Teva Pharma Shares Up 6% After Louisiana Opioid Settlement

 Teva Pharmaceutical Industries Ltd. shares were up 6% to $9.81 after the company said its U.S. affiliate, Teva Pharmaceuticals, has reached an agreement with the attorney general of Louisiana that settles the state's opioid-related claims.

The company said the agreement is contingent on confirmation from the state by Nov. 2 that all political subdivisions will release Teva as part of the settlement.

Under the terms of the settlement, Teva will pay Louisiana $15 million over an 18-year period and will provide an additional donation of lifesaving medicines to aid in opioid addiction and recovery, valued at $3 million.

Teva said it is continuing to negotiate a national settlement and remains open in parallel to pursuing opportunities with individual states such as the deal announced today, as long as it is consistent with the nationwide approach. The company will continue to defend itself in court in states such as New York and California, where it has not reached terms of a settlement agreement.

https://www.marketscreener.com/quote/stock/TEVA-PHARMACEUTICAL-INDUS-40246797/news/Teva-Pharma-Shares-Up-6-After-Louisiana-Opioid-Settlement-36539857/

AbbVie Says FDA Approves Qulipta as Migraine Treatment

 AbbVie Inc. on Tuesday said the U.S. Food and Drug Administration approved Qulipta for the preventive treatment of episodic migraine in adults.

The company said Qulipta, or atogepant, "demonstrated statistically significant, clinically meaningful rapid and continuous reductions in mean monthly migraine days among adults with episodic migraine compared to placebo."

Michael Severino, vice chairman and president of AbbVie, said "Millions of people living with migraine often lose days of productivity each month because attacks can be debilitating. Qulipta can help by reducing monthly migraine days with a once-daily, oral dose that works quickly and continuously."

AbbVie said it is the only pharmaceutical company offering three treatments across the full spectrum of migraine.

https://www.marketscreener.com/quote/stock/ABBVIE-INC-12136589/news/AbbVie-Says-FDA-Approves-Qulipta-as-Migraine-Treatment-36541861/

H.C. Wainwright Sees Buying Opportunity In Biotech Stock Selloff

 

• H.C. Wainwright said that Altimmune Inc 
  ALT-2.50%+ Free Alerts
   reported "positive" Phase 1 trial pemvidutide data, formerly known as ALT-801, in obese patients. 
• However, shares dropped, which he sees primarily because one patient experienced elevated ALT levels that resolved after a pause in dosing.
• Some of the losses have since been recovered after the stock was down 20.6% as of 10:46 a.m. ET on Tuesday.
• Management emphasized that the adverse event occurred in one out of 100 patients enrolled in the trial, in a patient who would not ordinarily be enrolled in an obesity or NASH study.
• Analyst Patrick Trucchio believes that ALT elevation might not occur in the future.
• He believes the selloff on such "a potential one-off event" has created a "compelling buying opportunity" ahead of multiple study starts and trial data readouts expected throughout 2022.
• The analyst keeps a Buy rating and $25 price target on Altimmune shares.

https://www.benzinga.com/analyst-ratings/analyst-color/21/09/23139415/h-c-wainwright-sees-buying-opportunity-in-this-biotech-stock-sell-off

Vaccination pace is largest but hardly only drag on economy: Biz leaders poll

 Corporate leaders are far less bullish about the economic recovery than they were back in the spring — and they fear that vaccination holdouts could stall or even reverse the progress that has been made.

A new survey by the National Association for Business Economics, or NABE, found a marked pullback in expectations for economic growth and output, especially in the near term. Survey respondents expect real growth in gross domestic product for this year to come in at 5.6 percent at the median — a significant drop from the median 6.7 percent growth expected in May, when the survey was last conducted.

"The erosion of forecasts and confidence has really mirrored what our economists have been saying, because we brought down our Q3 GDP forecast from 7.0 to 5.6 percent," said Sam Stovall, chief investment strategist at CFRA Research. "We just feel that things don't look as rosy as they did before."

Nearly 2 in 5 NABE survey respondents said downside economic risk outweighs upside risk for the year, and just 16 percent said conditions are weighted toward the upside. The figures were reversed in May, when 56 percent ranked upside risk as a higher probability and just 15 percent said saw greater downside risk to the outlook.

The key difference, and the factor that is weighing on hopes for the recovery, is the resurgence of Covid-19 fueled by the highly contagious delta variant of the coronavirus. Everybody who was banking on the pandemic's receding over the summer has had to modify their expectations in the face of a public health crisis that shows no sign of abating.

"We all believed we were through the pandemic five months ago, and I believe that the variant has caught many people by surprise," said Joseph Heider, president of Cirrus Wealth Management. "As this lingers on, executives are becoming more concerned and asking, 'Are we going to have this under control?'"

NABE survey chair Holly Wade, executive director of the NFIB Research Center, said in the survey outlook report, "Panelists point to a variant of the coronavirus, against which the vaccines may be ineffective as the main downside risk." Nearly two-thirds of respondents identified that as the greatest downside risk to the economy, and 9 percent more cited slowing vaccine uptake as the most worrisome hurdle. A plurality of 44 percent said a faster vaccine rollout is the best chance for higher-than-expected economic gain.

Heider said: "Vaccine resistance is, I think, larger than many people anticipated. I think it's creating real concerns as to our ability to reach herd immunity. And when we don't have herd immunity, the unvaccinated are human petri dishes for the virus to mutate."

Although the virus represents the biggest threat to near-term business recovery, analysts said it is far from the only headwind corporations face. "There's just many more variables and unknowns than there were six months ago," said Dick Pfister, CEO of AlphaCore Wealth Advisory.

In addition to the threat of Covid and potential variants, Pfister said, companies and investors are monitoring other unfolding circumstances. The Federal Reserve is edging closer to ending its bond buying, and more policymakers have expressed openness to raising interest rates sooner. The financial peril faced by the heavily indebted Chinese real estate giant Evergrande is making investors nervous, he said, as they try to gauge whether the company's teetering on the brink of collapse was an isolated incident.

"There's probably more than just one, and there are some fears from economists that this could be more systematic inside of China," he said.

A globally connected economy poses other sorts of risks, as well: A cascading series of bottlenecks in the global supply chain affecting semiconductors to energy has triggered much of the growing worry about rapidly increasing prices. The NABE survey found that 17 percent of respondents said supply chain disruptions were having a "significant impact" on business, while 27 percent more cited mild or moderate impacts.

"Inflation expectations have moved up significantly from those in the May 2021 survey," Wade said. On average, NABE respondents expect inflation to rise by 5.1 percent in the fourth quarter year over year, a jump from an expected 2.8 percent increase in the May survey.

David Wagner, portfolio manager at Aptus Capital Advisors, said the duration and the breadth of global supply disruption have triggered a re-evaluation in corner offices in the U.S. and around the world. In the spring, "it seemed like the supply chain problem was transitory," but the assumptions were dashed as the summer went on, he said, adding: "Supply chain problems are persisting for much longer than originally expected.

"Now that you're starting to see some kind of tangible supply chain backlog, I think that's got more people pessimistic. It caught people by surprise," Wagner said.

Rob Haworth, senior investment strategist at U.S. Bank Wealth Management, said, "Supply concerns are weighing on the mind of the market and economists because it has limited the amount of output we can get from certain industries."

Along with the supply shortages that are hindering production and driving up costs, the unbalanced labor market continues to constrain growth, as well — but there also are glimpses within those distortions of potential normalization. Although about one-third of survey respondents said they were facing a surfeit of workers, a larger proportion, 44 percent, said they were not experiencing a labor shortage. Respondents predict wage growth of 4 percent for the year, followed by a 3.5 percent increase next year — rates broadly in line with what many economists consider to be indicative of a well-functioning labor market.

"The labor market is not fully recovered — we're seeing that across other surveys, as well, and even the Fed's own Beige Book indicates that hiring has been challenging," Haworth said. "There's a lot of room for improvement, but it's really slow going."

https://www.nbcnews.com/business/economy/slow-pace-vaccinations-largest-drag-economy-new-survey-business-leaders-n1280204

Unvaccinated Americans say need for booster shots proves Covid vaccines 'don't work': Kaiser survey

 The divide in attitudes on Covid-19 vaccines between people who have or haven't gotten the shots hasn't changed with the introduction of booster shots.

In fact, vaccinated people say the third dose approved by U.S. regulators last week shows that scientists are trying to make the shots more effective while 71% of unvaccinated Americans say it's proof the vaccines don't work, according to a survey released Tuesday by the Kaiser Family Foundation.

Nearly 80% of vaccinated respondents see booster shots as a good sign.

"We have seen for sure that the vaccinated and unvaccinated have viewed the pandemic very differently," said Liz Hamel, the foundation's director of public opinion and survey research. "It's not really surprising to me that they view the conversation around booster shots differently."

Those still yet to receive a shot are among the "strongest holdouts," Hamel said, adding that the unvaccinated are more likely to believe the severity of the pandemic has been exaggerated, are less worried about getting sick, and have viewed the safety and efficacy of the vaccines differently than those who are vaccinated.

Kaiser surveyed 1,519 randomly selected adults from Sept. 13 through Sept. 22, after the Biden administration announced plans to roll out booster doses to all Americans, but before federal health officials recommended boosters for people 65 and older and those at high risk of illness. 

The split in attitudes toward vaccines more broadly continues to be a largely partisan one, the survey data shows, with 90% of respondents who are Democrats saying they have received at least one vaccine dose compared with 58% of Republicans. 

That division by political identity has remained steady at about 30 percentage points since vaccines became widely available in the spring, Hamel said, even as other gaps along lines of race and ethnicity have narrowed. 

The surge in Covid cases, hospitalizations and deaths due to the delta variant was the main motivator for a recent rise in vaccinations, the survey found, with the largest increases in vaccination rates between July and September seen among Hispanic adults and those ages 18 to 29. Similar shares of white, Black and Hispanic adults reported being vaccinated, at 71%, 70%, and 73%, respectively, saying they have had at least one shot. Hamel noted that a separate Kaiser analysis of state-reported data published last week found that Black and Hispanic Americans were still less likely than white Americans to have received a vaccine, but that the disparity across groups was narrowing over time.

The political split on vaccines extends to the public's plans to get a booster shot, as 68% of Democrats said they will "definitely" get one if recommended, nearly twice the share of Republican respondents.

The vast majority of fully vaccinated adults overall said they would "definitely" or "probably" get a booster if it were recommended for them by the Centers for Disease Control and Prevention and Food and Drug Administration.

The FDA on Wednesday authorized Pfizer and BioNTech's Covid booster shot for people 65 and older along with other vulnerable Americans. On Friday, CDC Director Dr. Rochelle Walensky authorized the distribution of boosters for those in high-risk occupational and institutional settings, overruling an advisory panel that had voted against that proposal. She also approved three other recommendations from the group that cleared the way to distribute boosters to people over 65, other vulnerable groups and a wide array of U.S. workers — from hospital employees to grocery store cashiers.

President Joe Biden received a booster shot on Monday since his age at 78 made him eligible for an extra dose under the CDC's latest guidance. 

"Boosters are important, but the most important thing we need to do is get more people vaccinated," Biden said before receiving his injection.

About 75% of the eligible population age 12 and older in the U.S. has received at least one vaccine dose, CDC data shows, and nearly 65% is fully vaccinated. Some 2.7 million people have received a booster shot since health officials authorized them for people with weakened immune systems in August.

The pace of daily shots picked up over the summer as the delta variant spread rapidly across the country, with the seven-day average of daily reported doses hitting a high mark of 954,000 on Sept. 3. It has slowed since, and the seven-day average sits at about 632,000 shots per day as of Monday.

Biden issued sweeping new vaccine mandates on Sept. 9 affecting private businesses and federal employees. Government staff and contractors are required to immunize against Covid with no alternative for testing, while any company with over 100 emplyees must implement vaccine mandates that include medical and religious exemptions.

One thing vaccinated and unvaccinated Americans do agree on, the Kaiser survey shows, is that Covid is not going away any time soon.

About 8 in 10 respondents, including large majorities of vaccinated and unvaccinated adults, said they expect that Covid will "continue at a lower level and be something the U.S. will learn to live with and manage with medical treatments and vaccines, like the seasonal flu." Only 14% said they think Covid will be largely eliminated in the U.S. as polio has been.

"A majority of the public seem resigned to accept the possibility that COVID-19 may never be fully defeated and instead will have to be dealt with as a chronic problem" said Mollyann Brodie, executive director of the Kaiser Family Foundation's public opinion and survey research program, in a press release.

https://www.cnbc.com/2021/09/28/unvaccinated-americans-say-the-need-for-boosters-proves-covid-vaccines-dont-work.html

Federal Judges: NYC Can Impose Vaccine Mandate on Teachers

 The nation's largest school district can immediately impose a vaccine mandate on its teachers and other workers, after all, a federal appeals panel decided Monday, leading lawyers for teachers to say they'll ask the U.S. Supreme Court to intervene.

The city's Department of Education said the mandate would now go into effect at the end of Friday, so that all teachers and staff would be vaccinated by Oct. 4, the following Monday.

The three-judge panel of the 2nd U.S. Circuit Court of Appeals in Manhattan issued a brief order late in the day that lifted a block of the mandate that a single appeals judge had put in place on Friday.

After an adverse ruling from a Brooklyn judge, a group of teachers had brought the case to the appeals court, which assigned a three-judge panel to hear oral arguments Wednesday. But the appeals panel issued its order Monday after written arguments were submitted by both sides.

Attorney Mark Fonte, who brought the lawsuit on behalf of teachers and others, said in a statement that he and attorney Louis Gelormino were immediately petitioning the Supreme Court to intervene.

"As of this moment the mandate is in place," he said, adding that he and Gelormino were "dismayed and disappointed by this turn of events."

Fonte added: "With thousands of teachers not vaccinated the City may regret what it wished for. Our children will be left with no teachers and no security in schools."

The city's Department of Education said in its statement, "Vaccinations are our strongest tool in the fight against COVID-19 – this ruling is on the right side of the law and will protect our students and staff."

Mayor Bill de Blasio announced in August that about 148,000 school employees would have to get at least a first dose of the COVID-19 vaccination by Sept. 27. The policy covers teachers, along with other staffers, such as custodians and cafeteria workers.

The practical effect of the mandate was that teachers and other employees would have been unable to work, beginning Tuesday, if they had failed to get vaccinated.

As of Monday, 87% of all Department of Education employees have been vaccinated, including 90% of teachers, de Blasio said.

But United Federation of Teachers President Michael Mulgrew said a survey of some of its members found that only a third thought their schools could open without disruption.

"The city has a lot of work before it to ensure that enough vaccinated staff will be available by the new deadline," he said in a statement.

Lawyers for teachers argued Monday in papers submitted to the 2nd Circuit that teachers who are placed on unpaid leave because they have not complied with the order will be irreparably harmed if the appeals court failed to block the mandate.

The lawyers wrote that the city's order will "leave teachers and paraprofessionals without the resources to pay rent, utilities, and other essentials. The harm is imminent."

They said the mandate would leave thousands of New York City children in the nation's largest school district without their teachers and other school workers.

"Imminent and irreparable harm exists," the lawyers insisted.

On Sunday, the city submitted written arguments to the appeals court, saying the preference by some teachers "to remain unvaccinated while teaching vulnerable schoolchildren is dwarfed by the public's interest in safely resuming full school operations for a million public school students and ensuring that caregivers citywide can send their children to school secure in the knowledge that sound safety protocols are in place."

City lawyers said courts have long recognized that vaccination mandates do not spoil the constitutional rights to due process that workers enjoy and have rejected similar challenges for over a century.

"Put bluntly, plaintiffs do not have a substantive due process right to teach children without being vaccinated against a dangerous infectious disease," they wrote. "The vaccination mandate is not just a rational public health measure, but a crucial one."

https://www.medscape.com/viewarticle/959880

Sorry, Employers: Vax Mandate Battle Is Just Beginning

 The vaccine mandate debate is just beginning, as a new announcement underscores the Biden administration’s vision to increase the vaccination rate while opponents push back against new measures as government overreach. 

Last week, the White House released guidance ordering federal contractors to be vaccinated no later than Dec. 8. The move has a few exceptions for what’s being called “urgent, mission-critical need," and legal experts still have questions about the scope of such a mandate, but many broadly agree it has substantial reach. One expert told Reuters that the move may impact “tens of millions” of workers across the country.

At the same time, 24 attorneys general across the country, representing Republican states, have announced they intend to push back against the Biden administration’s private sector mandate, which would require employers with more than 100 employees to vaccinate their workforces. They claim it will exacerbate the labor shortage, according to HR Dive, and the federal government lacks the ability to compel such a move. While legal challenges are assured, some early evidence suggests employer mandates do have a high uptake from staff. United Airlines said just a small percentage of its 67,000 employees resigned due to its companywide vaccine mandate.

https://www.bisnow.com/national/news/top-talent/sorry-vax-mandate-battle-just-beginning-110348