Drugs
Attorneys Dominic DiSabatino and Audrey Crowell (SheppardMullin) say the most notable change in two FDA draft guidances clarifying its approach to requirements and incentives for pediatric drug development is the agency’s intent to increase the clinical trial requirements for obtaining pediatric exclusivity. Writing in an online post, DiSabatino and
Drugs
In its 2022 report to Congress on drug shortages, FDA says its response to the Covid-19 pandemic highlighted two needs that require ongoing work to be fully addressed: * gaining better insight into the supply chain since manufacturers are not required to notify FDA of increases in demand that they
Drugs
FDA has published a guidance, Clinical Drug Interaction Studies with Combined Oral Contraceptives, to help sponsors of INDs and NDAs evaluate the drug-drug interaction (DDI) effects of their investigational drugs on combined oral contraceptives (COCs), design interaction studies, and determine how to communicate DDI study results and risk mitigation
Drugs
FDA has accepted for review a Merck supplemental BLA for Keytruda in combination with standard-of-care chemotherapy (gemcitabine and cisplatin) for treating patients with locally advanced unresectable or metastatic biliary tract cancer. The submission is based on data from the KEYNOTE-966 trial that showed Keytruda plus chemotherapy had
Drugs
FDA has selected CDER Office of Generic Drugs (OGD) safety and clinical evaluation acting director Iilun Murphy to serve as the next OGD director, replacing Sally Choe, who left the agency eight months ago to pursue opportunities outside the agency. CDER Office of Lifecycle Drug Products director Susan Rosencrance, who
Drugs
FDA has approved commercial production at a Bristol Myers Squibb cell therapy manufacturing facility in Devens, MA. The company says the site is its third commercial CAR T (chimeric antigen receptor cell therapy) manufacturing facility in the U.S.
Drugs
FDA’s Antimicrobial Drugs Advisory Committee 6/8 voted 21 to 0 that AstraZeneca and Sanofi’s nirsevimab has a favorable benefit-risk assessment for preventing respiratory syncytial virus (RSV) lower respiratory disease in neonates and infants born during or entering their first RSV season. Panel members also voted 19
Drugs
FDA medical reviewers say data from the Phase 3 CLARITY AD trial support the benefits of Eisai/Biogen’s Leqembi (lecanemab) in the early treatment of Alzheimer’s disease. In a briefing document released in advance of the 6/9 meeting of the Peripheral and Central Nervous Systems Drugs Advisory
Drugs
A 3/22-4/28/22 FDA inspection of three clinical trials conducted by Dr. Mobeen Mazhar in Houston, TX, undertaken as part of the agency’s bioresearch monitoring program, identified objectionable conditions. A 5/31 Warning Letter says it appears that Mazhar did not adhere to the applicable statutory
Drugs
Five Hogan Lovells attorneys say that if the FDA proposed Patient Medication Information (PMI) is finalized, it would represent “a major change in Rx drug labeling.” Writing in an online post, the attorneys say that manufacturers have struggled to translate approved instructions for healthcare providers into patient-friendly language for
Drugs
FDA has approved Merck’s Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients. The antiviral agent was originally approved in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant. It is administered once daily
Drugs
FibroGen says its pamrevlumab did not meet the primary endpoint in the Phase 3 LELANTOS-1 trial in treating non-ambulatory patients with Duchenne Muscular Dystrophy (DMD) on background corticosteroids. A company statement says pamrevlumab was generally safe and well tolerated and the majority of treatment-emergent events were mild
Drugs
Sen. Ron Wyden (D-OR) says FDA and the Drug Enforcement Agency (DEA) need to issue a joint statement on the attention deficit/hyperactivity disorder medication Adderall and its generics “to clarify the role and management of quotas, as well as the conflicting reports from agencies, manufacturers, and pharmacies that
Drugs
FDA has published the International Council for Harmonization (ICH) E6(R3) draft guidance Good Clinical Practice (GCP) with updated recommendations for good clinical practices aimed at modernizing the design and conduct of clinical trials. An agency notice (contains a link to the guidance) says the draft was developed to enable
Drugs
Norwich Pharmaceuticals is suing FDA in the DC federal court over its “arbitrary, capricious, and unlawful refusal to grant Norwich’s amended ANDA final approval” for the 550 mg strength of rifaximin (Salix’ Xifaxan) to treat irritable bowel syndrome with diarrhea. The suit says that in an 8/2022 decision,
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it generally agrees with the recommendations in an FDA draft guidance on notification of a permanent discontinuance or interruption in manufacturing under section 506C of the Federal Food, Drug, and Cosmetic Act. In a comment letter, PhRMA says the additional clarity provided
Drugs
Staff in CDER and the Oncology Center of Excellence say a pooled analysis showed the frontline immune-oncology/tyrosine kinase inhibitor (IO/TKI) combination therapy benefit was greater in the intermediate/poor-risk group than the favorable risk group. Writing in European Urology, the researchers say they pooled four frontline
Drugs
FDA has placed an import alert on drug products manufactured by Sun Pharmaceutical Industries in Gujrat, India due to significant GMP violations documented in a 5/2022 inspection of the facility. According to an FDA Letter referencing the import alert, 14 medically necessary products made by the company are being
Drugs
FDA has removed a partial clinical hold against Foghorn Therapeutics’ Phase 1 monotherapy dose escalation study of FHD-286 in acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). Foghorn says it will begin a Phase 1 study of FHD-286 in combination with decitabine or cytarabine in relapsed or refractory
Drugs
FDA has placed an import alert on drug products manufactured by Intas Pharmaceuticals in Ahmedabad, Gujarat, India due to significant GMP violations documented in a 12/2022 inspection of the facility. According to an FDA letter referencing the import alert, 25 medically necessary products made by the company are being
Drugs
FDA has extended by three months its review of a SpringWorks Therapeutics NDA for nirogacestat for treating adults with desmoid tumors. The previous user fee review action date was 8/27. FDA told the SpringWorks that it required more time to review the company’s analyses of submitted data that
Drugs
FDA has posted a final guidance entitled “Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.” The document is intended to assist ANDA sponsors with optional attachments that can be used when preparing cover letters that accompany controlled correspondence, original ANDAs, and amendments and supplements to ANDAs. The cover letter