PhRMA and BIO Say European Proposals Hurt Patent Rights
PhRMA and BIO called on U.S. trade officials to add the European Union to a list of countries that do not adequately protect intellectual property following the release of two…
Developers Voice Concern Over Draft Orphan Drug Loophole Guidance
FDA guidance that proposes to close what the agency sees as a “loophole” allowing drug developers to bypass pediatric study requirements would negatively impact child drug development if it becomes…
FDA Clarifies Informal Feedback Process Prior to Marketing Decisions
The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications. Source: International Pharmaceutical Regulatory Monitor
Celgene Partners with Prothena Therapeutics in Potential $2B Deal
Prothena Therapeutics has forged a collaboration with Celgene worth a potential $2B to develop new therapies for a broad range of neurodegenerative diseases. Source: BioSpace
GlaxoSmithKline Is Taking a Tough Approach to Budgets
The head of GlaxoSmithKline's pharmaceuticals division is pushing to cut its budget by 20 percent. Source: BioSpace
Seattle Genetics Gains Another FDA Approval
Seattle Genetics announced today that the FDA has granted approval for its Adcetris drug to treat Hodgkins Lymphoma. Source: BioSpace
Is There a Biotech Bubble Brewing in Boston?
Billions of dollars are being invested in Boston-based life science companies. Source: BioSpace
TCR2 Therapeutics Snags $125 Million To Expand T-Cell Program
TCR2 Therapeutics has raised $125 million in Series B financing to advance two T-Cell receptor (TCR) programs through clinical proof-of-concept. Source: BioSpace
Alder CEO Is Stepping Down
Alder BioPharmaceuticals announced that Randall Schatzman, the company’s president, chief executive officer and director, will be stepping down. Source: BioSpace
Indian API Manufacturer Warned for Serious GMP Violations
The FDA issued Malladi Drugs & Pharmaceuticals a warning letter for significant good manufacturing practice failures at an active pharmaceutical ingredient facility in Tamil Nadu. Source: Drug Industry Daily
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