Raphael Stevens

A sign for the Food and Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.Sarah Silbiger | Getty ImagesA third member of a key Food and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm, CNBC has learned.Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by CNBC.”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,” he wrote in resigning from the FDA’s Peripheral and Central Nervous System Advisory Committee.He wrote it was “clear” to him that the agency is not “presently capable of adequately integrating the 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,” he said.Shares of Biogen surged 38% on Monday after the FDA approved the biotech company’s drug, the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists expect plays a role in the devastating disease. The FDA approved the drug under a program called accelerated approval, which is usually used for cancer medications, expecting the drug would slow the cognitive decline in Alzheimer’s patients. The agency granted approval on the condition that Biogen conducts another clinical trial.The agency’s decision was a departure from the advice of its independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At the time, the panel also criticized agency staff for what it called an overly positive review of the data.At least two other FDA panel members have resigned as a result of the agency’s decision on the drug. Mayo Clinic neurologist Dr. David Knopman and Washington University neurologist Dr. Joel Perlmutter have also submitted resignation letters.”I was very disappointed at how the advisory committee input was treated by the FDA,” Knopman told Reuters. “I don’t wish to be put in a position like this again.”Federal regulators have faced intense pressure from friends and family members of Alzheimer’s patients asking to fast-track the drug, scientifically known as aducanumab, but the road to regulatory approval has been a controversial one since it showed promise in 2016.In March 2019, Biogen pulled development of the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the drug after all.When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it harder for other companies to enroll patients in their own drug trials.Some doctors have said they won’t prescribe aducanumab because of the mixed data package supporting the company’s application.– Reuters contributed to this report. More

In this articleCHWYAs homebound Americans waited out the coronavirus pandemic last year, people increasingly turned to animal shelters and adopted dogs and cats as lockdown companions.Though lockdowns have eased and the country has reopened, adoption rates have largely kept shape, according to Sumit Singh, CEO of Chewy.”Overall adoptions, we believe, [are] up still year over year by double-digit percentages both across dog and cat,” he told CNBC’s Jim Cramer Thursday.Additionally, it does not look like pets are being returned to shelters in elevated numbers, said Singh, who appeared for an interview on “Mad Money.” Chewy, a $33 billion online pet food and supply store, last month launched a pet adoption service and is currently working with 6,000 shelters, he noted.”The pets coming back into the shelters actually matches the rate that we were seeing in 2019, which actually would say that, when you balance out new adoptions and pets coming back, there’s still a whole lot more pets getting adopted right now, which is great for the industry.”While Singh did not cite any statistics, online searches for pets remain elevated and the pet owner market has expanded greatly, based on research from Piper Sandler. The firm reports that searches for terms like “petfinder” and “puppies for sale” are up on a two-year basis, though it began tapering in April.The pet products industry made $103.6 billion in sales in 2020, according to the American Pet Products Association. It’s the first time annual sales crossed the $100 billion mark, the trade group announced in March. The association projects that number to grow nearly 6% in 2021, which would exceed the historical average of about 3%.After the close Thursday, Chewy reported results from its fiscal first quarter that ended May 2. The company’s revenues grew 31.7% to $2.14 billion from $1.62 billion a year ago. Results topped Wall Street’s estimates on the top and bottom lines.Shares rose 2% during Thursday’s session to close at $79.35. The stock was down more than 1% in after-hour trading.Questions for Cramer? Call Cramer: 1-800-743-CNBCWant to take a deep dive into Cramer’s world? Hit him up! Mad Money Twitter – Jim Cramer Twitter – Facebook – InstagramQuestions, comments, suggestions for the “Mad Money” website? [email protected] More

In this article.DJI.IXIC.SPXInflation grew at the fastest rate in more than a decade last month, but CNBC’s Jim Cramer called it the worst kept secret on Wall Street and said the stock market took it in stride. The consumer price index, which measures the cost of a basket of goods like food and energy, increased 5% year-over-year in May, according to the Labor Department. While high, that was just a bit above the 4.7% gain expected by a Dow Jones survey. “When everyone expects an outrageous government statistic, then it isn’t actually outrageous when you get it,” he said on “Mad Money.” “So when the Labor Department reported a red-hot inflation number this morning … the market took it in stride.”Inflation came in at the hottest rate since August 2008, yet the S&P 500 rose 0.5% to a record close of 4,239.18.The Dow Jones Industrial Average inched up 0.1%, or 19.10 points, to 34,466.24 and the tech-heavy Nasdaq Composite ended at 14,020.33, a 0.8% gain. Both are within 1% of their best closes.Despite rising prices, the Federal Reserve is unlikely to change its position on interest rates, Cramer said. Central bank officials plan to keep rates at near-zero levels to make room for the U.S. economy to rebound from last year’s Covid-19 downturn.”There are too many things that went wrong last year, and most of them won’t be solved by higher rates,” Cramer said. “Businesses just weren’t prepared to handle such a strong economy, but that’s a high-quality problem and they don’t need a rate hike to work things out. Time will do it for them.”Fed Chair Jerome Powell said the central bank would allow inflation, which he thinks will be transitory, to rise above its 2% target. The fed funds rate, which influences lending, won’t see a hike until the labor market bounces back in full, the Fed said.The country has more than 7 million jobs to recover to meet that goal, with an unemployment rate or 5.8% last month.”I think Jay Powell’s gradual approach is prudent. I’m betting he’s going to be dead right,” Cramer said.Questions for Cramer? Call Cramer: 1-800-743-CNBCWant to take a deep dive into Cramer’s world? Hit him up! Mad Money Twitter – Jim Cramer Twitter – Facebook – InstagramQuestions, comments, suggestions for the “Mad Money” website? [email protected] More

In this articleSIGSignet Jewelers CEO Gina Drosos expressed optimism Thursday around the company’s investments in e-commerce, telling CNBC she expects them to pay off even after the Covid pandemic passes.”I think the pandemic has changed customer shopping behavior forever. We’re seeing a lot more customers come to us online, even if not to purchase, to look at selection, to become educated,” Drosos said on “Closing Bell.”It is translating into digital sales, to be sure. Earlier Thursday, the owner of Zales and Kay Jewelers reported e-commerce revenue of $346.3 million in the quarter ending May 1, an increase of 110% compared with the same period a year ago. It’s also up about 125% compared with the same quarter two years ago, before the Covid crisis.Signet’s overall sales for the 2022 fiscal first quarter checked in at $1.69 billion, beating Wall Street expectations of $1.62 billion. Per-share earnings of $2.23 topped analyst forecasts of $1.27.”Our transformation plan is working,” said Drosos, who has served as Signet CEO since 2017. The former Procter & Gamble executive has been a Signet board member since 2012.Drosos said Signet has taken a range of steps to capture share of the online jewelry market.”We added during the pandemic more than 700 virtual jewelry consultants,” Drosos said, and the company also recently added capabilities through Apple’s Business Chat and Google’s Business Messages.”We’re improving our websites rapidly — more than 100 new features added during the first quarter,” Drosos said. “We think we have a unique opportunity and a competitive advantage as we create a superior online experience connected to our scaled store footprint.”Signet, which also operates the Jared and Piercing Pagoda brands, has around 2,800 stores, according to its earnings release. In March, Drosos told CNBC the company was looking to “optimize” its locations, in part by reducing exposure to lower-quality malls.Shares of Signet rose 14% on Thursday, hitting a new 52-week high of $74.80 intraday, as investors reacted to the company’s before-the-bell earnings results and its full-year guidance hike.Signet’s stock is up 467% over the past 12 months, based on its Thursday close of $69.58 per share. More

A young man in West Virginia receives the vaccine while overlooking the West Virginia Capitol Building in Riggleman Hall.Stephen Zenner | LightRocket | Getty ImagesThere have been a higher-than-expected number of cases of heart inflammation in 16- to 24-year-olds after receiving their second dose of Pfizer’s or Moderna’s Covid-19 vaccines, the Centers for Disease Control and Prevention said Thursday, citing preliminary data from its vaccine safety monitor system.The CDC has received reports of 275 cases in that age group as of May 31, the agency said in a presentation prepared for a Food and Drug Administration advisory panel meeting Thursday. Scientists expected between 10 and 102 cases of myocarditis or pericarditis — where the heart muscle or the lining surrounding it become inflamed, according to the CDC.”We clearly have an imbalance there,” Dr. Tom Shimabukuro of the CDC’s Immunization Safety Office said Thursday at the FDA’s Vaccines and Related Biological Products Advisory Committee meeting to discuss safety issues surrounding the use of Covid-19 vaccines in children as young as 6 months old.CNBC Health & Science Read CNBC’s latest global coverage of the Covid pandemic:CDC says heart inflammation in 16- to 24-year-olds was higher than expected after second Covid shotEU and U.S. to call for a deeper probe into Covid origins India reports more than 6,000 daily Covid deaths — highest ever in the worldFauci blasts ‘preposterous’ Covid conspiracies, accuses his critics of ‘attacks on science’ Though rare, there have been a total of 475 reported cases of myocarditis or pericarditis in people age 30 and younger, according to the CDC. Most patients who were hospitalized, or 81% of them, had full recovery from their symptoms, the agency said. As of May 31, 15 people remain hospitalized, with three in intensive care.The majority of cases appear to occur in men and the median time to the onset of symptoms is two to three days, according to the CDC.Some of the reported cases may be something else other than myocarditis or pericarditis upon further investigation, Shimabukuro said.During a panel discussion later Thursday, Dr. Cody Meissner, a member of the committee, said he was “worried” about the heart issue reported in young vaccine recipients. He questioned whether there will be scarring of the muscular tissue or arrhythmia as a result of the condition.”I think that’s unlikely but we don’t know that,” said Meissner, also a professor of pediatrics at Tufts University School of Medicine. “So, before we start vaccinating millions of adolescents and children, it’s so important to find out what the consequences are.”The CDC’s vaccine safety group said last month it was looking into heart inflammation conditions in a “relatively few” people who received Covid vaccinations.The cases were predominantly in adolescents and young adults and usually occurred within four days after getting the shot, the CDC said at the time. The condition was seen more often in men and most cases appear to be mild, the agency said, though officials are following up with the patients.The CDC is coordinating its investigation with the FDA, which last month authorized the Pfizer-BioNTech vaccine for adolescents ages 12 to 15.”We still don’t know whether this is truly related to the vaccine,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during a virtual Q&A event on May 27. He added that the “handful” of cases reported have been “very mild, lasting a day or two” and usually happened after a second dose.Health experts say finding rare side effects once a vaccine or drug is administered to the general population is common and if myocarditis turns out to be related to the Covid vaccine, the risk is negligible when compared with the risks of being infected with Covid-19. More