FDA approves Takeda's lung cancer therapy

 Japanese pharma company Takeda Pharmaceutical Co said on Wednesday the U.S. Food and Drug Administration approved its drug, Exkivity, to treat a type of lung cancer.

Takeda said the approval was based on an early-to-mid-stage trial testing 114 patients with non-small cell lung cancer, with results showing clinically meaningful responses with a median duration of about 18 months.

Exkivity was approved for patients with a specific gene mutation called EGFR Exon20 insertions in non-small cell lung cancer, whose disease has progressed on or after chemotherapy.

The company said the approval for the indication was contingent upon verification and description of clinical benefit in a confirmatory trial.

Non-small cell lung cancer is the most common form of lung cancer, accounting for about 85% of the estimated 2.2 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.

The drug comes with a boxed warning flagging risks of potential heart toxicity, lung disease and heart rhythm disturbances.

https://www.marketscreener.com/quote/stock/TAKEDA-PHARMACEUTICAL-COM-6491073/news/Takeda-Pharmaceutical-U-S-FDA-approves-Takeda-s-lung-cancer-therapy-36437357/

Biden enlists Disney, Microsoft CEOs in push for vaccine mandates

 

U.S. President Joe Biden met on Wednesday with U.S. CEOs and other top business leaders as he pushes companies to require workers to be inoculated against COVID-19 amid a surge in infections among the unvaccinated.

Participants in the meeting included the chief executives of Walt Disney Co, Microsoft Corp and Walgreens Boots Alliance Inc .

Biden last week announced https://www.reuters.com/world/us/biden-deliver-six-step-plan-covid-19-pandemic-2021-09-09 vaccine mandates for nearly all federal employees, federal contractors, and larger companies as the number of U.S. infections continued to rise, hospital beds in some parts of the country filled up and mask requirements returned. After months of trying to persuade Americans to get free vaccinations, the White House is pushing state and local governments, companies and schools to adopt mandates requiring them instead.

Biden said at the beginning of the meeting that it would take some time to get the new requirements in place.

"It's about beating this virus and saving lives," he said.

Some Republican-led states and a sizable minority of Americans have defied vaccine recommendations from health officials, citing economic or freedom-of-choice arguments. With just 63% of the popula
tion having received at least one dose, the U.S. vaccination rate now lags https://graphics.reuters.com/world-coronavirus-tracker-and-maps/vaccination-rollout-and-access most developed economies.

Opinion polls have shown a majority of Americans support some form of vaccine mandate.

Biden told reporters https://www.reuters.com/world/us/white-house-says-it-is-encouraging-state-local-covid-vaccine-mandates-2021-09-14 on Tuesday that he had seen "positive support for mandates, by and large," although he conceded that there would always be a small percentage of people who would refuse to get inoculated.

The White House hopes Wednesday's meeting will serve "as a rallying cry for more businesses across the country to step up and institute similar measures," an official said, speaking on condition of anonymity.

The meeting involves business leaders and chief executives who have instituted vaccine requirements or are working to implement the new rules, the person said.

The policies announced last week require nearly all federal workers and federal contractors to get COVID-19 vaccinations and push large employers to have workers inoculated or tested weekly. The new measures would apply to businesses with more than 100 employees, about two-thirds of all U.S. workers.

Also among those meeting with Biden were the CEOs of the Kaiser Permanente healthcare system, the Children's Hospital of Philadelphia and Molly Moon's Homemade Ice Cream.

Josh Bolten, president of the Business Roundtable representing employers of 20 million workers, also attended. The Business Roundtable has welcomed Biden's announcement on mandates. Bolten was a chief of staff to Republican former President George W. Bush.

The fast-spreading Delta variant of the coronavirus has sparked a new wave of sickness and death, posing increased risk not just to the country but to a president who as a candidate promised to get control of the pandemic.

Some small employers have voiced frustration with the mandate. Large employers like U.S. automakers General Motors Co and Ford Motor Co and rare-earths producer MP Materials Corp said they are encouraging employees to get the vaccine, but they were quiet about Biden's executive order.

Raytheon Technologies Corp, a weapons maker and aerospace company that does extensive business with the U.S. government, said on Wednesday that it expects Biden's vaccine mandate will strengthen their business outlook heading into the fourth quarter.

https://www.marketscreener.com/quote/stock/MICROSOFT-CORPORATION-4835/news/Microsoft-Biden-enlists-Disney-Microsoft-CEOs-in-push-for-vaccine-mandates-36429229/

Hong Kong biotech company Prenetics to go public via $1.7 billion SPAC deal

 Hong Kong biotech company Prenetics will go public through a merger agreement with Artisan Acquisition, a special purpose acquisition company (SPAC), valuing the combined company at $1.7 billion, they said in a statement.

“The transaction values Prenetics at an enterprise value of $1.25 billion with a combined equity value of approximately $1.7 billion, making Prenetics the first unicorn from Hong Kong to be publicly listed in any market,” the companies said in a joint statement on Thursday.

The combined company will be traded on the Nasdaq and Prenetics will receive proceeds of up to $459 million in cash, the companies added.

The deal is expected to close in the fourth quarter of 2021 or the first quarter of 2022, they said.

As part of the deal, Prenetics’ existing equity holders will roll 100% of their equity into the combined company, the statement added.

Prenetics’ revenue is projected to grow at 215% year-on-year from $65 million in 2020 to $205 million in 2021, according to the joint statement. Prenetics has projected annual revenue of more than $600 million in 2025.

https://www.reuters.com/article/prenetics-ipo/update-1-hong-kong-biotech-company-prenetics-to-go-public-via-1-7-bln-spac-deal-idUSL1N2QI047

Indaptus Therapeutics Receives Notice of Allowance for Strategic Patent

 Key Patent for Platform Technology to Treat or Inhibit HBV and HIV Infections

Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the "Company”), today announced that the United States Patent and Trademark Office has issued a notice of allowance for claims related to the Company’s platform technology.

The patent, titled, “Methods of Treatment of Infections Using Bacteria,” (Application No. 16/584,644) provides broad protection for the application of the Company’s platform technology alone and in combination with standards of care for the treatment and inhibition of hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infections.

https://finance.yahoo.com/news/indaptus-therapeutics-receives-notice-allowance-110000625.html

Ampio osteoarthritis med shows improvement

 Ampion™ demonstrated statistically significant reduction in pain and improvement in function at 12 weeks in severe OAK patients

- Results reflect strong safety profile with no treatment related serious, material adverse events

- Ampio's current cash runway of approximately 12 months expected to provide sufficient near-term liquidity and flexibility to support existing business operations

- Ampio plans to meet with the Food and Drug Administration (FDA) to discuss the Phase III results and Biologics License Application (BLA)

https://finance.yahoo.com/news/ampio-pharmaceuticals-announces-top-line-131500254.html

Judge blocks NY state vaccine mandate for medical workers

 A New York federal judge on Tuesday temporarily blocked the state’s vaccine mandate for medical workers.

U.S. District Judge David Hurd issued an order temporarily barring the New York State Department of Health from enforcing or otherwise requiring compliance with the vaccine mandate since it does not grant religious exemptions.

A hearing for a preliminary injunction is slated for Sept. 22.

Hazel Crampton-Hays, press secretary to New York Gov. Kathy Hochul (D), told THe Hill that the governor's office is "considering all legal options." 

"Requiring vaccination of healthcare workers is critical to this battle. This order does not suspend the vaccine mandate, but it temporarily bars the Department of Health from enforcing the mandate where individuals have claims for religious exemption. We are considering all of our legal options to keep our communities safe," she continued. 

The ruling comes after a group of 17 medical workers sued the state on Monday asking to enjoin the order.

The complaint argued that the mandate violates the free exercise clause of the First Amendment as well as the 14th Amendment, which guarantees equal protection.

The suit also argues that the mandate violates Title VII of the Civil Rights Act of 1964, which prohibits employment discrimination based on factors such as religion, gender, race and national origin.

In mid-August, then-New York Gov. Andrew Cuomo (D) announced that health care employees would have to start their vaccination process by Sept. 27. This mandate applied to staff at hospitals and long-term care facilities.

Cuomo’s administration said at the time that the vaccine mandate would come with limited exceptions for religious and medical reasons.

However, the most recent rule adopted by the New York State Department of Health in late August provides for covered workers to obtain medical exemptions but doesn’t have a provision for religious exemptions.

The suit named New York Gov. Kathy Hochul (D), New York State Health Commissioner Howard Zucker and New York Attorney General Letitia James (D).

James’s office referred comment on the suit to the New York State Department of Health,which referred the Hill to Crampton-Hays' comment.

https://thehill.com/policy/healthcare/572215-judge-blocks-ny-state-vaccine-mandate-for-medical-workers

Fauci pushes back on coronavirus vaccine booster criticism

 White House chief medical adviser Anthony Fauci on Tuesday said he disagreed with a medical journal paper, co-authored by two outgoing federal vaccine regulators, that argued the science doesn't support giving COVID-19 booster shots to every American.

During an interview on MSNBC's Morning Joe, Fauci called the article "controversial" and said it conflates things that are not supposed to be connected. 

Specifically, Fauci said the U.S. can embark on a program of giving booster shots without sacrificing doses needed by the rest of the world.

"You can do both. The way we're doing in this country, you can have a program to give booster, in this case third shots for people who've gotten the two-dose Moderna and Pfizer vaccine, you can get them boosted if you put a considerable amount of resources and effort into getting low and middle income people vaccinated. And that's exactly what we're doing," Fauci said. 

The Biden administration is pushing for boosters to be widely available to all Americans beginning Sept. 20, pending approval or authorization from federal health agencies, and is trying to rally behind a consistent message across all agencies.

"If you look at the data, the data are strongly suggestive in this country, and more than just suggestive in Israel, that you have a waning of immunity among people across age groups, not just the very very elderly, you have clearly waning of immunity against infection and clear cut indication of waning of immunity against severe disease," Fauci added.

Fauci was addressing an article published in The Lancet on Monday, co-authored by scientists including Marion Gruber and Phil Krause, two longtime Food and Drug Administration officials who have been leading the agency's review of COVID-19 vaccine applications.

Both Gruber and Krause recently said they are departing the agency later this fall. Monday's article included a disclaimer that Gruber and Krause were writing as private citizens, not as government employees.

Still, their involvement brought heightened awareness to disagreement over the administration's booster approach coming from outside scientists who argue it's premature.

The paper argued that none of the current evidence on the COVID-19 vaccines shows a need for booster doses in the general population. 

The authors pointed to flaws with Israel's data, notably that the study followed up on patients after only a week, and  that "a very short-term protective effect would not necessarily imply worthwhile long-term benefit."

https://thehill.com/policy/healthcare/572257-fauci-pushes-back-on-booster-criticism