Target $64
https://finviz.com/quote.ashx?t=BMY&ty=c&ta=1&p=d
Thursday, April 7, 2022
House, Senate Dems introduce bills to combat 'abusive' pharma business practices
In the aftermath of Congress introducing legislation allowing Medicare to negotiate drug prices — which currently remains in limbo after the failed passage of the Build Back Better Act — some congressional Dems have shifted gears and have put their targets on other pharma business practices.
House Oversight Committee Chair Carolyn Maloney led a group of Democrat colleagues and introduced three bills on Thursday to target “business practices pharmaceutical companies use to suppress competition, maintain market monopolies, and keep drug prices high,” a statement from the officials said.
Sen. Debbie Stabenow, a Michigan Democrat and chair of the Senate’s finance subcommittee on health care, also introduced those same bills in the Senate with Minnesota Dem Tina Smith.
The three bills include:
The Discounted Drugs for Clinical Trials Act, which would go after brand name sponsors who restrict access to samples of drugs necessary for bioequivalence testing. The bill would grant certain researchers access to drugs or biologics for research purposes with a certain price cap: a maker’s cost to manufacture, maximum.
The Pharmaceutical Research and Transparency Act of 2022 would amend two currently-existing laws to have pharma companies publicly disclose their incurred costs to conduct clinical trials. The bill would create a public repository of cost data for drug clinical trials, would require parties to submit this cost data within a year after a trial is finished to that repository — plus report disaggregated costs in their annual SEC filings.
The Generic Substitution Non-Interference Act aims to block “Dispense-As-Written” campaigns, a type of campaign that the members of Congress called anti-competitive. It would make illegal certain practices that would require health care providers to write “dispense as written” on a prescription when a generic or biosimilar is available.
“These three bills target Big Pharma’s manipulative practices in order to strengthen competition, promote innovation, and increase transparency into research and development costs—all of which will help make drugs more affordable,” Maloney said in a statement.
Multiple non-profits and advocacy groups announced their support for the bills.
Doctors Without Borders praised the introduction of the clinical trial cost disclosure bill, while grassroots activist group US PIRG (Public Interest Research Group) health care campaign director Patricia Kelmar said that “these bills are a vital start to pulling down the obstacles to competition and bringing about needed reforms.”
Quidel Announces Preliminary Revenue for Q1
Quidel Corporation (NASDAQ: QDEL) ("Quidel"), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it expects total revenues in the first quarter of 2022 to be in the range of $990 million to $1,000 million, or growth of 164% to 166% from the first quarter 2021 revenue of $375.3 million. COVID-19 product revenues in the first quarter of 2022 are expected to be approximately $836 million, composed of approximately $657 million in QuickVue® COVID-19 test revenue and approximately $138 million in Sofia® SARS antigen test revenue.
"We had another outstanding quarter and an excellent start to the year, delivering a record quarter for revenue," said Douglas Bryant, President and Chief Executive Officer of Quidel. "In the first quarter of 2022, we sold approximately 113 million QuickVue COVID-19 antigen tests and approximately 12 million Sofia SARS antigen tests. We also expanded our installed base of Sofia analyzers to 79,000 instrument placements, which further widens our point-of-care footprint and increases opportunities to introduce our full portfolio of assays to patients and healthcare providers."
Mr. Bryant concluded, "Thanks to the continued dedication of our people, Quidel is well-positioned to deliver strong performance for the year and advance our mission to expand access to accurate, affordable diagnostic testing in professional, retail and government sectors."
These preliminary results are based on management’s initial analysis of operations for the quarter ended March 31, 2022. Quidel expects to issue full financial results for the first quarter of 2022 in May.
https://finance.yahoo.com/news/quidel-announces-preliminary-revenue-first-201000378.html
FDA Advisors Weigh COVID Booster Shots for Fall
Outlining a daunting timeline for development of any updated coronavirus vaccine for next fall, federal health officials told an expert advisory panel on Wednesday that clinical trials of potential candidates would have to begin by next month, and a final formula chosen by June, to meet that tight deadline.
The assessment came during a daylong meeting of outside advisers to the U.S. Food and Drug Administration, who met to discuss what the nation's COVID vaccine policy should look like moving forward.
But time is of the essence.
While numerous clinical studies of retooled shots are ongoing from vaccine manufacturers and the U.S. National Institutes of Health (NIH), they are too small to provide the kind of efficacy data that were produced for earlier vaccines, The New York Times reported.
Once larger trials are completed, vaccine manufacturers would need several months to produce hundreds of millions of doses of a reconfigured vaccine, Robert Johnson, director of an infectious disease division within the U.S. Department of Health and Human Services, told the panel.
"If you're not on your way to that clinical trial by the beginning of May, it is very difficult to have collectively across manufacturers enough product to meet that demand," Johnson said, the Times reported.
Dr. Peter Marks, who oversees vaccine regulation for the FDA, agreed that decision on a fall vaccine was needed by May or June.
But vaccine experts are still guessing at what the ever-changing pandemic will bring.
Questions include whether new variants will emerge and, if so, whether they will change the virus substantially. Many experts think another surge is likely this fall. Another question is how to modify existing vaccines so they work better.
Trevor Bedford, a biostatistician at the Fred Hutchinson Cancer Research Center, said during the meeting that the coronavirus has been mutating far faster than the flu virus, which has a redesigned vaccine every year, the Times reported.
Booster shots were also discussed during the gathering: Sharon Alroy-Preis, director of public health services for Israel's Health Ministry, described Israel's experience with a second booster shot for people ages 60 and older.
Last week, the United States followed suit and authorized a second booster for Americans ages 50 and older. The CDC recommended the second booster for anyone 65 and older and people ages 50 to 64 with underlying health conditions.
While Marks said the FDA did not consider the second booster to "be a major expansion or change," Dr. James Hildreth, president of the Meharry Medical College in Tennessee, asked why the FDA did not seek the advice of a panel it had convened to discuss future vaccine policy, the Times reported.
Jerry Weir, a senior FDA official, said the agency expects to ask the advisory panel to review any reconfiguration of existing vaccines before a future emergency authorization.
The meeting also included Dr. John Beigel, a clinical research director at the NIH, who described a new study designed to compare how well Moderna's existing vaccine works when stacked against modified versions meant to target known variants, either on their own or in combination, the Times reported.
The study will include enrolling 600 volunteers who have received their vaccines and a booster. Some will be given a dose of the existing vaccine. Others will get experimental vaccines that target the Omicron variant, Omicron plus the Beta variant, the Delta variant and a prototype virus that emerged first in the pandemic. Results may be ready by mid-summer, Beigel said.
More information
The U.S. COVID website has more on COVID-19.
https://consumer.healthday.com/b-4-7-fda-advisors-debate-booster-shots-for-fall-2657113730.html
Medicare finalizes its restrictions on new Alzheimer’s drug
Medicare on Thursday finalized its plan to restrict coverage for the controversial, pricey Alzheimer’s drug Aduhelm to patients participating in clinical trials.
The decision marks the end of an intense pressure campaign from drugmakers and some patient groups who wanted Medicare to reverse its initial proposal and pay for the drug for more patients. As clinical trials are usually run out of major medical centers, the decision will likely mean some interested patients won’t be able to access the drug.
The decision has implications beyond Aduhelm’s manufacturer, Biogen, as well. The coverage decision is not specific to Aduhelm, and could apply to all drugs in the class, including a forthcoming treatment that Eli Lilly has begun to submit for FDA approval.
In a major win for Lilly, however, Medicare said it will not require the exact same restrictions for drugs that aren’t approved based on surrogate endpoints. That could give other drug makers an opening to sidestep the same restrictions even if they’re making a similar medication for Alzheimer’s disease.
Since the Food and Drug Administration approved the drug last summer, doctors and scientists have raised questions about whether it actually works, government watchdogs have begun investigating whether the FDA followed proper procedure to approve it, and policy experts have questioned whether it is effective enough to justify its hefty price tag.
Medicare officials even hiked the entire program’s premiums to anticipate a potential flood of patients taking the pricey medication. But the new restrictions mean the drug will put less of a financial burden on the Medicare program. Health secretary Xavier Becerra said he soon plans to make a decision on whether to lower Medicare premiums for older adults after Medicare’s coverage decision for Aduhelm.
Aduhelm’s limited coverage policy is unprecedented, as Medicare almost always covers drugs if the FDA approves them. Aduhelm has been different because the agency approved the treatment without a guarantee that patients actually will see slower cognitive decline. The process that led to the drug’s approval is the subject of multiple investigations, following STAT’s reporting that Biogen had an extensive back-channel relationship with the FDA.
Medicare will also limit those who can get the drug to people who have mild forms of cognitive impairment or mild dementia, and who have amyloid plaques, the proteins Aduhelm is designed to target, in their brain. The patient population is narrower than the one the FDA approved the drug to treat, as the FDA did not require proof of amyloid plaques.
The narrow coverage policy is a major blow to Biogen, which had hoped that access to the Medicare patient market could invigorate the drug’s meager sales.
https://www.statnews.com/2022/04/07/medicare-final-decision-alzheimers-coverage-biogen-aduhelm/
All eyes on Florida, DeSantis – from fighting COVID to stopping wokeness, state is leading
It’s a funny time to be a new Floridian.
In January our family, very publicly, moved from New York City to south Florida.
Even before our move, it seemed like Florida was more central than ever to the national conversation. Gov. Ron DeSantis had famously taken a different path with COVID restrictions and was under intense scrutiny by the liberal media. Every move the governor made, from insisting parents have the final say whether their child wears a mask in school to hiring a sane and capable Florida surgeon general has garnered a serious amount of attention.
But in the last few weeks, that attention has been on steroids.
It started with the Parental Rights in Education bill, signed into law by the governor last week. In it, "Classroom instruction by school personnel or third parties on sexual orientation or gender identity may not occur in kindergarten through grade 3 or in a manner that is not age appropriate or developmentally appropriate."
I have yet to meet anyone in Florida who finds this controversial. I’m in a formerly blue part of the state. My local elected officials are mostly still Democrats. And yet every parent I’ve come across has been supportive of this law. There is no outcry on any of the local Facebook groups.
It seems like the tumult is completely manufactured on a national level by the liberal media that continues to interview only parents opposed to the law.
After Gov. DeSantis signed the parental rights bill, Disney, which had been pressured to speak out against the law just a few days before it was signed, had an internal meeting, the contents of which were leaked to journalist Christopher Rufo. The videos were extremely creepy, with Disney execs openly promising to indoctrinate children into gender theory.
I know several Floridian parents who are either letting their annual pass lapse or canceling trips to Disney and other parents who plan to monitor more closely what Disney produces before letting their kids consume the content.
Most consider this a self-inflicted wound by Disney. They let far-left activists lead the way and this is the result.
There’s a lot of conversation around new arrivals to the state and hoping they "vote the right way." But, in fact, every new arrival I’ve met has made the journey because they like DeSantis’ policies and wanted to be a part of them. I have taken to joking that I hope the Floridians who have been here all along will "vote right" since they haven’t always in the past.
Floridians know their state will be a focal point for the next few years as at least two, possibly three, Republican presidential candidates will be discussed. All eyes on Florida. They know that much of the national news from their state will be filtered through this lens. They’re ready.
https://www.foxnews.com/opinion/florida-desantis-fighting-covid-wokeness-karol-markowicz
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