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The judge found that safe harbor protections don’t apply because the patented products in question “are not subject to FDA premarket approval.” Read More
Pfizer estimated that only about 10 million treatment courses will be delivered by the end of June with the remaining 10 million not expected to be delivered until September’s end. Read More
Sen. Joe Manchin (D-W.Va.) reiterated his opposition yesterday to President Biden’s nearly $2 trillion social spending package, saying there are currently no negotiations underway — further sinking the Build Back Better Act’s prospects in the Senate. Read More
Federal prosecutors allege that Lucy Xi forwarded confidential information to her personal email, with large swaths of the proprietary information pertaining to experimental GSK cancer therapies. Read More
Applied Therapeutics got some coal in its stocking last week, when the FDA said the company needs clinical outcomes data, not just biomarker numbers, to support a New Drug Application (NDA) for AT-007, an investigational galactocemia treatment. Read More
A federal court has upheld the validity of Novartis’ patent covering a dosing regimen for its blockbuster multiple sclerosis therapy, Gilenya (fingolimod), rejecting a challenge from Chinese drugmaker HEC Pharma. Read More
The Centers for Medicare and Medicaid Services (CMS) has formally rescinded a Trump-era policy seeking to tie what Medicare pays for certain outpatient drugs to the lowest price paid by other developed nations. Read More
In the latest chapter in the 340B Drug Discount Program saga, HHS has appealed decisions issued in three federal courts that called into question the agency’s authority to punish drug companies who refuse to participate in the controversial program for safety-net hospitals. Read More
A Senate committee will vote whether to approve Robert Califf’s nomination to become FDA commissioner on Wednesday, Jan. 12 — a critical step before the full chamber can hold a confirmation vote on Biden’s pick to lead the nation’s drug regulator. Read More