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Navigating the Path to Compliance: Two Pharmas Discuss Their Challenges and Successes
Demystifying Performance Testing: Strategies to Qualify Combination Products
Celgene COO Smith exits suddenly in wake of MS miss
Tuesday, April 3, 2018
The departure of Celgene COO Scott Smith wasn't entirely surprising, given recent setbacks, including a delayed FDA decision on the company's MS candidate ozanimod.
J&J’s stay-out-of-jail marketing for Invega Sustenna raises eyebrows
Thursday, February 15, 2018
Mental health experts question whether allowing Johnson & Johnson to market its antipsychotic med Invega Sustenna as a way to prevent arrest is really a good idea.
Exelixis' Cabometyx nabs first-line nod in kidney cancer
Wednesday, December 20, 2017
Exelixis shares soared Tuesday after its kidney cancer drug won a broader FDA approval expected to push it past $1 billion in peak sales.
Novartis seeks to revive Neulasta biosim prospects with new data
Friday, December 8, 2017
The FDA initially rejected Novartis' biosimilar of Amgen's Neulasta, but today the Swiss drug giant took a step forward to making a second pass.
FDA refuses Acorda Parkinson's drug NDA over manufacturing issues
Tuesday, August 29, 2017
Approval of Acorda's candidate for an inhaled drug for Parkinson's disease is in jeopardy because of FDA questions about Acorda's manufacturing.
Novartis faces uphill battle turning Ilaris into CV blockbuster
Monday, August 28, 2017
Analysts were underwhelmed by Novartis' data on the potential for its anti-inflammatory drug Ilaris to reduce the risk of major cardiovascular events.
FDA slams Biocon sterile plant making biosimilars
Tuesday, August 8, 2017
The Biocon sterile manufacturing plant that got spanked by European and FDA regulators earlier this year has taken another whipping by the FDA.
Akorn gets all clear on re-inspection of Decatur, IL plant
Monday, December 12, 2016
Akorn, which had a sterile manufacturing plant in Decatur, IL slapped around by FDA inspectors last summer, said the FDA just came back for a re-inspection and this time around all is well.