House Approves Tax Bill That Ends Orphan-Drug Credit
A sweeping tax overhaul bill approved by the House in a 227-205 vote Thursday would eliminate the orphan-drug tax credit, although the version of the legislation up for Senate consideration…
FDA Proposes New Regulatory Framework for Regenerative Medicine
The FDA unveiled its new regenerative medicine oversight framework — the regulation of promising stem cell treatments, engineered tissues and cell therapies — by publishing four guidance documents focused on…
Class Action Claims Celgene Gamed The System to Guard Thalomid, Revlimid
A health plan for a carpenters’ union filed a class action lawsuit against Celgene, claiming the drugmaker engaged in anti-competitive practices to maintain its monopoly on Thalomid (thalidomide) and Revlimid…
FDA to Help Break the Stigma of Opioid Addiction MATs
FDA Commissioner Scott Gottlieb told lawmakers the agency will work to break the stigma associated with medication-assisted treatments for opioid dependence and addiction. Source: Generic Line
Judge Denies Injunction Against Maryland Price-Gouging Law
A federal judge declined to block Maryland’s new law on generic drug price-gouging that went into effect Oct. 1, but said a challenge based on the law’s vagueness can proceed.…
FDA to Give Advance Notice of RTRs, CRLs and Approvals
The FDA is streamlining its communications with generics manufacturers, and outlined its procedures for relaying the status of an ANDA review in a new manual for staff. Source: Generic Line
FDA Clarifies Approval Pathways for Applications in New Draft Guidance
In a new draft guidance, the FDA describes which abbreviated approval pathways are available for ANDAs and 505(b)(2) applications. Source: Generic Line
FDA Lays Out Requirements for ANDA Post-CRL Meetings
The FDA will agree to meet to discuss the ANDA deficiencies cited in a complete response letter to a sponsor only if the sponsor lists the questions it wants to…
Founded by Genzyme Alumni, Cambridge's X4 Pharma Scores $27M
X4 Pharma announced it had closed a $27M Series B financing. Source: BioSpace
Philadelphia Biotech Startup Context Therapeutics Names a New CFO, Effective Immediately
The company is strengthening its team as it transitions to a clinical development stage company. Source: BioSpace
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