Nektar Therapeutics said on Thursday its experimental drug, developed in collaboration with Eli Lilly, to treat autoimmune disease systemic lupus erythematosus had failed to the meet primary goal in a mid-stage study.
Thursday, February 23, 2023
Doctors Bristle At New FDA Authority To Ban Off-Label Uses For Drugs
After a string of court losses concerning the ability for doctors to prescribe drugs for off-label uses for which they were not approved, Congress has quietly given the Food and Drug Administration (FDA) more power to prohibit off-label use.
Buried in page 3,542 of the 4,155-page omnibus appropriations bill is the authority to ban off-label uses, under a section which applies to "banned devices" that some doctors fear could be broadly interpreted to cover drug treatments, Just the News reports.
The FDA requested this "very unprecedented" update after a string of court losses, Endpoints News senior editor Zachary Brennan told WBUR earlier this month, while cautioning that it's not clear whether the agency could broadly interpret "devices" to cover drug treatments.
Law firm Morrison Foerster specifically credited the revision to a 2021 ruling by the U.S. Court of Appeals for the D.C. Circuit that prohibited the FDA from banning "individual intended usages of an otherwise legally marketed device," in that case "electrical stimulation devices used to treat aggressive or self-injurious behavior." -Just the News
"FDA lobbyists got congress [sic] to grant the agency (not practicing doctors) the power to ban some uses of medications," said Johns Hopkins medical professor and National Academy of Medicine member Marty Makary in a Tuesday tweet.
"That's truly arrogant to think that the federal government is the one and only one who knows better than the physicians at the state boards of medicine about what good medicine is or what it isn't," said medical device and drug regulatory attorney Brad Thompson in a comment to WBUR.
"It may be that the clause is specifically directed to forbidding use of e.g. ivermectin in COVID," in which case the "data are mixed," according to retired microbiologist David Livermore in an emailed statement to Just the News.
Livermore called it a "disgrace and a dereliction of duty" that the NIH has failed to "properly study ivermectin either as a treatment or a prophylactic for COVID," and has given the FDA cover to potentially ban its use.
The new FDA authority could complicate a lawsuit by doctors that claims the agency effectively banned them from prescribing ivermectin to treat COVID by repeatedly telling the public the award-winning antiviral was dangerous for humans and providing false grounds for medical license investigations.
The agency claimed at a court hearing last fall that its guidance was "not mandatory." The litigants, including cancellation target Mary Talley Bowden, told the 5th U.S. Circuit Court of Appeals earlier this month that the FDA "cannot use unlawful means to accomplish exactly what it intended, then seek to wash its hands of the consequences." -Just the News
"Since the new provision lets the FDA skirt the ban on interfering with the practice of medicine by banning devices for particular uses, the agency will likely claim this as a precedent allowing it to ban off-label uses of drugs as well," wrote Joel Zinberg, associate clinical professor of surgery at the Icahn School of Medicine and former Columbia law , who accused the FDA of "unwarranted intrusion into the physician-patient relationship."
https://www.zerohedge.com/medical/doctors-bristle-new-fda-authority-ban-label-uses-drugs
Former Pharma Exec Charged With Insider Trading Around Government's $765 M Pandemic Loan To Kodak
A former pharma executive and his cousin were charged with insider trading regarding the announcement that Kodak was going to be the recipient of a government loan tied to Covid.
Former executive Andrew Stiles ascertained information about Kodak's applications for loans to help make chemicals for Covid-19 drugs and then traded on the information with his cousin. The pair made more than $500,000 a new report from Bloomberg says.
At the time, Stiles was an executive at a company that was working with Kodak on the project. He bought "more than 100,000 shares", according to authorities, before the stock surged after Donald Trump's White House said it was going to lend the company $765 million.
Stiles' cousin made "more than $700,000" on the trade, the report says. New York Attorney General Letitia James has led the insider trading probe, and also alleged that Kodak Chief Executive Officer James Continenza was in violation of laws by buying shares ahead of the announcement. Despite this, the company claims that Continenza had been "pre-cleared" to buy the shares.
Generic drugmaker Phlow Corp. is listed on Stiles' LinkedIn as his place of employment dating back to when the trading took place. Phlow said in May 2020 it had been awarded $354 million to make medicines for pandemic response by the government.
Both Stiles and his cousin have been charged with three counts of securities fraud and one count of conspiracy to commit wire fraud and securities fraud. The Kodak loan was originally targeted for helping the company repurpose manufacturing facilities to produce drug ingredients.
DaVita execs cite 'early optimism' on labor costs this year
A Covid-19 surge that never came and earlier improvements to labor costs pushed DaVita Inc. (NYSE: DVA) into the top end of its expectations for the fourth quarter.
Leadership for the Denver-based kidney care company said they expect higher wage demands to continue at above-normal levels this year, but below those seen in 2022.
https://www.bizjournals.com/denver/news/2023/02/23/davita-fourth-quarter-earnings.html
Apollo Medical results, guidance, call
Financial Highlights for the Year Ended December 31, 2022:
Total revenue of $1.14 billion, an increase of 48% from $773.9 million for the prior year
Net income attributable to ApolloMed of $49.0 million
Earnings per share - diluted ("EPS – diluted") of $1.08
Adjusted EBITDA of $140.0 million, an increase of 5%, compared to $133.5 million for the prior year, resulting in an Adjusted EBITDA margin of 12.2%(1)
Cash and cash equivalents of $288.0 million at December 31, 2022
Guidance:
ApolloMed is providing the following guidance for total revenue, net income, EBITDA, Adjusted EBITDA, and EPS - diluted. The net income and EBITDA guidance ranges below include the impact of the excluded assets held by Allied Physicians of California, a Professional Medical Corporation's ("APC"), which are solely for the benefit of APC and its shareholders. Any gains or losses associated with these excluded assets do not have an impact on Adjusted EBITDA and EPS - diluted. These guidance assumptions are based on the Company's existing business, current view of existing market conditions and assumptions for the year ending December 31, 2023.
($ in millions) | 2023 Guidance Range | ||
Low | High | ||
Total revenue | $ 1,300.0 | $ 1,500.0 | |
Net income | $ 49.5 | $ 71.5 | |
EBITDA | $ 89.5 | $ 129.5 | |
Adjusted EBITDA | $ 120.0 | $ 160.0 | |
EPS – diluted | $ 0.95 | $ 1.20 | |
Conference Call and Webcast Information:
ApolloMed will host a conference call at 5:30 a.m. PT/8:30 a.m. ET today (Friday, February 24, 2023), during which management will discuss the results of the fourth quarter and year ended December 31, 2022. To participate in the conference call, please use the following dial-in numbers about 5 minutes prior to the scheduled conference call time:
U.S. & Canada (Toll-Free): | (877) 407-9753 | |
International (Toll): | (201) 493-6739 |
The conference call can also be accessed at: https://event.choruscall.com/mediaframe/webcast.html?webcastid=0Kd2PA99.
An accompanying slide presentation will be available in PDF format on the "IR Calendar" page of the Company's website (https://www.apollomed.net/investors/news-events/ir-calendar) after issuance of the earnings release and will be filed as an exhibit to ApolloMed's current report on Form 8-K to be filed with the SEC, accessible at www.sec.gov.
Those who are unable to attend the live conference call may access the recording at the above webcast link, which will be made available shortly after the conclusion of the call.
https://finance.yahoo.com/news/apollo-medical-holdings-inc-reports-213500834.html
F-star Therapeutics jumps as it extends walk date with buyer
F-star Therapeutics (NASDAQ:FSTX) soared 18% after announcing that it's extended the termination date for its planned merger with invoX
States Seek Crackdown on Toxic Ingredients in Cosmetics to Close Gaps in Federal Oversight
Washington has joined more than a dozen other states in seeking to crack down on toxic substances in cosmetics after a state-funded study there found lead, arsenic, and formaldehyde in makeup, lotion, and hair-straightening products made by CoverGirl and other brands.
The U.S. stalled out on chemical regulations after the 1970s, according to Bhavna Shamasunder, an urban and environmental policy associate professor at Occidental College. And that has left a regulatory void, as lax federal oversight allows potentially toxic products that would be banned in Europe to be sold in American stores.
"Lots of products on the market aren't safe," Shamasunder said. "That's why states are helping create a solution — it's a patchwork approach."
The potential exposure to toxicants in cosmetics is especially worrisome for women of color, because studies show that Black women use more hair products than women of other racial groups and that Hispanic and Asian women have reported using more cosmetics in general than non-Hispanic Black and white women.
The Washington state legislation is a second attempt at passing the Toxic-Free Cosmetics Act, after legislators approved a bill in 2022 that was stripped of the ban on toxic ingredients in cosmetics. This year, lawmakers have additional context after a report commissioned by the legislature and published by the state Department of Ecology in January found multiple products with concerning levels of hazardous chemicals, including lead and arsenic in dark-tint CoverGirl Clean Fresh Pressed Powder foundation. CoverGirl Continuous Color Lipstick and Markwins Beauty Brands' Black Radiance Pressed Powder foundation were among other products from various brands containing lead, the report found.
Research teams asked Hispanic, Black, and multiracial women what beauty products they used. Researchers then tested 50 cosmetics purchased at Walmart, Target, and Dollar Tree, among other shops.
"Companies are adding preservatives like formaldehyde to cosmetics products," said Iris Deng, a toxics researcher for the Washington State Department of Ecology. "Lead and arsenic are different stories. They're detected as contaminants."
Markwins Beauty Brands did not respond to requests for comment.
"Nominal traces of certain elements may sometimes be present in product formulations as a consequence of natural mineral origin, as permitted by applicable law," Miriam Mahlow, a spokesperson for CoverGirl parent company Coty Inc., said in an emailed statement.
The Washington report's authors said European Union countries ban products like the dark-tint CoverGirl foundation. That's because arsenic and lead have been linked to brain and nervous system damage and cancer. There is "no known safe level of lead exposure," said Marissa Smith, Washington state's senior regulatory toxicologist, and formaldehyde is also a carcinogen.
"When we find these chemicals in products applied directly to our bodies, we know people are being exposed," Smith added. "Therefore, we can assume these exposures are contributing to health impacts."
Though most of the products' lead content was low, Smith said, people are often exposed for years on end, considerably increasing the danger.
The Washington ecology department findings were not altogether surprising: Other testing bodies have picked up preservatives such as formaldehyde or, more often, formaldehyde-releasing agents such as quaternium-15, DMDM hydantoin, imidazolidinyl urea, and diazolidinyl urea in hair-straightening products marketed especially to Black women. Formaldehyde is one of the chemicals used to embalm corpses before funerals.
In addition to Washington, at least 12 states — Hawaii, Illinois, Massachusetts, Michigan, Nevada, New Jersey, New York, North Carolina, Oregon, Rhode Island, Texas, and Vermont — are considering policies to restrict or require disclosure of toxic chemicals in cosmetics and other personal care products.
States are acting because the federal government possesses limited authority, said Melanie Benesh, vice president of government affairs for the Environmental Working Group, a nonprofit that researches what's in household and consumer products.
"The FDA has had limited resources to pursue ingredient bans," Benesh added.
Congress has not given the Environmental Protection Agency widespread authority to regulate such products, even though contaminants and preservatives from cosmetics end up in the water supply. In 2021, a California man petitioned the EPA to ban toxic chemicals in cosmetics under the Toxic Substances Control Act, but the petition was denied, said Lynn Bergeson, a lawyer in Washington, D.C., because cosmetics are outside the scope of the act's jurisdiction.
"The law is crystal clear on this," she said.
Bergeson said the regulation of chemicals is subject to the Federal Food, Drug, and Cosmetic Act, but the FDA regulates only color additives and chemicals in sunscreen because those products make the medical claim of decreasing the risk of skin cancer.
Minnesota, for example, fills in the regulatory gaps by testing for mercury, hydroquinone, and steroids in skin-lightening products. It also passed a law in 2013 banning formaldehyde in children's products such as lotions and bubble baths.
California has passed several laws that regulate cosmetics ingredients and labeling, including the California Safe Cosmetics Act in 2005. A law adopted in 2022 bans intentionally added perfluoroalkyl and polyfluoroalkyl substances, known as PFAS, in cosmetics and apparel starting in 2025.
Last year, Colorado also passed a ban of PFAS in makeup and other products.
But consumer safety experts said that states should not have to fill in the void left by federal regulations, and that a smarter approach would entail the federal government subjecting cosmetics ingredients to an approval process.
In the meantime, states are fighting an uphill battle, because thousands of chemicals are available to manufacturers. As a result, a gap exists between what consumers need for protection and regulators' ability to act, said Laurie Valeriano, executive director of Toxic-Free Future, a nonprofit that researches and advocates for environmental health.
"The federal systems are inadequate in that they do not require the safest chemicals to be used," Valeriano said. "Instead, they allow hazardous chemicals in personal care products, such as PFAS, phthalates, or even formaldehyde."
Moreover, the federal government's risk assessment system is flawed, she said, "because it attempts to determine how much risk from toxic exposures is acceptable." In contrast, the approach that Washington state hopes to legislate would assess the hazards and ask whether the chemicals are necessary, or if there are safer alternatives — which is to say prevent toxic ingredients in cosmetics in the first place.
It's a lot like the approach taken by the European Union.
"We put boundaries and restrictions around these chemicals," said Mike Rasenberg, hazard assessment director of the European Chemicals Agency in Helsinki.
Rasenberg said that because research shows formaldehyde causes nasal cancer, the EU has banned it, plus lead and arsenic, in beauty products. The EU's 27 countries also work together to test products for safety.
In Germany, more than 10,000 cosmetic products are examined annually, said Florian Kuhlmey, spokesperson for that country's Federal Office of Consumer Protection and Food Safety. And it doesn't end there. This year, Germany will examine about 200 samples of children's toothpaste for heavy metals and other elements banned in the EU for cosmetics, Kuhlmey added.
The legislation in Washington would move the state toward a more European approach to chemicals regulation. If approved, it would give retailers that sell products with banned ingredients until 2026 to sell existing stocks.
Meanwhile, customers can protect themselves by seeking out natural beauty products, Atlanta-area dermatologist Dr. Chynna Steele Johnson said.
"Lots of products have formaldehyde-releasing agents," Steele Johnson said. "But it isn't something customers can find on a label. My suggestion — and this goes for foods too — would be fewer ingredients are better."
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