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Three Members Of Key FDA Advisory Panel Resign Over Approval Of Biogen’s Alzheimer’s Drug

Three Members Of Key FDA Advisory Panel Resign Over Approval Of Biogen’s Alzheimer’s Drug

Plus, Tesla began deliveries of its Model S Plaid, Netflix is launching an online shop, and Apple hired a veteran from BMW.

Stocks were slightly higher at the open on Friday with the Dow adding 34 points, or 0.1%. The S&P 500 and Nasdaq both rose less than 0.1%.

A third member of a key FDA advisory panel has resigned over the agency’s controversial approval of Biogen’s new Alzheimer’s drug, Aduhelm (aducanumab). Harvard Medical School professor Dr. Aaron Kesselheim said the agency’s decision on the Biogen drug “was probably the worst drug approval decision in recent U.S. history” in his resignation letter. “At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease,” Kesselheim added in the letter, also writing that it was “clear” to him that the agency is not “presently capable of adequately integrating he Committee’s scientific recommendations into its approval decisions. This will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system.” Joel Perlmutter from the Washington University School of Medicine and David Knopman of the Mayo Clinic also resigned from the panel, and all three voted against the drug.

Tesla began deliveries of its new Model S Plaid, a high-performance version of the carmaker’s flagship electric sedan, with a livestream event from the company’s test track in Fremont, California. “Why make this really fast car that’s crazy fast?” CEO Elon Musk asked rhetorically. “There is something that’s quite important to the future of sustainable energy, which is that we’ve got to show that an electric car is the best car, hands down. …Faster than Porsche but safer than Volvo. We’re in production and gonna deliver the first 25 cars now, and then basically should be at several hundred cars per week soon and a thousand cars per week next quarter.” Credit Suisse analyst Dan Levy said in a note out this morning, “While the start of Plaid deliveries provides some excitement on the product front, we believe Plaid remains secondary to Tesla’s aspirations in Model 3/Y.”

Taking a page out of Disney’s book, Netflix is branching out into toys, games, and clothing based on its popular shows. The streaming giant announced the launch of Netflix.shop, a retail arm that will sell curated products from its catalog of shows and movies. The initial items will include streetwear and action figures from the anime series Yasuke and Eden, as well as apparel and decorative items inspired by the show Lupin. “And there’s more ahead. Keep an eye out for exclusive products from beloved titles like The Witcher and Stranger Things, as well as Netflix logo-wear from Japanese fashion house BEAMS,” Josh Simon, Netflix’s VP of Consumer Products, wrote in a post on the company’s website. “These limited-edition items join the vast assortment of consumer products we’ve made available through our trusted partners. The Netflix.shop will first be available in the U.S. before expanding into other countries around the world in the coming months.”

Apple has hired a veteran from BMW in the latest sign the iPhone maker is serious about building an electric car to compete with automakers like the aforementioned Tesla. Apple hired Ulrich Kranz, a former senior executive at BMW, to help lead its own vehicle efforts. Kranz stepped down as CEO of Canoo Inc, a developer of self-driving electric vehicles, a month ago, and at BMW he led the group that developed the i3 and i8 cars. Apple first began developing a vehicle in 2014, but shelved the effort around 2016. Last year, Apple gave oversight of the project to John Giannandrea, senior vice president of machine learning and artificial intelligence, and several months ago the company rebooted efforts to develop a full-fledged electric car, though development remains in the early stages.

And the FDA is reportedly forcing Johnson & Johnson to scrap around 60 million doses of its COVID-19 vaccine produced at a troubled Baltimore plant run by Emergent BioSolutions due to possible contamination, the New York Times reported today. The plant in question was shuttered in April after an inspection revealed several violations, including possible contamination of J&J’s vaccine with a key ingredient from AstraZeneca’s COVID vaccine. Roughly 170 million doses of both vaccines were in question after the inspection. “Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer,” the agency said. “While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.”

Stocks We’re Watching

Signet Jewelers Ltd (NYSE: SIG): Signet Jewelers shares are up nearly 4% this morning after the company reported fiscal first quarter 2022 results. “Our strong first quarter results demonstrate the momentum we are building as we continue Signet’s transformation,” CEO Virginia C. Drosos said in the earnings release. “We delivered strong performance across our portfolio. While the jewelry category is experiencing meaningful growth, we are outpacing market growth and gaining share consistent with our Inspiring Brilliance strategy. Specifically, we are winning in our biggest banners through consumer-inspired differentiation, as evidenced by double-digit revenue growth in both Kay and Zales versus this time two years ago. We are successfully beginning to stretch the top and bottom boundaries of the mid-market as Jared continues to grow at higher price points and in custom design, and Piercing Pagoda delivered its best quarter ever accessing more value inspired self-purchasing shoppers.  Further, our Connected Commerce strategy is resonating, delivering higher conversion rates and growth both online and in-stores. And finally, we are building a more innovative and agile culture with investments in talent, digital capabilities, newness in product assortment, and modern content and marketing channels that give us distinct competitive advantages. As I look ahead, I’m confident in our people and our strategy and believe 2021 will be another transformative year for Signet.”

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