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Pfizer Warning Letter Trips Up Sandoz/Momenta’s Expected Glatopa Launch

 
• By Bowman Cox

Sandoz/Momenta’s generic of Teva’s 40 mg Copaxone appeared imminent – until apparently unrelated FDA warning letter regarding contract manufacturer Pfizer’s McPherson, Kan., plant put review on hold.

FDA won’t approve a generic multiple sclerosis drug for months now that apparently unrelated quality issues at a contract manufacturer have triggered a warning letter from the agency.

Sandoz Inc. and Momenta Pharmaceuticals Inc. were well on their way to launching the first generic competitor to Teva Pharmaceutical Industries Ltd. ’s thrice weekly 40 mg Copaxone (glatiramer) when the contractor, Pfizer Inc., told them late Feb. 16 about the warning letter it had just received

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More from Manufacturing

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

Aragen’s CEO Says NIH Funding Cut Means Less R&D Money, And Tariffs Would Add To Woes

 
• By Vibha Ravi

Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an interview.

US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
• By Sue Sutter and Derrick Gingery

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.

More from Compliance

US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
• By Sue Sutter and Derrick Gingery

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.

Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

ICH Modernizes Stability Testing Guideline

 
• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.