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In an interview with Pharma Commerce associate editor Don Tracy, Lynn Kirkpatrick, PhD, CEO, Ensysce Biosciences, discusses the FDA's Breakthrough Therapy Designation for PF614-MPAR, which focuses on protecting patients from drug overdoses.

Lynn Kirkpatrick, PhD, CEO, Ensysce Biosciences, Discusses the Recent Breakthrough Therapy Designation for PF614-MPAR

Articles

As a result, time to treatment for the brand Gilead product is expected to increase from 16 to 14 days.

FDA Approves Updated Manufacturing Turnaround Time for Gilead’s CAR T-Cell Therapy

FDA to evaluate Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone for induction and consolidation treatment and with lenalidomide  for the maintenance treatment of adults newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant.

Johnson & Johnson Files sBLA for Darzalex Faspro Combination in Multiple Myeloma 

FDA to evaluate Padcev (enfortumab vedotin) with Merck’s Keytruda (pembrolizumab) for the first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer. 

Approval Sought for Keytruda/Padcev Combination for First-Line Treatment of Urothelial Cancer 

The pharmaceutical packaging company unveils a new siliconization line at its SQLM plant in France.

SGD Pharma Grows Siliconized Glass Vial Capacity

New England Journal of Medicine study provides a breakdown of how hospitals—especially those that qualify for discounts under the federal 340B Drug Pricing Program—are able to make a profit off insurer pharmaceutical expenditures. 

A Behind-the-Scenes Look at Drug Price Markups 

Breyanzi is a CD19-directed CAR T-cell therapy approved to treat multiple hematologic cancers.

FDA Grants Priority Review to Pair of Applications for Breyanzi for R/R Follicular Lymphoma, Mantle Cell Lymphoma

Gammagard Liquid is now FDA-approved to treat neuromuscular disability and impairment in adults with CIDP; as a replacement treatment for primary immunodeficiency in patients aged 2 years and older; and as a maintenance treatment to improve muscle strength and disability in adults with multifocal motor neuropathy.

Gammagard Liquid Gets FDA Approval for Chronic Inflammatory Demyelinating Polyneuropathy 

The latest financial commitment adds 24,000 liters of biologics drug substance-capacity to the company’s network.  

AbbVie Invests an Additional $223 Million in Singapore Manufacturing Plant

SRP-5051 is a next-generation peptide phosphorodiamidate morpholino oligomer showing promise in the treatment of Duchenne Muscular Dystrophy patients with a confirmed exon 51-amenable mutation.

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