Merrimack Pharmaceuticals Expands Phase II Lung Cancer Study
Merrimack Pharmaceuticals announced it is expanding enrollment in a Phase II lung cancer study. Source: BioSpace
Immutep Strikes Deal with Merck to Pair Product With Keytruda in Phase II Trial
Immutep Limited announced it will pair its lead immunotherapy product with Merck’s blockbuster PD-1 inhibitor Keytruda to treat three solid tumor types in a single trial. Source: BioSpace
Hong Kong Firm Draws Warning for Testing, Labeling Deficiencies
The FDA issued Nan San Pharmaceutical a warning letter for significant violations of CGMPs, including a failure to test product batches and inadequately labeling of product expiration dates. Source: Drug…
AAM, Perrigo Urge FDA to Clarify ANDA Submission Guidance
The FDA should revise its draft guidance on ANDA submissions to clarify sponsors’ responsibility for reviewing existing guidances on generics, stakeholders said in comments to the agency. Source: Drug Industry…
PRAC Recommends Contraindication for Zytiga and Xofigo
The EMA’s Pharmacovigilance Risk Assessment Committee recommended contraindicating the use of Zytiga (abiraterone acetate) with Xofigo (radium-223 dichloride) and prednisone/prednisolone, after preliminary clinical trial results showed the combination posed an…
FDA Says Most Accelerated Oncology Approvals Went on to Prove Clinical Benefit
Most oncology treatments that received the FDA’s accelerated approval pathway in the past 25 years have demonstrated a clinical benefit, according to a review by agency officials published in the…
FDA Regs Plunged in 2017 But Other Developments Built on Trends
Although 2017 saw significantly fewer new FDA regulations, other regulatory and enforcement activities at the agency built on existing long-term trends, according to a new report from PriceWaterhouseCoopers (PwC). Source:…
483 Roundup: Four Manufacturers Cited for Cleaning, Sanitation Issues
Four firms in Switzerland, the United Kingdom and the U.S. were hit with Form 483s for having inadequate cleaning and sanitization procedures, in addition to batch record issues. Source: Drug…
Warning Letter Roundup: Five Firms Warned for Sanitation, Procedural Issues
The FDA warned five firms in South Korea, China and Germany for various GMP violations, including problems with sanitation, facility procedures and complaint handling. Source: Drug GMP Report
9 signs it's time to find a new job
“Of all the strategems, to know when to quit is the best.” – Chinese Proverb. Knowing the right time to make a change at work is a sign of wisdom…
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