Drugs
Teva has filed suit in D.C. federal court claiming that an FDA interpretation of the definition of “first applicant” for a generic form of Restasis (cyclosporine) is unlawful. Attorney Kurt Karst (Hymen, Phelps & McNamara) writes in his firm’s FDA Law Blog that a new FDA position was
Drugs
Teva has filed suit in D.C. federal court claiming that an FDA interpretation of the definition of “first applicant” for a generic form of Restasis (cyclosporine) is unlawful. Attorney Kurt Karst (Hymen, Phelps & McNamara) writes in his firm’s FDA Law Blog that a new FDA position was
Drugs
FDA commissioner Scott Gottlieb says a new step in the agency’s effort to reduce drug costs by promoting competition is a request to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use to pursue common global development standards for generic drugs. Writing in an FDA
Drugs
FDA is evolving to keep pace with technology advances, and one area it wants to focus on is product labeling and new resources and approaches to “appropriately incorporate additional clinically important information into product labeling,” FDA chief of staff Lauren Silvis 10/17 told a Food and Drug Law Institute
Drugs
FDA has accepted for priority review an AbbVie supplemental NDA for Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) in previously untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Imbruvica is currently FDA-approved to treat adults with CLL/SLL as a single-agent for all
Drugs
Pfizer says an FDA draft guidance on use of expansion cohorts in first-in-human clinical trials to expedite development of cancer drugs and biologics will be helpful to sponsors. The company expresses concern that the draft is limited to oncology products. “Pfizer believes there may be other therapeutic contexts,
Drugs
CDER Office of Pharmaceutical Quality scientists are looking into the biochemical reactions of cancer cells to certain drugs that are designed to penetrate into subcellular structures known as mitochondria. An online Spotlight on CDER Science says that drugs that selectively enter and damage the mitochondria of cancer cells are of
Drugs
A 1/29-2/26 FDA inspection at Hanlim Pharm Co., Gyeonggi-do, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/3 Warning Letter says the specific violations were: * failing to follow appropriate written procedures that are designed to prevent microbiological
Drugs
A 5/29-6/8 FDA Bioresearch Monitoring Program inspection determined that Ignatius Godoy, Paramount, CA, violated regulations governing the proper conduct of clinical studies involving investigational new drugs in his role as clinical investigator in a study of a quadrivalent inactivated influenza virus vaccine in a pediatric population. A
Drugs
FDA has approved Pfizer’s Talzenna (talazoparib), a poly (ADP-ribose) polymerase inhibitor for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on results from companion diagnostic BRACAnalysis CDx test (Myriad Genetic Laboratories), an
Drugs
FDA has outlined a three-factor approach it uses to evaluate whether a drug- or device-related product communication is consistent with the product’s agency-required labeling. The factors come on the heels of a related guidance entitled Medical Product Communications That Are Consistent With the FDA-Required Labeling
Drugs
As part of its continuing push to modernize clinical trials, FDA 10/15 released two guidance documents to provide greater clarity and recommendation for drug developers. The first is a draft guidance, Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for
Drugs
FDA has approved EyePoint Pharmaceuticals’ Yutiq (fluocinolone acetonide intravitreal implant) for treating chronic non-infectious uveitis affecting the posterior segment of the eye. The product uses the company’s Durasert drug delivery technology and is a non-bioerodible intravitreal micro-insert in a drug delivery system containing 0.18 mg
Drugs
Novartis has agreed to buy Bannockburn, Illinois-based AveXis for $8.7 billion. As part of the deal, Novartis will gain lead gene therapy candidate AVXS-101 for spinal muscular atrophy. A BLA submission is planned for the second half of this year. Ferring Pharmaceuticals has agreed to acquire Rebiotix,
Drugs
FDA has released a guidance entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” In 2017, revisions were made to HHS’ Federal Policy for Protection of Human Research Subjects (45 CFR 46, Subpart A; “the Common Rule”), which set a 1/21/2019 compliance
Drugs
Bristol-Myers Squibb has reported disappointing topline results from its Phase 3 CheckMate -331 study evaluating Opdivo (nivolumab) versus the current standard of care, topotecan or amrubicin, in patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy. The study did not meet its primary endpoint of
Drugs
FDA has granted Sutro Biopharma an orphan drug designation for STRO-001 for treating multiple myeloma. The company says TRO-001 is a potential first-in-class antibody drug conjugate (ADC) targeting CD74, a protein highly expressed in B-cell malignancies. It was developed with Sutro’s cell-free protein
Drugs
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 8 to 7 to recommend not approving Trevena’s next-generation opioid oliceridine injection, indicated for managing moderate-to-severe pain in adult patients for whom an intravenous opioid is warranted. The mixed vote did not come as a total
Drugs
The 781 generic drugs approved by CDER’s Office of Generic Drugs in FY 2018 set a new record, up from the 763 approved in FY 2017, according to an FDA activities report. The report also shows there were 1,044 ANDA applications in FY 2018, down from 1,306
Drugs
FDA has cleared a TransEnterix 510(k) clearance for 3 millimeter diameter instruments for its Senhance System for use in microlaparoscopic surgeries. “The addition of 3 millimeter instruments will allow many high volume surgeries to be performed with smaller incisions, which supports our mission of advancing minimally invasive surgical capabilities
Drugs
FDA has approved a Boehringer Ingelheim supplemental NDA for new labeling on its Stiolto Respimat (tiotropium bromide and olodaterol) inhalation spray that includes data showing a meaningful reduction in chronic obstructive pulmonary disease (COPD) exacerbations driven by tiotropium. The agency also approved a revised indication to treat all patients with
Drugs
An FDA Webinar provides a detailed explanation of the agency’s July draft guidance on Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products—Content and Format. In the Webinar, CDER Office of Medical Policy special assistant for labeling Iris Masucci covers: (1) how to write,