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☆ GSK says RSV vaccine for older adults provides protection over two seasons
▼ + stars: | 2023-06-21 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

GlaxoSmithKline on Wednesday said its vaccine to protect adults ages 60 and older from respiratory syncytial virus, or RSV, remained effective across two seasons of the disease. The shot was also 78.8% effective against severe RSV disease after two seasons, compared with 94% after one season. The London-based company said high efficacy was similarly maintained in older adults with underlying conditions, who are most at risk of severe RSV. The committee will form a recommendation on when and how often the company's RSV shot — and a vaccine from rival Pfizer — should be administered in the U.S. Pfizer's RSV shot became the second to win approval shortly after.

Persons: —, drugmaker Organizations: GlaxoSmithKline, Northern Hemisphere, GSK, Pfizer, Centers for Disease Control, CDC, U.S, The, Drug Administration Locations: London

☆ Novo Nordisk sues clinics allegedly selling knockoff versions of Ozempic and Wegovy
▼ + stars: | 2023-06-20 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Novo Nordisk on Tuesday sued five medical spas and wellness clinics for allegedly selling cheaper, unauthorized versions of the company's weight loss drugs Ozempic and Wegovy. The suits accused the spas and clinics of marketing and selling "compounded" drug products that claim to contain semaglutide, the active ingredient in both Ozempic and Wegovy. Novo Nordisk asked the courts for orders blocking the sales of the unauthorized drugs and an unspecified amount of money damages. The spas and clinics named in the lawsuits include Pro Health Investments, Champion Health & Wellness Clinics and Flawless Image Medical Aesthetics. The FDA last month warned about the safety risks of unauthorized versions of Ozempic and Wegovy after reports emerged of adverse health reactions to compounded versions of the drugs.

Persons: Ozempic, Danish drugmaker, didn't Organizations: Novo Nordisk, CNBC, Food and Drug Administration, Pro Health Investments, Health, Wellness, Effinger, Ekzotika Corp, FDA Locations: Los Angeles , California, Danish, New York , Texas, Florida, Tennessee

☆ Pfizer, Moderna and Novavax gear up for fall Covid vaccine rollout with an important head start
▼ + stars: | 2023-06-20 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

But facing pressure to deliver new shots by the fall, Pfizer, Moderna and Novavax began development on versions of their vaccines targeting XBB.1.5 months before the FDA's decision. That doesn't include Johnson & Johnson , a once-leading Covid vaccine developer. Moderna expects a minimum of $5 billion in revenue from its Covid vaccine, its only available product. The cash-strapped company won U.S. approval for its Covid vaccine under emergency use just last year due to regulatory and manufacturing delays. The company hopes to rake in $1.06 billion to $1.24 billion in sales of its Covid vaccine this year.

Persons: Novavax, Dr, Melinda Wharton, Johnson Organizations: Chicago Department of Public Health, Southwest Senior Center, The U.S . Food, Pfizer, Moderna, FDA, Centers for Disease Control, National Center, Manufacturers, U.S, Moderna's Locations: COVID, Chicago , Illinois, The U.S, Novavax, U.S

☆ Eli Lilly to acquire Dice Therapeutics for $2.4 billion in autoimmune treatment push
▼ + stars: | 2023-06-20 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

Eli Lilly on Tuesday said it struck a $2.4 billion deal to acquire Dice Therapeutics in a bid to bulk up its treatment portfolio for immune-related diseases. Dice Therapeutics' share price jumped more than 37% to just under the purchase price. Auto-immune diseases can causes pain, fatigue, dizziness, depression and rashes, among other symptoms. There are more than 100 known autoimmune diseases, including lupus, rheumatoid arthritis, Crohn's disease and ulcerative colitis. Eli Lilly's immunology portfolio includes drugs like Taltz, which treats plaque psoriasis, and Olumiant, a treatment for rheumatoid arthritis.

Persons: Eli Lilly, Eli Lilly's, Patrik Jonsson, Eli, Taltz Organizations: Dice Therapeutics Locations: Francisco

☆ FDA recommends that updated Covid shots target omicron subvariant XBB.1.5 this fall
▼ + stars: | 2023-06-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

The U.S. Food and Drug Administration on Friday recommended that Covid vaccine manufacturers make single-strain shots for the fall that target omicron subvariant XBB.1.5, the dominant strain of the virus nationwide. XBB.1.5 is a descendant of the omicron variant, which caused cases in the U.S. to spike to record levels early last year. That panel unanimously voted that new jabs should be monovalent and target a member of the XBB family. The three companies have already been developing updated versions of their shots that target XBB.1.5. Dr. Peter Marks, head of the FDA's vaccine division, suggested Thursday that the updated vaccines could be available to the public around September.

Persons: Novavax, Peter Marks Organizations: . Food, Drug Administration, FDA, Pfizer, Moderna, Centers for Disease Control, Advisors, CNBC Locations: U.S

☆ FDA advisors raise doubts about seasonal updates to Covid vaccines as with flu shots
▼ + stars: | 2023-06-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

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. But the original voting question included language about whether the panel recommends a "periodic update" to Covid shots. But several advisors cautioned against calling Covid seasonal like the flu. "It's not clear to me that this is a seasonal virus yet," said Henry Bernstein, a pediatrician at Cohen Children's Medical Center. In response to the advisors, FDA's Marks emphasized that Covid shots will likely require another update "at some point."

Persons: Peter Marks, Arthur Reingold, Henry Bernstein, Mark Sawyer, Sawyer, FDA's Marks Organizations: Union Station, The U.S . Food, University of California, Children's Medical Locations: Los Angeles , California, The U.S, Berkeley, U.S, San Diego

☆ FDA advisors recommend that new Covid vaccines target an omicron XBB variant this fall
▼ + stars: | 2023-06-15 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The committee unanimously voted that the new jabs should be monovalent — meaning they are designed to protect against one variant of Covid — and target a member of the XBB family. Those strains of Covid are descendants of the omicron variant, which caused cases to surge to record levels early last year. Advisors also generally agreed that the new shots should specifically target a variant called XBB.1.5. There is also uncertainty about which age groups the FDA and CDC will advise to receive the updated shots this fall. But it's unclear how many Americans will roll up their sleeves to take the updated shots later this year.

Persons: Melinda Wharton, Novavax, John Jacobs, Peter Marks, David Kaslow Organizations: . Food, Centers for Disease Control, Advisors, Pfizer, Moderna, National Center, FDA, CDC, Novavax, omicron Locations: U.S, Novavax

☆ Health insurance stocks slide after UnitedHealth warns more surgeries will drive up medical costs
▼ + stars: | 2023-06-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

Health insurer stocks dropped on Wednesday after UnitedHealth Group warned of higher medical costs as older Americans start to catch up on surgeries they delayed during the Covid pandemic. Shares of UnitedHealth, the largest U.S. healthcare provider by market value, closed around 6% lower. Elevance Health closed roughly 7% lower, and CVS Health , which owns the insurer Aetna, slid nearly 8%. The company has recorded "strong outpatient care activity" throughout April, May and the early part of June, CFO John Rex said at a Goldman Sachs healthcare conference. Shares of medical device manufacturers Medtronic and Stryker jumped 2.5% and 4%, respectively, after UnitedHealth's remarks.

Persons: UnitedHealth, John Rex, Goldman Sachs, Medicare enrollees, Rex, Timothy Noel, Stryker, UnitedHealth's Organizations: UnitedHealth, Medicare, Humana, Elevance Health, CVS Health, Aetna, Insurance, Goldman, Healthcare, Tenet Healthcare

☆ Covid vaccine maker Novavax sees a pathway to survival – but it won’t be easy
▼ + stars: | 2023-06-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +10 min

Jakub Porzycki | NurPhoto | Getty ImagesNovavax has a clear message for Wall Street: The cash-strapped Covid vaccine maker sees a pathway to survival. The 36-year-old company will continue to rely on its protein-based Covid vaccine – its only commercially available product – for most of its revenue this year. Once the U.S. government's supply of free Covid vaccines runs out, all three companies will sell updated shots directly to health-care providers. A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands. But Taylor emphasized that the plan will help Novavax refocus on its top priority: delivering an updated vaccine in the coming months.

Persons: Jakub Porzycki, Novavax, Covid, Cowen, Brendan Smith, John Jacobs, Smith, that's, Silvia Taylor, Taylor, Jefferies, Roger Song, Patrick Van Katwijk, Mayank Mamtani, let's, Mamtani, Let's, Song, Ding Genhou Organizations: NurPhoto, Getty, Pfizer, Moderna, CNBC, Food and Drug Administration, World Health Organization, FDA, Dutch Health Service Organization, Riley Securities, U.S, Centers for Disease Control, CDC, Reuters, Visual China Locations: Krakow, Poland, Maryland, U.S, The Hague, Netherlands, Moderna, Geneva, Hohhot, Inner Mongolia Autonomous Region, China

☆ Illumina acquisition of Grail wins support from GOP lawmakers, state AGs as FTC tries to block it
▼ + stars: | 2023-06-13 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Republican lawmakers, state attorneys general and several advocacy groups have voiced their support for Illumina's acquisition of cancer-test developer Grail while the Federal Trade Commission fights to unwind the deal. The groups filed 14 amicus briefs Monday urging the U.S. 5th Circuit Court of Appeals to reverse an FTC order that would have Illumina undo the $7.1 billion Grail deal over concerns that it stifles competition. Thirty-four Republican lawmakers touted Grail's early screening test, which can detect more than 50 types of cancers through a single blood draw. And activist investor Carl Icahn, who holds a 1.4% stake in Illumina, launched a proxy fight with the company over the Grail deal. Icahn's opposition stemmed from Illumina's decision to close the acquisition without first gaining approval from antitrust regulators.

Persons: Illumina, Carl Icahn, Francis deSouza Organizations: Federal Trade Commission, U.S, FTC, Food and Drug Administration, European Commission Locations: San Diego, Alaska , Arkansas, Georgia , Idaho , Indiana , Iowa , Kentucky, Louisiana , Nebraska, South Carolina , Utah, Virginia, Illumina

☆ Eli Lilly CEO says Medicare price negotiations could harm drug development
▼ + stars: | 2023-06-13 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

Eli Lilly CEO David Ricks on Tuesday said Medicare price negotiations, which aim to cut costs for older Americans, could potentially harm drug development. "I'm really worried about the harm this will do to new cures and possibilities in medicine," Ricks said in an interview on CNBC's "The Exchange." He's the latest pharmaceutical executive to publicly blast the provision and law at large, which will likely reduce company profits. Global drugmaker Merck last week sued the Biden administration over Medicare price negotiations in a bid to weaken the program. Under the IRA provision, Medicare can start negotiating prices on small-molecule drugs as early as nine years after they receive Food and Drug Administration approval, compared with 13 years for biologics.

Persons: Eli Lilly, David Ricks, I'm, Ricks Organizations: Biden, Global drugmaker Merck, Drug Administration

☆ Bernie Sanders vows to oppose NIH nominee until Biden delivers plan to lower drug prices
▼ + stars: | 2023-06-13 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Sen. Bernie Sanders vowed to oppose President Joe Biden's pick to lead the National Institutes of Health – and any other health nominee – until the administration delivers a plan to lower prescription drug prices. Sanders, who chairs the Senate Health Committee, controls when his panel reviews nominees for the Department of Health and Human Services. A provision of the act penalizes drugmakers for charging prices that rise faster than inflation for people on Medicare. Lawmakers, researchers and advocates have repeatedly warned that drug prices in the U.S. outpace those in other nations and ultimately harm Americans who need to access lifesaving treatments. A provision of the act penalizes drugmakers for charging prices that rise faster than inflation for people on Medicare.

Persons: Bernie Sanders, Joe Biden, Sen, Joe Biden's, –, Sanders, Biden, Monica Bertagnolli Organizations: Capitol Hill, National Institutes of Health, Washington Post, Health, Department of Health, Human Services, National Cancer Institute, White House, Post, Medicare, Lawmakers, Democratic, NIH Locations: Washington, Vermont, U.S

☆ Updated Covid vaccines need to target XBB omicron variants this fall, FDA staff says
▼ + stars: | 2023-06-12 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

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. That means all three companies will start selling their updated Covid shots directly to health-care providers. The FDA staff's decision comes weeks after an advisory group to the World Health Organization recommended that Covid booster shots target XBB variants. Scientists have said that XBB strains are some of the most immune-evasive subvariants to date. Last year's Covid boosters were bivalent, meaning they targeted the original strain of the virus and omicron variants BA.4 and BA.5.

Organizations: . Food, Drug Administration, FDA, Pfizer, Moderna, World Health Organization, Moderna's, Centers for Disease Control Locations: U.S

☆ Illumina shareholders oust board chair, CEO survives Carl Icahn proxy battle
▼ + stars: | 2023-05-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

Activist investor Carl Icahn on Thursday won enough support from Illumina shareholders to oust the biotech company's board chair. Icahn had urged shareholders to vote off the company's CEO, Francis deSouza, and Thompson from the nine-member board. Shareholders also voted to install one of Icahn's three board nominees, Andrew Teno, a portfolio manager at Icahn Capital LP, an entity where Icahn manages investment funds. Earlier this month, proxy advisory firm Institutional Shareholder Services recommended that Illumina shareholders back Teno. Icahn, who owns a 1.4% stake in San Diego-based Illumina, had proposed two other director candidates who are his current or former employees.

☆ FDA grants full approval to Pfizer Covid treatment Paxlovid for high-risk adults
▼ + stars: | 2023-05-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +5 min

The Food and Drug Administration on Thursday granted full approval to Pfizer's Covid antiviral pill, Paxlovid, for adults who are at high risk of getting severely sick with the virus. The FDA first made Paxlovid available in December 2021 under emergency use authorization for high-risk individuals ages 12 and up. Both Pfizer and the FDA view the treatment as an important complementary tool to vaccination that can help high-risk Americans manage their Covid infections and ultimately save lives. For some doctors, another area of concern is Paxlovid "rebound cases." That's when patients who take the treatment see their Covid symptoms return or test positive shortly after they initially recover.

☆ Here’s what Pfizer and Moderna say is next for their Covid vaccines
▼ + stars: | 2023-05-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +9 min

Scott Olson | Getty ImagesThree years and billions of Covid vaccinations into the pandemic, Pfizer and Moderna say their work is far from over. Here's what Moderna and Pfizer say is next for their Covid shots. Annual Covid shotsPfizer and Moderna aim to keep up with a shift in the U.S. toward annual Covid shots rather than frequent booster doses. Miller, who helped lead the development of Moderna's Covid shot in 2020, said the advantages of using mRNA became evident earlier on in the pandemic. 'Next-generation' Covid shotsPfizer's and Moderna's Covid vaccines both deliver robust protection against the virus, but that immunity can start to fade after four to six months.

☆ Pfizer oral weight loss drug may be as effective as, quicker than Ozempic injection by Novo Nordisk, study says
▼ + stars: | 2023-05-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

An oral drug made by Pfizer causes a similar amount of weight loss as, and works quicker than, rival Novo Nordisk 's blockbuster injection Ozempic, according to results from a phase two clinical trial released Monday. The results suggest danuglipron may be as effective for weight as Ozempic over a shorter period of time. New York-based Pfizer is the latest pharmaceutical company to dip into the blockbuster weight loss drug market. Novo Nordisk's Ozempic and Wegovy catapulted to the national spotlight in recent years for being weight loss "miracles." But experts say the medicines may further perpetuate a dangerous diet culture that idealizes weight loss and thinness.

☆ FDA advisors recommend Pfizer’s RSV vaccine for infants but raise safety concerns
▼ + stars: | 2023-05-18 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration's independent panel of advisors on Thursday recommended full approval of Pfizer's vaccine that protects infants from RSV, but raised safety concerns over premature births that may be tied to the shot. Ten of the advisors said the safety data on Pfizer's shot was adequate, while four said it was not. The FDA earlier this month approved the first RSV shot for adults ages 60 and older from GlaxoSmithKline. The agency is expected to make a decision within weeks on Pfizer's other RSV shot for that same age group. Pfizer's shot for infants is administered to expectant mothers in the late second or third trimester of their pregnancy.

☆ Horizon Therapeutics says Amgen deal could close earlier than planned if FTC fails to block it
▼ + stars: | 2023-05-18 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Horizon Therapeutics expects its $27.8 billion sale to Amgen to close as early as the end of the third quarter, earlier than previously planned — if the Federal Trade Commission's attempt to block the deal fails — according to a document filed Thursday with the Securities and Exchange Commission. The FTC on Tuesday filed a lawsuit in Illinois federal court seeking to halt the acquisition, arguing it would "stifle competition" in the pharmaceutical industry. Horizon's estimate is earlier than when the companies and Wall Street analysts were initially expecting the deal to close after the FTC sued. If completed, the deal would give Amgen access to Horizon's blockbuster thyroid eye disease drug, Tepezza, and its gout medicine, Krystexxa. The agency said the deal would allow Amgen to "entrench the monopoly positions" of those two fast-growing drugs from Horizon.

☆ NJ Gov. Murphy would consider defying Supreme Court if justices back abortion pill ban
▼ + stars: | 2023-05-17 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Phil Murphy on Wednesday said he would consider defying the Supreme Court and continue to provide mifepristone if the court rules in favor of a ban on the abortion pill. When asked if the state would prescribe mifepristone after such a ruling, Murphy told MSNBC: "To be determined." It's going to cost them health, it's also going to cost peoples' lives, women in particular sadly. That's what's at stake, we'll do whatever it takes to save lives," said Murphy, a Democrat. The case hinges on whether the Food and Drug Administration's approval of the abortion pill should be rolled back.

☆ Pfizer to raise $31 billion in debt offering to fund Seagen acquisition, SEC filing shows
▼ + stars: | 2023-05-17 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

A logo for Pfizer is displayed on a monitor on the floor at the New York Stock Exchange, July 29, 2019. Pfizer plans to raise $31 billion through a debt offering to fund its proposed acquisition of cancer drugmaker Seagen , for what would be its largest takeover since 2009, according to a new filing with the Securities and Exchange Commission. Pfizer expects to complete the $43 billion Seagen buyout later this year or in early 2024. The debt offering is expected to close on May 19, according to a prospectus supplement New York-based Pfizer filed with the SEC late Tuesday. The pharma giant's debt offering would be the biggest since CVS Health sold $40 billion of bonds in 2018 to finance its acquisition of health insurer Aetna.

☆ Pfizer RSV vaccine for infants has 'generally favorable' safety data, FDA staff say
▼ + stars: | 2023-05-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

U.S. Food and Drug Administration staff on Tuesday said Pfizer's vaccine that protects infants from respiratory syncytial virus has "generally favorable" safety data. The agency is expected to make a decision within weeks on Pfizer's other RSV shot for that same age group. Pfizer's RSV vaccine that protects infants is administered to expectant mothers in the late second or third trimester of their pregnancy. Some of the participants' children also had low birth weights, the staff review said. But the FDA staff said it is unlikely that those deaths are related to Pfizer's shot.

☆ Horizon Therapeutics stock plunges on report FTC is preparing to block Amgen deal
▼ + stars: | 2023-05-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

Horizon Therapeutics ' stock price plunged more than 17% in premarket trading Tuesday after a report that the Federal Trade Commission is preparing to file a lawsuit to block the biotech company's $27.8 billion sale to Amgen . The FTC could sue to stop the acquisition as soon as Tuesday, Bloomberg reported, citing an unnamed source. An Amgen spokesperson told CNBC the company isn't aware of any decision made by the FTC. Representatives for Horizon Therapeutics did not immediately respond to a request for comment from CNBC. Thousand Oaks, California-based Amgen struck the deal to buy Horizon Therapeutics in early December and said it expected to complete the sale in the first half of this year.

“If you can understand the role, the protein structure and role, now you can start developing drugs around that,” Maniar said. Scientists can take around 12 months just to identify a biological target, according to the National Center for Biotechnology Information. Google Cloud’s suite has a three-pronged approach for making that process more efficient. The final component of Google Cloud’s suite helps researchers identify how the protein’s structure interacts with different molecules. But Renger said the company will be able to weed out molecules faster using Google Cloud's suite.

☆ Here's why Covid vaccines will still be free for uninsured Americans as public health emergency ends
▼ + stars: | 2023-05-12 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Vanessa Leroy | Bloomberg | Getty ImagesBut the vast majority of Americans will not have to pay out of pocket for Covid vaccines even after the federal government's stockpile runs out. Insured Americans will be able to access Covid shots as part of their coverage, without having to pay out of pocket. Under the arrangement, the CDC will continue to purchase Covid vaccines at a discount and distribute them through 64 state and local health departments. That HHS effort will leverage the "public commitments" by drug manufacturers to provide free Covid vaccines and treatments to uninsured people. Pfizer and Moderna have not said whether they would supply free shots to pharmacies.

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