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☆ FDA approves Pfizer’s first gene therapy for rare inherited bleeding disorder
▼ + stars: | 2024-04-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration on Friday approved Pfizer 's treatment for a rare genetic bleeding disorder, making it the company's first-ever gene therapy to win clearance in the U.S. The agency greenlit the drug, which will be marketed as Beqvez, for adults with moderate to severe hemophilia B who meet certain requirements. Without that protein, called factor IX, patients with hemophilia B bruise easily and bleed more frequently and for longer periods of time. The gene therapy will compete with Australia-based CSL Behring's Hemgenix, a similar treatment that won FDA approval for hemophilia B in 2022. The company is also developing a gene therapy for Duchenne muscular dystrophy, a genetic disorder that causes muscles to weaken gradually.

Persons: IX, hemophilia, Adam Cuker, Cuker Organizations: Drug Administration, Pfizer, U.S, Penn's, Spark Therapeutics, hemophilia Locations: U.S, Australia

☆ A CVS Health pharmacy in Vegas becomes first to join new national pharmacy union
▼ + stars: | 2024-04-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

A CVS Omicare pharmacy in Las Vegas has become the first location to join a new national pharmacy union, a milestone as organizers try to help thousands of U.S. pharmacy workers address what they call unsafe working conditions. Nearly 30 pharmacy staff at the Las Vegas branch of CVS's Omnicare won their union election on Thursday by a landslide margin of 87% to 13%. Those workers now join The Pharmacy Guild, which will represent them in labor negotiations with CVS. The Pharmacy Guild will now work to strike a union contract with CVS to address the concerns of Omnicare workers in Las Vegas. The Pharmacy Guild is seeing momentum build in other parts of the country.

Persons: CVS's Omnicare, Shane Jerominski, Jerominski Organizations: CVS, Las, Pharmacy, CNBC, IAM Healthcare, Walgreens, Rite - Locations: Las Vegas, CVS's, Nevada, Rhode Island

☆ Merck beats earnings expectations, raises outlook on strong Keytruda and vaccine sales
▼ + stars: | 2024-04-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Merck on Thursday reported first-quarter revenue and adjusted earnings that topped expectations as it posted strong sales of its blockbuster cancer drug Keytruda and vaccine products. The pharmaceutical giant also raised and narrowed its full-year revenue and adjusted earnings forecasts. Merck now expects 2024 sales to come in between $63.1 billion and $64.3 billion, up from previous guidance of $62.7 to $64.2 billion. That outlook includes a one-time charge of roughly 26 cents per share related to Merck's acquisition of Harpoon Therapeutics in January. Merck raked in $15.78 billion in revenue for the quarter, up 9% from the same period a year ago.

Persons: Merck Organizations: Merck, Harpoon Therapeutics, LSEG Locations: Rahway , New Jersey, U.S

☆ Bristol Myers Squibb beats on revenue, launches $1.5 billion cost cuts as it posts quarterly loss
▼ + stars: | 2024-04-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The Bristol Myers Squibb research and development center at Cambridge Crossing in Cambridge, Massachusetts, US, on Wednesday, Dec. 27, 2023. Bristol Myers Squibb on Thursday reported first-quarter revenue that topped expectations as its blockbuster blood thinner Eliquis and several new drugs posted sales growth. Two-thirds of savings are associated with drug research and development, Bristol Myers Squibb executives said during an earnings call on Thursday. Those deals come as Bristol Myers faces pressure to launch new drugs and offset the potential loss of revenue from top-selling treatments. Shares of Bristol Myers fell more than 1% in premarket trading Tuesday.

Persons: Bristol Myers, Samit Hirawat, Chris Boerner, Boerner, Revlimid Organizations: Bristol Myers Squibb, Bristol Myers, Karuna Therapeutics, SystImmune, Bristol, LSEG Locations: Cambridge, Cambridge , Massachusetts, Here's

☆ Walgreens to help bring cell and gene therapies to patients as it expands specialty pharmacy services
▼ + stars: | 2024-04-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

Walgreens on Thursday said it will start to work directly with drugmakers to bring cell and gene therapies to U.S. patients as part of a broader expansion of its specialty pharmacy services. The company said it is launching a new business unit dedicated to its specialty pharmacy segment, which will include specialty pharmacy subsidiary AllianceRx. Meanwhile, Shields Health Solutions, a subsidiary that supports health system-owned specialty pharmacies, will remain under Walgreens's U.S. health-care division. Specialty pharmacies provide medications that require extreme care in handling, storage and distribution. Among the company's new investments to "transform" its specialty pharmacy services, it will open a newly licensed facility in Pittsburgh dedicated to services for cell and gene therapies.

Persons: drugmakers Organizations: Walgreens, Walgreens Boots Alliance, Shields Health Solutions, Walgreens's Locations: Manhattan , New York City, U.S, Pittsburgh

☆ More than 3 million Medicare patients could be eligible for coverage of Wegovy to reduce heart disease risks, study says
▼ + stars: | 2024-04-24 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

But some eligible beneficiaries could still face out-of-pocket costs for the highly popular and expensive drug, KFF said. Certain Medicare prescription drug plans may also wait until 2025 to cover Wegovy. Medicare's budget could be strained as more plans cover the costs of Wegovy. Among the Medicare beneficiaries who are obese or overweight and have a history of heart disease, 1.9 million also have diabetes, according to KFF. That makes them already eligible for Medicare coverage of other GLP-1 drugs approved for that condition.

Persons: KFF Organizations: Novo Nordisk, Medicare, Drug Administration, Novo Locations: London, Britain, U.S

☆ Biogen tops profit estimates as cost cuts take hold, Alzheimer's drug Leqembi launch picks up
▼ + stars: | 2024-04-24 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Biogen on Wednesday reported first-quarter profit that topped estimates as the company's cost-cutting efforts took hold and sales of its closely watched Alzheimer's drug, Leqembi, came in higher than expected. Biogen and Eisai 's Leqembi became the first drug found to slow the progression of Alzheimer's disease to win approval in the U.S. in July. Leqembi brought in about $19 million in sales for the quarter, up from the $10 million the drug generated last year. In February, Biogen CEO Chris Viehbacher told reporters that there were around 2,000 patients currently on Leqembi. Adjusting for one-time items, the company reported earnings of $3.67 per share.

Persons: Biogen, Leqembi, FactSet, Chris Viehbacher, LSEG Organizations: LSEG Locations: U.S

☆ Most people on weight loss drugs are spending less on restaurants and takeout, survey says
▼ + stars: | 2024-04-20 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Most people taking those medications, called GLP-1s, say they are spending less on eating out at restaurants and ordering takeout, according to a Morgan Stanley survey released on Tuesday. GLP-1s include Novo Nordisk 's blockbuster weight loss injection Wegovy and diabetes counterpart Ozempic, along with Eli Lilly 's popular weight loss treatment Zepbound and diabetes injection Mounjaro. "There is growing evidence that the drugs have a meaningful impact on consumer behavior and spending on groceries and restaurants," Morgan Stanley analysts said in the survey. Those people are "early in their weight loss journey," but are making substantial changes to their diets and spending, according to the firm. Roughly half of people reported cutting consumption of regular sodas, alcohol and salty snacks by 50% or more since starting on weight loss drugs.

Persons: —, Morgan Stanley, Eli Lilly, Hollie Adams, Reuters Morgan Stanley, Morgan Stanley survery Organizations: Washington Post, Novo Nordisk, Reuters, Consumers Locations: Manhattan, London, Britain

☆ Eli Lilly’s weight loss drug Zepbound shows promise as a sleep apnea treatment in late-stage trials
▼ + stars: | 2024-04-17 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City, U.S., December 11, 2023. Eli Lilly on Wednesday said its highly popular weight loss drug Zepbound showed the potential to treat patients with the most common sleep-related breathing disorder in two late-stage clinical trials. Zepbound was more effective than a placebo at reducing the severity of obstructive sleep apnea, or OSA, in patients with obesity after a year, according to preliminary data from both trials. Eli Lilly previously announced that the FDA granted Zepbound "fast track designation" for patients with moderate-to-severe OSA and obesity. Zepbound has slipped into shortages since receiving approval in the U.S. for weight management in November.

Persons: Eli Lilly’s, Eli Lilly, Zepbound, Dr, Jeff Emmick, Eli Lilly's Organizations: U.S . Food, Drug Administration, FDA, OSA Locations: New York City, U.S

☆ Most doses of Eli Lilly's Zepbound, Mounjaro in short supply through June, FDA says
▼ + stars: | 2024-04-17 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City, U.S., December 11, 2023. Most doses of Eli Lilly 's highly popular weight loss drug Zepbound and diabetes counterpart Mounjaro will be in short supply through the second quarter of this year as demand jumps, according to an update on the Food and Drug Administration's drug shortage database on Wednesday. All doses of Zepbound and Mounjaro besides the 2.5-milligram versions of both treatments are in a shortage. "We recognize this situation may cause a disruption in peoples' treatment regimens and areworking with purpose and urgency to help meet the surge in demand," an Eli Lilly spokesperson said in a statement to CNBC. The company expects its investments in manufacturing and supply capacity "to progressively increase production of our medicines throughout 2024 and beyond," they added.

Persons: Eli Lilly’s, Eli Lilly Organizations: Food, Novo Nordisk, CNBC Locations: New York City, U.S

☆ Johnson & Johnson tops quarterly profit estimates as medical device sales jump
▼ + stars: | 2024-04-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

An entry sign to the Johnson & Johnson campus shows their logo in Irvine, California on August 28, 2019. Johnson & Johnson on Tuesday reported first-quarter adjusted earnings that topped Wall Street's expectations as sales in its medical devices business surged. The company reported $21.38 billion in total sales for the first three months of 2024, up more than 2% from the same quarter in 2023. The company now expects sales of $88 billion to $88.4 billion. Separately on Tuesday, J&J said it will increase its quarterly dividend to $1.24 per share, up 4.2% from $1.19 per share.

Persons: Johnson, J Organizations: Johnson, J's, Humana, UnitedHealth, Elevance, LSEG, & $ Locations: Irvine , California

☆ EU probe of weight loss and diabetes drugs like Wegovy, Ozempic finds no link to suicidal thoughts
▼ + stars: | 2024-04-12 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

European Union drug regulators found no evidence that highly popular weight loss and diabetes drugs such as Wegovy and Ozempic are linked to an increased risk of suicidal thoughts and self-injury, the regulator said Friday. The review examined several drugs from Novo Nordisk , including Wegovy and Ozempic. Clinical trials from Novo Nordisk and Eli Lilly have not demonstrated a link between GLP-1s and suicidal thoughts. The probe also included other active ingredients in older weight loss and diabetes drugs, including dulaglutide, exenatide and lixisenatide. Results from another study conducted by the agency also did not support a link between GLP-1 drugs and the risk of suicidal thoughts.

Persons: Eli Lilly, couldn't, Liraglutide Organizations: Novo Nordisk, European Union, European Medicines Agency, U.S . Food, Drug Administration, EMA, Icelandic Medicines Agency Locations: London, Britain, Novo, U.S, GLP, Wegovy, Ozempic

☆ Moderna halts plans to build Kenya vaccine plant as Covid shot demand plunges
▼ + stars: | 2024-04-11 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

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. Moderna's decision aligns with its broader effort to cut costs by resizing its Covid vaccine-manufacturing footprint. Moderna also had plans to start filling doses of its Covid vaccine in the continent as early as 2023. But the company has since determined that demand in Africa "is insufficient to support the viability of the factory planned in Kenya," Moderna said in a statement on Thursday. "This approach will allow Moderna to better align its infrastructure investments with the evolving healthcare needs and vaccine demand in Africa."

Persons: Moderna Organizations: Moderna, Kenyan Locations: Kenya, Africa

But J&J's drug is walking away with a notable edge over its rival. They add more options to a growing arsenal of treatments that have helped improve outcomes for people with multiple myeloma. But the new approvals also give J&J's therapy, which was developed with Legend Biotech, a clear advantage over Bristol Myers's drug. J&J's drug has gradually gained ground over Abecma in the CAR-T market for multiple myeloma, even though it first entered the market a year later. With the new approval on Friday, Jefferies' Shi expects J&J's drug to win the majority of that market share.

Persons: Jonathan Raa, Johnson, Myers's, Bristol Myers, Jefferies, Kelly Shi, Shi, Carvykti, Cantor Fitzgerald, Rick Bienkowski, Kelsey Goodwin, Annika, annikakim.constantino@nbcuni.com Organizations: Nurphoto, Bristol Myers Squibb, Johnson, Food and Drug Administration, FDA, Legend Biotech, Bristol, New York Stock Exchange, NYSE, Reuters, Mount Sinai Hospital, Getty Locations: Bristol, U.S, EU, Japan, Mount Sinai, New York City

☆ Pfizer's RSV vaccine shows potential to protect high-risk adults ages 18-59, widening possible use
▼ + stars: | 2024-04-09 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

A vaccine from Pfizer showed the potential to protect adults ages 18 to 59 who are at increased risk of getting severely sick from respiratory syncytial virus in a late stage clinical trial, the company said Tuesday. The initial data suggests that Pfizer's shot, known as Abrysvo, could help protect a far wider population from RSV. The jab is currently approved in the U.S., Europe, Japan and other countries for adults ages 60 and older and expectant mothers who can pass on protection to their fetuses. Nearly 10% of U.S. adults ages 18 to 49 have a chronic condition that puts them at risk of severe RSV disease, according to Pfizer. GSK's RSV vaccine for adults ages 60 and above booked around £1.2 billion ($1.5 billion) in sales last year.

Persons: Dr, Iona Munjal, Pfizer's Organizations: Pfizer, CNBC, GlaxoSmithKline Locations: U.S, Europe, Japan

☆ Many CVS drug plans will cover over-the-counter birth control pill at no cost
▼ + stars: | 2024-04-04 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

CVS Health on Thursday said its drug plans will cover the first over-the-counter birth control pill in the U.S. at no cost for many health plan sponsors, a decision that could open the door for more people to prevent unintended pregnancies without a prescription. The company's pharmacy benefit manager, CVS Caremark, said the pill will be added to its preventive services oral contraceptives list and will be covered at zero cost for many sponsors. Pharmacy benefit managers, or PBMs, maintain lists of drugs covered by health insurance plans and negotiate drug discounts with manufacturers. It marks the first time that many U.S. residents are able to buy birth control pills over the counter, the same way they would purchase common pills like Tylenol or Advil. The drug could significantly expand availability of contraception, especially for younger women and those in rural and underserved communities who often have trouble getting access to birth control methods.

Persons: Opill, Biden, Wade Organizations: CVS, CVS Caremark, CNBC, Pharmacy, Drug Administration Locations: San Anselmo , California, U.S, Perrigo

☆ Diabetes drug similar to Ozempic helped slow progression of Parkinson's disease in small trial
▼ + stars: | 2024-04-04 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

A highly popular class of drugs for diabetes and obesity is showing early potential to help patients with Parkinson's disease, too. But more research is needed to determine whether newer iterations of GLP-1s from Novo Nordisk and Eli Lilly may also help Parkinson's patients. The trial followed 156 people with early Parkinson's disease for a year. But one group was given an additional daily injection of Sanofi's drug, while the other was given a placebo. But use of Sanofi's drug was associated with an increased risk of gastrointestinal side effects, which are common across all GLP-1s.

Persons: Eli Lilly, Sanofi, drugmaker Organizations: Sanofi, Novo Nordisk, The New England, French Ministry of Health, Prevention, CNBC Locations: Novo, France, The

☆ Health insurer stocks slide as final Medicare Advantage rates disappoint
▼ + stars: | 2024-04-02 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

Shares of U.S. health insurers fell Tuesday after the Biden administration didn't boost payments for private Medicare plans as much as the insurance industry and investors had hoped. Shares of CVS Health fell more than 8% on Tuesday, while UnitedHealth Group 's stock slid nearly 7%. Shares of Elevance Health dropped more than 3% and Centene 's stock fell 6%. Meanwhile, Humana 's stock fell more than 10%. The health-care giant is far more dependent on those private Medicare plans, known as Medicare Advantage, than its rivals.

Persons: Biden, Humana Organizations: Humana Inc, CVS Health, Elevance Health Locations: Louisville , Kentucky, U.S

☆ Walgreens tops quarterly revenue estimates, but narrows profit outlook in 'challenging' economy
▼ + stars: | 2024-03-28 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

A person rides past a Walgreens truck, owned by the Walgreens Boots Alliance, Inc., in Manhattan, New York City, U.S., November 26, 2021. Walgreens on Thursday reported fiscal second-quarter sales that beat Wall Street's expectations, but lowered the high end of its full-year adjusted earnings outlook in part due to a "challenging" retail environment in the U.S. Analysts surveyed by LSEG expect full-year adjusted earnings of $3.24 per share. Walgreens has not provided that guidance since October, when it said it sees $141 billion to $145 billion in sales. aExcluding certain items, including the $5.8 billion non-cash charge related VillageMD, adjusted earnings per share were $1.20 for the quarter.

Persons: Manmohan Mahajan, Tim Wentworth, Mahajan, Wentworth Organizations: Walgreens, Walgreens Boots Alliance, Inc, U.S, LSEG Locations: Manhattan , New York City, U.S

☆ Novo Nordisk's $1,000 diabetes drug Ozempic can be made for less than $5 a month, study suggests
▼ + stars: | 2024-03-27 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

The blockbuster diabetes drug Ozempic could be manufactured for less than $5 a month, even as Novo Nordisk charges close to $1,000 per month for the injection in the U.S. before insurance, a study released Wednesday suggests. The study also comes after years of political pressure on Novo Nordisk and other drugmakers to slash high costs of diabetes care, especially insulin. Ozempic can generally be produced for less than various forms of insulin, according to the study published in JAMA Network Open. Novo Nordisk's list price for a monthly package of Ozempic is $935.77 before insurance and other rebates. In a statement on Wednesday, Novo Nordisk declined to provide production costs for Ozempic and its weight loss drug counterpart Wegovy.

Organizations: Nordisk, Yale University, King's College Hospital, Novo Nordisk, JAMA, Ozempic, University of Liverpool Locations: U.S, London

☆ Moderna moves three vaccines into final stage trials as it works to rebound from Covid slump
▼ + stars: | 2024-03-27 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Moderna has more to offer beyond its Covid vaccine. The update brings Moderna a step closer to having multiple products on the market, which it badly needs amid plunging demand for Covid shots worldwide. Moderna will chart its post-Covid future Wednesday during its fifth annual "Vaccines Day," an investor event in Boston focused on the company's vaccine portfolio. That includes its combination vaccine against Covid and the flu and a shot against another common herpes virus called cytomegalovirus, or CMV. It also includes a new and improved version of Moderna's Covid shot.

Persons: norovirus, Barr, Moderna, Blackstone, Stéphane Bancel Organizations: Moderna, Epstein, Covid, Blackstone Life Sciences, Blackstone Group Locations: Boston, U.S

☆ Altimmune says weight loss drug minimized muscle loss in trial results, which may set it apart
▼ + stars: | 2024-03-27 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Some health experts have said that obesity drugs could shrink critical muscle mass, which could raise the risk of injuries and decrease strength. Those results are similar to those often seen with diet and exercise programs for weight loss. "There is a growing appreciation that the quality of weight loss is as important as the quantity of weight loss." For example, Eli Lilly is testing whether combining its weight loss drug with a monoclonal antibody from Versanis Bio might help patients lose weight while preserving muscle mass. The pharmaceutical giant recently acquired Versanis, which is part of a slate of companies targeting the muscle-loss aspect of weight loss.

Persons: Altimmune, Eli Lilly, Scott Harris Organizations: Novo Nordisk, Novo Nordisk's Ozempic Locations: Altimmune's, Novo

☆ Viking Therapeutics stock jumps more than 25% on promising weight loss pill data
▼ + stars: | 2024-03-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Viking Therapeutics shares jumped more than 25% on Tuesday after the company said its experimental weight loss pill showed positive results in a small study and will enter the next stage of development later this year. The study results add to the excitement around the drugmaker's prospects in the budding weight loss drug market. Based on Tuesday's results, Viking plans to start a phase two trial of its weight loss pill later this year. Weight loss for those patients ranged up to 3.6% higher than those who received a placebo. Viking CEO Brian Lian said during a conference call on Tuesday that it's unclear "how durable" the weight loss is.

Persons: Eli Lilly, Viking, Brian Lian Organizations: Viking Therapeutics, Novo Nordisk, Viking

☆ Moderna says new Covid vaccine showed stronger immune response than current shot in study
▼ + stars: | 2024-03-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Moderna on Tuesday said a new version of its Covid vaccine triggered a stronger immune response against the virus than its current shot in a late-stage trial. Moderna's current Covid vaccine, known as Spikevax, is its only commercially available product. The biotech company's new shot could offer a longer shelf life and easier storage than its Covid vaccine. The company will accomplish that by shortening the length of the mRNA strand in the vaccine, Moderna previously told CNBC. The company's shot against respiratory syncytial virus is expected to win Food and Drug Administration approval in May.

Persons: Moderna Organizations: Moderna, Pfizer, CNBC, subvariants, Food, Drug Locations: U.S, Canada, Covid

☆ FDA approves Merck's drug for rare, deadly lung condition
▼ + stars: | 2024-03-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The Food and Drug Administration on Tuesday approved a drug from Merck designed to treat a progressive and life-threatening lung condition in a win for both the drugmaker and for patients suffering from the rare disease. The condition refers to when the small blood vessels in the lungs narrow. He noted that the drug will be a "paradigm shift" for patients living with PAH. That includes reducing the risk of death or worsening of the condition by 84% compared to an existing drug alone. Those trials include late-stage studies on patients with more advanced PAH disease, and those who are within the first year after diagnosis.

Persons: Chris Schott, Eliav Barr, PAH, Barr, Merck Organizations: Merck, Drug Administration, JPMorgan, CNBC, Acceleron Pharma Locations: Rahway , New Jersey, U.S, Winrevair

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