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☆ Novo Nordisk: trial data of oral weight-loss drug comparable to Wegovy
▼ + stars: | 2023-05-22 | by ( Louise Rasmussen | ) www.reuters.com time to read: +3 min

The results are another boost for Novo Nordisk whose weekly Wegovy injection has transformed the weight-loss market since its U.S. launch in June 2021, capturing the attention of patients, investors and even celebrities worldwide. The Danish drugmaker said in a statement that the headline results were statistically significant and showed superior weight loss when compared to a placebo. A global launch of the oral 50 milligram (mg) semaglutide drug is contingent on portfolio prioritisations and manufacturing capacity, the company added without giving further details. The results are comparable to the company's Wegovy injection, said Martin Holst Lange, head of development at Novo Nordisk. Novo Nordisk has had supply issues and struggled to keep up with soaring U.S. demand for Wegovy.

☆ 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.

Catalent, one of the top contract manufacturers for pharmaceutical companies, said a drop in revenue from COVID vaccine manufacturing had coincided with higher-than-expected costs and production challenges at its facilities in Indiana and in Brussels. Adding to woes, its cost-cutting plans have been delayed due to regulatory inspections and subsequent corrective actions, the company said. Despite Friday's gain in shares, Catalent's stock is down 19% since it first disclosed production challenges at its three major production plants in April. Catalent cut its full-year revenue to a range of $4.25 billion to $4.35 billion, from its prior forecast of $4.63 billion to $4.88 billion. It also slashed its annual adjusted net income forecast to between $187 million and $228 million, from between $567 million and $648 million previously.

☆ Catalent cuts annual forecast hurt by operational challenges
▼ + stars: | 2023-05-19 | by ( ) www.reuters.com time to read: +2 min

May 19 (Reuters) - Catalent Inc (CTLT.N) cut its full-year net revenue and profit forecast on Friday, reflecting operational challenges and higher-than-expected costs after it flagged an over $400 million hit to both its annual sales and core profit forecasts earlier this month. The contract drug manufacturer now sees its full-year revenue in the range of $4.25 billion to $4.35 billion compared with its prior forecast of $4.63 billion to $4.88 billion. Catalent said it now sees adjusted net income for the year in the range of $187 million to $228 million, compared with the previous forecast of $567 million to $648 million. Shares of Catalent reversed losses to be up 7.7% at $34.63 before the bell. Reporting by Bhanvi Satija, Sriparna Roy and Pratik Jain in Bengaluru; Editing by Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.

☆ Analysts say these 11 top-performing stocks are set to soar even more — giving one over 85% upside
▼ + stars: | 2023-05-18 | by ( Weizhen Tan | ) www.cnbc.com time to read: +2 min

The year is nearing its halfway mark, and global stocks have been doing much better than they had in volatile 2022. CNBC Pro screened for stocks that are beating the market nearly halfway into the year — and that analysts love. Only one stock had a 100% buy rating: Japan's Kansai Electric Power Company , a nuclear electric power generation firm. U.S. semiconductor firm Onsemi also made the screen, with analysts giving it 28% potential upside and a nearly 60% buy rating. Italian bank UniCredit had the highest potential upside in the list, at 85%, on top of a decent 88% buy rating.

☆ US FDA staff flag 'serious' safety risks for Intercept's NASH treatment
▼ + stars: | 2023-05-17 | by ( ) www.reuters.com time to read: +2 min

The U.S. Food and Drug Administration's (FDA) briefing document highlighted increased risk of diabetes and liver injury from using the obeticholic acid (OCA) oral tablets for the treatment of nonalcoholic steatohepatitis (NASH). "During the course of our review, FDA identified modest benefits and serious risks of OCA for treatment of NASH," the staff said in the document and listed increased risk of sludge formation in the gall bladder and imbalance of certain lipids. The staff asked the regulator's panel of outside advisors, who are meeting on Friday, to consider whether the modest benefits from using the drugs for NASH treatment outweigh the serious risks associated with it. The panel's meeting on Friday is the first such meeting for a NASH treatment. However, due to risks of serious liver injury, FDA restricted its usage in 2021 to primary biliary cholangitis patients with advanced cirrhosis, or severe liver scarring.

☆ Citi names its top biotech and pharma stock picks, giving one nearly 90% upside
▼ + stars: | 2023-05-17 | by ( Weizhen Tan | ) www.cnbc.com time to read: +2 min

The healthcare sector outperformed in Europe, India and China last month, according to Citi, which named its top picks worldwide. It gave Amylyx a price target of $53, giving it upside of around 88% from current levels. It gave Beam a price target of $60, implying upside of around 67%. Other European picks from Citi include Swiss healthcare company Roche and British pharma and biotech firm AstraZeneca . Asia stocks In Asia, Citi named Japanese pharmaceutical company Daiichi Sankyo , South Korean biotech firm Samsung Biologics and China's Wuxi Biologics as top picks.

☆ The CEO of virtual-care veteran Omada shares why he's avoiding the race to prescribe trendy new weight-loss drugs and what he's doing instead
▼ + stars: | 2023-05-17 | by ( Blake Dodge | ) www.businessinsider.com time to read: +5 min

Omada Health, a leader in managing diabetes, is grappling with how it can play a role. Health companies are at a crossroads in deciding how to respond to the frenzy for prescription weight-loss drugs such as Ozempic and Wegovy. Now, as the rise of these powerful drugs upends the weight-loss industry, Omada is grappling with how it can play a role. Instead of prescribing the drugs, Omada is pitching itself as a gatekeeper, akin to the role health insurers usually play. One survey from 2022 found that only about a fifth of companies cover weight-loss drugs for their workers.

☆ Ozempic Is Hard to Find. Some Pharmacies Are Offering Unauthorized Alternatives.
▼ + stars: | 2023-05-16 | by ( Dani Blum | ) www.nytimes.com time to read: +1 min

Ms. Davis, 55, did not have diabetes, but had gained 50 pounds during menopause and developed hypothyroidism, she said, and was eager to lose weight. After seeing someone claiming to be a doctor on TikTok saying he could help patients obtain a generic version of the medication, she reached out. After a few days and a brief video consultation with someone who introduced herself as a nurse practitioner, Ms. Davis had a prescription in hand. “It was really fast,” Ms. Davis said. In the scramble to find Ozempic, patients are seeking out telehealth platforms, medical spas and compounding pharmacies for what some tout as “generic” versions of the drug.

☆ Oppenheimer says investors are missing opportunities in three biotech areas and the related stocks
▼ + stars: | 2023-05-16 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +4 min

As biopharma investors follow the latest buzz around advancements in clinical research, they may be under-appreciating opportunities in neurology, psychiatry and genetic medicine, according to a report from Oppenheimer. "Valuation multiples across disease areas show CNS [ or central nervous system] and Genetic Medicine at relative low points." In July, the Food and Drug Administration could grant full approval to Leqembi , its Alzheimer's Disease treatment. As a very new area of medicine, gene therapy has greatest potential to accelerate sales growth as treatments come to market. He described immunology multiples as "generally stable" and genetic medicine multiples as highly volatile.

☆ Factbox: Novo Nordisk's weight-loss drug cuts heart disease risk in study
▼ + stars: | 2023-05-12 | by ( ) www.reuters.com time to read: +3 min

[1/2] A selection of injector pens for the Wegovy weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023. AMGENAmgen's (AMGN.O) experimental obesity drug, AMG133, showed a mean weight loss of 14.5% after 12 weeks of treatment at the highest monthly dose. The company plans to test higher doses of the drug over a longer treatment window in a mid-stage trial. ZEALAND PHARMADenmark's Zealand Pharma (ZELA.CO) and Boehringer Ingelheim's experimental obesity treatment achieved up to 14.9% weight loss in a mid-stage trial on Wednesday. OPKO HEALTH Opko Health (OPK.O) has completed a mid-stage trial of its obesity drug, pegapamodutide, which it expects will have fewer side effects.

Persons: Jim Vondruska, Wegovy, Eli Lilly, ELI LILLY Lilly, Mounjaro, LLY.N, danuglipron, AMGEN, ALTIMMUNE, Mariam Sunny, Pratik Jain, Sriparna Roy, Sriraj Kalluvila, Anil D'Silva Organizations: REUTERS, Novo Nordisk, Pfizer, NOVO NORDISK Novo Nordisk, Novo, PFIZER Pfizer Inc, danuglipron, THERAPEUTICS, Therapeutics, ZEALAND PHARMA Denmark's Zealand Pharma, Thomson Locations: Chicago , Illinois, U.S, Bengaluru

☆ Pharma’s obesity gold rush will have limits: podcast
▼ + stars: | 2023-05-11 | by ( Aimee Donnellan | ) www.reuters.com time to read: 1 min

LONDON, May 11 (Reuters Breakingviews) - Drugmakers Novo Nordisk and Eli Lilly are vying for a large slab of the weight loss medications market, which analysts reckon could be worth $100 bln by 2031. In this Viewsroom podcast, Breakingviews columnists discuss how investor optimism in a booming market is unwarranted. Listen to the podcastFollow @aimeedonnellan on Twitter(The author is a Reuters Breakingviews columnist. Subscribe to Breakingviews’ podcasts, Viewsroom and The Exchange. They do not reflect the views of Reuters News, which, under the Trust Principles, is committed to integrity, independence, and freedom from bias.

Both sides blame each other for high drug prices. Senator Bernie Sanders, who chairs the Senate Health, Education, Labor, and Pensions (HELP) Committee, is a fierce critic of both industries and will likely grill the executives. Optum Rx CEO Heather Cianfrocco will say manufacturers alone set the drug prices and abuse patent protections to stifle competition, her written testimony shows. Lilly, Novo Nordisk, and Sanofi all said in March they were cutting list prices by more than 70% for some insulin products. Uninsured people often have to pay full list prices, an average of $900 a month, forcing many to ration or skip doses.

☆ Zealand, Boehringer's drug meets main weight-loss goal in mid-stage trial
▼ + stars: | 2023-05-10 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

In a statement on Wednesday, the partners said that the Phase II dose-finding trial met its primary endpoint of weight loss, the Danish company added. Like the other drugs, BI 456906 works by reducing the effect of a gut hormone called glucagon-like peptide-1 (GLP-1) that is involved in regulating appetite and food intake. But BI 456906 also blocks another gut hormone called glucagon. Mounjaro also has a dual mechanism of action, but it blocks yet another gut hormone in addition to GLP-1. According to drug trial database clinicaltrials.gov, participants in the Zealand/Boehringer trial were put into five groups by chance, with four getting different doses of the experimental weekly shot and the fifth getting a placebo.

☆ How big companies are contending with a frenzy of demand for Ozempic from their workers
▼ + stars: | 2023-05-10 | by ( ) www.businessinsider.com time to read: +5 min

Demand for expensive weight-loss drugs such as Ozempic and Wegovy is soaring. Companies that foot the bill for their workers' health coverage are mulling whether to pay for them. Across the US, companies are facing a critical decision: whether to foot the bill for the expensive weight-loss drugs that have exploded in popularity in recent months. Andrews estimated that more than half the companies in the alliance covered weight-loss drugs. Andrews' comments offer a window into how big US companies are grappling with the rising demand for and high costs of weight-loss treatment.

☆ Eli Lilly CEO vows not to raise insulin prices again, while Novo Nordisk and Sanofi hedge
▼ + stars: | 2023-05-10 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Sen. Bernie Sanders, the committee's chair, asked Ricks and the CEOs of Novo Nordisk and Sanofi to commit to "never increase the price of any insulin drug again." Meanwhile, Novo Nordisk CEO Lars Fruergaard Jørgensen said the Danish company is committed to limiting price increases to "single digits." Net price refers to the amount insurers pay for an insulin drug after discounts and rebates. Sanofi said it plans to cut the price of its most popular insulin drug, Lantus, by 78% and reduce the list price of its short-acting insulin, Apidra, by 70%. At the hearing, Sanders called those actions "good news" and a result of public pressure.

☆ Why buzzy weight-loss drugs such as Ozempic and Wegovy cost so much more in the US
▼ + stars: | 2023-05-10 | by ( ) www.businessinsider.com time to read: +4 min

Trendy weight-loss drugs cost much more in the US than in other countries. The price of semaglutide, the drug sold as Wegovy, was three times higher in the US than in the UK. If you're searching for affordable weight-loss drugs, you may be better off looking outside of the US. New weight-loss drugs are unaffordableGetty ImagesWegovy and Ozempic are part of a class of weight-loss drugs known as GLP-1 agonists that have soared in popularity in recent months. Drug prices are highest in the USThe variation in prices for weight-loss drugs across the world is striking.

☆ Catalent shares tank on warning of $400 mln cut to annual revenue forecast
▼ + stars: | 2023-05-08 | by ( ) www.reuters.com time to read: +2 min

May 8 (Reuters) - Catalent Inc (CTLT.N) expects to cut by more than $400 million both its full-year revenue and core profit forecasts, the contract drug manufacturer said on Monday, sending its shares tumbling 27% to a three-year low. In April, Catalent had flagged productivity issues and warned that a slower-than-expected ramp up in production capacity would hit quarterly results. Catalent had been the sole contract manufacturer for Novo Nordisk's (NOVOb.CO) weight-loss drug Wegovy, but the Danish company last month unveiled a second contract manufacturer to help meet sky-rocketing demand. Catalent in February forecast full-year net revenue of $4.63 billion to $4.88 billion and adjusted earnings before interest, taxes, depreciation, and amortization (EBITDA) of $1.22 billion to $1.30 billion. Reporting by Sriparna Roy in Bengaluru; Editing by Savio D'SouzaOur Standards: The Thomson Reuters Trust Principles.

☆ Here are 10 global stocks analyst love coming out of the earnings week, Bank of America says
▼ + stars: | 2023-05-08 | by ( Ganesh Rao | ) www.cnbc.com time to read: +3 min

However, according to strategists at Bank of America, there were more downward than upward revisions of company earnings estimates by analysts. The investment bank said European companies saw a decrease in their earnings per share (EPS) revision ratio to 0.85 in April, down from 1.12 in March. Analysts tend to downgrade stocks despite companies reporting bumper profits if those earnings are unlikely to grow in the future. The below table highlights 10 European large-cap stocks with high EPS revision ratio, according to Bank of America. The EPS revision ratio for Novo Nordisk was also in positive territory, thanks to its blockbuster weight-loss drug Wegovy and others in the pipeline.

☆ After weight loss, Alzheimer's may be next frontier for drugs like Ozempic
▼ + stars: | 2023-05-08 | by ( Natalie Grover | ) www.reuters.com time to read: +6 min

LONDON, May 8 (Reuters) - Diabetes drugs that also promote weight loss such as Novo Nordisk’s (NOVOb.CO) Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer’s disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs. She said she has since been approached by pharmaceutical companies at an increasing pace, and is currently running an Alzheimer’s trial evaluating intranasal insulin in combination with another diabetes drug. Four companies with GLP-1 drugs, including two larger drugmakers, say they are watching for results of trials testing Novo's drug in Alzheimer's. Dementia affects more than 55 million people globally and the market for Alzheimer’s drugs is expected to grow to $9.4 billion by 2028 and for Parkinson’s to $6.6 billion, according to pharmaceutical data provider Citeline.

☆ How promising are new drugs to treat obesity?
▼ + stars: | 2023-05-05 | by ( Katia Hetter | ) edition.cnn.com time to read: +8 min

CNN —The pharmaceutical company Eli Lilly announced last week that a medication developed to treat diabetes, tirzepatide, also had a substantial effect on reducing weight. Another pharmaceutical company, Novo Nordisk, manufactures the medication semaglutide, which the FDA has already approved to treat diabetes under the brand name Ozempic and to treat obesity under the brand name Wegovy. How promising are they to treat obesity? CNN: How promising are these drugs to treat obesity? It is really important to treat obesity as the disease that it is — and having effective medications to do so is crucial.

☆ Saturna Capital's 3 stock funds are all out-earning their competitors while sticking to Islamic investing rules. Its managers told us how the combination works.
▼ + stars: | 2023-05-05 | by ( Marley Jay | ) www.businessinsider.com time to read: +5 min

Saturna follows Islamic rules, which also prohibit speculation and profiting from interest. The firm's Amana Income fund is the fourth-best US large company stock fund over the 12 months that ended March 31, according to Kiplinger. The firm's Developing World Fund has out-returned 92% of competing funds over the last five years. Scott Klimo is the chief investment officer and co-manages three stock funds for Saturna Capital. Buying an unprofitable or high-priced growth stock and hoping it goes on a rocket ride is not.

☆ Flying high on obesity success, Novo's appetite for deals grows
▼ + stars: | 2023-05-04 | by ( Natalie Grover | ) www.reuters.com time to read: +2 min

Its interest is largely in areas it has already invested in, including diabetes, obesity, cardiovascular disease and gene therapies, he said on a panel at the LSX World Congress conference. Since launching its popular Wegovy weight-loss drug in the United States in June 2021, Novo's shares have soared by 140%. The company has traditionally taken a wait-and-see approach to deals, often waiting for drugs to have success in later-stage trials before going for a deal. Since joining the drugmaker in 2018, the company has grown its business development capacity. "If you look at some of our competitors, there are hundreds of people in business development ... and we probably have 25," he said.

☆ Wegovy Maker to Limit Starter-Dose Supplies in U.S. as Demand Surges
▼ + stars: | 2023-05-04 | by ( Dominic Chopping | ) www.wsj.com time to read: 1 min

Ozempic and Wegovy have become popular as treatments for weight management. Photo: JIM VONDRUSKA/REUTERSThe Danish pharmaceutical giant that makes the obesity drug Wegovy said it would temporarily hold back some lower-strength starter doses in the U.S. in an effort to safeguard supplies for current patients amid soaring demand. The Food and Drug Administration cleared Wegovy, made by Novo Nordisk , as a treatment for chronic weight management in 2021. It has since exploded in popularity.

☆ Why You Might Not Be Able to Start Taking Wegovy
▼ + stars: | 2023-05-04 | by ( Dominic Chopping | Peter Loftus | ) www.wsj.com time to read: 1 min

Some drugs initially approved to treat Type 2 diabetes are now being used for cosmetic weight loss. WSJ’s Daniela Hernandez explains how they work, their side effects, and concerns over unintended consequences. Illustration: Elizabeth SmelovThe Danish pharmaceutical giant that makes the obesity drug Wegovy said it would temporarily hold back some lower-strength starter doses in the U.S. in an effort to safeguard supplies for current patients amid soaring demand. The Food and Drug Administration cleared Wegovy, made by Novo Nordisk , as a treatment for chronic weight management in 2021. It has since exploded in popularity.

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