Biologics
FDA has lifted a clinical hold against Sarepta Therapeutics against the company’s Duchenne muscular dystrophy micro-dystrophin gene therapy program. The hold was placed in July due to the presence of trace amounts of DNA fragment in research-grade third-party supplied plasmid in a manufacturing lot. “In response,
Drugs
FDA has approved Cook Medical’s new 5 mm diameter version of Zilver PTX, described by the company as the first 5 mm peripheral artery disease drug-eluting stent in the U.S. with lengths available up to 140 mm that is indicated to treat vessels as small as 4mm
Drugs
Joint Panel to Review Alkermes Depression NDA Federal Register notice: FDA announces an 11/1 joint advisory committee meeting to review an Alkermes NDA for major depressive disorder. 09/21/2018 Draft Guide on Clinicaltrials.com Money Penalties Federal Register notice: FDA makes available a draft guidance entitled “Civil Money
Drugs
Eli Lilly has agreed to acquire AurKa Pharma, a company established by TVM Capital Life Science to develop oncology compound AK-01, an Aurora kinase A inhibitor that was originally discovered at Lilly. The potential first-in-class drug is being studied in Phase 1 clinical trials in multiple types
FDA Policy/General
Federal Register notice: FDA has announced an 11/1 joint Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to review an Alkermes NDA for buprenorphine and samidorphan sublingual tablets, indicated as an adjunctive treatment of major depressive disorder. To view the
Biologics
FDA has granted Pfizer a Breakthrough Therapy designation for its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, indicated for preventing invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults aged 18 years and older. The company expects to start Phase 3 trials in a few months.
FDA Policy/General
FDA’s fiscal year 2019 Congressional appropriations, which are part of a four-bill minibus, are “imperiled” after being superseded by other spending bills and lawmakers push for an early recess in order to campaign in the mid-term elections, according to an analysis by the Alliance for a Stronger
Drugs
The FDA has charged A & O Enterprises (dba iV Bars), a seller of intravenously injected therapy products (iV Cocktails), with making a range of deceptive and unsupported health claims about their ability to treat serious diseases such as cancer, multiple sclerosis, and congestive heart failure. This is the first
Drugs
FDA has approved a Vita Medical PMA for the Recell Autologous Cell Harvesting Device for treating severe thermal burns in patients 18 years and older. The device uses a small amount of a patient’s own skin to prepare “spray-on skin cells” at the point of care in as
Drugs
FDA has granted MicuRx Pharmaceuticals fast track status and a qualified infectious disease product designation for contezolid (MRX-I) and its prodrug contezolid acefosamil (MRX-4) for treating acute bacterial skin and skin structure infections. The company describes contezolid and contezolid acefosamil as next-generation oxazolidinone agents with reduced hematologic
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.” The document discusses civil money penalties that may be assessed against responsible parties
Drugs
CDER director Janet Woodcock says FDA is considering whether there is more it can do under the FDA Safety and Innovation Act to better address drug shortages. Speaking in a Center podcast, Woodcock says they are researching whether they have the ability to require applicants of certain drugs to identify
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Product Identifier Requirements Under the Drug Supply Chain Security Act— Compliance Policy.” The is document describes FDA’s intention to enforce a Drug Supply Chain Security Act provision requiring manufacturers to begin affixing or imprinting product identifiers on their
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.” The document addresses several revisions of the United States Pharmacopeia drug substance monograph for heparin sodium, and drug product monographs for heparin lock flush solution and
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” This guidance specifies whether and under what circumstances packages and homogenous cases of product not labeled with a product identifier will (XXX SUBSTITUTE XXX)be grandfathered
Drugs
FDA has released the FDA-483 issued following a 4/3-4/12 inspection at ADMA Biologics, Boca Raton, FL. The document’s eight observations were: * failing to prevent unauthorized access of changes to data and to provide adequate controls to prevent omissions of data; * failing to control issuance and
Drugs
FDA says its review of all postmarketing reports of deaths and serious adverse events reported with use of Acadia Pharmaceuticals’ Parkinson’s drug Nuplazid (pimavanserin) did not identify any new or unexpected safety findings or findings that are inconsistent with the established safety profile described in the drug label. “After
Biologics
FDA says it has awarded five grants to higher education institutions and non-profit organizations to study and recommend improvements for the continuous manufacturing of biological products, as well as similar innovative monitoring and control techniques. FDA commissioner Scott Gottlieb says advanced manufacturing technologies “hold great promise for improvements in
Devices
Getinge has begun a field correction on about 5,223 Maquet/Getinge Cardiosave intra-aortic balloon pumps (IABP) sold by Datascope Corp. due to a potential interruption or inability to start therapy. The issue involves certain intra-aortic balloons prior to or during the use with Cardiosave IABP for users
Devices
FDA is disputing findings published in the Annals of Surgery that suggested an increased risk of certain connective tissue conditions, such as rheumatoid arthritis and scleroderma, in patients with breast implants. “We respectfully disagree with the authors’ conclusions,” an agency notice says. “In our editorial response, we note our concerns
Drugs
FDA has released the FDA-483 issued after a 7/23-7/28 and 7/30-8/3 agency inspection at Zhejiang Huahai Pharmaceutical Co., Linhai, Zhejiang Province, China. The 11 observations on the form were: * failing to have an adequate change control system to evaluate all changes that may
Drugs
An FDA pre-approval product inspection at the Strides Pharma Sciences formulations facility in Bangalore, India, was completed 8/25, resulting in issuance of an FDA-483 with three observations. The company says it believes the agency’s observations are not material in nature and says it has already responded