Drugs
Novartis has filed a Lanham Act suit in Washington, DC federal court against Janssen seeking to stop it from making false and misleading claims associated with Janssen’s Tremfya, indicated for treating moderate to severe plaque psoriasis. Novartis manufacturers and markets a competing product, Cosentyx. The Novartis lawsuit claims that
Drugs
Former Insys Therapeutics sales vice president Alec Burlakoff testified in Boston federal court last week on how he followed orders to recruit physician and pay illegal kickbacks to increase the sales of addictive Subsys, a fentanyl-based pain drug. It is the first federal trial involving executives of an opioid
Drugs
CDER Office of Prescription Drug Promotion (OPDP) has cited Phoenix Molecular Imaging Center for promoting an investigational drug, 11C-acetate, as safe and effective on a Web page touting prostate cancer imaging. “Your Web page describes 11C-Acetate as a useful PET scan agent for detecting recurrent prostate cancer,” a
Drugs
FDA has issued a final guidance on Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act. The document addresses the agency’s policies for developing a list of bulk drug substances that can be used in compounding. It
Drugs
The FTC has reached a settlement in FTC v. Actavis, a 2009 case alleging that Solvay and three generic drug companies illegally agreed to restrict generic competition to Solvay’s branded testosterone-replacement drug AndroGel for nine years. The settlement covers those products that Solvay may have been marketing or
Drugs
AurobindoPharma has expanded a 12/2018 recall to include 38 lots of valsartan and amlodipine and valsartan tablets after detecting trace amounts of a human carcinogen in the finished drug product. The impurity detected is N-nitrosodiethylamine, which is a substance that occurs naturally in certain foods, drinking water, air
Drugs
FDA has issued a Warning Letter to CanaRx for causing the distribution of unapproved new drugs and misbranded drugs to U.S. consumers. The letter outlines the company’s “scheme” to contract with public and private entities to provide prescription drug coverage to their employees. “In the scheme, CanaRx facilitates
Drugs
Pulse Biosciences has submitted a 510(k) for the CellFX System for use in common dermatologic procedures to remove general benign lesions including sebaceous hyperplasia, a common but difficult to treat facial lesion and seborrheic keratosis, the most common benign raised pigmented lesion. The device uses “non-thermal delivery of
Drugs
FDA has approved an Adlon Therapeutics 505(b)(2) NDA for Adhansia XR (methylphenidate hydrochloride) extended-release capsules for treating attention-deficit/hyperactivity disorder in patients six years and older. In a simulated adult workplace environment study, Adhansia XR demonstrated statistically significant improvement over placebo at 1, 2, 5, 8,
Biologics
FDA officials say the agency lacks the resources needed to pursue a comprehensive crackdown on the growing private stem cell industry. Responding to a lengthy Washington Post investigative report reviewing cases of several people who have been hospitalized after being injected with products made from umbilical cord blood, FDA commissioner
Drugs
FDA has approved a Janssen Pharmaceutical supplemental BLA for Tremfya (guselkumab) One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis. The company says One-Press offers a controlled injection that hides the needle throughout the process. Approval was based on results from the
Drugs
FDA says it has concluded that the scope of exclusivity ordered by a federal court for Eagle’s leukemia drug Bendeka extends to all applications containing the same active moiety as Bendeka, bendamustine, and bars approval of any application containing bendamustine for any exclusivity-protected indication starting on the 12/
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) says that in 2018 it worked on implementing four strategic priorities: collaboration, innovation, communication, and engagement. The OPQ 2018 annual report says it improved integration of internal processes to find more efficiencies. It also held public events to encourage quality-related innovation within
Drugs
On the heels of a substantial budget boost (see story) for this fiscal year, FDA commissioner Scott Gottlieb has outlined for U.S. House of Representative appropriators significant modernization efforts underway in CDER’s Office of New Drugs (OND). Beginning in the next few months, CDER will adopt new standard
Drugs
Parexel International has hired former FDA Oncology Center of Excellence deputy director Amy McKee as regulatory consulting services vice president. McKee, who spent 11 years at FDA, will focus on building Parexel’s new cross-functional oncology initiative, according to the company. At FDA, she served as Office of Hematology
Drugs
FDA has approved Genentech’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) subcutaneous injection for treating patients with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with
Drugs
Lehigh Valley Technologies (LVT) has agreed to pay $4 million to settle False Claims Act allegations that it designed a scheme to avoid paying fees to FDA associated with NDAs. A Justice Department news release says the Allentown, PA, firm is a drug company that develops and commercializes certain human
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA’s efforts on biomarker qualification, including through the agency’s biomarker qualification program. “The issuance of the draft guidance represents another critical step in qualification of drug development tools by providing a clear and predictable framework for sponsors engaged
Drugs
Two drug stakeholders say they support a request in a Pfizer 8/22/18 citizen petition that FDA issue guidance to ensure truthful and non-misleading communications by reference product sponsors on biosimilar safety and effectiveness, including interchangeable biologics, relative to the reference products. The Association for Accessible Medicines and
Drugs
The Office of Generic Drugs (OGD) says that in 2018, the first year for GDUFA 2, it approved or tentatively approved 1,021 ANDAs and published more than 250 new or revised guidances, product-specific guidances, and manuals of policies and procedures for stakeholders. In its annual report, OGD also
Drugs
Bayer says it has completed a rolling NDA submission to FDA for its investigational prostate cancer drug darolutamide. The company says the submission is based on data from a Phase 3 ARAMIS trial in men with non-metastatic castration-resistant prostate cancer. FDA has given darolutamide a fast track designation.
Drugs
FDA has issued Adamis Pharmaceuticals a Refusal to File letter on an NDA for its sublingual tadalafil product, indicated for treating erectile dysfunction. Upon a preliminary review, FDA determined that the NDA was not sufficiently complete to permit a substantive review, according to the company. The agency requested that Adamis