Drugs
FDA has awarded $1.7 million to five universities to fund a two-year, wide-ranging research project intended to help the agency better understand how to employ its quality management resources when inspecting drug company manufacturing operations. Schools participating the project are Indiana University, Ohio State University, University of
Drugs
FDA has issued a Warning Letter to Dollar Tree discount stores for receiving over-the-counter drug products produced by foreign manufacturers that were found to have “serious violations of federal law.” The letter outlines multiple violations of current good manufacturing practices at contract manufacturers used to produce the company’
Drugs
FDA has accepted for priority review an AstraZeneca and Merck NDA for MEK 1/2 inhibitor selumetinib for pediatric patients with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs). The agency is expected to set a second quarter 2020 user fee review action target date, the companies say
Drugs
CGMP consultant Dave Elder says an International Conference on Harmonization draft guidance for product lifecycle management, currently at stage 2b, is intended to extend the use of Quality by Design to established products and thus supplements the existing Quality by Design guidance that has been published for drug substances and
Drugs
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 14 to 2 to not recommend approval of Eli Lilly and Boehringer Ingelheim’s empagliflozin 2.5 mg because the drug’s benefits do not outweigh its risks as an adjunct to insulin for adults with Type 1 diabetes. The
Drugs
FDA says it has formally convened the Botanical Safety Consortium (BSC) under a memorandum of understanding signed between the agency, the National Institute of Environmental Health Sciences, and the Health and Environmental Sciences Institute. The memorandum established the framework for the BSC, FDA says. The consortium’s mission is to
Drugs
FDA says it has approved BeiGene’s Brukinsa (zanubrutinib) capsules for treating adult patients with mantle cell lymphoma who have received at least one prior therapy. Brukinsa was approved on the basis of a clinical trial of 86 patients with mantle cell lymphoma who had received at least one prior
Drugs
FDA has released the FDA-483 issued following a 9/1-9/18 agency inspection at Isorx Corp., a Richmond, CA, producer of sterile and non-sterile drugs. The four inspection observations were: * failing to disinfect materials or supplies before entering the aseptic processing areas; * disinfecting agents and cleaning wipes
Drugs
FDA has granted X4 Pharmaceuticals a breakthrough therapy designation for mavorixafor for the treatment of adult patients with WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. The company described mavorixafor as a potential first-in-class,
Drugs
FDA has placed a clinical hold on a Marker Therapeutics planned Phase 2 study of its MultiTAA T-cell therapy in post-allogeneic hematopoietic stem cell transplant patients with acute myeloid leukemia in both the adjuvant and active disease setting. The company says the agency “reviewed our submission and requested
Drugs
Researchers from Harvard Medical School and other institutions say FDA should update and revise existing guidances for anti-infective drug approvals to recommend appropriate clinical outcomes consistent with general scientific and regulatory parameters. Writing online in JAMA Internal Medicine, the researchers say that 21 of 27 guidances reviewed recommended surrogate
Drugs
HHS secretary Alex Azar says the administration is changing a key element in its plan to lower drug prices because President Donald Trump wants the plan to go further than originally announced. The Hill reports that Azar spoke at an Axios event and said that under the original proposal some
Drugs
FDA has been making less use of human drug advisory committees, scheduling only 23 meetings this year, according to an analysis by Eye on FDA. There are 31 total advisory committees, with 18 of them relating to human drugs. The report says that 19 of the 23 meetings were related
Drugs
The Stericycle Expert Solutions First Quarter recall index says drug recalls decreased 6.5% to 72, the second-lowest number in the past 12 quarters. However, recalled units stayed high at just over 22 million. “The average number of recalls per quarter so far in 2019 is trending to be
Drugs
Braeburn says that in light of the FDA decision to grant its April petition requesting revocation of Indivior’s orphan designation for Sublocade (buprenorphine extended-release) injection, Braeburn’s Brixadi (buprenorphine) weekly and monthly extended-release injection to treat opioid use disorder can be marketed as of 12/1/20.
Drugs
GlaxoSmithKline says next year it will seek approval for Nucala (mepolizumab) for treating patients living with Hypereosinophilic Syndrome (HES) based on just-announced positive results from a pivotal study. The Phase 3 study met its primary endpoint — demonstrating a statistically significant result with 50% fewer patients experiencing a HES flare
Drugs
A 5/27-6/5 FDA inspection at Mylan Laboratories’ Unit 8, Andhra Pradesh, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). An 11/5 Warning Letter says specific violations were: * failing to have adequate written procedures for the receipt, identification, and
Drugs
A 4/22-5/3 FDA inspection at Cadila Healthcare, Ahmedabad, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A 10/29 Warning Letter lists the specific violations as: * failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or
Drugs
An FDA briefing paper released in advance of the 11/14 Endocrinologic and Metabolic Diseases Advisory Committee discussion of Amarin’s Vascepa (icosapent ethyl) for an indication to reduce the risk of cardiovascular events as an adjunct to statin therapy in adults with elevated triglycerides and other cardiovascular disease risk
Drugs
FDA principal deputy commissioner for policy Lloyd Schiller told the Council for Responsible Nutrition 11/7 that FDA is looking at possible changes to law that would enable the agency to keep pace with changes in the dietary supplement market that has grown significantly in the last 25 years under
Drugs
FDA has placed on clinical hold the Solid Biosciences IGNITE DMD Phase 1/2 study of the company’s SGT-001 under investigation to treat Duchenne muscular dystrophy. The company says that to date six patients have been dosed with SGT-001. It reports that the third patient experienced a
Drugs
FDA has granted F2G Ltd. a breakthrough therapy designation for olorofim for treating invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species. The company says that olorofim is the