FDA
The U.S. FDA has decided to put together an advisory committee meeting of outside experts to review a New Drug Application for roxadustat, FibroGen and its partner AstraZeneca’s investigational anemia therapy.
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A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
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Karolinska Development’s portfolio company OssDsign announces that its latest product Cranioplug has received 510(k) clearance by the FDA, which allows marketing and sales of the product in US. The implant is the first product of its kind in the US market.
Xofluza (baloxavir marboxil) was approved for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. The new medication has a novel mechanism of action that, Roche said, inhibits polymerase acidic endonuclease, an enzyme that is essential for the flu virus to replicate.
The FDA approved Sanofi and Regeneron’s Dupixent (dupilumab) as an add-on maintenance therapy for patients with moderate-to-severe asthma. The approved group is age 12 years and older with either an eosinophilic phenotype or with an oral corticosteroid-dependent asthma.
Myriad Genetics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved BRACAnalysis CDx® to be used by healthcare professionals to identify patients with HER2-negative metastatic breast cancer (mBC) who have a germline BRCA mutation and are eligible for treatment with Pfizer’s PARP (poly ADP ribose polymerase) inhibitor, TALZENNA® (talazoparib).
This week will have moderate activity by the U.S. Food and Drug Administration (FDA). Although they jumped the gun on Regeneron and Sanofi’s cancer drug, there are still plenty of other decisions being made this week. Here’s a look.
Multiple biotech companies are scheduled to release their quarterly reports next week. BioSpace takes a quick look at some these companies and the announcements they have made through 3Q2018.
The U.S. FDA approved Pfizer’s PARP inhibitor, Talzenna (talazoparib), for patients with a germline BRCA-mutated (gBRCAm), HER2-negative breast cancer. The agency also approved Myriad Genetics’ diagnostic assay to identify the mutation.
In looking at companies that are shaping the future, Time Magazine selected 50 business that are leading the charge. While many tech companies lead the way, there are several pharma and life science companies that are also disrupting the future.
The U.S. Food and Drug Administration gave Akcea Therapeutics and its parent company Ionis Pharmaceuticals the green light for Tegsedi, its treatment for polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Genentech snagged a new regulatory approval for its hemophilia treatment, Hemlibra. On Thursday the U.S. Food and Drug Administration approved the medication for hemophilia A patients who do not have factor VIII inhibitors.