Nurses at 2 NYC hospitals go on strike

 More than 7,000 nurses from two New York City hospitals went on strike on Monday morning amid failed bargaining for better contracts.

The New York State Nurses Association announced early in the morning that nurses at Mount Sinai Medical Center, on the Upper East Side, and Montefiore Medical Center, in the Bronx, will go on strike to demand fair working conditions, increased wages and health care and retirement security.

“After bargaining late into the night at Montefiore and Mount Sinai Hospital yesterday, no tentative agreements were reached,” the press release states. “Today, more than 7,000 nurses at two hospitals are on strike for fair contracts that improve patient care.”

Mario Cilento, the president of the New York State AFL-CIO, said nurses are forced to work in “unimaginable conditions,” including short staffing, which has left them no other option but to strike.

“The hospitals treatment of these nurses is proof that all their words of adulation for their healthcare heroes during the pandemic were hollow,” Cilento said in a statement. “It is time for the hospitals to treat these nurses fairly, with the dignity and respect they deserve, to ensure nurses can get back to serving their communities by providing superior care to their patients.”

“If you are sick, please do not delay getting medical care, regardless of whether we are on strike,” the statement added. “Patients should seek hospital care immediately if they need it. We would rather be the ones providing that care, but our bosses have pushed us to be out here instead.”

New York Gov. Kathy Hochul (D) called for a binding arbitration Sunday so that the union and the hospitals can “swiftly reach a resolution.” Both hospitals were in support of an arbitration agreement so that the union may postpone their strike, but the union declined to do so.

“The New York State Department of Health will continue to enforce staffing requirements under the law at these hospitals to maintain the delivery of essential health care services to the community and protect patient health and safety,” Hochul said in a statement. “Likewise, the Health Department will continue to ensure that all providers are meeting the requirements of the law.”

The New York State Nurses Association said in a statement posted to Twitter that, “We welcome the Governor’s support for fair contracts that protect our patents and we will not give up on our fight to ensure that our nurses have enough nurses at the bedside.”

Both hospitals released statements saying that the union refused to accept a 19.1 percent compounded wage increase over three years. Montefiore Medical Center said the union “decided to walk away from the bedsides of their patients” when they announced the strike.

“We remain committed to seamless and compassionate care, recognizing that the union leadership’s decision will spark fear and uncertainty across our community,” Montefiore Medical Center’s statement added. “This is a sad day for New York City.”

“The union refused to accept the exact same offer of a 19.1 percent wage increase over three years that it agreed to at eight other hospitals, including Mount Sinai Morningside and Mount Sinai West, and disregarded Governor Hochul’s proposal for binding arbitration to avoid a strike,” Mount Sinai Medical Center said in a press release.

https://thehill.com/blogs/blog-briefing-room/news/3805113-nurses-at-two-new-york-city-hospitals-go-on-strike/

New guidance recommends drugs, surgery for obese children

 The American Academy of Pediatrics (AAP) has issued new guidelines for treating children and adolescents with obesity in an effort to address the growing toll of the disease on the nation’s youth. 

The update, which marks the first comprehensive guidance from the AAP in 15 years on the subject, includes recommendations for different medications, along with metabolic and bariatric surgery. It also touts a holistic approach to treating the disease by recognizing the complex genetic, physiologic, socioeconomic, and environmental factors that contribute to the increased risk of obesity. 

Obesity is defined as a body mass index (BMI) at or above the 95th percentile, while overweight is classified as a BMI over the 85th percentile for children and teens of the same age and sex. 

According to the new guidelines, only those with a BMI equal to or greater than 120 percent of the 95th percentile should be evaluated for metabolic and bariatric surgery. This recommendation is also limited to youth aged 13 or older.

Medications are only recommended as an adjunct to health behavior and lifestyle treatment in those aged 12 and older. 

Obesity affects around 20 percent of children between the ages of two and 19 in the United States, while rates have tripled in the last 30 years. 

When left untreated, obesity can lead to cardiovascular diseases, diabetes, depression and other chronic conditions. 

“Weight is a sensitive topic for most of us, and children and teens are especially aware of the harsh and unfair stigma that comes with being affected by it,” said Sarah Hampl, a lead author of the guideline, in a statement. 

“Research tells us that we need to take a close look at families — where they live, their access to nutritious food, health care and opportunities for physical activity — as well as other factors that are associated with health, quality-of- life outcomes and risks. Our kids need the medical support, understanding and resources we can provide within a treatment plan that involves the whole family.” 

Along with medication and surgery, the guidelines recommend strategies like motivational interviewing and intensive health behavior and lifestyle treatment, which take the child’s health status, family system, community, and resources into account. 

Providers had previously often employed a “watch and wait” strategy to address childhood obesity, or delayed treatment altogether to see if children outgrew or overcame obesity. The new recommendations reject this practice. 

“The goal is to help patients make changes in lifestyle, behaviors or environment in a way that is sustainable and involves families in decision-making at every step of the way,” said Sandra Hassink, another author of the guideline.

Genetics and biological factors play a role in obesity, though environmental factors also contribute to an increased risk. These can include the availability of affordable healthy food, marketing of unhealthy food, household food insecurity and low socioeconomic status. 

Childhood obesity is especially prevalent among communities of color and is driven in part by structural racism. This factor “drives disparities and inequities in childhood obesity and obesity-related comorbidities,” authors wrote in their executive summary of the recommendations. 

Previous research has linked systemic racism with obesity, as BIPOC can suffer chronic stress from experiencing racism. These individuals also can face barriers when trying to access health care, and once they do, may face systemic racism within the system. 

In addition to addressing the factors that contribute to an increased risk of obesity, the authors emphasize the need for supportive payment and public health policies to cover the costs of obesity prevention, evaluation, and treatment. 

“The medical costs of obesity on children, families and our society as a whole are well-documented and require urgent action,” said Hampl. 

“This is a complex issue, but there are multiple ways we can take steps to intervene now and help children and teens build the foundation for a long, healthy life.”

https://thehill.com/changing-america/well-being/prevention-cures/3805280-new-guidance-recommends-drugs-surgery-for-obese-children/

Cerus 2023 guidance disappoints

 Cerus Corporation (Nasdaq: CERS) today announced preliminary product revenue for the fourth quarter and full-year 2022 and provided product revenue guidance for full-year 2023.

Cerus’ unaudited preliminary product revenue for the fourth quarter of 2022 totaled $44.0 million, representing an increase of 10% over the $39.9 million recognized during the fourth quarter of 2021. The Company expects its unaudited preliminary full-year 2022 product revenue to be $162.0 million, which would be at the top end of the Company’s 2022 product revenue guidance range of $160-$162 million and reflect year-over-year growth of 24%. These preliminary full-year product revenue results have not been audited and are subject to change.

"Cerus’ commercial execution in the fourth quarter of 2022 was consistent with our strong performance throughout the first three quarters of the year. We believe the continued growth in demand for the INTERCEPT Blood System, particularly in the U.S., reflected the ongoing resiliency of our business as well as the integral role played by pathogen reduction in safeguarding the global blood supply," stated William "Obi" Greenman, Cerus’ president and chief executive officer.

"Given the current macroeconomic environment, Euro to U.S. dollar exchange rates at or near parity, heightened volatility and resulting uncertainty, we expect 2023 to be a bridge year for the Company as we continue to build the foundation for broader INTERCEPT adoption," continued Greenman. "While we may see the uncertainty and trepidation persist through 2023, we believe these will be most acutely felt during the first quarter as customers assess the year prior to entering into more normalized and consistent operations." As a result of these factors, the Company expects full-year 2023 product revenue will be in the range of $165-$170 million.

https://finance.yahoo.com/news/cerus-corporation-announces-preliminary-fourth-133000437.html

Coherus to Acquire Exclusive U.S. Commercial Rights to Eylea® Biosimilar

Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) announced today that it has executed a binding term sheet with Klinge Biopharma GmbH (Klinge Biopharma) for the exclusive commercialization rights to FYB203, a biosimilar candidate to Eylea® (aflibercept), in the United States. The parties expect to complete the transaction in Q1 2023, and Coherus plans to file a Biologics License Application with the U.S. Food and Drug Administration later this year. Coherus intends to launch the product at Eylea® biosimilar market formation, currently expected to be in 2025, if approved.

“This additional ophthalmology product will allow us to broadly target the entire $7 billion class of anti-VEGF products, substantially increasing our market opportunity to support mid-to-long term growth and revenue potential,” said Coherus’ CEO, Denny Lanfear. “This agreement extends the Company's commitment to expand choice and improve access for physicians and patients seeking high-quality, cost-effective alternatives in anti-VEGF therapies throughout the continuum of care.”

“An Eylea® biosimilar will be an excellent strategic fit for Coherus given our demonstrated biosimilar commercialization competency as shown by UDENYCA®, as well as our recent successful launch of CIMERLITM, the first and only FDA-approved biosimilar interchangeable with Lucentis®”, said Paul Reider, Chief Commercial Officer of Coherus. “The addition of an Eylea® biosimilar will be highly synergistic with our retina portfolio, leveraging our existing dedicated retina sales team and patient services hub to enable successful access and reimbursement.”

Under the binding term sheet, Coherus will make a total upfront payment of approximately €30 million, comprised of cash and Coherus common stock, thirty days after the execution of the definitive agreements. Coherus will also make other regulatory and launch milestone payments and share profits approximately equally in consideration for the commercialization rights to FYB203 in the United States.

FYB203, which Klinge Biopharma has in-licensed from the German biosimilar developer Formycon AG, is being evaluated in a Phase 3 clinical trial (MAGELLAN-AMD) and topline results are expected in the next few weeks. MAGELLAN-AMD is a randomized, double-blind, multicenter study designed to evaluate the efficacy and safety of FYB203 compared to the reference product, Eylea®, in terms of safety, efficacy, and immunogenicity in patients with Neovascular (wet) Age-Related Macular Degeneration (nAMD). The study recruited 434 patients to receive one intravitreal injection of FYB203 every 4 weeks for the first 3 doses, followed by one intravitreal injection every 8 weeks through study completion. The primary outcome assessment is a change from baseline in Best Corrected Visual Acuity (BCVA) at 8 weeks.

https://finance.yahoo.com/news/coherus-agrees-acquire-exclusive-u-132000644.html

Phathom: Positive Topline in Phase 3 Gastroesophageal Reflux Disease Trial

 

• Both vonoprazan 10 mg and 20 mg doses met the primary endpoint and showed highly statistically significant greater percentage of 24-hour heartburn free days as compared to placebo (p<0.0001)
  

• Data expected to provide the basis for future regulatory submission for vonoprazan as a daily treatment for patients with NERD, pending completion of 20-week safety extension period
  

• Over 45 million people in the U.S. are estimated to have NERD, the largest subcategory of gastroesophageal reflux disease (GERD)

https://finance.yahoo.com/news/phathom-pharmaceuticals-announces-positive-topline-230000479.html

MIMEDX Confirms 2022 Outlook, Comments on Evolving Medicare Reimbursement

 Reaffirms Fourth Quarter and Full Year 2022 Expectations

The Company announced that it expects its fourth quarter and full year 2022 net sales to be in the ranges of $73 million to $76 million and $266 million to $269 million, respectively, unchanged from the outlook provided during the Company’s third quarter 2022 results conference call in November 2022.

Comments on Potential Exposure to Changes for Medicare Reimbursement of Skin Substitutes
Recently, several wide-ranging proposals have been published for public comment and are under consideration by the U.S. Centers for Medicare and Medicaid Services (“CMS”). In addition, three Medicare Administrative Contractors (“MACs”) have recently published for public comment changes to their Local Coverage Determinations (“LCDs”) that they are considering. If adopted, these proposals would significantly change Medicare policies governing the reimbursement of skin substitute products principally when used for wound treatment in the private physician office setting.

MIMEDX business in the private physician office setting accounted for approximately 28% of the Company’s 2022 sales, of which roughly three-quarters were likely reimbursed by CMS. By product type, over 90% of its sales to this site-of-service are derived from sales of EPIFIX® (Q4186), with the remainder primarily coming from EPICORD® (Q4187) product sales.

While there remains uncertainty regarding the timing, form or extent to which these proposals may be adopted, if at all, MIMEDX has taken steps to mitigate its risks associated with these potential changes.

https://finance.yahoo.com/news/mimedx-confirms-fourth-quarter-full-130200753.html

Krystal: 3-Month Extension of BLA PDUFA Date

  Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that on January 5, 2023, the U.S. Food and Drug Administration (FDA) notified the Company that based on manufacturing information submitted to the Agency on December 20, 2022, in response to an information request, the PDUFA date has been revised to May 19, 2023, and proposed labeling discussions to no later than April 20, 2023.

The manufacturing information submitted by the Company included additional information about a replaced hardware unit in the concentration step of the manufacturing process and comparability data supporting the use of the unit. The unit did not affect processing parameters or product contact materials. The FDA considered this new information as a major amendment to the application that will require additional time for review.

The BLA late-cycle review meeting was completed on December 15, 2022. During this meeting, the FDA indicated that there will be no Advisory Committee meeting for B-VEC and a Risk Evaluation and Mitigation Strategies (REMS) program is not needed for the B-VEC application. All pre-approval inspections of clinical sites and internal manufacturing and testing facilities have been successfully completed.

https://finance.yahoo.com/news/krystal-biotech-announces-fda-3-130000661.html