Drugs
FDA commissioner Scott Gottlieb says recent guidances are part of an effort to modernize clinical trials to take advantage of novel opportunities such as trials in which small groups of patients are selected based on biomarkers or other criteria suggesting they are likely to benefit. In a statement, Gottlieb says
Drugs
The Justice Department says that five individuals and two companies have pleaded guilty to felony charges in a multi-million-dollar scheme to fraudulently sell popular dietary supplements. The department says the pleas were entered in a Texas federal court acknowledging that the companies and individuals played roles in developing,
Drugs
Attorney and healthcare communications consultant Mark Senak (FleishmanHillard) says his analysis of CDER Office of Prescription Drug Promotion (OPDP) enforcement actions since 2004 shows that actions regarding promoting an unapproved drug have risen substantially, signaling that this is a current enforcement priority for OPDP. Writing in his Eye on FDA
Drugs
FDA has granted Purdue Pharma a fast track designation for nalmefene hydrochloride injection, an investigational opioid antagonist for the emergency treatment of known or suspected opioid overdose. Nalmefene has a longer duration of effect than naloxone, another opioid antagonist currently approved for opioid overdose, the company says. The agency designation
Drugs
FDA has just released the FDA-483 issued following a 6/14-8/1/18 inspection at Immunomedics, a Morris Plains, NJ, clinical trial sponsor. The four observations were: * not all participating investigators were informed of new observations discovered by or reported to the sponsor; * failing to ensure proper monitoring
Drugs
Janssen Pharmaceutical has submitted a supplemental BLA for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. The submission, which is based on data from the Phase 3 MAIA (MMY3008) clinical study, is being reviewed
Drugs
FDA has approved an Aerie Pharmaceuticals NDA for Rocklatan (netarsudil and latanoprost) ophthalmic solution, 0.02/0.005% to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Approval is based on data from two Phase 3 studies, MERCURY 1 and MERCURY 2, with Rocklatan
Drugs
A New York federal judge has denied a Teva motion for summary judgment in a whistleblower case over speakers bureau promotion of two of its drugs. In the case, former Teva sales representatives allege that the speaker program for the firm’s Azilect (rasagiline) tablets, a Parkinson’s disease drug,
Drugs
FDA has issued five new guidances intended to encourage a broadening of eligibility criteria to allow more people participating in clinical trials of drugs and biological products for treating cancer, including patients with HIV, HBV, HCV, organ dysfunction, and prior or concurrent malignancies and brain metastases. The agency says that
Drugs
A Texas federal judge has entered a consent decree ordering Guardian Pharmacy Services, a Dallas drug compounder, to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act and other requirements. An FDA news release says that despite receiving
Drugs
A 3/27-4/3/18 FDA inspection at Pfizer’s Hospira Healthcare India drug manufacturing facility in Tamil Nadu, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/4 Warning Letter says the specific violations were: * failing to ensure that laboratory records
Drugs
HHS secretary Alex M. Azar III has appointed National Cancer Institute director Norman E. Sharpless to serve as acting FDA commissioner after Scott Gottlieb leaves next month. Gottlieb announced his resignation to spend more time with his family (see earlier story). Sharpless previously served as director of the University of
Drugs
FDA has approved an Alkem Laboratories ANDA for a new generic of Diovan (valsartan), an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The agency says it prioritized the submission’s review to “help relieve the recent shortage of this critical medicine as a result
Drugs
FDA has released the FDA-483 issued following a 2/7-2/15 inspection at Biocon Limited, a Bangalore, India, drug product manufacturer. The two inspection observations were: * procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, adequately validated, and/or followed;
Drugs
FDA has approved Regeneron Pharmaceuticals’ Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids, the company
Drugs
The Trump Administration has proposed a 7% boost ($419 million) in FDA’s 2020 budget, which includes more than $220 million to continue advancing new initiatives that will promote medical product innovation. An agency release says that the additional resources would “help the agency combat the opioid epidemic; advance new
Drugs
CytoDyn says it is seeking fast track status for its humanized CCR5 monoclonal antibody, leronlimab (PRO 140), after it showed a significant reduction in the volume of human breast cancer tumor metastasis in a murine xenograft model. “The metastatic tumor volume was reduced by more than 98% after seven weeks,
Drugs
American Health Packaging has recalled one lot of valsartan tablets,160 mg , due to the detection of trace amounts of an unexpected carcinogen in the finished drug product. The impurity is N-Nitrosodiethylamine, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes,
Drugs
FDA has granted Genentech accelerated approval for Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for treating adults with unresectable locally advanced or metastatic triple-negative breast cancer in people whose tumors express PD-L1. Approval was based on data showing favorable
Drugs
FDA has accepted for priority review a Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps. Patients with the condition often experience recurrence despite previous treatment with surgery or systemic corticosteroids, the company says. The agency
Drugs
Genentech has submitted a supplemental NDA for Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. FDA is reviewing the application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process
Drugs
FDA has issued an updated draft guidance, Nonproprietary Naming of Biological Products, indicating that the agency no longer intends to modify the proper names of biological products that have already been licensed or approved under the Public Health Service Act without an FDA-designated suffix in their proper names. The