Posts

Showing posts with the label BiotechandPharmaceuticals

FDA advisors raise doubts about seasonal updates to Covid vaccines as with flu shots

Image
[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

Healthy Returns: Higher medical costs are pinching insurers

Image
[ad_1] A UnitedHealth Group health insurance card is seen in a wallet, Oct.14, 2019. Lucy Nicholson | Reuters Good afternoon! Health insurers are feeling the squeeze as older patients head to the doctor more than expected. CVS , which owns health insurer Aetna, on Wednesday  slashed its full-year profit outlook , citing the potential for higher medical costs to bite into its profits. That warning came two weeks after insurance giant  Humana  cited the same factor as it issued a  dismal 2024 earnings guidance . Medical costs from Medicare Advantage patients have  spiked over the last year  as more older adults return to hospitals to undergo procedures they had delayed during the Covid pandemic, such as joint and hip replacements.  Medicare Advantage , a type of privately run health insurance plan contracted by Medicare, has long been a key source of growth and profits for the insurance industry.  More than half  of Medicare beneficiaries are enrolled in such plans, enticed by lower

Patients on Alzheimer's drug Leqembi see benefits over three years, Eisai study says

Image
[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

Democratic attorneys general sue FDA to drop all remaining restrictions on abortion pill

Image
[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

Prescriptions for Eli Lilly’s new weight-loss drug get off to a strong start and confirm bright outlook

Image
[ad_1] The launch of Eli Lilly 's weight-loss drug Zepbound — a key pillar of our investment thesis in the pharmaceuticals giant — is going swimmingly in the U.S., Jefferies said Friday. Weekly Zepbound prescriptions totaled 7,700 in the week ended Dec. 8, its fourth on the U.S. market, according to Jefferies, which cited data compiled by health-care analytics firm IQVIA. That is more than Novo Nordisk 's Wegovy — currently the most popular obesity drug in the country — had in its fourth week after being approved in 2021, Jefferies concluded. "Zepbound has shown strong launch momentum in the weeks following its first prescription recorded," the analysts wrote in a research note. That's an encouraging finding for investors, given it will be more than a month before Eli Lilly reports earnings with formal revenue contributions from its much-hyped obesity drug. The Club holding typically reports fourth-quarter results in late January or early February. To be sure

Health-care ETFs tend to rise around next week's annual JPMorgan conference. Here's what to know

Image
[ad_1] Next week is one of the biggest of the year for health-care investors, and it has historically been a good time to own ETFs that track the industry. The 2023 JPMorgan Health Care Conference is set to kick off next Monday in San Francisco. The event features keynote speeches from the CEOs of Sage Therapeutics and Eli Lilly , as well as presentations from dozens of other health-care and biotech companies. The conference typically sees many companies preannounce quarterly results, revise outlooks and update investors about clinical trials. While those updates can break both ways for individual companies, they have recently been good news for the sector as a whole. Over the past five years, many of the biggest ETFs in health care and biotech have seen an average positive return in the first half of January, when the conference is typically held. The three funds below — the SPDR S & P Biotech ETF (XBI) , the Health Care Select Sector SPDR Fund (XLV) and the iShares U.S. Medi

AI, wearables and more — these markets are booming as the world ages. The pros share 4 stock picks

Image
[ad_1] The world is aging rapidly, and there are more and more ways to invest in this theme. Shams Afzal, managing director at Carnegie Investment Counsel, noted that 17% of the U.S. population is now over the age of 65, and that proportion is expected to grow higher. And the demographics of that age group is changing. There's been a "marked jump" in education levels — just 5% of those aged above 65 were degree holders in 1950, much lower than the 29% in 2018, Afzal said, citing Population Reference Bureau statistics. The gender gap in terms of mortality has also narrowed, from seven years in 1990 to five years in 2017, he said. "The aging population discussion in recent years has mostly revolved around future challenges to labor productivity and its economic growth implications," he said. "We see meaningful efforts by companies large and small, working to enhance the quality of life for individuals in this age group," Afzal, also a portfolio mana

Moderna halts plans to build Kenya vaccine plant as Covid shot demand plunges

Image
[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

U.S. will require airline passengers traveling from China to test negative for Covid

Image
[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

Healthy Returns: Drugmakers are racing to develop more convenient weight loss pills

Image
[ad_1] Aykut Karahan | Istock | Getty Images Think a friend or colleague should be getting this newsletter? Share  this link  with them to sign up. Good afternoon! Several drugmakers are hurrying to capitalize on one of the next major innovations coming to the booming weight loss drug market: effective, convenient and potentially affordable obesity pills.  Most of the weight loss and diabetes drugs available now are weekly injections, such as Novo Nordisk's Wegovy and Ozempic and Eli Lilly's Zepbound and Mounjaro. They are among medications called GLP-1 agonists, which have skyrocketed in popularity over the last year.  Now these rivals and other drugmakers such as Pfizer are hoping to develop oral weight loss and diabetes drugs that are more convenient for patients to take and easier to manufacture at scale. That development may help alleviate the supply shortages plaguing the existing injectable treatments in the U.S. Pills are also typically cheaper than injections, b

Hurricane Idalia barrels toward Georgia after hitting Florida coast, leaving at least two dead

Image
[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

North Carolina lawmakers intervene to defend abortion pill restrictions in case testing FDA power

Image
[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

Blocking FDA approval of abortion pill could stifle innovation in the biopharma industry, experts say

Image
[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

FDA approves GSK's RSV vaccine for older adults, world's first shot against virus

Image
[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