L.A. eyes requiring vaccine proof at restaurants, gyms, indoor sporting events

 Los Angeles will consider a proposal to require proof of COVID-19 inoculation as a condition of entry at a host of indoor public spaces in what, if passed, would be the widest-ranging vaccination-verification effort in the city yet.

The motion, introduced Wednesday by council President Nury Martinez and Councilmember Mitch O’Farrell, would require eligible individuals to demonstrate that they’ve received at least one vaccination dose to visit indoor places such as restaurants, bars, retail stores, gyms, spas, movie theaters, stadiums and concert venues.

“Enough is enough already,” Martinez said in a statement. “Hospital workers are exhausted, moms who have put aside their careers are tired, and our kids cannot afford the loss of another school year. We have three vaccines that work and are readily available, so what’s it going to take? Our kids are about to return to school, and the unvaccinated are putting their lives at risk every day. Ask your questions, talk to your doctor and get the vaccine. Let’s put this behind us.”

Officials in New York City announced Tuesday that they would implement similar vaccination-verification requirements. And L.A. City Atty. Mike Feuer, a mayoral candidate, penned a letter that same day urging county officials to also require proof of vaccination to visit the gym, eat in a restaurant or attend an indoor performance.

“Hard-working Angelenos, their customers and the general public deserve to be safe in public spaces,” O’Farrell said in a statement. “The vaccines are our most effective form of protection, and the time to act is now.”

The move comes as more public agencies and private sector firms as well as retailers and restaurants are also beginning to require proof of employees’ or patrons’ inoculation status.

Two Los Angeles County supervisors on Tuesday proposed a vaccination-verification requirement for more than 100,000 government workers, a day after health giant Kaiser Permanente announced it was making vaccinations mandatory for all employees and physicians, as nearly a quarter of its 240,000 employees remain uninoculated.

As of now, California has not implemented the sort of widespread vaccination-verification now planned in New York City, where officials announced Tuesday that they will require proof of inoculation status to enter gyms, indoor entertainment venues and restaurants.

When asked about New York’s decision, the California Department of Public Health responded: “California led the way by requiring vaccine verification of state and health care employees and continues to encourage local governments and business to follow suit. State guidelines allow community leaders to establish rules based on local conditions.”

L.A. County is also “not requiring proof of vaccination for customers to enter specific businesses at this point in time,” though public health officials added in a statement Tuesday that they “applaud those businesses that are assessing risks to their employees and customers and adding additional layers of protection, including requiring proof of vaccination.”

Los Angeles Mayor Eric Garcetti “always listens to the guidance from county public health experts on these issues, and there is no such mandate recommended or planned at this time,” according to spokesman Alex Comisar.

“But with cases and hospitalizations rising rapidly, we are not taking anything off the table,” Comisar said. “The mayor strongly urges everyone to get vaccinated, and supports businesses that are taking steps to keep their workers and customers safe.”

Here are some early indications that vaccine requirements could be working.

From July 25 to 31, providers throughout California administered an average of nearly 44,000 first vaccine doses per day, according to data compiled by The Times.

That’s up notably from the previous week, when an average of about 37,300 first doses were doled out daily; and a 41% increase from two weeks ago, when the average was just under 31,100.

These figures cover both those who received their initial dose of the Pfizer-BioNTech or Moderna vaccine or the single-shot Johnson & Johnson vaccine.

California’s vaccination pace still lags far behind its springtime peak, however. Over the week of April 4-10, for example, providers were administering roughly 251,000 first doses per day, on average.

https://www.latimes.com/california/story/2021-08-04/l-a-will-consider-proposal-requiring-vaccinations-at-restaurants-gyms-sporting-events

Amgen vows to fight after IRS demands $3.6B in back taxes

 No one enjoys owing the IRS, especially when the bill totals $3.6 billion.

But that’s apparently the amount in back taxes the U.S. tax collecting agency is seeking from Amgen, not including interest, for the years 2010, 2011 and 2012, according to the company’s earnings release on Tuesday. 

The California-based drugmaker, however, doesn’t want to cough up to Uncle Sam without a fight. In July, Amgen filed a petition in the U.S. Tax Court refuting notices, saying it will “vigorously” contest the IRS' bid.

The IRS is also proposing "significant adjustments" for 2013 and 2015, Amgen Chief Financial Officer Peter Griffith said on a call with analysts. The agency is in the process of auditing 2016 through 2018, which will likely end up with similar results, Griffith said. 

“We strongly believe the IRS’ position is without merit,” he told analysts during the second-quarter earnings call. The dispute could take years to resolve, Griffith added.

The IRS's tax claims revolve around how Amgen allocates its profits between its largest manufacturing facility in Puerto Rico to the U.S., Griffith said. Amgen holds a “difference of opinion on the significant risk and complexity we undertake with activities performed” at the Puerto Rico site, he said. 

While Amgen didn’t detail the IRS’ specific quarrels with its tax scheme, other large companies, such as Coca Cola, have recently come under the agency’s microscope for offshoring profits in a bid for lower tax rates, The Wall Street Journal reports. 

The finance chief didn’t answer how much the company might owe in interest, saying that would be up to the IRS. Any additional taxes imposed could be reduced by up to $900 million based on reparation taxes Amgen has previously accrued on foreign earnings, the company said. 

Amgen’s tax revelation came amid a mixed quarter for the drugmaker, which raked in $6.5 billion during the period. While that was a 5% increase compared with last year, the COVID-19 recovery has been gradual and will likely hit sales for the rest of the year, Amgen forecasted. 

Some of its mainstay growth drivers reported declining year-over-year sales as well. Migraine med Aimovig drew in $82 million over the quarter, a 16% decline compared with last year, while arthritis med Enbrel dropped 8% to $1.1 billion. 

On a positive note, the number of new patients starting Amgen’s psoriasis drug Otezla reached near pre-pandemic levels before COVID-19 shuttered doctors' offices. Except those gains were offset by patients switching to other treatments, Amgen said. Otezla raked in $423 million, also down 5%. 

That could spell trouble as Amgen vies to expand Otezla’s label to mild to moderate plaque psoriasis patients later this year. The treatment, which the company picked up from Celgene, is already approved to treat severe plaque psoriasis.

Otezla's decline was likely the result of “pent up treatment decision making that didn’t happen because patients weren’t going to see their dermatologist last year,” Amgen’s global commercial operations chief Murdo Gordon said on Tuesday's call. The company remains optimistic about Otezla’s prospects, he said.

Meanwhile, Amgen is hard at work rolling out its potential oncology blockbuster Lumakras, which scored a historic FDA nod in May as the first treatment for non-small cell lung cancer (NSCLC) with a particular genetic mutation called KRAS G12C.

Amgen didn’t disclose how much Lumakras generated in sales since its accelerated approval. The company did note that more than 2,000 patients have received the drug so far. 

Diagnosing KRAS patients and moving that info to the front page of pathology reports are seen as key to Lumakras’ early commercial success. For its part, Amgen said its data show KRAS testing for NSCLC patients has grown, and that most testing labs are now labeling the mutation as "actionable."

“We’re very pleased with the enthusiasm Lumakras has generated in the oncology community," Gordon said. 

https://www.fiercepharma.com/pharma/irs-wants-amgen-to-cough-up-3-6b-back-taxes-but-it-s-not-budging-yet

Incyte's still counting on timely Jakafi, ruxolitinib cream FDA verdicts

Incyte has run into several FDA setbacks in the past few months, including delays for decisions on Jakafi and its topical version ruxolitinib cream. But execs still believe the company can overcome the hiccups, and it’s not waiting to prepare for the rollouts.

After the FDA in June postponed decisions on Jakafi in steroid-refractory chronic graft-versus-host disease (cGVHD) and ruxolitinib cream in atopic dermatitis, Incyte is still confident it can win approvals, CEO Herve Hoppenot said during an investors’ call Tuesday. In fact, the company is already gearing up for the launches.

Following the delays, Incyte now looks to hear back from the agency on rux cream on Sep. 21, and on Jakafi the next day.

Incyte has already put in place 120 sales reps in the U.S. for rux cream, and “they are anticipating the launch in September,” Barry Flannelly, Incyte’s North America chief, said during the call. Moreover, all of the dermatology industry leaders are “fully anticipating the approval of rux cream and looking forward to it,” he added.

The delays for Jakafi and rux cream—as well as many other JAK inhibitors—stemmed from concerning safety findings from a postmarketing study that linked Pfizer’s Xeljanz with increased risks of heart-related side effects and cancer over TNF inhibitors.

In addition to rux cream, AbbVie’s Rinvoq, Eli Lilly’s Incyte-partnered Olumiant and Pfizer’s investigational abrocitinib are also gunning for approvals in atopic dermatitis. Those JAK inhibitors have also have their FDA applications delayed.

While Incyte execs have voiced optimism, there's still reason to question whether the approvals will come in September. The FDA last month further deferred decisions on Rinvoq, Olumiant, Xeljanz and abrocitinib after earlier delays.

As RBC Capital Markets analyst Brian Abrahams sees it, the FDA is likely weighing additional safety analyses from the oral JAK inhibitors to understand safety for topical rux. Longer, 52-week data presented in June from the two phase 3 TRuE-AD trials showed no new safety signals and “no adverse events suggestive of a relationship to systemic exposure,” Incyte’s chief medical officer, Steven Stein, said during the call.

Citing physician enthusiasm for the medicine, Abrahams predicted rux cream could reach $700 million in peak sales in atopic dermatitis.

As for Jakafi’s application in cGVHD, Abrahams figured that postponement isn’t likely to have any major impact given the drug is already widely used in the disease off-label. Jakafi is currently approved to treat steroid-refractory acute GVHD.

Meanwhile, Incyte has other expansions planned for its two drugs. Those ambitions could also depend on the outcomes of FDA’s extended review of the JAK class.  

In May, Incyte unveiled that rux cream hit its goals in two phase 3 trials in vitiligo, a skin condition characterized by the loss of pigment cells. The company plans to file in vitiligo “as soon as possible” after the eczema verdict on September 21, Stein said.

For Jakafi, Incyte is advancing a once-daily regimen with a filing now on track for the first half of 2022 pending additional stability data, according to Stein. Jakafi is currently given twice daily.

On the financial side, Incyte said that Jakafi sales grew 12% year-over-year to $529 million in the second quarter. New patient starts for the drug in its three FDA-approved indications—GVHD, polycythemia vera and myelofibrosis—are all back to pre-pandemic levels, Flannelly said.

https://www.fiercepharma.com/pharma/despite-multiple-delays-across-pharmas-incyte-still-counts-timely-jakafi-ruxolitinib-cream

Hundreds of migrants vaccinated against coronavirus in U.S.-Mexico border city

 Health authorities in northern Mexico vaccinated hundreds of migrants living in makeshift tents a few meters from a pedestrian crossing bridge to the United States in the border city of Tijuana on Tuesday.

The COVID-19 vaccine doses were given to migrants a day after the U.S. Centers for Disease Control extended the so-called Title 42 order that allows U.S. officials to send thousands of non-Mexicans back to Mexico without the chance to seek asylum or other protections in the United States.

An official from the health department in Baja California said 450 doses were being given at the camp, of about 4,000 available. He did not say if more would be used at the camp on other days.

Officials also did not confirm whether the vaccinations would extend to other areas with large concentrations of migrants, such as shelters in Tijuana or other border cities.

"I feel very safe now because here ... there are many people and one can easily catch this disease," said Roberto Espana, a Guatemalan migrant who was the first to get the shot.

"I'll wait for the second dose in three weeks," said Espana, who arrived in the area four months ago hoping to ask U.S. officials for asylum.

Authorities from the United States and Mexico have made efforts to reopen the border, which has been closed to crossings considered non-essential since March 2020. Despite prioritizing vaccinating border cities, the restrictions remain in place.

Reluctance to relax the restrictions may be exacerbated by lower vaccination rates among the transient migrant population, some of whom like Espana have spent months hoping to make U.S. asylum claims.

"It is not that the government is very concerned about the situation of migrants but rather that there is pressure to reopen the border, even of an economic nature", said Karla Valenzuela, a researcher on migration issues for the Universidad Iberoamericana.

https://news.yahoo.com/hundreds-migrants-vaccinated-against-coronavirus-205655121.html

Full FDA approval for Pfizer vaccine expected in early September

The US drug regulator is set to fully approve the Pfizer/BioNTech COVID-19 vaccine by early next month, the New York Times reported Tuesday.

The Food and Drug Administration has set an “unofficial deadline” of the September 6 Labor Day holiday “or sooner” to give the shot the final green light, the newspaper reported, citing sources familiar with the plan.

The vaccine is currently being administered via an emergency use authorization that was granted in December.

The FDA had said in a statement last week that granting the Pfizer vaccine final approval was one of the agency’s highest priorities and anticipated being finished with the final review soon.

Full approval could boost vaccine-hesitant people’s confidence in getting the shot as the ultra-contagious Delta variant sweeps through the world, driving case counts to levels not seen since the winter.

https://www.timesofisrael.com/full-us-approval-for-pfizer-vaccine-expected-in-early-september-report/

Businesses, schools can mandate use of Covid-19 vaccines under EUAs, DOJ says

 As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

DOJ says that, consistent with the FDA’s interpretation of section 564 of the Food, Drug, and Cosmetic Act, only certain information needs to be provided to potential vaccine recipients, such as the fact that FDA “has authorized the emergency use of the product,” “the significant known and potential benefits and risks of such use,” and “the extent to which such benefits and risks are unknown.” But it does not prohibit imposing mandates, DOJ says, adding:

Some have questioned whether such entities can lawfully impose such requirements in light of the fact that section 564 instructs that potential vaccine recipients are to be informed that they have the ‘option to accept or refuse’ receipt of the vaccine. In the past few months, several lawsuits have also been filed challenging various entities’ vaccination requirements on the same theory. The only judicial decision to have addressed this issue so far summarily rejected the challenge.

In one such example, an employee of the Durham County Sheriff’s Office in North Carolina sued his former employer in April after he was fired for declining to receive a Covid-19 vaccine. He argued that he was “being forced to take an experimental, unapproved vaccine against his will.” Late last month, the employee dropped his lawsuit.

In Texas, Houston Methodist was one of the nation’s first health systems to impose a coronavirus vaccine mandate in April, leading to Jennifer Bridges and 116 other employees to file suit, arguing they’re being coerced into taking an unapproved vaccine.

“This is not coercion,” District court judge Lynn Hughes wrote in his opinion on June 12. “Methodist is trying to do their business of saving lives without giving them the Covid-19 virus. It is a choice made to keep staff, patients, and their families safer. Bridges can freely choose to accept or refuse a Covid-19 vaccine; however, if she refuses, she will simply need to work somewhere else.”

A federal judge similarly upheld the University of Indiana’s vaccine mandate last week, and other colleges and universities’ vaccination mandates are likely coming soon.

The US Department of Veterans Affairs on Monday became the first federal agency to mandate the use of the vaccines.

“We’re mandating vaccines for Title 38 employees because it’s the best way to keep Veterans safe, especially as the Delta variant spreads across the country,” VA Secretary Denis McDonough said in a statement.

Efforts have trickled down to states and cities now too. In California starting in August, state employees and health care workers must show proof of vaccination or get tested regularly. New York City in September will turn to a similar policy. Meanwhile, more than 50 medical groups also called for mandatory vaccinations of all health care workers, the Washington Post reported.

And per the DOJ, the mandates are entirely legal:

Indeed, if Congress had intended to restrict entities from imposing EUA vaccination requirements, it chose a strangely oblique way to do so, embedding the restriction in a provision that on its face requires only that individuals be provided with certain information (and grouping that requirement with other conditions that are likewise informational in nature). Congress could have created such a restriction by simply stating that persons (or certain categories of persons) may not require others to use an EUA product.

https://endpts.com/businesses-and-schools-can-mandate-the-use-of-covid-19-vaccines-under-euas-doj-says/

Positive Results in Hand, Sage Scraps Two Phase III Zuranolone Studies

 Sage Therapeutics ended two late-stage studies of its depression drug zuranolone after discussions with the U.S. Food and Drug Administration (FDA) led the company to believe they were unnecessary for potential regulatory approval.

In its second quarter announcement, Cambridge, Mass.-based Sage announced the termination of the REDWOOD and RAINFOREST studies of zuranolone, which is being assessed as a treatment for both major depressive disorder, as well as post-partum depression. 

Zuranolone is a next-generation positive allosteric modulator (PAM) of GABAA receptors. Zuranolone, which is being jointly developed with Biogen, has received breakthrough therapy designation from the FDA for the treatment of major depressive disorder (MDD).

The REDWOOD and RAINFOREST studies had previously been suspended in late 2019 after zuranolone experienced a clinical setback in MDD. Following that clinical failure to distinguish itself from placebo, Sage underwent a corporate restructuring that included the termination of more than half its workforce. The two studies will not likely be needed, at least according to Sage, following the positive data from the Phase III Waterfall study in MDD.

In that trial, zuranolone met its primary endpoint demonstrating statistically significant and clinically meaningful improvement in depressive symptoms compared with placebo at the 15-day mark. The drug was well-tolerated, and patients who received the experimental treatment did not report weight gain, sexual dysfunction, euphoria or other side effects common with many antidepressant medications. Additional analysis and full data from the WATERFALL Study will be presented at a future study.

If the WATERFALL study is insufficient to support potential approval, Sage also has two other MDD studies expected to read out later this year, CORAL and SHORELINE. The CORAL study is assessing a two-week course of zuranolone 50 mg, when co-initiated with a new antidepressant, in patients with MDD. The SHORELINE study is a one-year study of 50mg of zuranolone in patients with MDD.

Sage Chief Executive Officer Barry Greene said the company had made significant progress in the first half of 2021.

“Our goal of making medicines that matter for people with brain health disorders is more important than ever, and we are committed to delivering innovative therapies. The LANDSCAPE and NEST programs for zuranolone are examples of Sage’s unique approach to designing integrated clinical development strategies that we believe will enable us to bring paradigm shifting treatments to market and address the greatest unmet needs for patients,” Greene said in a statement. 

The NEST and LANDSCAPE studies are assessing zuranolone as a potential rapid-acting, durable, two-week treatment for PPD and MDD, respectively. 

Zuranolone is also being assessed for PPD in the SKYLARK study, a Phase III trial evaluating the experimental drug over a two-week period. The trial has been slow to enroll, mainly due to the pandemic, and Sage said it anticipates data from the study in mid-2022. 

In addition to zuranolone, Sage is developing SAGE-324, a next-generation PAM of GABAA receptors, as a potential treatment for neurological conditions, such as essential tremor (ET), epilepsy and Parkinson’s disease. A Phase II study in ET met its primary endpoint. 

https://www.biospace.com/article/sage-therapeutics-terminates-two-phase-iii-zuranolone-studies-it-deems-unnecessary-for-approval/