Food and Drug Administration (FDA)
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In September 2016, the U.S. FDA approved Sarepta Therapeutics’ eteplirsen, now marketed as Exondys 51, for Duchenne muscular dystrophy (DMD). And now, two years later, the European Medicines Agency (EMA) has rejected Sarepta’s application for Exondys 51.
New York-based Y-mAbs Therapeutics will look at securing $96 million through an initial public offering to support development of its antibody-based therapeutic treatments for cancer.
The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL), basically a rejection, to Netherlands-based Pharming Group for its supplemental Biologics License Application (sBLA) for Ruconest.
Privately-held Galera Therapeutics, Inc. secured $150 million in a Series C funding round that will be used to drive its experimental head and neck cancer treatment GC4419 into Phase III trials, as well as support pre-commercialization activities.
AstraZeneca released positive results from the BORA Phase III extension clinical trial of Fasenra (benralizumab) as an add-on maintenance therapy in patients with severe eosinophilic asthma that had already completed either the SIROCCO or CALIMA Phase III trials.
Allergan and its development partner Sosei Group have voluntarily suspended clinical trials of HTL0018318 in Alzheimer’s and other types of dementia because of safety problems.
In a 99 to 1 vote, the Senate passed the bill that looks to cut down on the flow of illegal narcotics entering the United States through the mail, as well as taking aim at the abuse of prescription opioid medication – a problem that has grown to an epidemic in the United States.
Hemophilia patients could have an easier time taking their medication if the U.S. Food and Drug Administration (FDA) gives the green light for the newest indication of Genentech’s Hemlibra for patients who do not have Factor VIII inhibitors.
Shares of Cambridge, Mass.-based Mersana Therapeutics are up more than 7 percent in premarket trading after the company announced that it will be able to continue with its Phase I trial studying the antibody drug conjugate XMT-1522 as a potential treatment for some breast cancer patients.
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