Global News

[ad_1] A person receives a COVID-19 vaccination dose, during a free distribution of COVID-19 rapid test kits for those who received vaccination shots or booster shots, at Union Station on January 7, 2022 in Los Angeles, California. Mario Tama | Getty Images The U.S. Food and Drug Administration 's independent panel of advisors raised doubts about the need to "periodically" update Covid vaccines, noting that it's unclear if the virus is seasonal like the flu. Advisors on Thursday unanimously voted that new jabs for the fall should be monovalent — meaning they are designed against one variant of Covid — and target one of the omicron XBB strains . Those are now the dominant variants nationwide.  But the original voting question included language about whether the panel recommends a "periodic update" to Covid shots.  Dr. Peter Marks, head of the FDA's vaccine division, asked the panel's chair to strike the wording from the question after severa

[ad_1] The newly FDA approved Alzheimer's treatment Leqembi is prepared at Abington Neurological Associates in Abington, PA., on Tuesday, November 7, 2023.  Hannah Yoon | The Washington Post | Getty Images The breakthrough Alzheimer's drug Leqembi slowed disease progression in patients over three years, demonstrating the need for them to stay on the treatment long term, according to new data released Tuesday by Japanese drugmaker Eisai .  The study results on Leqembi, which Eisai shares with Biogen , also found that a patient's Alzheimer's disease worsens after they stop treatment. Rates of adverse side effects associated with Leqembi, including brain bleeding and swelling, dropped after six months of treatment, Dr. Lynn Kramer, Eisai's chief clinical officer of deep human biology learning, told CNBC.  That decline is critical: Those side effects in the brain have raised concerns among some doctors and are the main reason a European drug regulator recommend

[ad_1] Boxes of mifepristone, the first pill given in a medical abortion, are prepared for patients at Women's Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13, 2023.  Evelyn Hockstein | Reuters A coalition of a dozen Democratic attorneys general sued the Food and Drug Administration on Friday to force the agency to drop all remaining restrictions on the abortion pill, the latest case in an escalating series of legal battles over access to the medication. The attorneys general asked a federal court in the eastern district of Washington to declare that the abortion pill, mifepristone, is safe and effective and that all remaining restrictions on the medication are unconstitutional. The lawsuit was led by Washington state Attorney General Bob Ferguson and Oregon's AG Ellen Rosenblum. The attorneys general of Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont were also part of the suit. The attorneys g

[ad_1] A nurse prepares a dose of Moderna Covid-19 vaccine at Oltepesi Dispensary in Kajiado, Kenya, on September 9, 2021. Patrick Meinhardt | AFP | Getty Images Moderna on Thursday said it has paused plans to build a vaccine-manufacturing site in Kenya after a steep drop in demand for its Covid vaccines . The biotech company said it has not received any vaccine orders for Africa since 2022 and has taken more than $1 billion in losses and write-downs related to the cancellation of previous orders from the continent. Moderna's decision aligns with its broader effort to cut costs by resizing its Covid vaccine-manufacturing footprint. The company's business took a major hit last year as demand for those jabs waned worldwide, with people relying less on protective vaccines and treatments against the virus. Shares of Moderna fell 45% last year, but the stock is up around 6% this year. In March 2022, the company said it would invest about $500 million in the Kenyan site and

[ad_1] Travelers check in at Shanghai's Hongqiao International Airport in on Dec. 12, 2022, after China relaxed domestic travel restrictions. Qilai Shen | Bloomberg | Getty Images The Biden administration will require airline passengers traveling from China to test negative for Covid before entering the U.S. as concern grows that widespread transmission of the virus in the world's most populous country could result in new variants. All airline passengers 2 years and older originating from China, Hong Kong or Macau will be required to get tested for Covid-19 no more than two days before their flight to the U.S. and show a negative result to the airline upon departure, the Centers for Disease Control and Prevention announced on Wednesday. The requirements, which apply regardless of nationality and vaccination status, start Jan. 5. Travelers can get a PCR test or a rapid self test that is administered and monitored by a telehealth service. The rapid test must be authorized by

[ad_1] Hurricane Idalia barreled toward southeastern Georgia after hitting Florida's Gulf Coast with life-threatening storm surges, leaving at least two people dead and hundreds of thousands without power. More than 280,000 people in Florida were without power as of early afternoon, according to PowerOutage.US. At least two people died in weather-related car crashes in Alachua and Pasco counties, police said.  At least 30 of Florida's 67 counties issued some type of evacuation order prior to the storm. People who did not evacuate should shelter in place, according to the state's emergency management agency. Idalia made landfall in the morning as a catastrophic Category 3 storm at Keaton Beach on the Big Bend coast, less than 90 miles southeast of the state capital of Tallahassee. The hurricane has since weakened to a Category 1 storm with maximum sustained winds of 90 miles per hour, according to the National Hurricane Center.  Idalia is expected to weaken further as i

[ad_1] Boxes of the medication Mifepristone used to induce a medical abortion are prepared for patients at Planned Parenthood health center in Birmingham, Alabama, March 14, 2022. Evelyn Hockstein | Reuters A federal judge on Friday allowed North Carolina lawmakers to defend restrictions on the abortion pill mifepristone, after the state attorney general declined to do so. Dr. Amy Bryant, a North Carolina physician, sued the state in January to block its restrictions on mifepristone because they go beyond the Food and Drug Administration's regulations. State Attorney General Joshua Stein, a Democrat, agreed with Bryant and declined to defend the state's restrictions on mifepristone. Stein told North Carolina lawmakers the FDA determined that restrictions like those in North Carolina unduly burden patients' access to a safe and effective drug. The president of North Carolina's Senate, Philip Berger, and state House Speaker Timothy Moore intervened to defend the stat

[ad_1] A messy legal fight over the Food and Drug Administration's approval of the abortion pill mifepristone poses risks to the biopharma industry that go beyond the single drug. If a subsequent decision tosses out the pill's approval, it could potentially stifle innovation in the sector and deter investments in the development of life-changing drugs, biopharma companies and experts in law and economics say.  related investing news The ruling Friday by U.S. District Judge Matthew Kacsmaryk of Amarillo, Texas, appears to be the first time a court has suspended the FDA's approval of a medication. The 5th U.S. Circuit Court of Appeals late Wednesday partly granted the Biden administration's request to put the order on hold, making mifepristone available for now but with significant restrictions .  The Justice Department will seek emergency intervention from the U.S. Supreme Court, it said Thursday. Nationwide access to mifepristone still hangs in the balance as the

[ad_1] A GSK lab in London. Oli Scarff | Getty Images The Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline for use on adults ages 60 and older. The approval, the first ever globally by a regulatory body for an RSV vaccine , is a decisive victory for GSK in a race against drugmakers Pfizer and Moderna to bring to market a shot that targets the respiratory syncytial virus . Shares of GSK rose nearly 2% Wednesday following the approval. GSK's chief scientific officer Tony Wood said in a statement the decision "marks a turning point" in the company's effort to reduce the "significant burden" of RSV. The company will now focus on ensuring eligible older adults in the U.S. can access the vaccine "as quickly as possible," he said. GSK will also work toward regulatory review and approval of the shot in other countries. London-based GSK during an earnings presentation last week said it has "mil

[ad_1] Eli Lilly logo is shown on one of the company's offices in San Diego, California, U.S., September 17, 2020.  Mike Blake | Reuters Eli Lilly on Tuesday reported first-quarter adjusted profit that topped Wall Street's expectations and hiked its full-year guidance on strong sales of its blockbuster diabetes drug Mounjaro and newly launched weight loss treatment Zepbound. The drugmaker now expects full-year adjusted earnings of $13.50 to $14.00 per share, up from previous guidance of $12.20 to $12.70 per share. Eli Lilly also expects revenue for the year to come in between $42.4 billion and $43.6 billion, an increase of $2 billion at either end of the range. Analysts surveyed by LSEG expected full-year adjusted earnings of $12.50 per share and sales of $41.44 billion.  The company said the boosted guidance is in part due to optimism around increased production of Zepbound, Mounjaro and similar drugs for the rest of the year. "Now that we're four months into th

[ad_1] Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023. Eli Lilly & Co.'s shares climbed in early US trading after its experimental drug for Alzheimer's slowed the progress of the disease in a final-stage trial, paving the way for the company to apply for US approval. AJ Mast | Bloomberg | Getty Images Eli Lilly said Friday that the Food and Drug Administration has pushed back its approval decision deadline for the drugmaker's experimental Alzheimer's treatment donanemab in a surprise move. The agency plans to call a last-minute meeting of its outside advisors to further review the treatment's safety and efficacy in a late-stage trial, Eli Lilly said. The FDA has not disclosed the date of that meeting, so a potential approval would likely come after this month. The FDA was expected to decide whether to greenlight the medicine by the end of the first quarter. That deadline was already delayed from an expected approval last ye

[ad_1] President Joe Biden delivers remarks about the Build Back Better legislation's new rules around prescription drug prices in the East Room of the White House on December 06, 2021 in Washington, DC. Chip Somodevilla | Getty Images Five of Pfizer's drugs will cost less for Medicare recipients starting next month as part of President Joe Biden's plan to lower prescription drug costs, the Department of Health and Human Services said Wednesday.  Pfizer's drugs are among the first set of 27 Part B prescription drugs that will be subject to Medicare inflation rebates starting April 1, according to the department. That requires Pfizer and other prescription drug companies to refund Medicare through rebates because the prices for those drugs rose faster than the rate of inflation.  Pfizer's drugs include the blood thinner Fragmin , which was approved by the Food and Drug Administration in 1994. It also includes Atgam , a medicine used to treat symptoms of Renal

[ad_1] Syringe with Covid-19 vaccine against the XBB Variant. Fight against virus Covid-19 Coronavirus, Vaccination and immunization. Undefined Undefined | Istock | Getty Images U.S. Food and Drug Administration staff on Monday said updated Covid boosters should target XBB omicron subvariants for the upcoming fall and winter vaccination campaign.  The U.S. should use a monovalent vaccine targeting either XBB.1.5, XBB.1.16, or XBB.2.3, collectively the dominant strains nationwide, the staff said in a briefing document .  related investing news The FDA staff made the conclusion ahead of a meeting on Thursday, when a panel of external advisors to the agency will recommend a strain for new Covid shots to target later this year. There is no set date for when the vaccination campaign will begin. Vaccine manufacturers will be expected to update their shots once that strain is selected. Pfizer , Moderna and Novavax are already developing versions of their respective vaccines targeti

[ad_1] A panel of independent advisors to the Food and Drug Administration unanimously recommended Thursday that the antibody nirsevimab be approved for use to protect infants from respiratory syncytial virus , the leading cause of hospitalization among newborns. If the FDA approves nirsevimab, the antibody would become the first medical intervention available in the U.S. that can protect all infants from RSV . The FDA, which is not obligated to follow the recommendation of its advisory panel, is expected to make a final decision on nirsevimab in the third quarter. Nirsevimab is a monoclonal antibody made by AstraZeneca . The medication would be marketed by Sanofi . The advisory panel voted 21-0 to recommend its approval. In a separate vote, the advisors also recommended nirsevimab's use in children up to 2 years old who remain vulnerable to the virus in their second RSV season. That vote was 19-2. RSV kills nearly 100 babies in the United States every year, according to sci