Kenvue Inc., the consumer products spinoff from Johnson & Johnson (JNJ), has grown the roster of banks underwriting its initial public offering beyond the two original leads . Goldman Sachs & Co. LLC and JP Morgan, according to a filing on Friday. The new banks include BofA Securities, Citigroup, Deutsche Bank Securities, BNP Paribas, HSBC, RBC Capital Markets, UBS Investment Bank, BBVA, ING, IMI-Intesa Sanpaolo, Santander, UniCredit Capital Markets; Academy Securities, Independence Point Securities, Ramirez & Co. Inc., R. Seelaus & Co. LLC, and Siebert Williams Shank. Kenvue has yet to announce an estimated price range and share count for its IPO. The company plans to list its shares of common stock on the New York Stock Exchange under the symbol "KVUE".
Monday, March 6, 2023
U.S. opens probe into Amazon's Zoox robotaxi self-certification
A U.S. auto safety regulator said on Monday it is opening a probe into the self-certification by Zoox, Amazon Inc's self-driving vehicle unit, in 2022 of a robotaxi without traditional driving controls.
The National Highway Traffic Safety Administration (NHTSA) sets the requirements for such vehicles and a company then develops its own process to prove that they meet the requirements. In September the NHTSA had directed Zoox to answer questions about its basis for certifying its vehicle, and that review is ongoing.
NHTSA said Monday it is opening an audit query to determine whether the Zoox "certification basis depended upon unilaterally developed test procedures or determinations that certain standards were inapplicable due to the unique configuration of the vehicle."
Zoox general counsel Christopher Nalevanko said in a statement that the company's self-certification tests "have met or exceeded applicable (federal) performance requirements. We are committed to working closely with NHTSA on the questions they have, and we remain confident in our self-certification process and data."
The Zoox robotaxi - built as a fully autonomous vehicle from scratch rather than retrofitting existing cars for self-driving - comes without a steering wheel or pedals and has room for four passengers, with two facing each other.
Last month, Zoox said it had successfully tested a robotaxi with employees as passengers on a public road in order to bring the vehicle closer to commercial service for the general public.
The Feb. 11 test, conducted between two Zoox buildings a mile apart at the company's headquarters in Foster City, California, was part of the launch of a no-cost employee shuttle service that will also help the company refine its technology.
Chief Executive Aicha Evans last month declined to provide a timeline for the commercial launch, which will need additional government clearances.
Online retailer Amazon, which has been aggressively expanding into self-driving technology, bought Zoox for $1.3 billion in 2020.
https://www.yahoo.com/lifestyle/1-u-opens-probe-amazons-185218069.html
Newsom slams Walgreens, says California will cease doing business with company
California Gov. Gavin Newsom slammed Walgreens in a tweet Monday morning, saying California would no longer be doing business with the chain and linking to a CNN story about the company not distributing abortion pills to 20 states. “California won’t be doing business with Walgreens or any company that cowers to extremists and puts women’s lives at risk.”
“We’re done,” Newsom added in the tweet.
Walgreens last week announced it won’t sell abortion pills by mail to 20 conservative-led states. The statement came after attorney generals in the 20 states warned Walgreens and pharmacy chain CVS that they could face legal consequences if they sold abortion pills by mail to those states.
A spokesman for Walgreens confirmed to the Associated Press that the company sent a response to the AGs in each state, saying it would not dispense mifepristone in the states. Restrictions on abortion pills have been imposed in 19 U.S. states and there’s a court battle over whether they have the power to do so in defiance of U.S. Food and Drug Administration policy.
Gov. Newsom has vowed to make California a safe-haven for women seeking an abortion following the Supreme Court’s overturning of Roe vs. Wade last year.
Accelerated approval incoming? Moderna 'hopeful' for personalized cancer vaccine
Moderna will look to use the FDA’s accelerated approval pathway for its personalized cancer vaccine, president Stephen Hoge said at Cowen’s annual conference on healthcare.
The company read out Phase IIb results in December suggesting the mRNA-based therapy reduced melanoma patients’ risk of cancer recurrence or death by 44% in combination with Keytruda, with a p-value of 0.0266 and a hazard ratio of 0.56. However, Hoge said on Monday that investigators are curious whether that hazard ratio may improve over time.
They’re also analyzing translational biomarker data that could show “not only is the picture robust and strong, but there may be populations that are already really strong,” Hoge said.
“At some point, this randomized 150-person Phase IIb study that we ran might — might — be able to become the basis of accelerated approval,” he added. “It’s too early to say but we are hopeful that the data will mature that way.”
Last month, Moderna announced plans to launch a Phase III study in adjuvant melanoma this year and “rapidly expand” into other tumor types such as non-small cell lung cancer.
“The first chapter is going to be: go after places where Keytruda works,” CEO Stéphane Bancel said on Monday at the WSJ Health Forum in Boston. “But also the scientific and clinical teams are working to figure out other places where Keytruda did not work, that maybe there’s a scientific rationale where you combine Keytruda and the Moderna vaccine to potentially get over the hump of the immune system to get to clinical impact.”
As for respiratory disease, Moderna plans to file for approval of its experimental RSV vaccine in older adults in the first half of this year. Pfizer received priority review for its own candidate last month, and expects a decision by May. Moderna’s flu program, dubbed mRNA-1010, is currently in Phase III and headed for an interim analysis by the end of this quarter. Once the company lands those individual approvals, Hoge expects to roll out combination doses relatively quickly.
“We are focused on getting those first-generation models approved, working our way through the big three very quickly here, and then we will go very fast — think of what we did with the Covid updates — on the combos and then roll those out shortly thereafter,” Hoge said.
Bancel added during the WSJ presentation that Moderna’s “true goal” is combination vaccines for respiratory viruses, including flu and Covid vaccines adapted to seasonal strains and RSV.
“I don’t know about you, but I don’t like to get two, three, or four shots a winter,” Bancel said. “I think for most people, it is going to be hard to remember: Which one did I already get, when?”
Moderna has considered pricing its Covid shots between $110 and $130 per dose in the US, the same price suggested by Pfizer last fall. On Friday, Bancel added that the price will reflect a “wide range” depending on circumstances such as discounts. He also specified that the company is moving toward single-dose prefilled syringes, which “increased the cost tremendously.”
“I think a lot of people don’t realize that the price that was offered to the government during the pandemic was actually a massive discount to value,” the CEO said.
Regardless of their insurance status, all Americans will be able to receive the Moderna vaccine at no out-of-pocket cost, he reaffirmed on Friday.
https://endpts.com/accelerated-approval-incoming-moderna-hopeful-for-personalized-cancer-vaccine/
Shortage of asthma drug albuterol worsens amid factory closures
A common asthma drug is in short supply after one of the last major manufacturers shut down operations.
Albuterol is used to treat asthma, along with conditions like Respiratory syncytial virus (RSV), which surged earlier in the year. The drug is one of the most commonly prescribed in the U.S. and it’s been on the FDA’s shortage list for months.
Akorn Pharmaceuticals, which was one of the major suppliers of albuterol, shut down operations at the end of February as part of Chapter 7 bankruptcy proceedings. The company had previously been found to have manufacturing violations at its Illinois and New Jersey factories.
The company stopped shipping albuterol before it shut down, and the drug has been on the FDA’s shortage list for months.
If a drug is in short supply, the FDA has the authority to take measures to address the shortage, including extending the expiration date on existing supply, expediting new supply lines and finding foreign-made alternatives.
With Akorn shut down, there is only one major domestic company that can supply albuterol to hospitals and pharmacies. The U.S. relies heavily on foreign countries, including China and India, for pharmaceutical ingredients and drugs, and the COVID-19 pandemic highlighted the need for domestic supply chains.
Albuterol hasn’t been the only drug affected by supply chain disruptions. The ADHD drug Adderall and anti-viral medication Tamiflu have also been in short supply, leaving patients scrambling for options.
Hospitals are already preparing for a shortage, monitoring their supplies of albuterol and preparing for more emergency room visits from patients who may not be able to get the inhaler that helps them breathe.
The American College of Allergy, Asthma and Immunology is advising patients on how to handle a possible shortage. Their advice includes making sure not to overuse an inhaler, checking with doctors for alternative medications and, if necessary, using expired inhalers that may still be partially effective.
House panel to consider GOP bill banning transgender women, girls from female team sports
Federal legislation to ban transgender women and girls from competing on sports teams for women and girls will be heard for the first time Wednesday morning, the House Committee on Education and the Workforce announced Monday.
The “Protection of Women and Girls in Sports Act,” introduced in February by Rep. Greg Steube (R-Fla.), seeks to amend Title IX — the federal civil rights law prohibiting sex-based discrimination — to recognize sex as that which is “based solely on a person’s reproductive biology and genetics at birth.”
It is the third time Steube has introduced the legislation, which failed to pass during the last two Congresses, when Democrats controlled the House. A discharge petition filed in April by Steube and Rep. Jim Banks (R-Ind.) to bring last year’s bill to the House floor garnered only 187 signatures, falling short of the 218 needed to force a vote.
Speaker Kevin McCarthy (R-Calif.) has on multiple occasions signaled his support for the legislation, which now stands a better chance of passing in the House’s new Republican majority. House Education and Labor Committee Chairwoman Virginia Foxx (R-N.C.) has also voiced support for Steube’s bill.
In a statement last month, Steube said transgender female athletes have “no place in women’s sports” and accused Lia Thomas, the former University of Pennsylvania swimmer who last year became the first transgender athlete to win an NCAA Division I championship, of “robbing” second-place finisher Emma Weyant, a cisgender woman, of the title.
The question of whether transgender women and girls should be allowed to compete on sports teams for women and girls has invaded meeting rooms across the country over the past year, with professional organizations, local sports associations and even individual school districts adopting policies that restrict the ability of transgender athletes to compete on teams in accordance with their gender identity.
Eighteen states since 2020 have enacted laws that bar transgender athletes from competing on school sports teams consistent with their gender identity, though preliminary injunctions are currently blocking the enforcement of bans in Idaho, West Virginia, Indiana and Utah.
Legislators in more than a dozen states this year have introduced similar measures. The Wyoming legislature passed a bill last week to prohibit transgender girls from competing on middle school and high school sports teams, sending the measure to Gov. Mark Gordon (R) for final approval.
In a statement on Monday, Rep. Mark Pocan (D-Wis.), the chairman of the Congressional Equality Caucus, condemned Steube’s bill and accused Republicans of attempting to “demonize” LGBTQ people.
“This is not about girls’ and women’s sports; it’s about attacking trans kids,” Pocan said.
House Bill 734 has been endorsed by several conservative groups, including the Alliance Defending Freedom, the American Principles Project, the Family Policy Alliance and the Ethics and Public Policy Center.
The Conservative Political Action Conference (CPAC) and its embattled chairman, Matt Schlapp, are also backing Steube’s bill. In February, Schlapp said failing to pass the measure in Congress would send a message to Democrats that “their henchmen can turn the whole country into their woke nightmare.”
Schlapp and CPAC last week also threw their support behind Rep. Marjorie Taylor Greene’s (R-Ga.) “Protect Children’s Innocence Act,” which would make it a felony for doctors to provide gender-affirming health care to transgender minors. Greene is slated to introduce the bill, which she failed to pass during the last Congress, this week.