Google delays workers’ return to office, will require COVID vaccinations for employees

 Google is postponing a return to the office for most workers until mid-October and rolling out a policy that will eventually require everyone to be vaccinated once its sprawling campuses are fully reopened in an attempt to fight the spreading Delta variant.

In a Wednesday email sent to Google’s more than 130,000 employees, CEO Sundar Pichai said the company is now aiming to have most of its workforce back to its offices beginning Oct. 18 instead of its previous target date of Sept. 1. The decision also affects tens of thousands of contractors who Google intends to continue to pay while access to its campuses remains limited.

“This extension will allow us time to ramp back into work while providing flexibility for those who need it,” Pichai wrote.

And Pichai disclosed that once offices are fully reopened, everyone working there will have be vaccinated. The requirement will be first imposed at Google’s Mountain View, Calif. headquarters and other U.S. offices before being extended to the more than 40 other countries where the Google operates.

The vaccine mandate will be adjusted to adhere to the laws and regulators of each location, Pichai wrote, and exceptions will be made for medical and other “protected” reasons.

“Getting vaccinated is one of the most important ways to keep ourselves and our communities healthy in the months ahead,” Pichai explained.

Google’s decision to require vaccines to be in the office comes on the heels of similar moves affecting hundreds of thousands government workers in California and New York as part of stepped-up measures to fight the Delta variant.

The rapid rise in cases during the past month has prompted more public health officials to urge stricter measures to help overcome vaccine skepticism and misinformation.

The vaccine requirement rolling out in California next month covers more than 240,000 government employees. The city and county of San Francisco is also requiring its roughly 35,000 workers to be vaccinated or risk disciplinary action after the Food and Drug Administration approves one of the vaccines now being distributed under an emergency order.

It’s unclear how many of Google’s workers still haven’t been vaccinated, although Pichai described the rate as high in his email.

Google’s decision to extend its remote-work follows a similar move by another technology powerhouse, Apple, which recently moved its return-to-office plans from September to October, too.

The delays by Apple and Google could influence other major employers to take similar precautions, given that the technology industry has been at the forefront of the shift to remote work that has been triggered by the spread of the novel coronavirus.

Even before the World Health Organization declared a pandemic in March 2020, Google, Apple and many other prominent tech firms had been telling their employees to work from home. This marks the third time that Google has pushed back the date for fully reopening its offices.

Google’s vaccine requirement also could embolden other employers to issue similar mandates to guard against outbreaks of the Delta variant and minimize the need to wear masks in the office.

While most companies are planning to bring back their workers at least a few days a week, others in the tech industry have decided to let employees do their jobs from remote locations permanently.

https://ktla.com/news/california/google-delays-workers-return-to-office-will-require-covid-vaccinations-for-employees/

Humana execs: COVID represents a $600M headwind this year

 Humana executives said Wednesday that the impacts of COVID-19 represent a $600 million headwind on the company's finances this year.

While the insurer expects those costs to largely be offset by a number of positives, such as better-than-expected specialty and Medicaid performance and the closure of its acquisition of Kindred at Home, there's still plenty of uncertainty around the pandemic, leaders told investors on the company's Q2 earnings call.

For example, there are still uncertainties about care utilization moving forward, CEO Bruce Broussard said on the call. While care use has bounced back significantly from the pandemic lows, where it will land by the end of the year is still murky, he said.

In addition, the spread of the delta variant of COVID-19 has driven up virus-related hospitalizations in recent weeks, a trend the insurer is watching closely, he said.

Centene CEO Michael Neidorff made similar comments on the company's second-quarter earnings call Tuesday morning, saying the rest of the year could be "choppy" if delta infections continue to rise.

Humana CFO Susan Diamond said on the call that the insurer does not expect similar pandemic-related headwinds to carry into 2022, but is planning for them in the 2021 guidance.

"While we continue to navigate these pandemic-related uncertainties in 2021…we expect 2022 to be a more normal year," Broussard said.

Humana brought in $588 million in profit for the second quarter of 2021, down 67.8% from its haul in the prior-year quarter.

This echoes its peers' quarterly performance. Insurers posted sky-high profits in the second quarter of 2020 as healthcare utilization plummeted under the pandemic, raking in so much cash that Congress began a probe of their finances.

In Q2 2020, Humana earned $1.8 billion in profit. While this quarter's results represent a steep drop off year over year, they did surpass Wall Street's expectations, according to Zacks Investment Research.

Revenues were up year over year, according to the earnings report, reaching $20.6 billion. This also beat the Street, according to Zacks.

Profit is also down through June 30 compared to the first half of 2020, according to the report. Through the first two quarters of this year, Humana earned $1.4 billion in profit, compared to 2.3 billion in the first half of 2020.

Revenue increased 8.7% year over year, however. Through the first half of this year, Humana has brought in $41.3 billion in revenue compared to $38 billion in the first half of 2020.

"This year, we continue to focus on delivering strong operating performance, while navigating a dynamic environment due to the ongoing COVID-19 pandemic, all while staying true to our commitment to delivering the highest quality healthcare experience for our members and patients," Broussard said in a statement.

Humana's membership also saw a bump compared to Q2 2020, the insurer said. As of June 30, total medical membership stood at 17 million, representing an increase of 254,000 from the prior-year quarter.

As a result of the performance, Humana said it would boost its guidance for the year to between $24.97 and $25.47. It also raised its revenue guidance to between $82.5 billion and $83.5 billion.

https://www.fiercehealthcare.com/payer/humana-boosts-guidance-as-its-posts-588m-q2-profit

Efficacy of Pfizer/BioNTech Covid vaccine slips to 84% after six months

 The efficacy of the Covid-19 vaccine developed by Pfizer and BioNTech fell from 96% to 84% over six months, according to data released Wednesday, a decline that could fuel Pfizer’s case that a third dose will eventually be required.

The data, released in a preprint that has not been reviewed by outside scientists, suggest the vaccine was 91% effective overall at preventing Covid-19 over the course of six months.

In the ongoing study, which enrolled more than 44,000 volunteers, the vaccine’s efficacy in preventing any Covid-19 infection that causes even minor symptoms appeared to decline by an average of 6% every two months after administration. It peaked at more than 96% within two months of vaccination and slipped to 84% after six months.

Against severe disease, which includes people with low blood oxygen levels or who are hospitalized, the overall efficacy of the vaccine was 97%.

To Paul Offit, a pediatrician and vaccine expert at Children’s Hospital of Philadelphia, the results are “very reassuring.” The potential need for booster shots is tied to the number of fully vaccinated people who develop severe disease, Offit said. That number is just 3% after six months, suggesting two doses of Pfizer’s vaccine offers adequate protection, he said.

While the data suggest Pfizer and BioNTech’s vaccine provides lasting protection against the worst symptoms of Covid-19, the paper leaves open the possibility that booster doses will eventually be necessary to curtail infection. If the vaccine’s efficacy continues to decline at the rate observed in the paper, it would fall below the 50% threshold — a benchmark for vaccine utility — within 18 months of vaccination.

That would support Pfizer’s contention that two doses of the vaccine won’t be enough to provide long-term protection. Federal authorities have maintained that people who have been fully vaccinated don’t need booster doses yet but that they are continuing to look at new data.

Moderna’s vaccine was 90% effective against symptomatic Covid-19 and 95% effective against severe disease after six months, the company said in April. Johnson & Johnson has not yet disclosed six-month efficacy data.

The Pfizer study, which enrolled volunteers in Europe and the Americas, doesn’t address whether the vaccine might be less effective against the fast-spreading Delta variant. Pfizer and BioNTech have conducted lab studies suggesting the vaccine should be able to neutralize the variant, but there is no large-scale clinical data to confirm that conclusion.

Just over half of the study’s participants were male. About 82% of participants were white, 9.5% were Black, 4.3% were Asian, 1% were Native American. Roughly 26% of volunteers identified as Hispanic.

https://www.statnews.com/2021/07/28/efficacy-of-pfizer-biontech-covid-vaccine-slips-to-84-after-six-months-data-show/

Pfizer dumps mid-phase NASH prospect, slew of early efforts in Q2 clear-out

 Pfizer had a theory that consumption of fructose could play a role in metabolic disorders, but the pharmaceutical giant is moving on from a non-alcoholic steatohepatitis (NASH) candidate after testing the idea in a mid-stage trial.

The New York-based company revealed that PF-06835919 has been removed from its pipeline in NASH after wrapping up a phase 2 clinical trial. The therapy is the latest NASH candidate to be culled from Pfizer's herd. 

PF-06835919 moved into clinical development on the strength of evidence that consumption of fructose plays a role in metabolic disorders such as NASH. Conversion of fructose by the enzyme ketohexokinase marks the start of the metabolic cascade, so Pfizer thought that inhibiting it could be a way to tackle NASH. The hypothesis was supported by tests showing mice without the enzyme are protected from fructose-induced obesity and non-alcoholic fatty liver disease (NAFLD).

NAFLD is a group of disorders that cause fat to build up in the liver. NASH is an aggressive form of NAFLD that causes liver inflammation and can progress to damage or failure of the organ. 

Pfizer initiated a 164-subject, placebo-controlled phase 2a study in 2019 to test the fructose theory. The trial was designed to show the effect of the ketohexokinase inhibitor on whole liver fat and average blood glucose in patients who had NAFLD with Type 2 diabetes. That study has now wrapped up, and it's off to the scrap heap for PF-06835919.

The action follows earlier decisions to stop development of NASH treatments including PF-05221304 and a DGAT2 inhibitor. Pfizer is still interested in DGAT2, though, with one prospect in mid-phase trials and another asset back in phase 1. 

The big pharma is not the only company to struggle in NASH. Genfit and NGM Biopharmaceuticals have both experienced late-stage failures in recent years. Many candidates have been plagued by adverse events such as itchiness that have caused patients to drop out of trials. 

Pfizer disclosed the latest change to its NASH pipeline as part of financial results that also revealed the discontinuation of other programs. The utomilumab-Yescarta trial that was initiated with Gilead’s Kite in 2018 has been listed as a discontinued phase 1 project. The study was assessing the effect of giving large B-cell lymphoma patients Pfizer’s CD137 agonist with the CAR-T cell therapy. 

Also discontinued are a phase 1 HER2 antibody-drug conjugate and a phase 1 therapeutic cancer vaccine. Both projects originated at Pfizer and were scheduled to finish this year.

Elsewhere in its quarterly update, Pfizer shared details of the progress of the protease inhibitors under development for COVID-19. Pfizer expects to move an intravenous drug, PF-07304814, into a phase 2/3 clinical trial in hospitalized patients in the third quarter. 

An oral asset, PF-07321332, entered phase 2/3 this month that's focused on nonhospitalized high risk adults. The move was on the strength of data suggesting exposure levels will be sufficient to inhibit viral replication. Pfizer expects to have phase 2/3 data in the fourth quarter.

https://www.fiercebiotech.com/biotech/pfizer-dumps-midphase-nash-prospect-quarterly-pipeline-cull

FDA warns increased death risk for freshly approved Oncopeptides myeloma drug

 It was only February when the FDA granted an accelerated approval for Oncopeptides’ Pepaxto to treat relapsed or refractory multiple myeloma. But now the agency is alerting patients and doctors of the drug’s increased risk of death and threatening a potential market withdrawal.

Wednesday, the FDA issued a public alert, warning that Pepaxto, or melphalan flufenamide, may cause myeloma patients to die early, according to results from a confirmatory trial that’s required by the agency.

The FDA has suspended patient enrollment in all Pepaxto clinical trials. The agency may hold a public meeting to discuss the new safety signal and “explore the continued marketing of Pepaxto,” it said.

The Stockholm-based company flagged the safety signal from the phase 3 OCEAN study earlier this month. It found that more patients treated with Pepaxto and the steroid dexamethasone died, compared with those who received Bristol Myers Squibb’s Pomalyst and dexamethasone. The risk of death was 10% higher for Pepaxto.

At the time, Oncopeptides said the surprising difference is “primarily explained” by pre-specified subgroups.

This is not the first time the FDA has found itself warning of a cancer therapy’s potential detrimental effect to patients based on finding from a confirmatory clinical trial. The agency last year flagged that patients with previously untreated triple-negative breast cancer performed worse on a combination of Tecentriq and the chemotherapy paclitaxel than they did on chemotherapy alone. The findings were from the phase 3 IMpassion131 trial, which was supposed to confirm an accelerated nod for the combination of Tecentriq with Abraxane, or nab-paclitaxel, in PD-L1-positive TNBC.

Failure to show a survival benefit in a confirmatory trial has led to market withdrawals before—let alone an increased risk of death. In 2019, Eli Lilly pulled its sarcoma drug Lartruvo after a confirmatory phase 3 trial showed that adding the drug to chemotherapy didn’t prolong patients’ lives. The drug won its conditional nod in 2016 based on a smaller trial.

The Pepaxto snafu is another blow to the FDA’s accelerated approval program, which is designed to get novel drugs to patients faster, typically based on surrogate trial markers. The program was put under public spotlight in the wake of the FDA’s controversial approval of Biogen’s Alzheimer’s disease drug Aduhelm.

Drug reviewers at the FDA have recently conducted an industrywide review of accelerated approvals of immuno-oncology agents that have failed in confirmatory trials. That campaign has led to voluntary withdrawals of six indications for PD-1/L1 inhibitors.

https://www.fiercepharma.com/pharma/fda-warns-increased-death-risk-for-freshly-approved-myeloma-drug-threatening-potential

Hill Rom Stock Shoots Higher As Baxter In Early Talks

 

• According to people familiar with the matter, Baxter International Inc BAX 0.6% is reportedly in talks to buy Hill-Rom Holdings Inc HRC 9.12%.
• The talks are at an early stage, some of the people said, and there’s no guarantee a deal will be reached. 
• It would be pretty substantial should there be one, as Hill-Rom has a market value of about $8 billion.
• Hill-Rom has already rebuffed a $144-per-share bid from Baxter, Wall Street Journal reported.

https://www.benzinga.com/m-a/21/07/22201852/hill-rom-stock-shoots-higher-as-baxter-in-early-talks-to-acquire-company-wsj

Medi-Cal coverage extended to undocumented Californians age 50+

 Undocumented Californians age 50 and older will now be able to receive full-scope Medi-Cal benefits thanks to new legislation signed into law by Gov. Gavin Newsom.

Newsom signed Assembly Bill 133 during a press event at a health clinic in Fresno County on Tuesday, July 27. The bill extends health benefits to approximately 235,000 low-income undocumented state residents, “including preventive services, long-term care and In-Home Supportive Services,” the governor’s office said in a press release.

The signing of AB 133 makes California the first state in the country to extend Medi-Cal eligibility to all adults age 50 and up, regardless of immigration status.

“I thank the Legislature for its steadfast partnership to bring California closer to universal health care coverage and advance comprehensive initiatives to ensure California’s communities come back from the pandemic stronger and healthier than before,” Newsom said in the release.

The goal of the bill, according to Newsom, is to make healthcare more equitable in California and to take a more prevention-focused approach. Also included in the bill are components to address homelessness in the state through behavioral health funding, including expanded treatment and housing options.

https://www.abc10.com/article/news/health/undocumented-californians-medi-cal-coverage-age-50-up/103-0f0b3b5a-675b-4298-9c21-9b1ec44ee6cf