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☆ Novo Nordisk says obesity pill leads to 15% weight loss; availability "to be determined"
▼ + stars: | 2023-06-26 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

Novo plans to seek U.S. Food and Drug Administration approval of the high-dose pill later this year, but timing of a market launch is "to be determined," according to Mico Guevarra, medical director at Novo Nordisk. Novo Nordisk already markets an oral semaglutide, under the brand name Rybelsus, for treatment of type 2 diabetes, but its highest dose is 14mg. Oral semaglutide, according to the FDA label, needs to be taken in the morning on an empty stomach, 30 minutes before eating, drinking, or using any other oral medication - you are allowed only 4 ounces of plain water. If you eat too soon, the pill is less effective, but if you wait longer than 30 minutes its absorption may be enhanced. read moreNovo Nordisk said most patients in its obesity trial reported gastrointestinal side effects from oral semaglutide, including mostly mild-to-moderate nausea, constipation, diarrhea and vomiting.

Persons: semaglutide, Mico, Guevarra, Eli Lilly, LLY.N, Deena Beasley, Diane Craft Organizations: DIEGO, Nordisk, Food, Drug, Novo Nordisk, American Diabetes Association, FDA, Thomson Locations: Danish

☆ Welcome to the Era of Very Earnest Parenting
▼ + stars: | 2023-05-13 | by ( Caitlin Moscatello | ) www.nytimes.com time to read: +2 min

Another popular account is Big Little Feelings, created by two longtime friends, Kristin Gallant, 36, and Deena Margolin, 33, a licensed psychotherapist. Started just before the pandemic began, Big Little Feelings now has more than three million followers on Instagram, and the mood is more moms-in-survival-mode. Solid Starts, which helps parents safely introduce new foods and avoid picky eating, has 2.6 million followers on Instagram. Taking Cara Babies, a sleep training guide for exhausted parents, has 2.4 million followers. Busy Toddler, an account dedicated to thoughtful play, has two million followers.

☆ 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.

The drug, donanemab, met all goals of the trial. "These are the strongest phase 3 data for an Alzheimer's treatment to date," said Maria Carrillo, chief science officer for the Alzheimer's Association. In the donanemab treatment group, Lilly said brain swelling, a known side effect of drugs of this type, occurred in 24% of the participants, with 6.1% experiencing symptoms. In the Leqembi Phase 3 trial, the drug was associated with brain swelling in nearly 13% of its study participants. It also said 47% of donanemab patients in the 18-month trial had no disease progression at 12 months, compared with 29% of the placebo group.

Lilly has not previously discussed its Medicare coverage optimism publicly. The U.S. Centers for Medicare & Medicaid Services (CMS) did not immediately respond to a request for comment. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices. Amyvid, Lilly's Alzheimer's imaging agent that can detect amyloid plaques on PET scans, has been subject to CMS' evidence development program for a decade. "It shuts out many patients," said Dr. Maria Carrillo, chief science officer of the Alzheimer’s Association, "especially minorities and rural patients."

☆ Analysis: Twitter's advertising business seen facing slow recovery
▼ + stars: | 2023-04-13 | by ( Sheila Dang | ) www.reuters.com time to read: +5 min

Musk, who also runs electric carmaker Tesla Inc (TSLA.O), earlier this week told the BBC that most of Twitter's advertisers are returning to the platform and the business was "roughly breaking even." Research firm Insider Intelligence this week slashed its forecast for Twitter's global ad revenue this year by 37% to $2.98 billion. That would represent a 28% decline from Twitter's 2022 ad revenue of $4.14 billion. 33 among Twitter's top advertisers before Musk's acquisition, according to Sensor Tower. Twitter's ad business is "eroding" and its subscription product Twitter Blue is seeing only moderate success, Similarweb said in a blog post.

☆ Lilly says experimental Alzheimer's drug reduces amyloid in small study
▼ + stars: | 2023-03-31 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

The higher the dose of the antibody drug, which was given by subcutaneous injection, the larger the effect, Lilly said. The Indianapolis-based drugmaker is launching a Phase III study of the experimental antibody, remternetug, but declined to comment on which doses will be selected for larger, later-stage trials. Lilly, at a medical conference in Gothenburg, Sweden, presented interim data from 41 study participants. Trial results published last year showed that, in patients with early Alzheimer's, Leqembi reduced the rate of cognitive decline by 27% compared with a placebo. Brooks said that sharing its early remternetug data "reinforces Lilly's commitment and investment in the Alzheimer's disease space ...

☆ Amgen to cut 450 jobs in second round of layoffs this year
▼ + stars: | 2023-03-17 | by ( ) www.reuters.com time to read: +1 min

March 16 (Reuters) - Amgen Inc (AMGN.O) said on Thursday it would cut 450 jobs, or less than 2% of its workforce, making it the company's second round of layoffs this year amid intensifying pressure on drug prices and high inflation. "We made these changes to realign our expense base in the face of intensifying pressure on drug prices and high levels of inflation," a company spokeswoman said in a statement to Reuters. Layoffs by U.S. companies over January and February this year touched the highest since 2009, a report showed. The biotech company forecasted 2023 revenue in a range of $26 billion to $27.2 billion, while analysts had estimated $27.17 billion. Reporting by Akanksha Khushi and Deena Beasley; Editing by Rashmi Aich and Subhranshu SahuOur Standards: The Thomson Reuters Trust Principles.

☆ Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer's drug
▼ + stars: | 2023-01-19 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

REUTERS/Mike SegarJan 19 (Reuters) - Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration had rejected accelerated approval of its experimental Alzheimer's drug because it had not submitted enough trial data from patients who were treated for at least a year. That study, Lilly said, would form the basis of donanemab's application for traditional FDA approval shortly thereafter. The FDA can grant "accelerated" approval to drugs based on their impact on a measurement, in this case amyloid brain plaques, likely to correlate with patient response. Donanemab is in the same class as aducanumab and lecanemab, the latter being a treatment for early Alzheimer's that was given accelerated approval by the FDA earlier this month. Sales of amyloid-lowering Alzheimer's drugs, which need to be given by infusion, are expected to be minimal until they receive standard FDA approval.

☆ Drug companies favor biotech meds over pills, citing new U.S. law
▼ + stars: | 2023-01-13 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

The pharmaceutical industry, whose members gathered in the thousands this week in San Francisco for the annual JP Morgan Healthcare conference, opposed the legislation and has begun implementing strategies to mitigate its impact. "In 10 years, we'll have far fewer small molecules being developed than we do today." He questioned the benefit of "rules that really just disincentivize investment in what ends up being convenient drugs, drugs for tough conditions like cancer and drugs that get really cheap when they go generic." Most medicines on the market today are small molecules, which can be taken by mouth, absorbed into the bloodstream and easily penetrate cell membranes. He noted it is not unusual for pharmaceutical companies to choose not to pursue a drug they once thought promising.

☆ U.S. FDA approves Eisai, Biogen Alzheimer's drug
▼ + stars: | 2023-01-06 | by ( Deena Beasley | ) www.reuters.com time to read: +2 min

[1/2] The logo of Eisai Co Ltd is displayed at the company headquarters in Tokyo, Japan, March 8, 2018. REUTERS/Issei KatoJan 6 (Reuters) - The U.S. Food and Drug Administration on Friday approved the Alzheimer's drug lecanemab developed by Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) for patients in the earliest stages of the mind-wasting disease. Eisai said the drug would launch at an annual price of $26,500. Eisai officials have said the company also plans to submit data from a recent successful clinical trial in 1,800 patients as the basis for a full standard review of Leqembi. That trial found that Leqembi, which is given by infusion, slowed the rate of cognitive decline in patients with early Alzheimer's by 27% compared to a placebo.

☆ U.S. new drug price exceeds $200,000 median in 2022
▼ + stars: | 2023-01-05 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

The median annual price of the 17 novel drugs the U.S. Food and Drug Administration (FDA) approved since July 2022 is $193,900, down from $257,000 in the first half of 2022, Reuters found. For full year 2022, the median was $222,003. Reuters Graphics Reuters GraphicsIn 2021, the median annual price was $180,000 for the 30 drugs first marketed through mid-July, according to a study published recently in JAMA. Health insurers and other payers often demand discounts and rebates for prescription drugs once competing treatments become available. As patents expire, lower-cost generics also mitigate prescription drug price inflation, which in the 12 months through November 2022 was 1.9%, according to the Bureau of Labor Statistics.

According to the group's projections, cases in China would peak around April 1, when deaths would reach 322,000. About a third of China's population will have been infected by then, IHME Director Christopher Murray said. China's national health authority has not reported any official COVID deaths since the lifting of COVID restrictions. Based on China's population of 1.41 billion, and without measures such as a mass vaccination booster campaign, that amounts to 964,400 deaths. China's National Health Commission said on Friday it was ramping up vaccinations and building stocks of ventilators and essential drugs.

"The jury is still out," on which technology will dominate, said Dr. Sadik Esener, director of the Cancer Early Detection Advanced Research Center at the OHSU Knight Cancer Institute in Portland, Oregon. He added it could take as long as 20 years to show that an early cancer detection test saved lives. If proven to work, early cancer detection tests could help doctors identify cancer risk in patients long before symptoms or other indicators develop. DIFFERENT APPROACHESSeveral of the leading contenders take vastly different approaches to cancer detection and it is not yet clear which methods will prove most useful or when. Some are working on blood tests to detect different markers of early cancer, including proteins.

☆ Guardant DNA blood test finds 83% of colorectal cancers in trial, shares fall 39%
▼ + stars: | 2022-12-15 | by ( Deena Beasley | ) www.reuters.com time to read: +2 min

Cologuard, a stool-based DNA test, identifies 92% of colorectal cancers and 42% of pre-cancerous polyps, according to data from Exact Sciences (EXAS.O), which markets the test. Guardant said that a subsequent colonoscopy ruled out colon cancer in 10% of people who tested positive with its DNA blood test. "This is a huge unmet clinical need," Talasaz said of a blood test for detecting colon cancer. "There are still 50 million people out there who are not complying with colorectal cancer screening." Guardant is currently enrolling patients in a different trial of its DNA blood test for detecting lung cancer, Talasaz said.

☆ Amgen says experimental obesity drug has promising durability
▼ + stars: | 2022-12-03 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

LOS ANGELES, Dec 3 (Reuters) - Amgen Inc's (AMGN.O) experimental obesity drug demonstrated promising durability trends in an early trial, paving the way for a larger mid-stage study early next year, company officials said ahead of a data presentation on Saturday. The small Phase I trial found that patients maintained their weight loss for 70 days after receiving the highest tested dose of the injected drug, currently known as AMG133. Amgen shares have gained about 5% since the company said on Nov. 7 that 12 weeks of trial treatment at the highest monthly dose of AMG133 resulted in mean weight loss of 14.5%. Patients treated with AMG133 did have side effects including nausea and vomiting, but most cases were mild and resolved within a couple of days after the first dose, Amgen said. The drug was developed from work at Amgen to identify genetic signals associated with lower fat mass and body weight, and also healthy metabolic profiles, explained Saptarsi Haldar, head of cardiovascular metabolic discovery at Amgen.

☆ Eisai, Biogen Alzheimer's drug slows cognitive decline, safety for some becomes focus
▼ + stars: | 2022-11-30 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

The drug, lecanemab, was associated with a type of brain swelling in 12.6% of trial patients, a side effect previously seen with similar drugs. He suggested that could be because homozygous study patients who were given a placebo fared better than expected. Overall, lecanemab patients benefited by 23% to 26% compared with a placebo on these secondary trial goals. Detailed data from the study were presented at the Clinical Trials on Alzheimer's Disease meeting in San Francisco and published in the New England Journal of Medicine. Dr. Howard Fillit, chief science officer at the Alzheimer’s Drug Discovery Foundation, said doctors always balance the benefits and risks of therapies.

☆ Stunned Saudi Soccer Fans Celebrate Victory Over Argentina and Messi
▼ + stars: | 2022-11-22 | by ( Donna Abdulaziz | ) www.wsj.com time to read: 1 min

DOHA, Qatar—Saudi fans erupted in ecstasy and disbelief on Tuesday following their national team’s stunning World Cup victory over Argentina and, in particular, Argentine global superstar Lionel Messi, who is hugely popular in the soccer-addicted kingdom and serves as its tourism ambassador. “It’s not just that we won. It’s that we beat Messi,” said Deena Abdulwahab, 45, a mother of four from the Red Sea city of Jeddah. She took her children out to celebrate among the honking cars and waving flags on the seaside boardwalk.

☆ Health tech boom: Raising capital as economy shifts
▼ + stars: | 2022-11-15 | by ( ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailHealth tech boom: Raising capital as economy shiftsDeena Shakir, Lux Capital Partner, and Neel Shah, Maven Chief Medical Officer, join 'TechCheck' to discuss spending in health tech, Covid-19 fueling a renewed interest health benefits, and consolidation in the health tech sector.

☆ Fire breaks out at Chevron's El Segundo, California refinery
▼ + stars: | 2022-11-09 | by ( ) www.reuters.com time to read: +1 min

Nov 8 (Reuters) - Chevron (CVX.N) said fire crews were responding to an isolated fire inside its 269,000-barrel-per-day El Segundo refinery in California on Tuesday, with no injuries due to the incident. The time of dispatch was 6:13 pm, with a response at the two-alarm level from El Segundo, Manhattan Beach, Redondo Beach and La County Fire, El Segundo fire chief Deena Lee said, adding it was unclear whether the material involved is jet fuel or diesel. Local media reports said the fire had occurred in a particular section in the refinery. read moreCalifornian fuel markets are known for rapidly moving price increases, as they rely on production from West Coast refineries and imports from Asia. Reporting by Arpan Varghese and Ashitha Shivaprasad in Bengaluru; Editing by Jacqueline WongOur Standards: The Thomson Reuters Trust Principles.

☆ New U.S. cancer drug prices rise 53% in five years -report
▼ + stars: | 2022-11-02 | by ( Deena Beasley | ) www.reuters.com time to read: +4 min

"I do think there is a possibility we see launch prices go up," she said. Reuters GraphicsPorter, who championed inflation-based caps on drug prices, is calling for additional national legislation to link launch prices to how well a drug works. The report found that the average launch price of a self-administered cancer drug, after adjusting for inflation, rose by nearly 26% to $238,000 between 2017 and 2021. By 2022, six out of the eight newly-launched oral cancer drugs had prices over $200,000 per year. Based on current trends, the report calculated that by 2026, when Medicare will first be able to negotiate drug prices, the average self-administered cancer drug launch price will be nearly $325,000 per year and over $525,000 for pills and biologics.

☆ Women in venture capital are writing the rules of maternity leave and bending the male-dominated culture to their will
▼ + stars: | 2022-10-31 | by ( Melia Russell | Madeline Renbarger | ) www.businessinsider.com time to read: +13 min

And with more women entering the male-dominated venture industry, firms are being forced to craft maternity leave policies on the fly to accommodate new mothers. Forty years ago, the clubby male world of venture capital admitted so few women that maternity leave as a benefit was effectively nonexistent. "There is no playbook about how to take maternity leave or raise a family while also accelerating your career as an investor." Lux CapitalLike in many male-dominated industries, maternity leave as a benefit for investors doesn't come up in conversation until someone needs it. Though, the best policies, investors said, give women choices about how they operate on leave, rather than prescribing a one-size-fits-all leave.

☆ Asian shares rise on hopes of rate hike slowdown
▼ + stars: | 2022-10-26 | by ( Ankur Banerjee | Deena Beasley | ) www.reuters.com time to read: +4 min

Meanwhile, MSCI's broadest index of Asia-Pacific shares outside Japan (.MIAPJ0000PUS) was up 1%, led by a bounce in Hong Kong, while Japan's Nikkei (.N225) rose 1.1% by mid-morning. Three-year Australian government bond futures were knocked from peaks but managed to hold steady for the day at 96.400. Japanese government bonds rallied sharply after the Bank of Japan again said it would increase bond buying operations. Brent crude futures for December dropped $1.17, or 1.3%, to $92.35 a barrel at 0111 GMT, after climbing 26 cents in the previous session. U.S. West Texas Intermediate (WTI) crude futures for December delivery were down 88 cents, or 1%, to $84.44 a barrel.

☆ 3 traits Lux Capital's Deena Shakir looks for in early-stage startup founders as healthcare bets shrink
▼ + stars: | 2022-10-26 | by ( Rebecca Torrence | ) www.businessinsider.com time to read: +5 min

Lux Capital has backed multiple first-time founders this year even as their investment pace slows. In early-stage investments, Lux Capital's Deena Shakir said founders' characters are paramount. Of those 13 founders, Lux Capital has backed four, making it the most-represented venture-capital firm on the list. Here are the top three traits Shakir said she's looking for right now in the founders that Lux Capital backs, in no particular order:1. Founder-market fitWhen examining a startup, Shakir said she has to first ask the question of why the founder is starting this particular company.

Shares of Biogen and Eisai were halted, but shares of Eli Lilly & Co , which is also developing an Alzheimer's drug, were up 6.7% in after hours trade. Aduhelm was the first new Alzheimer's drug approved in 20 years after a long list of high-profile failures for the industry. Symptomatic brain swelling was seen in 2.8% of those in the lecanemab group and none of the placebo group, they said. Aduhelm's approval was a rare bright spot for Alzheimer's patients, but critics have called for more evidence that amyloid-targeting drugs are worth the cost. Other plaque-targeting antibodies in late-stage development for Alzheimer's patients include Roche Holding AG's (ROG.S) gantenerumab and Eli Lilly's donanemab.

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