Drugs
FDA is planning several pilot programs to test ways to improve foreign inspections, agency staff have told Bloomberg Law. For an online story, Bloomberg talked to several attorneys about the foreign inspection program and the need for improvements. The attorneys said that increasing agency staff, using unannounced inspections, and hiring
Drugs
FDA has denied the substantive portions of a Novartis Gene Therapies 12/17/21 due diligence petition asking that the agency determine that Regenxbio did not act with due diligence during the regulatory review period of Zolgensma (onasemnogene abeparvovec-xioi) for purposes of patent term extension. The agency response says
Drugs
FDA has granted fast track designation for 7 Hills Pharma’s 7HP349, its lead clinical-stage immunosuppressant in combination with a CTLA-4 inhibitor to treat patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor. The company says 7HP349 is designated as an oral
Drugs
FDA and the Reagan-Udall Foundation are hosting a 3/29 virtual public workshop to discuss “critical questions” around access to naloxone and its use to reverse opioid overdoses. “An integral part of our efforts to combat opioid-related drug overdose is making naloxone more readily available and accessible,” CDER
Drugs
FDA has granted Myrtelle a Fast Track, Rare Pediatric Disease, and Orphan Drug designations for its lead clinical-stage gene therapy, rAAV-Olig001-ASPA, for treating patients with Canavan Disease. The condition is a fatal childhood genetic brain disease in which mutations in the Aspartoacylase gene (ASPA) prevent normal Aspartoacylase
Drugs
FDA has given the green light to Kairos Pharma to begin a clinical trial of its activated T cell therapy (KROS 201) in patients with recurrent glioblastoma, a type of brain cancer. The Phase 1 trial will be conducted at Cedars Sinai Medical Center in Los Angeles. KROS 201 activated
Drugs
FDA has released the FDA-483s issued following two 3/22-4/2/21 inspections at WuXi Biologics Co., a WuXi, Jiangsu, China, drug substance and drug product manufacturer. The first FDA-483 has these five observations: * failing to exercise appropriate controls over computer or related systems to prevent changes
Drugs
A California federal judge has sentenced the former CEO and COO of JHL Biotech for their roles in conspiring to commit trade secret theft and wire fraud. Former CEO Racho Jordanov was sentenced to 12 months and one day in prison and 36 months of supervised release, including nine months
Drugs
Five men have been charged by the federal government with conspiring to smuggle prescription drugs into the U.S. illegally. Two of the defendants also were charged with money laundering conspiracy and one with a single count of money laundering. A Department of Justice statement says the defendants operated two
Drugs
FDA has lifted clinical holds on Aprea Therapeutics’ clinical trials involving eprenetapopt in combination with azacitidine in myeloid malignancy programs. In 8/2021, FDA placed holds on the company’s Phase 3 frontline Myelodysplastic Syndrome (MDS) clinical trial, a Phase 2 MDS/acute myeloid leukemia post-transplant clinical trial, and
Drugs
Biogen says new data show that after 128 weeks of Aduhelm (aducanumab-awwa) treatment, patients in the long-term extension phase of Phase 3 trials “continued to experience reductions in two key Alzheimer’s disease pathologies….” A company statement said the data were “meaningful findings, which further our understanding of
Drugs
Several senators and representatives say Pharmaceutical Research and Manufacturers of America (PhRMA) provided misleading information to them in response to their letter asking about high drug prices. In a statement (contains links to letters to and from PhRMA), the members of Congress say their 3/1 letter to PhRMA expressed
Drugs
FDA has approved an AbbVie supplemental NDA for Rinvoq (upadacitinib) for treating adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. The company says the approval marks the first indication for Rinvoq in gastroenterology and
Drugs
An 8/24-8/31/21 FDA inspection at Accu Bio-Chem Laboratories, a Glendale, CA, contract testing laboratory, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/24 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure
Drugs
Due to disappointing overall survival data, Merck has stopped its Phase 3 KEYLYNK-010 trial evaluating Keytruda, an anti-PD-1 therapy, in combination with Lynparza, a PARP inhibitor, for treating patients with metastatic castration-resistant prostate cancer who progressed after treatment with chemotherapy and either abiraterone acetate or enzalutamide.
Drugs
FDA has published a draft guidance, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, to assist industry and academic sponsors in developing such products. The document provides CAR T cell-specific recommendations about chemistry, manufacturing, and control; pharmacology and toxicology; and clinical study design. Recommendations specific
Drugs
FDA has approved Mylan’s generic of AstraZeneca’s Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol for treating asthma in patients age 6 and older and maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. An
Drugs
Pfizer and BioNTech have submitted an FDA Emergency Use Authorization application for a second booster dose in adults 65 years of age and older who have received an initial booster of any of the authorized or approved Covid-19 vaccines. The submission is based on two real-world data sets
Drugs
FDA has extened by three months its review of Incyte’s supplemental NDA for Opzelura (ruxolitinib) cream for treating vitiligo. The new user fee review action target date is 7/18. The review extension is intended to provide FDA needed time to review additional data from ongoing Phase 3 studies
Drugs
FDA has approved AstraZeneca’s Lynparza (olaparib) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Approval was based on data from
Drugs
FDA has released a five-page Form FDA-483 issued to Leesar Inc. following a 10/2021 inspection of the Fort Myers, FL outsourcing facility. For example, the agency said the firm failed to thoroughly review an out-of-specification potency test result for a lot of vancomycin 1.5g.
Drugs
FDA has granted Allogene Therapeutics a fast track designation for its allogeneic CAR T product (ALLO-316) for treating patients with advanced or metastatic clear cell renal cell carcinoma (RCC) in those who’ve failed standard RCC therapies. “ALLO-316 targets CD70, which is highly expressed in RCC with limited