An upcoming FDA action date for Regeneron Pharmaceuticals' rare immune disease candidate, pozelimab, could lead to a significant boost.
https://seekingalpha.com/news/4003175-regeneron-could-see-share-price-bounce-potential-approvals
Tuesday, August 15, 2023
AngioDynamics gets breakthrough status for non-surgical heart therapy device
AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving quality of life for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the Company’s AngioVac System for the proposed indications for use to include the non-surgical removal of vegetation from the right heart.
The FDA Breakthrough Device designation is designed to help patients gain timely access to medical devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions for which no approved or cleared alternatives exist.
https://finance.yahoo.com/news/angiodynamics-receives-fda-breakthrough-device-200100174.html
Sanofi Was Mystery Bidder That Lost Reata to Biogen
- Paris-based company is “Party A” in regulatory filing
- Biogen beat Sanofi by 50 cents to win the biotech company
Biogen Inc. narrowly beat out Sanofi SA to clinch its $7.3 billion acquisition of Reata Pharmaceuticals, according to people familiar with the matter.
An entity identified as “Party A” in a regulatory filing Friday lost the competition for Reata by 50 cents per share after several rounds of bidding. Party A was Sanofi, the people said, asking to not be identified because the matter isn’t public. Representatives for Reata, Sanofi and Biogen declined to comment.
Drug distributor Cardinal sees sales boost from weight-loss drugs in 2024
Drug distributor Cardinal Health Inc on Tuesday raised fiscal 2024 expectations for sales at its pharmaceutical unit, banking on growing demand for newer weight-loss drugs, including GLP-1 treatments.
GLP-1s, which have seen overwhelming demand in the United States, are a class of drugs that help regulate blood sugar, slow the rate at which the stomach empties of food and decrease appetite by mimicking a gut hormone.
The drugs include Novo Nordisk's semaglutide, sold under brand name Wegovy for obesity and Ozempic for diabetes, as well as Eli Lilly's diabetes treatment Mounjaro, which is being prescribed for obesity even though it's not approved for it.
Cardinal peers AmerisourceBergen and McKesson have also flagged a potential boost to revenues for drug distributors due to high demand for these drugs.
"Looking forward, we see that there's nothing that we can foresee in the near term that will change those trends," Cardinal CFO Aaron Alt said on a conference call, referring to demand for GLP-1 drugs.
It now expects revenue from its pharmaceuticals unit to rise 10% to 12% in fiscal 2024, compared with its previous expectation of about 10% growth.
However, the company added the trend would not add to its profit. It raised its 2024 profit forecast slightly to a range of $6.50 to $6.75 per share, from $6.45 to $6.70 it had forecast previously.
Analysts on average were expecting a profit of $6.59 per share, according to Refinitiv.
Excluding one-off items, Cardinal Health reported a profit of $1.55 per share in the fourth quarter ended June 30, topping expectations of $1.49 per share.
Quarterly sales stood at $53.45 billion, $730 million above analysts' average estimate.
https://finance.yahoo.com/news/1-drug-distributor-cardinal-sees-173009475.html
China's fertility rate drops to record low 1.09 in 2022- state media
China's fertility rate is estimated to have dropped to a record low of 1.09 in 2022, the National Business Daily said on Tuesday, a figure likely to rattle authorities as they try to boost the country's declining number of new births.
The state-backed Daily said the figure from China's Population and Development Research Center put it as having the lowest fertility level among countries with a population of more than 100 million.
China's fertility rate is already one of the world's lowest alongside South Korea, Taiwan, Hong Kong and Singapore.
Concerned about China's first population drop in six decades and its rapid ageing population, Beijing is urgently trying an array of measures to lift the birth rate including financial incentives and improved childcare facilities.
President Xi Jinping in May presided over a meeting to study the topic.
China has said it will focus on education, science and technology to improve population quality and strive to maintain a "moderate fertility" level to support economic growth in future.
High childcare costs and having to stop their careers have put many women off having more children or any at all. Gender discrimination and traditional stereotypes of women caring for their children are still widespread throughout the country.Authorities have in recent months increased rhetoric on sharing the duty of child rearing but paternity leave is still limited in most provinces.
Hong Kong's Family Planning Association said in a separate release on Tuesday that the number of childless women in the special Chinese administrative region more than doubled from five years ago to 43.2% last year.
The percentage of couples with one or two children also tumbled while the average number of children per woman dropped from 1.3 in 2017 to a record low of 0.9 last year, according to its survey.
https://news.yahoo.com/chinas-fertility-rate-drops-record-115959680.html
UK's ITV invests in pain relief brand Flarin
ITV on Tuesday said it had agreed to invest in pain relief brand Flarin Holdings Ltd, making it the British broadcaster's first consumer healthcare investment.
The company has agreed to subscribe for 2 million pounds ($2.55 million) worth of shares in Flarin, with an option to subscribe for two more tranches of 1.5 million pounds each.
In return, Flarin would get advertising space across ITV's channels and ITVX.
https://news.yahoo.com/uks-itv-invests-pain-relief-131918438.html
Walgreens must face US, Virginia Medicaid fraud lawsuit over hepatitis C drugs
A federal appeals court on Tuesday revived a lawsuit in which the United States and Virginia accused Walgreens Boots Alliance of defrauding Virginia's Medicaid program by falsely representing that some patients were eligible for expensive hepatitis C drugs.
In a 3-0 decision, the 4th U.S. Circuit Court of Appeals in Richmond, Virginia, cleared the way for the nation's largest pharmacy chain to face claims it violated the federal False Claims Act and Virginia state law.
The case arose from alleged misconduct by a clinical pharmacy manager at a Walgreens in Kingsport, Tennessee.
She was accused of falsifying patient records, including lab results, between January 2015 and June 2016 to obtain prior authorization from Virginia Medicaid for reimbursement for the drugs Sovaldi, Harvoni and Daklinza.
Revenue from the Kingsport store grew by 321% during that time, court records showed.
Walgreens began an investigation, but did not repay money it received for 12 Virginia Medicaid patients, even after the manager pleaded guilty to a similar scheme in Tennessee.
In December 2021, a trial judge dismissed the lawsuit, saying Walgreens' misrepresentations were immaterial because Virginia's prior authorization requirements violated federal law.
But in Tuesday's decision, Circuit Judge Albert Diaz said Walgreens' alleged misrepresentations were material under the False Claims Act because they "did, in fact, influence the decisionmakers" at Virginia Medicaid.
He also said Walgreens could not escape liability by attacking Virginia's eligibility requirements as illegal.
"Allowing Walgreens to avoid liability by challenging Virginia's eligibility criteria only after getting caught would hinder the act's purpose of holding fraudsters accountable," Diaz wrote.
Walgreens declined to comment.
The U.S. Department of Justice also declined to comment, while the office of Virginia Attorney general Jason Miyares did not immediately respond to requests for comment.
The case is U.S. et al v Walgreen Co, 4th U.S. Circuit Court of Appeals, No. 22-1491.
https://news.yahoo.com/walgreen-must-face-us-lawsuit-144834479.html
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