New WHO recommendations on COVID vaccines create more revenue uncertainty: analyst

 Two weeks after the World Health Organization revised its guidance on COVID-19 vaccination, data analytics company GlobalData says the future of vaccine rollouts is becoming “highly uncertain.”

Over the last few months, manufacturers of the world’s most used COVID vaccines—Moderna and Pfizer/BioNTech—have said they expect a major decline in demand for their shots this year. But the WHO guidance and other factors at play may cause the companies to cut their sales expectations further for 2023.

“Combined with recent guidance calling for decreased use of boosters and the U.S. Senate’s decision to end the national emergency declaration early, COVID-19 revenue streams may fade quickly for vaccine developers,” GlobalData pharma analyst Nancy Jaser said in a release.

The WHO’s Strategic Group of Experts on Immunization (SAGE) no longer recommends annual COVID-19 vaccine boosters for healthy adults under 60 years of age after they have received a primary vaccine series and a booster. The experts also no longer recommend vaccinating healthy children of age 17 and younger against the virus.

In January, Pfizer said it expected sales of Comirnaty to reach $13.5 billion in 2023 after generating revenue of $36.8 billion in 2021 and $37.8 billion last year from the shot. During its first-quarter earnings report, set for May 2, Pfizer could adjust its expected sales projection for the vaccine.

Two weeks ago, Pfizer’s partner on the shot, BioNTech, said it expects sales of 5 billion euros ($5.4 billion) from the vaccine in 2023, after selling 17.3 billion euros ($18.7 billion) last year.

Meanwhile, Moderna said in January that it expects to make at least $5 billion from Spikevax in 2023 following a haul of $18.4 billion last year. But six weeks ago, when it reported its fourth-quarter earnings, the company did not zero in on a sales prediction for 2023. The company holds an investor vaccine webcast on Tuesday that could provide more clarity on its expectations.

“Significant drops in global demand and revenue for COVID-19 vaccines are expected in the coming years as the threat of the pandemic winds down and vaccination guidance by health authorities loosens,” Jaser added. “The massive outbreaks caused by the omicron variant led to the currently high levels of immunity observed in all age groups through both vaccination efforts and infections across the globe.”

Another element of uncertainty for Pfizer and Moderna is how their new prices for COVID-19 vaccines will affect demand. Both companies said they could raise the U.S. price of shots up to $130 as the United States transitions from providing the vaccines for free. 

https://www.fiercepharma.com/pharma/new-who-recommendations-covid-vaccines-create-more-uncertainty-sales-globaldata

Astellas takes $340M charge on Evrenzo, joins GSK in nixing cell therapy collab with Adaptimmune

 Astellas is doing some house cleaning under new CEO Naoki Okamura, writing off assets before its full-year earnings report.

The Japanese pharma will take an impairment loss of about 45 billion yen ($340 million) related to the FibroGen-partnered anemia drug Evrenzo, also known as roxadustat. The charge specifically relates to the drug not meeting sales expectations.

Simultaneously, Astellas said it has decided to pull the plug on a regenerative hearing loss candidate dubbed FX-322, which just failed in a phase 2b trial. Astellas licensed the drug from Frequency Therapeutics.

In another R&D rewinding, Astellas is ending a partnership with Adaptimmune Therapeutics around stem cell-derived, off-the-shelf T cell therapies. The termination deals another blow to Adaptimmune as GSK just walked away from their cell therapy collaboration as well.

The Frequency and Adaptimmune setbacks led Astellas to book impairment charges of 8.6 billion yen and 4.7 billion yen, respectively.

Astellas announced the moves Tuesday, ahead of its fiscal year 2022 earnings report, which is scheduled for April 27. Because of the new losses, Astellas expects its full-year profit to come in at about 105 billion yen ($790 million), or 30% lower than previously projected.

The three actions were largely expected.

Evrenzo is approved in Japan and Europe for anemia associated with chronic kidney disease in both dialysis and non-dialysis patients. After lackluster growth, Astellas said it took the charges “considering the sales situation in each country.” In the nine months ended in December, Astellas only recorded 2.4 billion yen ($18 million) from Evrenzo.

The situation was no better for Evrenzo’s original developer FibroGen and its other partner AstraZeneca. Following an FDA rejection in 2021 and a failure by the companies to agree on a clinical path forward for the drug in CKD anemia, FibroGen is shifting its focus to other anemia types. The company is awaiting a phase 3 readout in myelodysplastic syndromes and a China phase 3 readout in chemotherapy-induced anemia, with both expected by June.

As for FX-322, Astellas obtained ex-U.S. rights to the small-molecule therapy in 2019 by paying Frequency $80 million up front. At that time, Frequency was in the process of launching a phase 2a study.

But fast forward to February, Frequency said a phase 2b trial found that FX-322 had failed to improve speech perception in people with noise-induced sensorineural hearing loss, the most common type of hearing loss. As a result, Frequency decided to discontinue FX-322 and a second hearing loss program.

Turning to Adaptimmune. Astellas originally partnered with the U.K. cancer immunotherapy specialist in a broad deal covering allogeneic CAR-T and TCR T-cell therapies in 2020. For $50 million upfront, Adaptimmune agreed to pick out up to three targets for Astellas.

Then things took a turn last year for Adptimmune. In October, GSK said it would return full control of a nearly clinical trial-ready PRAME-targeted TCR T-cell program, plus the clinical-stage NY-ESO cell therapy.

As for Astellas, these setbacks add on to the repeated hiccups the company has run into for its gene therapy projects. The Japanese pharma a year ago took a $170 million impairment loss from ending its Duchenne muscular dystrophy gene therapy candidates. And the company just got a reprieve in January when the FDA lifted a clinical hold on a phase 1/2 study for its Pompe disease gene therapy.

But there’s also been some good news for the drugmaker. Astellas’ Seagen-partnered Padcev just got a key FDA approval for use alongside Merck & Co.’s Keytruda as a first-line treatment for bladder cancer patients who are ineligible for cisplatin-based chemotherapy.

To charter the next phase of growth, Astellas elevated Naoki Okamura as its new CEO starting in April. As the company put it, 2023 is the “right time to go on the aggressive to further accelerate growth.”

Under a five-year strategic plan, Astellas aims to reach 1.2 trillion yen ($900 million) in combined sales for Pfizer-partnered Xtandi and six “strategic products” by fiscal year 2025. Both Padcev and Evrenzo are on the list.

As for R&D investments, Astellas has said it will mainly focus on five areas: genetic regulation, immuno-oncology, blindness & regeneration, mitochondria, and targeted protein degradation.

https://www.fiercepharma.com/pharma/astellas-writes-340m-fibrogens-evrenzo-joins-gsk-nixing-cell-therapy-collab-adaptimmune

NYC lawmakers introduce bill to ban businesses from using facial recognition tech

 New York City Council members have introduced two bills that would ban businesses and residential buildings from using facial recognition technology to identify customers or tenants without their consent.

Both bills are scheduled to be introduced at the City Council meeting on April 27 following a Committee on Technology meeting two days earlier.

The first bill, sponsored by council members Shahana K. Hanif and Jennifer Gutiérrez, would amend NYC code to make it illegal for private businesses — including arenas and stadiums — from using “biometric identifier information” to identify or verify a customer. 

Biometric identifier information includes personal data received from scans of the face, eye, voice, hand or fingerprints.

If businesses or venues choose to collect biometric information, they must notify customers and require written consent, according to the bill. They would also be prohibited from sharing any of the information with third parties or storing it themselves.

Any place or provider of public accommodation using the technology would have to develop a publicly available written policy that would include guidelines for destroying the information, the bill states.

Madison Square Garden uses facial recognition software as part of its security.

Matthew McDermott

Intentional violations of the law would result in a $5,000 fine per violation, as well as any legal fees involved, according to the bill.

A second bill, sponsored by Carlina Rivera, targets using the technology in residential buildings. If passed, it would make it “unlawful for an owner of a multiple dwelling to install, activate or use any biometric recognition technology that identifies tenants or the guest of a tenant.”

Pierina Ana Sanchez and Tiffany Cabán are also sponsoring the bill.

The bills come as Madison Square Garden owner James Dolan was found to be using facial recognition technology to keep lawyers in active litigation against him or his properties out of his venues — like a mother who was denied entrance into Radio City Music Hall to see the Rockettes with her daughter’s Girl Scout troop in December.

The Knicks and Rangers owner also reportedly extended the ban to fans who were critical of his ownership of the teams. 

Businesses would be forced to notify customers and have them provide written consent if they were using any “biometric identifier information” under the bill.

Matthew McDermott

In response, the New York State Liquor Authority last month began proceedings that could strip MSG, Radio City Music Hall and the Beacon Theater of their liquor licenses after slapping the James Dolan-owned properties with administrative charges.

Dolan’s corporate entity, Madison Square Garden Entertainment Corp., filed a petition in Manhattan Supreme Court in response asking a judge to stop the SLA violations, calling the enforcement “an abuse of power.”

In a statement to The Post on Wednesday evening, MSG said that it uses facial recognition tech in compliance with the law to keep the arena safe.

“Facial recognition technology is a useful tool widely used throughout the country, including the sports and entertainment industry, retail locations, casinos and airports,” a spokesperson said. “We have always made it clear to our guests and to the public that we use facial recognition, in compliance with all applicable laws, as one of our tools to provide a safe and secure environment for our customers and ourselves.” 

New York City Council members will introduce a bill later this month that would ban facial recognition technology from private businesses.

dpa/picture alliance via Getty Images

New York City and Portland, Oregon, are currently the only two cities in the nation that have placed limits on the use of such technology in the private sector, according to Bloomberg.

Facial recognition has been banned by police and government agencies in some states and cities like Massachusetts and San Francisco, the outlet reported.

https://nypost.com/2023/04/12/nyc-lawmakers-introduce-bill-to-ban-businesses-from-using-facial-recognition-tech/

New Yorkers flee over taxes, housing prices: ‘The city literally spit us out’

 They’re moving out.

A shocking 27% of New Yorkers are planning to leave the Empire State in the next five years, with 30% saying they wish they lived somewhere else, according to a poll from Siena College Research Institute released Wednesday.

Affordability, ease of retirement, politics and crime and safety were among New Yorkers’ biggest gripes, according to the poll. Among the most dissatisfied: Republicans, independents, black people and those earning under $50 thousand a year. 

Here, New Yorkers share their reasons for fleeing New York.

Priced out of housing market

When Bonnie Grubbs, a teacher, and her husband, Alex, a musician and arborist, outgrew their 660-square-foot converted two-bedroom co-op in Clinton Hill in 2021, they found themselves priced out of bigger homes in their $700 thousand price range.

And so they moved into a $3,000 rental on the border of Bed-Stuy — where they were plagued by frequent power outages, rodent infestations and an unreliable landlord. The last straw was when the ceiling caved in on them after the upstairs neighbor’s radiator broke.

“My friends said the city literally spit us out,” Bonnie, 36, told The Post.

Bonnie and Alex Grubbs relished their New York City life, but they had to do what’s best for their family and finances. This year, they moved to San Antonio and have plans to buy a home.

Alex (left) and Bonnie Grubbs in New York with their two sons and dog.

In February of this year, they moved to San Antonio with Bonnie’s family where they are living rent-free until they can buy a place of their own.  

“All of our money was going to childcare, and all of our money was going to rent. We were tight [with cash] in a way we hadn’t been since we were freshly married in grad school. It didn’t feel good.”

Outgrowing roommates

At 26, Zoe Hines, a music publicist, is ready to have an apartment — one that doesn’t involve roommates and flights of stairs. 

She loves the convenience of city living, but says she’s sick of the congestion and ready for a sunny start and more living space for her money in Los Angeles. When she learned her friend in LA was paying around the same price — $2,475 a month — to live alone and with more amenities, she decided to plan her move for this June.

Zoe Hines, 26, a music publicist, plans to move to Los Angeles for a bigger apartment and more calming energy, she said, in June.

“The amount of space he had in his room — he had his own bathroom — it seemed like so much more,” she said. “I feel like LA has more flexibility, so that’s something I’m looking forward to. I want to switch it up and have a calm lifestyle where everything is slowed down for me.”

Cash-strapped from taxes

Alexis Wilson and her fiancé Matt Andrews, both nurses, recently moved from New York to southwest Florida with the hopes of starting a family.

They needed to stretch their paychecks and wanted to move to a state without income taxes.

“When we moved we saw a drastic increase in our paychecks,” Wilson, 27, told The Post.

Alexis Wilson and her fiancé Matt Andrews at their new home in Florida.

They were also able to double their square footage in the Sunshine State — plus they have access to a dog park, pool and gym.

“We were able to buy a house after a year and a half of renting, which I don’t believe would have been possible in New York with the amount of taxes.”

Aging out of state

Carol Anderson, 76, lived in her apartment on the Upper East Side since 1985. But by 2022, her maintenance was going up another 10%. She was paying $3,900 a month in maintenance fees, another $3,200 in mortgage payments and had she kept a car in the city, she would have been shelling out nearly $800 for a parking space.

“I was in New York for $10,000 a month,” Anderson, who runs a successful communications firm, told The Post.

Carol Anderson lived on the Upper East Side of Manhattan since 1985. But this year, she relocated to New Orleans.

“I don’t know how the middle class can really make it. Every penny I was making was going to paying bills. I wasn’t saving anything,” she said, noting that she unsuccessfully tried to refinance her home.

In June 2022, she decided to move down south to New Orleans where she’s paying $2,200 a month in maintenance fees for a condo —and one-third of what she paid in New York on real estate taxes, she said.

“I aged out of New York,” Anderson said. “I love New Orleans more.”

https://nypost.com/2023/04/12/nearly-30-percent-of-new-yorkers-plan-to-leave-in-next-five-years/