Drugs
The Covid-19 pandemic has led to a further deterioration in the U.S. clinical trials system, CDER director Janet Woodcock acknowledged 9/29 during a Friends of Cancer Research program. Woodcock, who is currently on detail to Operation Warp Speed, said that once the pandemic emergency is over, the
Drugs
FDA has published a draft guidance, E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential—Questions and Answers. The document contains revisions to sections 5.1 and 6.1 of the current questions and answers for the International Council for Harmonization’s ICH E14
Drugs
FDA says the GDUFA science and research program has awarded a five-year, $5 million grant to the Universities of Maryland and Michigan to establish a Center for Research on Complex Generics. An announcement says the center “aims to enhance research collaborations with the generic industry to further FDA’s
Drugs
The HHS Office of Inspector General (OIG) says FDA has struggled the measure the effectiveness of the REMS (Risk Evaluation and Mitigation Strategies) for transmucosal immediate-release fentanyl (TIRF) drugs and extended-release/long-acting (ER/LA) opioids in mitigating the misuse of opioids. An OIG report says that while
Drugs
A 2/10-2/20 FDA inspection at Panacea Biotec, New Delhi, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/24 Warning Letter says specific violations were: * failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans,
Drugs
A 2/6-2/14/19 FDA inspection at Intrathecal Compounding Specialist, Scott, LA, found serious deficiencies in the firm’s practices for producing sterile drug products that put patients at risk. A 9/15 Warning Letter gives examples of the firm preparing, packing, or holding drug products intended or
Drugs
FDA has announced a 10/13 virtual public meeting on Patient-Focused Drug Development (PFDD) for Systemic Sclerosis to obtain patients’ perspectives on disease impact on daily life and treatment approaches. PFDD is FDA’s systematic approach to “help ensure that patients’ experiences, perspectives, needs, and priorities are captured and
Drugs
FDA has issued a guidance entitled ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs. The document is intended to assist applicants in preparing and submitting amendments to tentatively approved ANDAs, including requests for final approval. It also provides recommendations on the timing and content of amendments
Drugs
FDA has released a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe. The document is intended to assist ANDA applicants in responding to complete response letters (CRLs) from FDA. It provides information and recommendations regarding potential courses of action for an ANDA
Drugs
FDA has approved a Shionogi & Co. supplemental NDA for Fetroja (cefiderocol) for treating patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas
Drugs
FDA has posted an International Council for Harmonization (ICH) draft guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk — Questions and Answers. The draft document addresses common questions that have arisen since the ICH M7 guideline was implemented based on recommendations
Drugs
Bristol Myers Squibb (BMS) says CheckMate-274, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) after surgery in patients with high-risk, muscle-invasive urothelial carcinoma, met its primary endpoints of improving disease-free survival versus placebo in both all randomized patients and in patients whose tumor cells express PD-
Drugs
FDA has approved Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator gene that is responsive to KALYDECO based on clinical or in vitro assay
Drugs
FDA has approved GlaxoSmithKline’s Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease. The new indication for Nucala is the first approval for HES patients in nearly 14
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FDA has granted RemeGen a Breakthrough Therapy designation for disitamab vedotin (RC48), an anti-HER2 antibody drug conjugate for second-line treatment of patients with HER2 positive locally advanced or metastatic urothelial cancer who have also previously received platinum-containing chemotherapy treatment. Earlier this year, the agency approved the company’
Drugs
The House Committee on Oversight and Reform will hold two days of hearings with major drug company executives 9/30 and 10/1 to consider the companies’ pricing practices for some of the costliest drugs in the U.S. “These companies sell medications that are critical to our health and
Drugs
FDA has announced a two-day (10/15-16) public Webinar on “New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment.” The Webinar supports a new Questions & Answers to ICH E14 and S7B guidance, which were recently released by ICH as a draft guideline for public consultation.
Drugs
A new FDA safety alert warns that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. It says there are reports of teenagers ending up in emergency rooms or dying after participating
Drugs
FDA has granted Leap Therapeutics a fast track designation for DKN-01 and its use in treating certain patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high Dickkopf-1 (DKK1) protein. DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of DKK1 protein,
Drugs
The Justice Department says Gilead Sciences will pay $97 million to resolve allegations that it violated the False Claims Act by illegally using a foundation as a conduit to pay the copays of thousands of Medicare patients taking the firm’s Letairis pulmonary arterial hypertension drug. A department statement says
Drugs
In an abrupt break from decades of prior policy, FDA and HHS announced late 9/24 a final rule that allows FDA-authorized programs to import certain prescription drugs from Canada if specific conditions to ensure the importation poses no additional risk to public health and safety. A final guidance
Drugs
Novartis Gene Therapies says that based on an FDA recommendation it will undertake a pivotal confirmatory study to supplement the existing STRONG data on the intrathecal formulation of AVXS-101 in older patients with spinal muscular atrophy. The company says the agency acknowledged the potential of AVXS-101 IT in