Brenda Sandburg
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Latest From Brenda Sandburg
Patent Settlements: FTC Gets Teva To Eschew 'No-Authorized Generic' Deals
Global settlement resolves charges against Teva in three pending FTC antitrust suits and expands terms of 2015 consent decree.
Can Government Petition PTAB To Review Patents? Supreme Court Seems Skeptical
Justice Sotoymayor suggests 'the deck is stacked' against private citizen who is dragged by government into AIA's post-grant review proceedings. Court denies petition seeking to revive Maryland's anti-price gouging law.
Regenerative Medicine Therapies: Manufacturing Changes May Not Impact RMAT Designation
Final guidance notes that preliminary clinical evidence may come from studies conducted outside the US, says historical controls may be considered in clinical trial designs.
Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts
Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.
Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts
Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.
Rare Diseases: US FDA Gives More Guidance On Premarket Safety Evaluation, Historical Controls
Agency specifies several approaches to augment safety assessment in a new draft guidance, which also encourages participation by patients and their advocates in the drug development process.