Drugs
Delaware federal court judge Richard Andrews has granted a Shire motion to dismiss a 2/7/17 Federal Trade Commission (FTC) complaint alleging that the company abused the FDA citizen petition process to prevent generic competition to its Vancocin. FTC said Shire “inundated” FDA with 46 regulatory and court filings
Drugs
The Biotechnology Innovation Organization (BIO) says its members would benefit from more clarity in terms of a specific timeframe for when FDA might make a preliminary non-binding opinion on whether an application meets the criteria for priority review voucher eligibility. “We recommend that the preliminary opinion be conveyed in
Drugs
FDA has approved a Novo Nordisk supplemental NDA for Tresiba (insulin degludec injection) 100 U/mL, 200 U/mL to include data from the DEVOTE safety outcomes study. The following data from the study in patients with Type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) are now included in the
Drugs
FDA has issued a guidance on “Chronic Obstructive Pulmonary Disease (COPD): Use of the St. George’s Respiratory Questionnaire as a Patient-reported Outcome Assessment Tool.” The document addresses the use of the questionnaire in interventional clinical trials in patients with COPD. Information in the guidance was previously provided in
Drugs
FDA has cleared a DarioHealth 510(k) for the company’s Lightning-enabled version of its Dario Blood Glucose Monitoring System which enables the use of the Dario app on iPhone 7, 8 and X smart mobile devices. The clearance permits DarioHealth to offer its glucose meter smartphon connectivity with
Drugs
An Illinois federal jury 3/26 found AbbVie liable for injuries to an Oregon man allegedly caused by the company’s testosterone replacement therapy AndroGel. The jury ordered AbbVie to pay Jesse Mitchell $3.2 million in the fourth bellwether trial in federal multidistrict litigation (mdl) 2545 in the Northern
Drugs
FDA has issued a draft guidance on “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act” that discusses the agency’s interpretation of the statutory phrase “bulk drug substances for which there is a clinical need.” It also
Drugs
After consulting with FDA, AbbVie has decided to not seek accelerated approval for Rova-T (rovalpituzumab tesirine) as a third-line treatment for relapsed/refractory small cell lung cancer based on the magnitude of effects across multiple parameters in a single-arm study. “Although the results from the study were
Drugs
The House passed a right-to-try bill late 3/21 that would allow terminally ill patients access in certain circumstances to experimental therapies (see earlier story). The bill passed on a vote of 267-149, with 35 Democrats supporting the measure and two Republicans against it. It now heads
Drugs
FDA commissioner Scott Gottlieb says the agency is analyzing opioid analgesic dispensing and refill patterns by medical indication and provider specialty and obtaining important insight into the amount of opioid analgesic that patients appear to need to control acute pain by medical indication. In 3/21 testimony before the House
Drugs
FDA has released the FDA-483 with five observations from a 3/5-3/9 inspection at the Dr. Reddy’s Laboratories active pharmaceutical ingredient (API) manufacturing facility in Medak, Telengana, India. The observations were: * failing to fully follow responsibilities and procedures applicable to the quality control unit; * failing to
Drugs
FDA has approved an expanded indication for Novartis’ Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients aged one year or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP). Previously, the product was approved for treating adult patients with newly
Drugs
FDA says a Drugs@FDA Express mobile application is now available through iTunes and Google Play. On the mobile app, users can search for information about FDA-approved branded and generic prescription and over-the-counter drugs and biological therapeutic products. The agency says the Express app is a streamlined
Drugs
FDA has cleared an Orthofix International 510(k) for its new internal fixation system, the G-Beam Fusion Beaming System, intended for use in treating Charcot foot, a debilitating condition where the bones in the foot weaken and collapse. The device is designed to be implanted in the medial and
Drugs
Attorney Mark Schwartz (Hyman, Phelps & McNamara) says in an online post in his firm’s FDA Law Blog that the FDA quality metrics reporting program first announced in 2015 now appears to be on hold. Although the agency had said in 11/2016 that it intended to open an
Drugs
FDA has approved a Sun Pharmaceutical Industries NDA for Ilumya (tildrakizumab-asmn) for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The drug selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor, which
Drugs
FDA has approved an expanded indication for Seattle Genetics’ Adcetris (brentuximab vedotin) to treat adults with previously untreated stage 3 or 4 classical Hodgkin lymphoma (cHL) in combination with chemotherapy. An FDA media statement says Adcetris combines an antibody and a drug, allowing the antibody to direct the drug to
Drugs
FDA commissioner Scott Gottlieb and two colleagues say the agency is using new screening technology at international mail facilities (IMFs) to enable it to screen more packages to prevent illegal products with hidden drug ingredients from entering the U.S. Writing in an FDA Voice blog post, the three say
Drugs
FDA has approved a Teligent ANDA for halobetasol propionate ointment, 0.05%, indicated for treating a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Total brand and generic annual sales are reported to be about $31 million.
Drugs
FDA has granted Fennec Pharmaceuticals a fast track designation for Pedmark (sodium thiosulfate) for preventing cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma. There are currently no drugs approved in the U.S. for the condition, according to the company. The drug has been studied in two Phase
Drugs
Treatment effects from pivotal trials supporting FDA approval of novel therapeutics based on surrogate markers of disease are often larger than the treatment effects observed among post-approval trials using surrogate markers as trial endpoints, specifically for non-continuous surrogate markers, according to a study published online in BMC Medicine.
Drugs
FDA says it is releasing a draft guidance to provide more complete and relevant information on the process for submitting postmarketing safety information on combination products. FDA commissioner Scott Gottlieb says the guidance “explains when a single, complete report can be used to meet multiple reporting requirements and what the