Drugs
An 8/2-8/7/21 FDA inspection at Indiana Chem-Port, Vadodara Gujarat, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs). A 2/2 Warning Letter says the deviations were: * failing to ensure that equipment surfaces in contact with APIs do not
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A 7/12-7/26/21 FDA Bioresearch Monitoring Program inspection at Avila Herbals, Christiansburg, VA, determined that the owner/clinical investigator did not follow applicable legal requirements governing the conduct of clinical investigations and the protection of human subjects. A 2/4 Warning Letter cites these issues: * failing to
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FDA has placed a clinical hold against Legend Biotech and its Phase 1 clinical trial for LB1901, an investigational autologous chimeric antigen receptor T-cell therapy targeting malignant CD4+ T-cells for treating adults with relapsed or refractory T-cell lymphoma. The agency notified the company by email and indicated
Drugs
FDA has cited Denali Therapeutics’ preclinical toxicology assessment and has requested changes to the company’s clinical trial protocol, informed consent form, and investigator brochure, according to the company’s account of a formal clinical hold notification from the agency on its DNL919 IND, an Alzheimer’s candidate. Last month,
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FDA has accepted for review a Spectrum Pharmaceuticals NDA for poziotinib and its use in treating patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. The user fee review action target date is 11/24. The company is seeking
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CDER’s Office of Generic Drugs says it reached a milestone last year when it approved 100-designated “Competitive Generic Therapy (CGT)” ANDAs. The CGT pathway for generic drugs helps incentivize the entry of drugs with “inadequate generic competition” to the market. “This milestone is a sign the program is
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ProQR Therapeutics says a pivotal Phase 2-3 trial (Illuminate) evaluating sepofarsen for treating genetic eye disease CEP290-mediated Leber congenital amaurosis 10 (LCA10) did not meet its primary endpoint or notable secondary endpoints. The company said there was no benefit observed in either treatment arm versus sham against the
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Pfizer and BioNTech are delaying their rolling BLA for an amended Emergency Use Authorization for the Covid-19 vaccine to include children six months through four years of age. The companies, which have already submitted data on a two-dose vaccine, want to wait for further data on a studied
Drugs
FDA has granted Eli Lilly an emergency use authorization for its monoclonal antibody bebtelovimab and its use in treating Covid-19. The agency says that the therapy, which retains activity against the omicron variant, is for treating mild to moderate Covid-19 in adults and pediatric patients (12 years of
Drugs
A 2/10 Taiho Oncology petition asks FDA to impose restrictions on generic drug applicants citing Taiho’s Lonsurf (trifluridine and tipiracil) tablets for oral use as the reference-listed drug. Specifically, the petition asks FDA to: * refuse to approve any ANDA for generic trifluridine and tipiracil tablets that relies
Drugs
Ardelyx says it received 2/4 an appeal denied letter (ADL) from the FDA Office of Cardiology, Hematology, Endocrinology, and Nephrology, and will appeal that decision to the Office of New Drugs. In an SEC filing, the company says it had submitted a formal dispute resolution request early in 12/
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A 2/3 petition submitted by the Axinn law firm asks FDA to: * deny any Injectafer (ferric carboxymaltose injection) sNDAs for labeling changes based on the FAIR-HF and CONFIRM-HF trials, including any supportive data from AFFIRM-AHF, unless intended to add or strengthen a Contraindication, Warning, Precaution, or
Drugs
FDA has denied petitions submitted by attorney Jordan Thomas (Labaton Sucharow) asking the agency to halt two Cassava Sciences trials of its novel Alzheimer’s drug simufilam pending an FDA audit of concerns raised in the petitions. The initial petition called on FDA to audit: * the publications relied on by
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FDA has accepted for priority review a Sanofi sBLA for Dupixent (dupilumab) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The
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Harvard Medical School and Engelberg Foundation researchers say it is time for drug manufacturers to offer the U.S. government reasonable prices for drugs discovered using federal funding. Writing in the New England Journal of Medicine (registration or subscription required), the researchers say the alternative is for the government to
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FDA has granted Bayer a fast track designation for its investigational blood thinner asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke. The company describes asundexian as an oral inhibitor of Factor XIa (FXIa) that Bayer is developing as a potential treatment
Drugs
Public Citizen is petitioning FDA and the Drug Enforcement Administration to open proceedings to place gabapentin (Almatica Pharma’s Gralise and Pfizer’s Neurontin) and gabapentin enacarbil (Arbor’s Horizant) into Schedule V of the Controlled Substances Act. The petition says scheduling the drugs is necessary because they have a
Drugs
FDA’s Oncologic Drugs Advisory Committee 2/10 voted 14 to 1 that Innovent Biologics and Eli Lilly’s “me too” checkpoint inhibitor sintilimab plus chemotherapy, indicated for treating metastatic non-small-cell lung cancer (NSCLC), requires an additional clinical trial demonstrating applicability to U.S. patients and U.S.
Drugs
The national sales director for the now-defunct New England Compounding Center (NECC), Robert Ronzio, has been sentenced in Massachusetts federal court to time served in connection with conspiring to defraud FDA. Ronzio pleaded guilty in 2016 and cooperated with the government, testifying at the trials of three other NECC
Drugs
FDA has approved a Sanofi BLA for Enjaymo (sutimlimab-jome) for decreasing the need for red blood cell transfusions due to hemolysis in adults with cold agglutinin disease (CAD). The rare autoimmune hemolytic anemia is caused by antibodies (cold agglutinins) binding to the surface of red blood cells, which causes
Drugs
FDA has told Axsome Therapeutics that it will now meet its inspection deadline on inspecting the company’s contract manufacturing facility related to a 9/2021-submitted NDA for AXS-07 (meloxicam-rizatriptan) for the acute treatment of migraine. Previously, the agency had notified Axsome that due to Covid-19
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FDA has published a draft guidance, Development of Non-Opioid Analgesics for Acute Pain, as required by the Substance-Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. The document addresses the agency’s current thinking on three specific topics — development of non-opioid analgesic