Industry News
Research, Science & Manufacturer Updates
The U.S. Food and DrugAdministration (FDA) approved BioProducts Laboratory’s Gammaplex(immune globulin intravenous [human]5% liquid) for pediatric patients 2 years of age and older who have primary immunodeficiency disease (PI).
The U.S. Food and Drug Administration(FDA) has approved revised product labeling for Wilate (von Willebrand factor/coagulation factorVIII complex [human]) to include prevention of excessive bleeding during and after minor and major surgery in adult and pediatric von Willebrand disease patients.
A new report shows that stem cell transplants might soon offer multiple sclerosis (MS) patients an effective way to stave off relapses and improve their overall neurologic condition.
The U.S. Food and Drug Administration(FDA) has granted exclusivity to Flublok influenza vaccine for a period of 12 years.
Scientists at the University of South Australia and colleagues from Third Military Medical University in Chongqing, China, have found that the drug Edaravone alleviates Alzheimer’s disease pathologies at multiple levels and improves learning and memory functions in mice.
The Medicare Access and CHIP Reauthorization Act of 2015, which was enacted into law on April 16, will prohibit Medicare supplemental insurance(Medigap) policies from covering the Part B deductible for people who become eligible for Medicare on or afterJan. 1, 2020.
In two recent studies, researchers found that immune checkpoint inhibitors show promise in treating advanced melanoma.
In a first-in-people clinical trial, personalized tailor-made melanoma vaccines given to three patients with advanced melanoma appeared to increase the number and diversity of cancer-fighting T cells responding to the tumors.
At its annual meeting in June, the American Medical Association (AMA) adopted a new policy to seek more stringent state immunization requirements to allow exemptions only for medical reasons.
The Centers for Medicare and Medicaid Services (CMS) has expanded coverage to include in-home use of HYQVIA(immune globulin infusion 10 percent [human] with recombinant humanhyaluronidase) to treat primary immunodeficiency patients.
The U.S. FDA has issued a final rule requiring manufacturers to give six months’ notice if they plan to discontinue or interrupt production.
Pfizer (a licensee of Gliknik Inc.) has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its recombinant intravenous immune globulin (IVIG)-mimetic drug
GL-2045 to treat chronic inflammatory demyelinating polyneuropathy (CIDP).