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Patients taking blockbuster obesity drugs Ozempic or Wegovy will pack the pounds back on after they stop taking the medications. Studies have similarly shown weight rebound in people who stop taking Ozempic. So has Ozempic, which was first authorized to treat diabetes and is now being used off-label for weight loss. The shortage and other factors like out-of-pocket costs without insurance or unpleasant side effects have forced some people to stop taking Ozempic or Wegovy. Conde-Knape said so far data indicate that weight loss is maintained with long-term use of the drugs.
Carl Icahn on Wednesday said Illumina should bring back its former CEO "immediately," his latest move in a brewing proxy fight with the biotech company. Flatley helmed the company for 17 years before he was succeeded by current CEO Francis deSouza in 2016. Icahn, who owns a 1.4% stake in Illumina, lambasted the company's current management in the interview. He told the Journal that executives are making the mistake of holding onto Illumina's $7.1 billion acquisition of cancer test developer Grail in 2021. He told the Journal that Illumina can't afford to keep Grail under current macroeconomic conditions.
The U.S. supply of infant formula industry is still vulnerable to safety issues and supply disruptions more than a year after a nationwide shortage that left parents scrambling to feed their children, a former Food and Drug Administration official told U.S. lawmakers on Tuesday. The FDA announced a nationwide recall on that day of Abbott Nutrition 's popular Similac, Alimentum and EleCare baby formulas that sparked the nationwide shortage. The infant formula was recalled after several infants became sick with bacterial infections and two died. The plant was shuttered for months, sharply reducing formula supply across the U.S. He pointed to structural and cultural issues within the agency, a failure to monitor the food supply chain and inadequate public health surveillance of the fatal bacteria, Cronobacter sakazakii, that contaminated Abbott's formula.
Laboratory Corporation of America will pay the U.S. $2.1 million to settle allegations that it overbilled the Department of Defense for genetic tests that involved children and fetuses, the Justice Department announced Monday. Hecker-Gross' allegations surrounded genetic tests performed under a contract LabCorp entered with the Defense Department in 2012. Hecker-Gross alleged that LabCorp overcharged and double or triple-billed DOD for genetic tests performed by GeneDx. There were $210,959 in overcharges on 38 tests, including $113,525.50 for 21 tests billed between March 2016 and January 2017 alone, the lawsuit alleged. In 1996, LabCorp agreed to pay $187 million for fraudulently billing the government for unnecessary tests on elderly patients.
Shares of BioNTech on Monday slid by more than 6% in morning trading after the German drugmaker shared a gloomy 2023 sales outlook for its Covid vaccine jointly developed with Pfizer . The drugmaker expects that demand to fall further this year, forecasting Covid vaccine revenue to hit 5 billion euros, or $5.4 billion. BioNTech noted in an earnings release that its efforts to adapt the Covid vaccine to new strains of the virus are expected to increase demand for the product this year. BioNTech is the latest company to forecast a slump in demand for Covid products as the world emerges from the pandemic. Its partner Pfizer told investors in January that it expects Covid vaccine sales to plummet by 64% this year and sales of its Covid antiviral treatment Paxlovid to drop by 58%.
Abortion is legal in Wyoming again, oddly enough as the result of a state constitutional amendment pushed by conservatives opposed to Obamacare more than a decade ago. Anti-abortion lawmakers in Wyoming have tried to work around the 2012 amendment in passing the ban on abortion. The state's sweeping ban, dubbed "Life is a Human Right Act," claims that abortion is not a form of health care. It's unclear whether the court will ultimately agree that the anti-Obamacare amendment prohibits a state abortion ban. For instance, a judge in Ohio in October temporarily blocked the state's abortion ban because of a constitutional provision adopted in 2011 as a backlash to Obamacare.
Carl Icahn on Friday alleged that Illumina 's directors demanded extra personal liability insurance before the biotech company signed off on a $7.1 billion acquisition of cancer test developer Grail in 2021. Icahn, who owns a 1.4% stake in Illumina, is pushing for board seats at the DNA sequencing company. Illumina prevailed over the U.S. Federal Trade Commission's opposition to the Grail deal in September, but is fighting for European regulatory approval. Last year, the EU's executive body, the European Commission, blocked Illumina's acquisition of Grail over concerns it would hurt consumer choice. The company's market cap has shrunk to roughly $34 billion from about $75 billion in August 2021, the month it closed the Grail deal.
(Photo by Rachel Wisniewski/For the Washington Post)People who take Pfizer 's Covid antiviral treatment Paxlovid shortly after infection may reduce their risk of developing long Covid, regardless of their age, vaccination status or infection history, new research suggests. The study, published in the journal JAMA Internal Medicine on Thursday, found that people who took Paxlovid within five days of a positive Covid test saw a 26% lower risk of long Covid compared with those who didn't receive it. The new study comes as researchers work to fill the knowledge gap about long Covid, an often debilitating condition with limited data and no proven treatment available. Long Covid refers to new, returning or ongoing health issues more than four weeks after an initial Covid infection, according to the Centers for Disease Control and Prevention. She called the new study "very exciting and promising" because it's the first to show an association between Paxlovid and a decreased risk of long Covid.
Shares of Sanofi and Regeneron both jumped by more than 6% on Thursday after the pharmaceutical companies released promising data showing their jointly developed asthma drug Dupixent also shows promise in treating COPD patients. New data from a phase three clinical trial shows Dupixent reduced bad bouts of chronic obstructive pulmonary disease, or COPD, by 30% compared with a placebo over 52 weeks. The trial enrolled COPD patients with type 2 inflammation — an allergic response that can result in decreased lung function. The companies said a second phase three trial of Dupixent in COPD is ongoing, with data expected in 2024. He added that J.P. Morgan expects to see new COPD patients adding $1.5 billion to $2 billion in new sales for Dupixent.
The Food and Drug Administration's independent panel of advisors on Wednesday voted against the effectiveness of Biogen's investigational ALS drug for a rare and aggressive form of the disease. The drug tofersen was developed to treat a rare genetic form of amyotrophic lateral sclerosis, or ALS. That number is even smaller in the U.S., with roughly 330 people affected by the SOD1 mutation. The median survival time from diagnosis with the rare form of ALS to death is 2.7 years, according to the company. The SOD1 mutation is associated with 20% of cases that occur within families.
The Food and Drug Administration's independent panel of advisors on Wednesday declined to endorse accelerated approval of Biogen's investigational ALS drug for a rare and aggressive form of the disease. The drug tofersen was developed to treat a rare genetic form of amyotrophic lateral sclerosis, or ALS. That number is even smaller in the U.S., with roughly 330 people affected by the SOD1 mutation. The median survival time from diagnosis with the rare form of ALS to death is 2.7 years, according to the company. The SOD1 mutation is associated with 20% of cases that occur within families.
Co-funded by the National Institutes of Health, the study released Monday challenges older research that suggested a prior Covid infection enhanced a vaccinated individual's immune response — a phenomenon known as hybrid immunity, which some scientists believe provides the best protection against reinfection. In the study, researchers from Stanford University analyzed how immune cells found in the blood called CD4+ T cells and CD8+ T cells respond to Covid infection and vaccination. The study found that vaccinating people who had never been infected with Covid before produced "robust" CD4+ and CD8+ T cell responses to the virus. Vaccination in those people also generated cell-signaling molecules that recruit other immune cells to help fight Covid, they said. Ray said the study, while interesting, needs to factor in long-term knowledge about how Covid immunity works: "It's probably not the last chapter in this story."
U.S. Food and Drug Administration staff on Monday said Biogen's investigational ALS drug may have a "clinical benefit" on a rare and aggressive form of the disease, despite failing a broader late-stage clinical trial last year. A separate exploratory analysis of the drug suggests "a clinical benefit with a longer duration of treatment," the staff wrote. It also found that tofersen reduced levels of a protein called neurofilament light (NfL,) which is "correlated with disease severity, disease progression rate, and survival in patients with ALS," according to the FDA staff. The first is to move forward with recommending accelerated approval based on tofersen's reduction of NfL in ALS patients. "SOD1-linked ALS is a particularly rare and aggressive form of an already rare and devastating disease," said Dr. Neil Thakur, The ALS Association's chief mission officer.
Biotech company Illumina pushed back Monday against Carl Icahn's proxy fight over the company's acquisition of cancer test developer Grail, saying the activist investor's board nominees "do not add value." "To paraphrase William Shakespeare's Hamlet, something is rotten in the state of Illumina," Icahn wrote. Illumina said winning a jurisdictional appeal would eliminate any potential fine and "gives the greatest optionality for Illumina to maximize value for shareholders." The company also claimed Icahn recognizes the value of Grail to shareholders, pointing to a CNBC interview last week where Icahn referred to Grail as Illumina's "best equipment." Illumina touted Grail in its release, saying it has "tremendous long-term value creation potential."
The World Health Organization on Friday called on China to release new data linking the Covid pandemic's origins to animal samples at Wuhan Market after the country recently took down the research. Researchers from several countries downloaded and analyzed the data before it was removed, and presented their findings to the WHO last weekend. But she said it does establish that animals who can carry Covid were sold at the market, which is "new information." The WHO is pushing for studies to be conducted in other markets in Wuhan and across China, according to Van Kerkhove. She added that the WHO "won't be able to remove different hypotheses" until China reuploads its data.
Sanofi already offers a $35 monthly cap on insulin for uninsured diabetes patients. The company is the last major insulin manufacturer to try to head off government efforts to cap monthly costs by announcing its own steep price cuts for the lifesaving hormone. Eli Lilly and Novo Nordisk made similar sweeping cuts earlier this month after years of political pressure and public outrage over the high costs of diabetes care. President Joe Biden's Inflation Reduction Act capped monthly insulin costs for Medicare beneficiaries at $35, but it did not provide protection to diabetes patients who are covered by private insurance. Approximately 8.4 million diabetes patients rely on insulin, the American Diabetes Association said.
The Food and Drug Administration's independent panel of advisors recommended full approval of Pfizer's Covid-19 antiviral pill Paxlovid for high-risk adults 16-1 on Thursday, but flagged potentially harmful drug interactions. The FDA first made Paxlovid available in December 2021 for emergency use in high-risk individuals ages 12 and up. More than half of Paxlovid-eligible Medicare and Veterans Affairs patients are on medications that have drug interactions with Paxlovid, according to an FDA review of safety surveillance data. Roughly 74% of Paxlovid prescriptions were from adult primary care practitioners who may not be experienced with managing the possible adverse drug interactions, the FDA review added. To complete a full course of the drug, patients must take three Paxlovid pills twice a day for five days.
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. 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. Later this year, Medicare will start negotiating lower prescription drug prices for its beneficiaries.
The U.S. Food and Drug Administration on Tuesday authorized Pfizer's omicron booster shot for kids under five years old who were previously vaccinated with three doses of the company's original vaccine. The new shot is bivalent, meaning it targets the original Covid strain as well as omicron BA.4 and BA.5. Pfizer's primary series for young children consists of three doses, while rival drugmaker Moderna's primary series for that same age group is only two. Since December, children in that age group who completed two doses of Pfizer's original vaccine have been eligible to receive the omicron booster as their third shot, or last dose in their primary series. One month after the children received the omicron booster, they demonstrated an immune response to both the original Covid strain and omicron BA.5 and BA.5
More than 12 million courses of Paxlovid have been delivered to pharmacies across the U.S., according to federal data. The FDA staff reviewed Pfizer's mid-to-late stage clinical trials of Paxlovid. In one trial called EPIC-HR, Paxlovid showed an 86% reduction in the risk of hospitalization or death in high-risk adults who hadn't received a Covid vaccine. Paxlovid has been plagued by reports of "rebound" Covid infections, where patients see their Covid symptoms or a positive test return after finishing a five-day course of the oral drug. That was also regardless of patients' risk of severe disease, or whether Covid's omicron variant or an earlier strain was dominant, according to the staff.
Novo Nordisk Inc. NovoLog brand insulin pens are arranged for a photograph in the Brooklyn borough of New York, U.S., on Friday, April 5, 2019. Novo Nordisk, one of the world's biggest insulin makers, will cut the list price of its NovoLog insulin by 75% and the prices for Levemir and Novolin by 65%, the company said in a press release. NovoLog's list price will fall to $139.71 from $558.83 for a pack of five injection pens. The company also said it plans to reduce the list price of its unbranded insulin products to match the lowered price of each respective branded insulin. Novo Nordisk, Lilly and Sanofi control over 90% of the global insulin market.
Moderna shares jumped by nearly 7% on Wednesday after TD Cowen upgraded the stock, saying the company will "be a leader" in the RSV vaccine market. Cowen pointed to the company's potential RSV vaccine, noting that key opinion leaders believe RSV will be a "three-player vaccine market" between Moderna and drugmakers Pfizer and GSK. Moderna's RSV vaccine performed well in clinical trials and was well tolerated by patients, the note said. Moderna's RSV vaccines for adults ages 60 and older received Breakthrough Therapy Designation from the Food and Drug Administration in late January. Cowen noted that Moderna believes the regulatory support of its competitors' RSV candidates "should read-through" to its own.
Pfizer CEO Albert Bourla on Monday said the pharmaceutical giant will be able to deliver Seagen's cancer therapy to the world "at a scale that has not been seen before" with its $43 billion acquisition. Seagen will bulk up Pfizer's cancer treatment portfolio, bringing four approved cancer therapies with combined sales of nearly $2 billion in 2022. "These medicines are on a strong growth trajectory, with significant lifecycle programs anticipated to drive continued impact uptake and growth," Bourla said on a conference call earlier Monday morning. Seagen expects to generate about $2.2 billion in revenue this year, representing 12% year-over-year growth, according to a Pfizer press release. Pfizer added that Seagen could contribute more than $10 billion in risk-adjusted sales by 2030, "with potential for significant growth" beyond that year.
The virus instantly transformed the holidays, forcing many Americans to break long-standing traditions and grapple with a new reality: Gathering with loved ones can potentially put people's health at risk. Now, nearly three years after the virus first sent the U.S. into lockdowns, are the tides turning back toward pre-pandemic habits — or has Covid permanently changed the way Americans celebrate? This year's Thanksgiving, New Year's and other end-of-the-year festivities may feel like the pre-pandemic holidays for many households. But Covid has still changed the way we celebrate with others, even if we don't fully realize it, experts say — and it's hard to tell whether the holidays will ever fully revert back to how they were before March 2020. Here are three fundamental ways the pandemic has changed the holidays for Americans, from Covid safety and family traditions to who we choose to spend our time with.
It's Annika, and you pronounce it by saying the name "Ann," followed by the name "Nick" and a moment of realization: "Ah." Remembering any name is hard, and it's harder when they're uncommon like mine, so I don't always blame them. My name is closely tied to my identity, and mispronunciations weigh more heavily on me than most people think. Xuenan Lily Hu, a product manager in New York, says she often chooses to go by "Lily" instead of "Xuenan," but she doesn't always like it. "When I choose to go by Lily instead, it makes me feel like I let go of that part of my identity to settle comfortably in conformity."
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