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European Union regulators on Wednesday fined Illumina a record 432 million euros ($476 million) for closing its acquisition of cancer test developer Grail without first securing regulatory approval. The fine from the European Commission, the EU's executive body, amounts to 10% of San Diego-based Illumina's turnover. The Illumina fine exceeds the commission's previous largest merger regulation fine of $125 million, or 1% of annual turnover, imposed on telecommunications company Altice in 2018. Illumina has already put aside $453 million to cover a potential maximum fine of 10% of turnover, according to a regulatory filing from earlier this year. "This is a very serious infringement, which requires the imposition of a proportionate fine, with the aim of deterring such conduct," the European Commission continued.
Persons: Illumina Organizations: European Commission, EU, Altice Locations: San Diego, Menlo Park , California
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, August 29, 2020. WASHINGTON — The Food and Drug Administration will address concerns raised by Senate Majority Leader Chuck Schumer about a caffeinated energy drink popular among teens. An agency spokesperson said it "is reviewing the concerns" outlined in Schumer's letter to FDA Commissioner Dr. Robert Califf about the dangers of Prime Energy, a beverage founded by YouTube stars Logan Paul and KSI. Prime Energy is not intended for anyone under the age of 18, according to a company representative. Prime Energy boasts 200 mg of caffeine.
Persons: Chuck Schumer, Robert Califf, Logan Paul, KSI, Schumer, Paul, Annika Kim Constantino Organizations: Food and Drug Administration, FDA, WASHINGTON, Drug Administration, Energy, YouTube, Prime Energy, American Academy of Child, Psychiatry Locations: White Oak , Maryland
In this photo illustration, boxes of the diabetes drug Ozempic rest on a pharmacy counter on April 17, 2023 in Los Angeles, California. But it could potentially include Eli Lilly 's diabetes drug Mounjaro, which is approved in the EU. Liraglutide is the active ingredient in Novo Nordisk's weight loss drug Saxenda. Semaglutide is the active ingredient in the Danish company's weight loss injection, Wegovy, and its diabetes counterpart, Ozempic. They mimic a hormone produced in the gut called GLP-1 to suppress a person's appetite and ultimately aid with weight loss.
Persons: Eli Lilly, It's, Liraglutide, Semaglutide, ideation Organizations: Novo Nordisk, European Medicines Agency, Pfizer, EMA, CNBC, Icelandic Medicines Agency, Novo Nordisk's Saxenda, Food and Drug Administration Locations: Los Angeles , California, Danish, Wegovy's, U.S
A selection of injector pens for the Wegovy weight loss drug are shown in this photo illustration in Chicago, Illinois, March 31, 2023. And a group of patients in the analysis who didn't take a weight loss drug saw their health-care costs decrease by 4% on average during the same time period. Weight loss drugs are also known as GLP-1 agonists, which mimic a hormone produced in the gut to suppress a person's appetite. Prime Therapeutics' analysis does not indicate why patients stopped taking weight loss drugs. But experts say the medicines may further perpetuate a dangerous diet culture that idealizes weight loss and thinness.
Persons: Joseph Leach, Eli Lilly, Elon Musk Organizations: Novo Nordisk, CNBC, Prime Therapeutics, Food and Drug Administration, Therapeutics, Reuters, Pfizer, National Institutes of Health Locations: Chicago , Illinois, U.S, Danish
The Biden administration unveiled a plan Tuesday to eliminate the growing threat of fentanyl laced with xylazine, an illegal street drug cocktail that is fueling a wave of overdose deaths. It also aims to disrupt the illegal xylazine supply chain, among other efforts. Those agencies must develop and submit an implementation report to the White House in 60 days. The White House plan's long-term goal is a 15% reduction in xylazine-positive drug overdoses in at least three of four U.S. Census regions by 2025. Every one of these numbers is tragic," White House domestic policy advisor Neera Tanden said during a call with reporters.
Persons: Biden, Joe Biden's, Dr, Rahul Gupta, Xylazine, Neera Tanden Organizations: New York, Centers for Disease Control, and Drug Administration, White House, White, Office of National Drug Control, CDC, House
It's unclear how many doses of Novavax's jab – its only commercially available product after 35 years – went unused. Under the amended agreement, Novavax will also provide Canada with fewer doses of its vaccine on a revised delivery schedule. In May, Novavax adopted a more positive outlook and announced a sweeping cost-cutting plan alongside its first-quarter earnings report. Novavax's stock price jumped around 30% on that news, but Wall Street hasn't entirely bought into the recovery plan: The company's stock price is still down roughly 15% since the start of the year after shedding more than 90% of its value in 2022. Novavax still faces a number of challenges ahead, including competing with Pfizer and Moderna in the commercial Covid vaccine market and a pending $700 million arbitration over a canceled vaccine purchase agreement.
Persons: , Novavax Organizations: SEC, Canadian, Securities and Exchange Commission, Pfizer, Moderna Locations: Maryland, Canada
Sales of the Alzheimer's drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said after the groundbreaking treatment won approval in the U.S.Wall Street is chewing over the Food and Drug Administration's Thursday approval of Leqembi – a milestone in the treatment of the disease, even though the drug isn't a cure. Leqembi, from drugmakers Eisai and Biogen , is the first medicine proven to slow the progression of Alzheimer's in people at the early stages of the memory-robbing disease. Yee added that the firm's channel checks suggest doctors see the registry requirement "as a potential real-world challenge – at least in the initial phase." That includes navigating Medicare's registry requirement and coordinating PET scans and MRIs to screen for dangerous side effects of the drug. But Goodman, like other analysts, also noted that "we continue to expect a slow ramp in 2023 and acceleration moving into 2024."
Persons: Jay Reinstein, drugmakers, Yatin Suneja, Jefferies, Michael Yee, Yee, Paul Matteis, Marc Goodman, Goodman Organizations: Georgetown University Hospital, Wall, Food, Leqembi, FDA, National Institute, Aging, ARIA, SVB Securities Locations: Washington , DC, U.S
Joe Raedle | Getty ImagesU.S. public health officials say the risk of locally transmitted malaria in the country remains low as seven new cases in Florida and Texas raise questions. "Despite these cases, the risk of locally acquired malaria remains extremely low in the United States," the agency added. The seven are the first known cases of "locally acquired" malaria in the country since 2003. Health experts say the new locally acquired cases shouldn't warrant panic about widespread malaria transmission in the U.S. Here's what you need to know about the locally acquired malaria cases in the U.S. – and why the risk of transmission remains low right now.
Persons: Barrington Sanders, Joe Raedle, it's, vivax, Daniel Parker, , Parker, Sadie Ryan, Ryan, Chandan Khanna, UC Irvine's Parker, we're, Rajiv Chowdhury, Chowdhury, Stephane de Sakutin Organizations: Miami - Dade Mosquito Control, Getty, Florida Department of Health, Centers for Disease Control, CDC, CNBC, UC Irvine, University of Florida, Florida Climate Institute, Local, Sarasota County Mosquito Management Services, AFP, UC, Florida International University Locations: Miami, Miami , Florida, Florida, Texas, Sarasota County, United States, U.S, Florida , Texas, Sarasota, Sarasota , Florida
Moderna on Wednesday said it struck a deal with Chinese officials to research, develop and manufacture messenger RNA medicines in the country, despite rising tensions between the U.S. and China. The Massachusetts-based biotech company signed a memorandum of understanding and a related land collaboration deal to develop drugs that will "be exclusively for the Chinese people" and won't "be exported," a Moderna spokesperson told CNBC. The Moderna spokesperson did not confirm the report or comment on the size of the deal. Moderna in May said it was keen to sell its mRNA Covid vaccine to China after registering a legal entity in the world's second-largest economy. The country has also struggled to develop mRNA technology at home during the pandemic.
Persons: Stéphane Bancel, It's, drugmakers, Biden Organizations: Moderna, U.S, CNBC, The Moderna, Pfizer, China's Ministry of Commerce, AstraZeneca, Novo Nordisk, Merck, Sanofi, GE HealthCare Technologies Locations: China, The Massachusetts, Shanghai, Japan, Canada, Australia, Kenya, Beijing, New York
People on diabetes and weight loss drugs such as Novo Nordisk 's Ozempic and Wegovy should stop taking them before having elective surgery to reduce the risk of serious health complications, a prominent group of doctors said. Under the ASA's guidance, people taking GLP-1 drugs on a daily basis should skip treatment on the day of elective surgery. Those taking GLP-1s weekly should stop treatment a week before the scheduled surgery, the group said. Prior to surgery, doctors should consider consulting with an endocrinologist for guidance on patients who take GLP-1s for diabetes. If a patient has none of those symptoms but did not stop using GLP-1s before the surgery, doctors should consider using ultrasound to check if they have a "full stomach."
Persons: Michael Champeau, Champeau, Eli Lilly Organizations: Novo Nordisk, American Society of Anesthesiologists, ASA, Nordisk's Ozempic Locations: Los Angeles , California, People
The Centers for Disease Control and Prevention on Thursday recommended that adults ages 60 and above receive a single dose of RSV vaccines from Pfizer and GSK after consulting their doctors. "These vaccines provide an opportunity to help protect older adults against severe RSV illness at a time when multiple respiratory infections are likely to circulate," the CDC said in a statement. The virus is a common respiratory infection that usually causes mild, cold-like symptoms, but more severe cases in older adults and children. Each year, RSV kills 6,000 to 10,000 seniors and a few hundred children younger than 5, according to CDC data. But the panel raised concerns about the lack of efficacy data on subgroups of the elderly population at the highest risk of severe RSV.
Persons: Rochelle Walensky, Michael Melgar Organizations: Disease Control, Pfizer, GSK, CDC, U.S . Food, Drug Administration, Spokespeople Locations: U.S
Federal authorities charged a former Pfizer employee and his close friend Thursday with illegally trading shares based on non-public trial results on the pharmaceutical company's Covid antiviral pill Paxlovid. The Justice Department and the Securities and Exchange Commission both announced respective insider trading charges against the former employee, Amit Dagar, and his friend, Atul Bhiwapurkar. "The charges in this case relate to the personal conduct of a former Pfizer employee in violation of the company's policies," a Pfizer spokesperson told CNBC. He was also charged with one count of conspiracy to commit securities fraud, which carries a maximum sentence of five years in prison. The DOJ announced the charges along with several other allegations of illegal trading, including charges related to the Trump media merger.
Persons: Paxlovid, Amit Dagar, Atul Bhiwapurkar, Dagar, didn't Organizations: New England, of Medicine, Pfizer, The Justice Department, Securities and Exchange Commission, DOJ, CNBC, Attorneys, Trump Locations: Hillsborough , New Jersey, Bhiwapurkar, Milpitas , California
Drugmakers are jockeying to capitalize on the next major innovation coming to the blockbuster weight loss industry: effective, convenient and potentially affordable obesity pills. But for now, one experimental oral drug from Eli Lilly appears to have an edge over pills from Novo Nordisk and Pfizer — even though it may not win U.S. approval first. Pills are also typically cheaper than injections, though it's unclear if that will be the case with the obesity pills. None of the three drugmakers has provided estimates for how much the new obesity pills would cost. Eli Lilly is still in the middle of phase three clinical trials on its oral drug, orforglipron, meaning it's likely to hit the market later.
Persons: It's, there's, Eli Lilly, Pfizer — Organizations: Novo Nordisk, Pfizer, CNBC, Food and Drug Administration Locations: U.S, orforglipron
A view of the Regeneron Pharmaceuticals headquarters in Tarrytown, New York. Shares of Regeneron fell nearly 9% Tuesday after the U.S. Food and Drug Administration declined to approve a higher-dose version of the company's blockbuster eye disease treatment. Regeneron said the rejection was "solely due to an ongoing review of inspection findings at a third-party filler." That suggests the drug could potentially win approval down the road. But a delay won't help the company fight off threats to its Eylea drug franchise, which is facing competition from Roche Holdings ' eye drug, Vabysmo.
Persons: Regeneron Organizations: Regeneron Pharmaceuticals, U.S . Food, Drug Administration, Roche Holdings Locations: Tarrytown , New York, U.S
Eli Lilly ’s experimental drug helped patients lose up to 24% of their weight after almost a year, the highest reduction seen in the obesity treatment space to date, according to new mid-stage clinical trial results released Monday. The trial's researchers said average weight loss did not appear to plateau after 48 weeks, suggesting a longer study could show even more. Eli Lilly’s other obesity drug Mounjaro, which is approved for type 2 diabetes, has helped patients lose up to 21% of their weight in clinical trials. Novo Nordisk’ s Wegovy, cleared for weight loss, has shown up to 15% weight loss in trials. But Wegovy only mimics one hunger-regulating hormone called GLP-1, while Mounjaro mimics GLP-1 and another hormone called GIP.
Persons: Eli Lilly ’, Eli Lilly, Eli Lilly’s retatrutide, ” Michael Weintraub, Eli Lilly’s, Eli Lilly's retatrutide Organizations: NYU Langone Health, Novo Nordisk
Novo Nordisk 's high-dose experimental obesity pill helped overweight or obese adults lose around 15% of their body weight, according to new late-stage clinical trial results. Novo Nordisk told Reuters it plans to file for Food and Drug Administration approval of the drug later this year. But the highest dose of Rybelsus is 14 milligrams, while the company's experimental obesity pill has a far larger dose of 50 milligrams. Other companies are also developing oral weight loss treatments to appeal to those who don't want weekly injections. Pfizer is also developing its own weight loss pill, called danuglipron, which patients take twice a day.
Persons: Eli Lilly, Dr, Filip Knop, Knop, Eli Lilly's, Elon Musk Organizations: Novo Nordisk, Reuters, Food and Drug, Pfizer, University of Copenhagen, Novo, Companies, Novo Nordisk's Ozempic, National Institutes of Health Locations: Danish
Pfizer on Monday said it would stop developing its experimental obesity and diabetes pill, lotiglipron, due to elevated liver enzymes in patients who took the drug once a day in mid-stage clinical studies. New York-based Pfizer said it will instead focus on its other oral obesity drug, danuglipron, which is in a fully enrolled phase two clinical trial. Pfizer CEO Albert Bourla has said that an obesity pill could eventually generate $10 billion each year for the company. The new class of obesity drugs is piquing public interest and causing a weight loss industry gold rush. Analysts believe Eli Lilly’s pill has an edge over Pfizer’s danuglipron.
Persons: William Sessa, Albert Bourla, Eli Lilly, Eli Lilly’s, danuglipron, Wells, Mohit Bansal, orforglipron, Bansal Organizations: Pfizer, Novo Nordisk, National Institutes of Health Locations: New York, danuglipron
Governor Kathy Hochul holds media availability press conference and makes an announcement on abortion rights at the office on 633 3rd Avenue. Kathy Hochul on Friday signed a bill that would legally protect doctors who prescribe and send abortion pills to patients living in other states where the procedure is outlawed. Under the measure, New York abortion providers can serve more out-of-state patients without fear of litigation. Similar telehealth abortion laws have been enacted in Massachusetts, Colorado, Vermont and Washington. The bill builds upon similar legislation passed last year, which aimed to protect New York abortion care providers from litigation, but did not specifically address telehealth.
Persons: Kathy Hochul, Hochul, Wade, we're, Matthew Kacsmaryk Organizations: New York Gov, NBC, The, Food and Drug Administration, Northern District of, FDA Locations: New York, U.S, York, Massachusetts , Colorado , Vermont, Washington, Northern District, Northern District of Texas
President Joe Biden signs an executive order in support of Joining Forces, the initiative to support military and veteran families, caregivers, and survivors on June 9, 2023 at Fort Liberty, North Carolina. Biden's order also:Directs those departments to consider new ways to broaden access to affordable over-the-counter birth control medications, such as Plan B emergency contraception. Instructs the Veterans Affairs and the Office of Personnel Management to consider actions that would shore up birth control access for veterans and federal employees, among other provisions. The president's order does not suggest a timeline for shoring up that access and does not direct federal departments to consider new requirements to codify access to birth control. Approximately 65% of women ages 15 to 49 used birth control from 2017 to 2019, according to the Centers for Disease Control and Prevention.
Persons: Joe Biden, Wade, Clarence Thomas, Xavier Becerra, Matthew Kacsmaryk, Roe Organizations: Forces, Fort Liberty, White House, White, Treasury, Labor Department, Department of Health, Human Services, Food and Drug Administration, Affordable, FDA, Veterans Affairs, Management, Centers for Disease Control, CDC, Democratic, Northern District of Locations: Fort Liberty , North Carolina, U.S, Northern District, Northern District of Texas
Moderna on Thursday applied for U.S. Food and Drug Administration approval of the biotech company's updated Covid vaccine for the fall. Moderna and rivals Pfize r and Novavax already began to develop versions of their vaccines targeting XBB.1.5 months before the FDA's recommendation. Clinical trial data on more than 100 people similarly demonstrates the monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants. All trial participants had previously received four Covid vaccine doses. The U.S. is expected to shift Covid vaccine distribution to the private sector as soon as the fall.
Persons: Moderna's, Stéphane Bancel Organizations: U.S . Food, Drug Administration, Moderna, . Food, Drug, FDA, Pfizer, Novavax, Moderna's, Centers for Disease Control Locations: U.S
Vaccinating one million adults ages 65 and above with a single RSV shot from Pfizer or GSK may prevent thousands of hospitalizations over two seasons of the virus, according to a Centers for Disease Control and Prevention analysis. The committee recommended that adults ages 60 and older may receive one dose of Pfizer's or GSK's respiratory syncytial virus shot after consulting their doctor. The analysis also found that vaccinating one million adults in the same age group with one dose of GSK's shot may prevent roughly 2,300 hospitalizations and 23,000 outpatient visits. Each year, RSV hospitalizes 60,000 to 160,000 older adults and kills 6,000 to 10,000, according to CDC data. Last year, cases of RSV – along with Covid and the flu – in children and older adults overwhelmed hospitals across the nation.
Persons: Michael Melgar Organizations: Pfizer, GSK, Centers for Disease Control, University of Michigan, Northern Hemisphere
Russell Westbrook, who played for the Washington Wizards in the 2020-21 NBA season, reacts prior to playing against the Denver Nuggets at Capital One Arena in Washington, D.C., February 17, 2021. Qatar's sovereign wealth fund has offered to buy a minority stake in Monumental Sports & Entertainment, the parent company of the Washington Wizards and other Washington, D.C., sports teams, the National Basketball Association said Thursday. The NBA is still reviewing the deal with the Qatar Investment Authority, league spokesperson Mike Bass said in a statement to CNBC. The NBA in November began to allow sovereign wealth funds and other institutional investors to buy noncontrolling stakes in the league's teams. In addition to the Wizards, Monumental owns the National Hockey League's Washington Capitals and the Women's National Basketball Association team, the Washington Mystics.
Persons: Russell Westbrook, Mike Bass, QIA, Bass Organizations: Washington Wizards, NBA, Denver Nuggets, Capital, Washington , D.C, Monumental Sports & Entertainment, D.C, National Basketball Association, Qatar Investment Authority, CNBC, Sportico, Wizards, Monumental, Hockey League's Washington Capitals, Women's National Basketball Association, Washington Mystics, NBA G League, NBC Sports Washington, Monumental Sports Locations: Washington ,, Washington, Monumental, Qatar
The pharmaceutical industry's largest lobbying group and two other organizations Wednesday sued the Biden administration over Medicare's new powers to slash drug prices for seniors under the Inflation Reduction Act. Pharmaceutical Research and Manufacturers of America, along with the National Infusion Center Association and the Global Colon Cancer Association, argue that the Medicare negotiations with drugmakers violate the U.S. Constitution, in a complaint filed in federal district court in Texas. The groups asked the court to declare the program unconstitutional and prevent the Department of Health and Human Services from implementing Medicare negotiations without "adequate procedural protections" for drug manufacturers. It marks the fourth lawsuit challenging the controversial provision of the Inflation Reduction Act, which became law last summer in a major victory for President Joe Biden and Democratic lawmakers. The lawsuit also argues the policy violates due process by denying pharmaceutical companies and the public input on how Medicare negotiations will be implemented.
Persons: Eli Lilly, Johnson, Joe Biden, PhRMA —, drugmakers, Stephen Ubl, Ubl Organizations: New York Stock Exchange, Biden, Pharmaceutical Research, Manufacturers of America, National, Center Association, Global Colon Cancer Association, drugmakers, Constitution, Pfizer, Johnson, of Health, Human Services, HHS, Democratic, Merck, Bristol Myers Squibb —, U.S . Chamber of Commerce, PhRMA Locations: U.S, Texas
The virus is a common respiratory infection that usually causes mild, cold-like symptoms, but more severe cases in older adults and children. Pfizer and GSK on Wednesday both presented new clinical trial data to the panel, which provided a first glimpse of their shots' durability after one RSV season. That's down from more than 85% at the end of the first season in older adults. For less severe RSV disease, efficacy declined to 67.2% over two seasons from 82% after one season. The shots would help the U.S. combat the upcoming RSV season in the fall after an unusually severe RSV season last year.
Persons: Rochelle Walensky, That's, Michael Melgar, Melgar Organizations: Centers for Disease Control, Pfizer, GSK, Food and Drug Administration, CDC, Northern, Seniors Locations: Los Angeles, United States
Pfizer 's vaccine that protects adults ages 60 and older from respiratory syncytial virus was slightly less effective after 18 months, according to clinical trial results the company announced Wednesday. The data is from New York-based Pfizer's clinical trial on more than 34,000 older adults over two RSV seasons, or 24 months. The vaccine was roughly 49% effective against the same condition with two or more symptoms after 18 months, according to Pfizer. Anderson said studies are ongoing, and so is research evaluating the shot's efficacy in older adults with weak immune systems. RSV kills 6,000 to 10,000 older adults and hospitalizes 60,000 to 160,000 of them every year, according to the CDC.
Persons: Pfizer's, It's, Annaliesa Anderson, Anderson, Pfizer hasn't Organizations: Pfizer, Northern, That's, Centers for Disease Control, and Drug Administration, GlaxoSmithKline, CNBC, CDC Locations: New York, U.S
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