Rite Aid prepares to file for bankruptcy

 Rite Aid Corp is preparing to file for bankruptcy in coming weeks to address lawsuits the company is facing over its alleged role in the sale of opioids, the Wall Street Journal reported on Friday, citing people familiar with the plan.

The Chapter 11 filing would cover Rite Aid’s more than $3.3 billion debt load and pending legal allegations that it oversupplied prescription painkillers, the newspaper reported.

Regionally focused Rite Aid operates more than 2,330 stores in 17 U.S. states, although it is much smaller than rivals like Walgreens Boots Alliance and CVS Health .

Along with other pharmacy chains, Rite Aid has been named a defendant in lawsuits that alleged they helped fuel the opioid crisis in the United States.

The U.S. Department of Justice in March

sued

Rite Aid, accusing the pharmacy chain of missing "red flags" as it illegally filled hundreds of thousands of prescriptions for controlled substances, including opioids.

More than

900,000 people

have died of drug overdoses in the United States since 1999, with opioids playing an outsized role, according to data from the U.S. Centers for Disease Control and Prevention. 

https://finance.yahoo.com/news/1-drug-retailer-rite-aid-162341273.html

Excessive Social Media Use Is No. 1 Concern For Parents As Kids Head Back To School

 by Mary Gillis via The Epoch Times (emphasis ours),

An increasing number of parents have expressed concern over their children’s digital habits as their kids return to the classroom, findings from a new poll show.

Two-thirds of parents surveyed say overall screen time, followed by social media overuse and internet safety, are major concerns, according to the University of Michigan C.S. Mott Children’s Hospital National Poll on Children’s Health.

“Children are using digital devices and social media at younger ages, and parents may struggle with how to appropriately monitor use to prevent negative impacts on safety, self-esteem, social connections, and habits that may interfere with sleep and other areas of health,” said Mott Poll co-director and Mott pediatrician Dr. Susan Woolford in a news release.

Harmful Effects of Social Media

Findings from the poll, based on a nationally representative sample of over 2,000 respondents, also reveal that 50 percent of parents are concerned about mental health problems such as depression, suicide, stress, and anxiety associated with excessive screen use.

Social media platforms include Instagram, TikTok, Snapchat, and Facebook.

Findings from a 2019 study published in JAMA Psychiatry showed preteens and teens who spent more than three hours per day on social media had a 60 percent higher risk of developing mental health problems. Separate research shows unhealthy scrolling is a significant source of distraction that can lead to addiction, which then adversely impacts academic performance and fuels unrealistic expectations when kids compare themselves to popular, self-declared influencers.

According to an official blog by the National Eating Disorder Association, social media platforms are linked to a fixation on appearance, pressure to be muscular, and reduced body satisfaction. Social media also sets students up for cyberbullying. Fifty-nine percent of teens in the United States say they’ve been bullied or harassed online.

What to Do

The back-to-school months are an excellent time to reinstate expectations and set limits that may have been lifted during the summer months.

“It is typical for parents to relax those rules during the summer, but once school starts, parents and children need to have a conversation about limits on social media and screen time by setting up agreed-upon rules,” Dr. Michelle Escovedo, an adolescent medicine specialist at Cedars-Sinai Guerin Children’s in Los Angeles, said in a recent virtual community conversation about the back-to-school season.

The American Psychological Association (APA) recommends the following strategies to keep kids safe:

1. Limit Screen Time

Limit social media by utilizing available screen time settings so kids and teens learn self-control. Lack of self-control can lead to addiction. Brain specialists have shown that acquiring likes, engaging with people, and temporarily escaping reality trigger the brain’s reward system by releasing dopamine, the same neurotransmitter released with other addictions like eating and gambling.

2019 data from the research firm Statista show that 40 percent of U.S. online users aged 18 to 22 reported feeling addicted to social media, with 5 percent of respondents describing themselves as being “completely” addicted.

2. Ensure Kids Get Enough Sleep

Prohibit screen time that interferes with at least eight hours of sleep.

According to the National Institutes of Health (NIH), a lack of z’s impairs a child’s neurodevelopment, increases impulsivity, and leads to aggressive behavior and thinking problems. Insufficient sleep is also associated with an increased risk for chronic conditions such as diabetes and obesity.

3. Watch for Concerning Behavior

Be on the lookout for behaviors that escalate to the point where:

• They interfere with the child’s daily routines and commitments, such as school, work, friendships, and extracurricular activities.
• The child often chooses social media over in-person social interactions.
• The child cannot get at least eight hours of quality sleep each night.
• The child is prevented from engaging in regular physical activity.
• The child uses social media even when they express a desire to stop.
• The child experiences strong cravings to check social media.
• The child lies or uses deceptive behavior to spend time online.

https://www.zerohedge.com/political/excessive-social-media-use-no-1-concern-parents-kids-head-back-school-new-poll

Novo Nordisk obesity drug Wegovy eases symptoms of heart failure, study finds

 The Novo Nordisk (NOVO-B.KO) obesity drug semaglutide, marketed as Wegovy, can significantly reduce symptoms related to heart failure, according to a study published Friday in the New England Journal of Medicine. On a questionnaire measuring the symptoms and physical limitations of heart failure with preserved ejection fraction, patients on Wegovy showed an average increase of 16.6 points at 52 weeks, compared with 8.7 points on placebo, according to the study. The Wegovy patients improved their six-minute walking distance and had reduced inflammation, the study found. The Wegovy patients also lost an average 13.3% of body weight, compared with 2.6% for those on placebo. The results come just two weeks after Novo Nordisk released study results showing that semaglutide can reduce the risk of heart attacks and strokes. Novo Nordisk's American depositary receipts were down 0.3% premarket on Friday and have gained 37% in the year to date, while the S&P 500 is up 14%.

https://www.morningstar.com/news/marketwatch/20230825292/novo-nordisk-obesity-drug-wegovy-eases-symptoms-of-heart-failure-study-finds

Merck and Eisai say late-stage trial of treatment for head and neck cancer did not meet goals

 Merck & Co. Inc. (MRK) and Eisai Co. Ltd. said Friday a late-stage trial of a treatment for head and neck cancer failed to meet its main goals and the companies have decided to shut it down. The Phase 3 trial sought to evaluate Merck's Keytruda plus Lenvima, an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma. The primary endpoints were overall survival, porgression-free survival and objective response rate. Two planned interim analyses conducted by an independent data monitoring committee found in the first analysis that Keytruda and Lenvima achieved a statistically significant improvement in PFS and ORR compared with Keytruda and placebo. But the second analysis, the two did not demonstrate an improvement in OS compared to KEYTRUDA plus placebo, "and the likelihood of reaching the protocol-specified threshold for statistical significance for OS was evaluated by Merck and Eisai and deemed to be low," said the companies. The partners have decided to close the study and are informing investigators of that decision.

https://www.morningstar.com/news/marketwatch/20230825241/merck-and-eisai-say-late-stage-trial-of-treatment-for-head-and-neck-cancer-did-not-meet-goals

Facebook post lands Exeltis in hot water

 Women's health pharma Exeltis USA has been reprimanded by the FDA for making a Facebook post that promoted its birth control product Slynd, overstating its efficacy and failing to mention potential side effects.

The FDA's untitled letter says that Exeltis made "false or misleading claims" for oral progestin-based contraceptive Slynd (drospirenone) on the social media platform and ran the promotional message without submitting notification to the agency, as is required by the agency's regulations.

Slynd was launched by Exeltis in 2019 with the assertion that it was the first and only progestin-only pill providing pregnancy prevention with a 24-hour missed pill window – versus three hours for other oestrogen-free products – and a 24-day active/4-day inactive regimen designed to improve tolerability.

According to the company, the 24/4 approach provides for more stable hormone levels compared to traditional 21/7 dose regimens, avoiding hormone withdrawal effects.

In its Facebook post, Exeltis made the following claim: "Offer your patients oestrogen-free birth control with periods on a schedule". The FDA said the claim overstates the efficacy of Slynd, as there is no clinical evidence that the drug can lead to predictable bleeding.

The post also failed to mention any risk information about the contraceptive, including contraindications that include renal impairment, adrenal insufficiency, a history of cervical cancer or other progestin-sensitive cancers, benign or malignant liver tumours, other liver problems, and undiagnosed abnormal uterine bleeding. Side effects were also not included.

Finally, the letter upbraids Exeltis for not notifying the FDA of the promotional post by providing form FDA-2253, which should be filed at the time of publication and include a copy of the labelling.

It also instructs Exeltis to cease any similar forms of advertising that violate regulations and respond to the regulator within 15 days to indicate what it is doing to rectify procedures or challenge the FDA's conclusions about the post.

Social media platforms have raised issues for pharma companies as promotional vehicles for the products, as they often have limited space to get a message across, but the FDA has taken a firm line on the inclusion of safety information.

"If a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character space-limited communication [and] should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product," says its guidance.

Recent posts from Exeltis on Facebook feature videos that include a shot of Slynd's side effects and contraindications.

Untitled letters tend to be infrequent, but this is the second to be sent out by the FDA's Office of Prescription Drug Promotion (OPDP) in a matter of weeks, perhaps pointing to increased attention by the regulator on online promotions.

It comes after Xeris Pharmaceuticals was rapped for making false or misleading efficacy claims for Cushing's syndrome therapy Recorlev (levoketoconazole) on its consumer-facing website and minimising the drug's side effects.

https://pharmaphorum.com/news/facebook-post-lands-exeltis-hot-water

eFFECTOR:: Wainwright Predicts Blockbuster Status For Cancer Candidates

 HC Wainwright has initiated coverage on eFFECTOR Therapeutics Inc 

EFTR+1.38%+ Free Alerts

 with a Buy rating and a price target of $5.

Analysts Robert Burns and Raghuram Selvaraju draw investors' attention to eFFECTOR's lead candidate, zotatifin, a novel, selective inhibitor of eIF4A (a helicase enzyme responsible for unwinding complex secondary structures in "onco" RNAs, enabling select tumor cells to overproduce proteins associated with cellular growth, including the estrogen receptor (ER) and components of the KRAS signaling pathway.

Another possible near-term value driver with tomivosertib in lung cancer is a potent, selective oral small molecule inhibitor of MNK (a serine/threonine kinase target).

The analysts write that the potential positioning of tomivosertib as a broadspectrum agent that can overcome patient resistance to widely-used checkpoint inhibitor therapy could enable the drug to achieve blockbuster commercial status. 

Pfizer Inc PFE collaboration provides strategic validation and potential long-term upside to forecasts.

HC Wainwright says zotatifin and tomivosertib could target very substantial commercial niches, reach the market in the 2027 time frame, and achieve blockbuster status by 2030. 

The analysts project peak zotatifin sales of $1.6 billion by 2035, with peak tomivosertib sales reaching roughly $1.4 billion.

https://www.benzinga.com/analyst-ratings/analyst-color/23/08/34029173/effector-stock-to-rally-over-500-analyst-predict-blockbuster-status-for-cancer-cand

SpringWorks' Investigational Cancer Treatment Is Standard Care, Wainwright Unfazed By FDA Update

 In March, the FDA issued SpringWorks Therapeutics Inc 

SWTX-2.21%+ Free Alerts

 with a Form 483 letter due to a failure to ensure that the analysis of an exploratory endpoint in the Phase 3 DeFi trial, which evaluated nirogacestat for the treatment of desmoid tumor (DT) patients that have experienced progressive disease.

Desmoid tumors are noncancerous growths that occur in the connective tissue. Desmoid tumors most often occur in the abdomen, arms, and legs.

In June, SpringWorks Therapeutics announced that the FDA updated the Prescription Drug User Fee Act action date for the New Drug Application for nirogacestat from the previous date of August 27, 2023, by three months.

HC Wainwright notes that new tumors were included in calculating the sum of target tumors for seven patients, which was not under the statistical analysis plan (SAP). 

However, there was no change to nirogacestat's efficacy profile after SpringWorks corrected the analysis. 

The analysts Robert Burns and Raghuram Selvaraju note that the FDA has completed all required inspections.

Accordingly, given the strength of the DeFi trial results, the analysts continue to view nirogacestat as the eventual standard-of-care regimen for treating DTs and write that it should ultimately receive FDA approval, including pain reduction in the label. 

The analyst reiterates the Buy rating for the stock with a price target of $66, noting that the FDA inspection report does not alter the analyst's conviction regarding nirogacestat's probability of approval.

https://www.benzinga.com/analyst-ratings/analyst-color/23/08/34029468/springworks-investigational-cancer-treatment-is-standard-care-analyst-unfazed-by-fd