Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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The Ministry of Health and Prevention recently organized a community awareness event to celebrate World Food Day in collaboration with the College of Health Sciences - Nutrition Department of the University of Sharjah held under the theme of ‘Healthy diet and cooking.’
The U.S. Food and Drug Administration will update its review process for the approval of medical devices in the wake of a report that showed more than 80,000 injuries have been associated with medical devices for pain management since 2008.
Shares of Boston-based Zafgen, Inc. plunged more than 32 percent in pre-market trading after the company announced the U.S. Food and Drug Administration has slapped a clinical hold on its plans to launch a clinical trial in the United States for an experimental diabetes medicine due to safety concerns.
AbbVie could be eyeing another potential billion dollars of annual revenue following the accelerated approval of Venclexta for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older or who cannot tolerate intensive chemotherapy.
Approval is based on Phase 3 SPARTAN clinical study data which showed apalutamide decreased the risk of distant metastasis or death by 72 percent and improved median metastasis-free survival by more than two years
Tulane researchers James McLachlan and Lisa Morici explain how nanoparticles shed from bacteria can be used in future vaccines to illicit a more potent immune response than existing technologies. The project aims to design a more effective vaccine against pertussis.
Biomimicry, looking at how things are done in nature and applying that to solve problems, is utilized by many researchers. BioSpace looks at some examples of how scientists are performing cutting-edge research using biomimicry.
Since taking over as chief executive officer of Swiss pharma giant Novartis, Vas Narasimhan has been actively reshaping the company to focus on therapies that will drive revenue well into the future.
The company and the agency discussed the development of SYN-004 (ribaxamase) to prevent antibiotic-mediated Clostridium difficile infection (CDI).
The report, which was issued by the Council of Economic Advisors, pointed to changes in the approval process at the FDA in the approval process of generic drugs has led to greater competition in the marketplace, which has lowered the costs of the medications.