138 in healthy volunteers in December of 2022.  Aclaris expects topline data from the MAD trial in the second half of 2023.

Preclinical Development Program:

  • ATI-2231, an investigational oral MK2 inhibitor compound: 
    Currently being explored as a potential treatment for pancreatic cancer and metastatic breast cancer as well as in preventing bone loss in patients with metastatic breast cancer
     
    • Second MK2 inhibitor generated from Aclaris’ proprietary KINect® drug discovery platform and designed to have a long plasma half-life.
    • Aclaris expects an IND to be submitted in 2023.

Upcoming Corporate Presentation

Dr. Manion will provide a corporate overview at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2023 at 2:15 PM PT/5:15 PM ET.  The conference is being held in San Francisco, CA. A copy of Aclaris’ corporate presentation will be posted to the Investor’s page of the Aclaris corporate website prior to the event.

A webcast of the presentation may be accessed through the “Events” page of the “Investors” section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

https://www.biospace.com/article/releases/aclaris-therapeutics-provides-2023-outlook/

Longeveron: Corporate Update, 2023 Strategic Priorities and Anticipated Milestones

 – Expects to enroll first patient in Phase 2 clinical trial of Lomecel-B™ for Aging-Related Frailty in Japan in 1Q23 –

– Extended cash runway into 2H24 –

https://www.biospace.com/article/releases/update-longeveron-provides-corporate-update-and-announces-2023-strategic-priorities-and-anticipated-milestones/

Fusion IND expected to be submitted in Q1 2023

 FPI-2068 IND expected to be submitted in the first quarter of 2023

FPI-1434 Phase 1 data expected in the second quarter of 2023

FPI-1966 Phase 1 study open and enrolling patients; Company expects to provide clinical data update in 2024

New actinium-225 partnership with BWXT Medical, a global leader in medical isotope supply, supports growing pipeline opportunities

https://www.biospace.com/article/releases/fusion-pharmaceuticals-reports-progress-and-provides-recent-corporate-highlights/

Revance: Application (sBLA) OKd for DAXXIFY for Treatment of Cervical Dystonia

  Revance Therapeutics, Inc.,  (Nasdaq: RVNC) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults, a chronic and debilitating neurologic condition affecting the muscles of the neck.1 Revance was provided a Prescription Drug User Fee Act (PDUFA) date of August 19, 2023.

https://www.biospace.com/article/releases/revance-announces-u-s-fda-acceptance-of-supplemental-biologics-license-application-sbla-for-daxxify-daxibotulinumtoxina-lanm-for-injection-for-the-treatment-of-cervical-dystonia/