Drugs
A National Bureau of Economic Research (not a government agency) working paper surveying “The Landscape of U.S. Generic Prescription Drug Markets, 2004-2016,” says there is evidence to suggest that prices of generic drugs are statistically significantly increasing over time, particularly following implementation of the 2010 Affordable Care Act
Drugs
FDA has accepted for priority review an AstraZeneca NDA for acalabrutinib, a highly-selective Bruton tyrosine kinase inhibitor for treating patients with relapsed/refractory mantle cell lymphoma who have received at least one prior therapy. The submission is based on results from the Phase 2 ACE-LY-004 clinical trial.
Drugs
FDA has approved an expanded indication for Pharmacyclics’ Imbruvica (ibrutinib) to include chronic graft versus host disease (cGVHD) after failure of one or more treatments. The agency says it is the first approved therapy for treating cGVHD. Imbruvica, a kinase inhibitor, was previously approved for certain indications in treating chronic
Drugs
FDA has published a draft guidance, Child-Resistant Packaging Statements in Drug Product Labeling, to assist firms that choose to include child-resistant packaging (CRP) statements in the drug product labeling. The guidance discusses what information should be included to support CRP statements in labeling for NDAs, ANDAs, BLAs, and
Drugs
FDA has issued a guidance, Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases, to assist sponsors in the clinical development of new antibacterial drugs. Specifically, the document explains the agency’s current thinking about possible streamlined development programs and clinical trial designs
Drugs
Teva says that an FDA draft guidance on pre-submission facility correspondence associated with priority ANDA submissions seeks information that goes above and beyond what was included in the commitment letter for reauthorization of the Generic Drug User Fee Act. “The pre-submission facility correspondence guidance exceeds the details included
Drugs
Four stakeholder organizations are praising the FDA program for enhanced review transparency and communication statement of work that was negotiated as part of the Biosimilars User Fee Agreement. The Association for Accessible Medicines (formerly the Generic Pharmaceutical Association) and its Biosimilars Council say the need to provide adequate agency resources
Drugs
A 9/28/15-10/13/15 FDA inspection at Medical Center Pharmacy, Cleveland, TN, found serious deficiencies in the firm’s practices for producing sterile drug products, which put patients at risk, according to a 7/21 Warning Letter from the agency’s Office of Pharmaceutical Quality post in
Drugs
Sen. Bernie Sanders (I-VT) and Rep. Peter DeFazio (D-OR) are proposing to amend the Federal Food, Drug, and Cosmetic Act with a rule requiring federal agencies and federally funded nonprofits to secure reasonable pricing agreements from drug manufacturers before they grant the manufacturers exclusive rights to make drugs,
Drugs
Four stakeholder organizations are praising the FDA program for enhanced review transparency and communication statement of work that was negotiated as part of the Biosimilars User Fee Agreement. The Association for Accessible Medicines (formerly the Generic Pharmaceutical Association) and its Biosimilars Council say the need to provide adequate agency resources
Drugs
FDA has granted Bristol-Myers Squibb accelerated approval for Opdivo (nivolumab) for treating patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. Approval was based on data from the CHECKMATE
Drugs
FDA has approved Celgene’s Idhifa (enasidenib) for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, Abbott’s RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2
Drugs
FDA has granted AstraZeneca and MedImmune a breakthrough therapy designation for Imfinzi (durvalumab) for treating patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The designation was granted based on interim results from the Phase III PACIFIC trial,
Drugs
Amgen has submitted a supplemental BLA for Prolia (denosumab) for treating patients with glucocorticoid-induced osteoporosis. The submission is based on a Phase 3 study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment. The data showed that treatment with Prolia for 12 months
Drugs
FDA safety reviewers have raised some concern with a Janssen Biotech BLA for Plivensia (sirukumab) injection going before the agency’s Arthritis Advisory Committee 8/2. The major safety findings with sirukumab were related to immunosuppression (XXX DELETE XXX)consistent with other disease-modifying anti-rheumatic drugs DMARDs, but the
Drugs
FDA’s Vaccines and Related Biological Products Advisory Committee has voted 12 to 1 to recommend approval of a Dynavax Technologies BLA for Heplisav-B [hepatitis b vaccine, recombinant (adjuvanted)] for immunization against hepatitis B infection in adults 18 years of age and older. The positive vote came despite safety
Drugs
President Trump should declare a national emergency in order to deal with the ongoing opioid crisis, according to a just-released White House commissioned interim report. A final report will be issued in this fall. Declaring a national emergency would help the administration get a handle on the crisis, according
Drugs
ICU Medical has recalled one lot of 0.9% sodium chloride injection, USP 1,000 mL due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container. “Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local
Drugs
Adjunctive Cardiovascular Status Indicator Into Class 2 Federal Register notice: FDA classifies as Class 2 the adjunctive cardiovascular status indicator (special controls). 07/28/2017 List of Difficult Drugs for Compounding Federal Register notice: FDA develops a list of drug products and categories of drug products that are difficult to
Drugs
Apace Packaging has recalled one lot of cyclobenzaprine HCl tablets, USP 5 mg 50ct unit dose, and one lot of amantadine HCl capsules, USP 100 mg 50ct unit dose. The actions were taken due to a potential mislabeling error. A small number of cartons containing cyclobenzaprine HCl may be mislabeled
Drugs
FDA has announced a 9/13 public workshop on “Developing a Framework for Regulatory Use of Real-World Evidence.” Convened by the Duke Center for Health Policy under a cooperative agreement with FDA, stakeholders at the meeting will be asked to discuss the use of real-world data and real-
Drugs
FDA has issued a safety alert after it received recent adverse event reports about Guardian Pharmacy Services’ compounded triamicinolone and moxifloxacin product for intravitreal injection. An agency notice says that the reports were received after at least 43 patients were administered intravitreal (eye) injections at the end of a cataract