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FDA approves Humira biosimilar as first-ever interchangeable monoclonal antibody
Boehringer Ingelheim has shown biosimilar manufacturers the way to win interchangeability with the world’s highest-grossing drug — but the company’s Cyltezo won’t come out until July 2023. Will future Humira competitors have better luck winning an earlier launch date?
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Consumer / Employer, Legal, SYN
Pharmacists join chorus calling for DOJ to stop Optum-Change Healthcare merger
Independent and community pharmacies seek to prevent UHG and Change merging into a “corporate monster” that will stifle competition.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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HHS rule bolsters health equity, Brooks-LaSure tells state rulemakers
New healthcare marketplace policies seek to make the ACA more equitable by investing in low-income and underinsured communities, changing the rules in ways that upset some insurers but delight many state and consumer health advocates.
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“No Surprises” enforcement left to states, big questions left unanswered in HHS rule
Enforcement of the No Surprises Act is still a work in progress, but CMS is ready to give out As for effort. Whether patients will agree with that grade still remains to be seen.
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Artificial Intelligence, BioPharma, Legal
DeepMind has unlocked protein-based medicine – what does that mean for drug patents?
One of science’s great puzzles is being solved by artificial intelligence and the answers shared freely on the internet. How can life sciences companies make the most of DeepMind’s discoveries while protecting their own?
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Avoid surprises by preparing to implement the No Surprises Act
The clock is ticking down for payers and providers to comply with the No Surprises Act, which protects patients from balance billing for the most common ancillary medical services. Here’s how to get your ducks in a row.
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DC Circuit: Insurers have to report Medicare Advantage overpayments to CMS
Overturning a district court’s decision that had earlier vacated the Medicare Advantage Overpayment Rule, the DC Circuit opened a Pandora’s Box of DOJ False Claims Act litigation last week.
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Teva’s generic label not skinny enough to protect from $234M damages to GSK
When is a skinny label skinny enough to protect a generic drug from claims of patent infringement? The answer remains up to interpretation after an important, controversial decision from the Federal Circuit.
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Fight over “pay for delay” heats up in Washington
Legislators threaten to ban settlements where branded companies “pay” generics makers to “delay” market entry, while drugmakers say the current framework balances competition and innovation. Who will prevail?
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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Pharma, Policy, BioPharma, Legal, Payers
Can Amazon change how the PBM and pharmacy worlds operate?
Despite mounting court and legislative scrutiny of pharmacy and prescription benefit manager practices, Amazon has chosen to throw its hat into the discount pharmacy ring. Could Amazon “disrupt” prescription drug delivery?
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Devices & Diagnostics, Legal, SYN
SCOTUS limits patent judges’ power but preserves PTAB review
The justices ruled that the authority of the judges of the Patent Trial and Appeal Board is unconstitutional, but by giving the USPTO director greater oversight, the highest court likely saved this favored tool of generic patent challengers.
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CVS drug buyers say pharmacy overcharged them $100M as trial opens
Six years after initially filing suit against CVS, insured customers of the pharmacy giant who charge that it misrepresented the “usual and customary” prices of drugs are finally getting their day in court.
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Saving private practice? Navigating the legal and ethical minefield of physician-private equity deals
While physicians face incredible pressures to consolidate or receive investment to survive, there are ethical, legal and practical considerations doctors must seriously consider before deciding to take private equity.