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The U.S. Patent and Trademark Office (PTO) has found against Longhorn Vaccines & Diagnostics for committing “egregious abuse” of the Patent Trial and Appeal Board (PTAB) process during its review of Longhorn patent claims filed against Spectrum Solutions’ COVID-19 test. Read More
Integra LifeSciences has initiated a voluntary recall of all its products manufactured at its Boston facility for the past five years after discovering, through an internal investigation, that the products contained higher than acceptable levels of endotoxins. Read More
This month, our review of recent clinical trial results features a drug for anemia due to chronic kidney disease that saw success after an FDA complete response letter, positive results for an ovarian cancer treatment and a hemophilia therapy as well as a lymphoma drug trial derailed by a serious adverse reaction.Read More
A New Jersey federal judge has ruled that Mylan cannot pursue a generic version of Janssen Pharmaceuticals’ injectable schizophrenia drug, Invega Trinza. Read More
India-based drugmaker Champaklal Maganlal Homeo Pharmacy (CMHP) has drawn two FDA warning letters in recent weeks over untested glycerin in gastrointestinal products for children, among other serious current good manufacturing practice (cGMP) violations. Read More
The FDA has spelled out when drugmakers may use generally accepted scientific knowledge (GASK) to support a drug or biologic application, in a new draft guidance. Read More
The International Council on Harmonisation (ICH) has released a draft guideline on good clinical practice (GCP), designed to facilitate acceptance of clinical trial data by ICH member countries and regions. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from advanced gene and cell therapy, ICH E8 R1 recommendations and FDA’s sterilization pilot. Read More
Republican lawmakers are renewing their push to speed FDA approvals by allowing the agency to automatically approve drugs and devices that have been approved and sold in other developed and trustworthy countries. Read More
The Ironworkers District Council of New England Health and Welfare Fund has filed a class action complaint against Teva Pharmaceuticals accusing the company of a nearly decade-long anticompetitive scheme to delay generic competition for its QVAR (beclomethasone dipropionate HFA) asthma inhalers. Read More
Ironwood Pharmaceuticals is acquiring VectivBio for $1.15 billion, netting a promising late-stage clinical asset aimed at treating severe, rare gastrointestinal conditions. Read More