AstraZeneca beats US shareholder lawsuit over COVID-19 vaccine disclosures

 

AstraZeneca Plc on Monday won the dismissal of a U.S. shareholder lawsuit claiming that the company failed to disclose problems in developing its COVID-19 vaccine, making it unlikely to win regulatory approval to market the vaccine in the United States.

U.S. District Judge Paul Oetken in Manhattan said AstraZeneca shareholders in the proposed class action failed to identify any misleading statements, or adequately allege that the company intended to defraud them.

Oetken dismissed the lawsuit with prejudice, meaning it cannot be brought again.

Lawyers for the shareholders did not immediately respond to requests for comment. AstraZeneca and its lawyers did not immediately respond to similar requests.

The case is In re AstraZeneca Plc Securities Litigation, U.S. District Court, Southern District of New York, No. 21-00722.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-beats-US-shareholder-lawsuit-over-COVID-19-vaccine-disclosures-41754693/

Nestle's Gerber CEO sees formula shortage improving by October

 

Nestle SA's Gerber Products Company is still in "critical task force mode" due to the U.S. infant formula shortage, its CEO Tarun Malkani said last week, adding that he expects the crunch to improve by October.

Gerber added market share as it pumped out formula to meet the heightened demand during the shortage, caused by supply chain crunches and the closure of an Abbott Laboratories plant in Michigan, Malkani said last Thursday during a media event at Nestle's U.S. headquarters in Arlington, Virginia.

The Nestle brand, which makes the Good Start line of infant formulas, now has market share of roughly mid-9%, Malkani said. Before the crisis, its market share was around 8.5%, he said.

"We need the marketplace to rebalance," he said.

Availability of powder baby formula, the bulk of the market, has been improving on store shelves, with roughly 79% in stock as of Sept. 4, according to data provider IRI. It reached as low as 69% mid-July, according to IRI.

To ease the shortage, the U.S. government and Food and Drug Administration made it easier for manufacturers to get shipments into the country from overseas.

Gerber "pruned" novelty infant formulas in the beginning of the crisis to focus on those needed most, he said.

Nestle also flew in infant formula supplies from Europe to the United States

Major U.S. retailers including Walmart Inc and Target Corp both said last month they have seen formula supplies improve. Target said it was still rationing the product online and in store

https://www.marketscreener.com/news/latest/Nestle-s-Gerber-CEO-sees-formula-shortage-improving-by-October--41754886/

Transcript : Oscar Health, Inc. Presents at Morgan Stanley 20th Annual Global Healthcare Conference

 https://www.marketscreener.com/quote/stock/OSCAR-HEALTH-INC-119722488/news/Transcript-Oscar-Health-Inc-Presents-at-Morgan-Stanley-20th-Annual-Global-Healthcare-Conference-41754412/

Esmo 2022 – Exact trails Grail on sensitivity

 Exact Sciences spent $1.7bn on Thrive in 2020 to get its hands on that company’s liquid biopsy, then called CancerSeek. Data presented on Friday at Esmo, however, suggest that this assay, which Exact now refers to simply as its multi-cancer early detection (MCED) test, might not be quite as good as the competition. The data come from a retrospective, case-control study intended to validate four blood biomarkers – aneuploidy, DNA methylation, mutations and proteins – detected by the assay. They indicated that the test could detect cancers from 15 organ sites with a mean sensitivity of 61% and mean specificity of 98%. But splitting the data by stage of the cancer suggests that Exact’s assay might not be quite as sensitive as Grail/Illumina’s Galleri pan-cancer test was in a similar trial, as the graph below shows. This is not a strictly fair juxtaposition, of course, since cross-trial comparisons never are; moreover the tests picked up different tumour types, which will have affected their accuracy figures. Exact is currently conducting a larger case-control trial, results of which will determine the final design of the MCED test, which will next year go into a pivotal US study called Soar. 

No box warning set to leave Bristol’s Sotyktu in the black

 The US approval of Bristol Myers Squibb’s Tyk2 inhibitor deucravacitinib, now branded Sotyktu, will almost certainly put pressure on the rival oral psoriasis product Otezla given Sotyktu's better-than-expected label. There had been concerns that, with Tyk2 a member of the Jak family, the FDA might have taken an ultra-cautious view on safety; however, the much-feared black box warning and onerous testing requirements did not emerge, and many are predicting that Sotyktu could dominate the oral market for new psoriasis patients soon after its September launch, notwithstanding its $75,000 list price. The wider significance of Sotyktu’s approval is the potential shift towards more efficacious oral psoriasis options and the validation of Tyk2 as a target. Other Tyk2 inhibitors waiting in the wings include Nimbus’s NDI-034858 and Ventyx’s VTX958; the latter's stock soared 69% today. Privately held Nimbus, which today raised $125m, has the next most-advanced Tyk2 inhibitor, in phase 2, but has previously reported issues with neutropenia, lipid abnormalities and CPK elevation. Meanwhile, developers of other oral psoriasis options outside Tyk2, such as Dice Therapeutics and Immunic, saw their stock sink.

Selected clinical-stage Tyk2 inhibitors for psoriasis
Product/project	Company	Status
Sotyktu	Bristol Myers Squibb	Approved - launch September 2022
NDI-034858	Nimbus Therapeutics	Ph2 - data expected Q4 2022/Q1 2023
VTX958	Ventyx Biosciences	Ph1 - ph2 trials due to start Q4 2022
GLPG-3667	Galapagos	Ph1 - ph2 trials due to start in 2022
ESK-001	Alumis	Ph1 - primary completion date Dec 2022
ICP-488	Innocare	Ph1 - primary completion date Jan 2023
Source: Evaluate Pharma, clinicaltrials.gov & company statements. https://www.evaluate.com/vantage/articles/news/snippets/no-box-warning-set-leave-bristols-sotyktu-black

Biden to sign order 'boosting biotech as part of cancer moonshot update'

 President Biden on Monday will announce the director of a new agency focused on biomedical innovation and sign an executive order on biotechnologies as part of an update on his administration’s efforts to cure cancer.

Biden will travel to Boston on the 60th anniversary of former President John F. Kennedy’s “Moonshot” speech at Rice University, where Kennedy outlined his goal for the United States to land a man on the moon.

The president will provide an update on his administration’s “Cancer Moonshot,” an initiative he relaunched in February with the goal to cut the cancer death rate in half over the next 25 years and improve the lives of caregivers and cancer survivors.

Biden on Monday will announce the appointment of Renee Wegrzyn as the inaugural director of Advanced Research Projects Agency for Health, an agency created in March focused on developing biomedical technologies to improve health outcomes.

The president will also sign an executive order launching a national biotechnology and biomanufacturing initiative. The order will bolster research and aim to solidify supply chains so that biotechnologies used in the fight against cancer are developed and produced in the U.S., according to a White House fact sheet.

“This initiative is rooted in the principles of equity, ethics, safety, and security that will help benefit all Americans and the global community, and maintain United States technological leadership and economic competitiveness,” the White House said.

Biden will also give an update on the progress of his “Cancer Cabinet,” a group of advisers and administration officials tasked with securing funding and developing treatments for cancer.

The president will highlight recent developments like the passage of the Inflation Reduction Act by Democrats in Congress, which includes provisions to lower prescription drug costs, some of which are used to treat certain forms of cancer.

He will also note the launch of a National Cancer Institute study aimed at identifying blood tests that can detect one or more cancers with the goal of earlier detection in cancer patients.

Before the speech on Monday, Biden will make remarks on the investments in the bipartisan infrastructure law in Boston.

The cause of ending cancer has been personal for Biden, whose son, Beau Biden, died of brain cancer in 2015 at the age of 46. The president has talked about ending cancer throughout his campaign and presidency, saying it would be a priority for him. He has also framed it as a bipartisan effort, meeting with members of both parties at the White House last year to discuss the effort.

https://thehill.com/homenews/administration/3638371-biden-to-sign-executive-order-as-part-of-update-on-cancer-moonshot/

Concerns about COVID exposure at work steady since last fall: Gallup

 A third of employed adults are concerned about exposure to COVID-19 at work, a figure that is relatively unchanged since the fall last year, according to a new Gallup poll.

The new survey found only a 3-point drop from November 2021, when 36 percent of workers expressed at least moderate concern for exposure to COVID-19 at work.

The percentage has fallen, however, from the first six months of the pandemic in 2020. Roughly half of respondents were uneasy about exposure at work at the time, while the percentage of those saying they are “not concerned at all” has grown from 23 percent in 2020 to a record high of 39 percent in the latest polling.

Exposure concerns did not significantly vary by age, but the new survey did find a substantial gender gap.

Forty-one percent of working women worry significantly about COVID-19 exposure at work, compared to 26 percent of working men.

Respondents’ concerns also split along party lines, a disparity seen throughout the pandemic that has now widened more than at any other point. 

Just more than half of Democrats surveyed in the new poll — 51 percent — expressed at least moderate concern about work-related COVID-19 exposure, while just 26 percent of independents and 14 percent of Republicans agreed

Two-thirds of workers indicated they expect infections to increase this fall and winter. About a quarter — 26 percent — said they expected infections to increase a great deal, compared to 43 percent who said infections would increase a moderate amount and about a quarter who thought it would remain the same.

Just 6 percent said they expect infections to decrease to any extent this fall and winter, the poll found.

A slight majority expressed worry about new strains of COVID-19, and fewer than half were confident that vaccines will protect people from newer variants.

The poll was conducted before Americans started receiving booster shots designed to target omicron variants. 

The Food and Drug Administration and the Centers for Disease Control and Prevention in recent weeks have approved the new shots, marking the first time the vaccines have been updated since the start of the pandemic.

Top White House health officials, including Anthony Fauci, the nation’s leading infectious disease expert, have indicated people will likely need annual COVID-19 booster shots.

The Gallup poll was conducted July 26-Aug. 2 with a random sample of 3,682 adults, including 1,274 workers. Gallup weighted the sample to match national demographics, and the margin of error is 3 percentage points.

https://thehill.com/policy/healthcare/3638617-concerns-about-covid-exposure-at-work-steady-since-last-fall-gallup/