Court Says Pfizer’s Copays for Heart Drug May Violate Anti-Kickback Law
Pfizer’s proposed copay assistance program for its $225,000-a-year heart treatment would violate the Federal Anti-Kickback Statute (AKS). Source: Drug Industry Daily
Patient Data From Many Cancer Trials Inaccessible to Drug Researchers, Study Finds
Only 45 percent of cancer drug trials made their individual participant data (IPD) available to other qualified researchers over the past 10 years, according to a new study. Source: Drug…
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
FDA has approved Enhertu (fam-trastuzumab-deruxtecan-nxki), the first approved therapy targeted to patients with unresectable or metastatic HER2-low breast cancer subtype, a newly defined subset of HER2-negative breast cancer. Source: Drug…
Pfizer to Purchase Sickle Cell Drugmaker Global Blood Therapeutics
Pfizer announced that it will pay $5.4 billion for Global Blood Therapeutics (GBT), manufacturer of Oxbryta (voxelotor), one of a handful of drugs for treating sickle cell anemia. Source: Drug…
PhRMA Lashes Out Against Senate Bill Allowing Medicare to Negotiate Drug Prices
The Pharmaceutical Research and Manufacturers of America (PhRMA) is incensed about the reconciliation bill the Senate passed on Sunday night, which would permit the government to negotiate with drugmakers on…
Senate Passes Historic Drug Pricing Bill
After more than a year of missed opportunities, Senate Democrats yesterday passed a landmark, $740 billion reconciliation bill that would grant Medicare the authority to negotiate the price of prescription…
California OTC Drugmaker Draws FDA Warning for Repeated Lapses, Unapproved Drugs
The FDA issued a warning letter to over-the-counter (OTC) drug manufacturer DSP Skin Care for quality lapses at its facility in Los Angeles, Calif., noting that the company had failed…
Senate Set to Pass Historic Drug Pricing Bill
After more than a year of missed opportunities, Senate Democrats are finally slated to pass a landmark, $740 billion reconciliation bill as soon as today that would grant Medicare the…
FDA Seeks Additional Trial for Acadia’s Nuplazid Alzheimer’s sNDA
In a continuing saga of disapprovals, the FDA issued a Complete Response Letter (CRL) to Acadia Pharmaceuticals on its supplemental New Drug Application (sNDA) to expand the use of its…
AstraZeneca, Bristol Myers Squibb and McKesson Diabetes Drug Case Dismissed
A federal court in Kentucky has dismissed a multidistrict lawsuit against AstraZeneca, Bristol Myers Squibb and McKesson that alleges they sold two diabetes drugs that caused heart failure in some…