5 Things to Know About the New Drug Pricing Negotiations

August 30, 2023

Category: Pricing, Regulations

The Biden administration has picked the first 10 high-priced prescription drugs subject to federal price negotiations, taking a swipe at the powerful pharmaceutical industry. It marks a major turning point in a long-fought battle to control ever-rising drug prices for […]

FDA Halts Clinical Trial Enrollment for Gilead’s Magrolimab in AML Studies

August 21, 2023

On Aug. 21, 2023, Gilead Sciences announced that FDA has placed a partial clinical hold on the company initiating new patients into US studies for magrolimab, an investigational anti-CD47 immunotherapy, to treat acute myeloid leukemia (AML). FDA’s decision follows a […]

FDA Approves Akeega for BRCA-Positive Metastatic Prostate Cancer

August 17, 2023

Category: Industry, Pharma

The U.S. Food & Drug Administration has approved Akeega (niraparib and abiraterone acetate) for the treatment of BRCA-positive metastatic castration-resistant prostate cancer. The approval makes Akeega the first and only dual action tablet combining a poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor […]

Industry, Pharma

Handling New Therapies Moving Through Drug Development at a Rapid Pace

September 13, 2023

Via: Biopharm International

Drug development is inherently costly and time-intensive, with potential attrition a persistent burden on companies’ finances (1). As companies gain a deeper understanding of cell and molecular biology and seek to develop more complex therapeutics for patient populations, they will […]

Cell and Gene Therapy, Industry

Novartis stops work on gene therapy acquired in Gyroscope deal

September 11, 2023

Via: Biopharma Dive

Novartis has stopped work on a gene therapy candidate it acquired a little under two years ago, according to an investor in the company the Swiss drugmaker bought. The decision to discontinue research follows a recommendation from a data monitoring […]

FDA, Regulations

FDA Eliminates REMS for Lotronex (alosetron hydrochloride)

September 8, 2023


Lotronex (alosetron hydrochloride) and approved generics are FDA approved for the treatment of irritable bowel syndrome in women whose predominant bowel symptom is diarrhea. Although safety risks for Lotronex (alosetron hydrochloride) and approved generics still exist, FDA has determined the […]

Biotech, Industry

Seagen partners with Nurix to create new kind of cancer drug

September 7, 2023

Via: Biopharma Dive

Seagen is the biotech sector’s leading developer of antibody-drug conjugates, which deliver cell-killing toxins to diseased cells by attaching them to an antibody that seeks out proteins on tumor cells. Its first, Adcetris, is on track to become a blockbuster […]