Drugs
A North Carolina federal court decision dismissing all claims raised by Exela Pharma Sciences against Sandoz due to federal preemption is cited by attorney James Beck (Reed Shaw) as a primer for defense lawyers on the ways that preemption precludes private plaintiffs from second-guessing FDA decisions on the marketing
Drugs
Facing a 150-day deadline to respond, FDA has denied without comment specific requests made in a Taiho Oncology petition received 4/28 concerning its Lonsurf (trifluridine and tipiracil) tablets. The response says the petition asked FDA to: * refrain from filing or approving any ANDA or 505(b)(2) application
Drugs
An FDA drug safety communication says the agency is requiring an update to the Boxed Warning and requiring class-wide labeling changes for benzodiazepines to include the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions to help improve their safe use. An agency statement says the drugs are
Drugs
FDA has accepted and granted priority review for a Pfizer sNDA for Xalkori (crizotinib) for treating pediatric patients with relapsed or refractory systemic anaplastic large-cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK) positive. The agency granted breakthrough designation for the ALK-positive ALCL indication 5/2018. If the
Drugs
A 3/10-3/17 FDA inspection at the HNC Products drug manufacturing facility in Clinton, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/10 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a
Drugs
FDA has sent a complete response letter (CRL) to Hikma Pharmaceuticals on its ANDA for a generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder). The company describes the letter as containing “minor” issues and says it is working closely with the agency to quickly address
Drugs
FDA has granted priority review for the BLA submitted by Bristol-Myers Squibb and bluebird bio for idecabtagene vicleucel (ide-cel), an investigational B-cell maturation antigen-directed chimeric antigen receptor T-cell immunotherapy for treating adults with multiple myeloma who have received at least three prior therapies, including an
Drugs
A 2/26-3/10 FDA inspection at Coupler Enterprises, Warrington, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/15 Warning Letter says specific violations were: * failing to inspect the packaging and labeling facilities immediately before use to assure that all drug
Drugs
FDA says it intends to amend its medical product intended use regulations that describe the types of evidence relevant to determining whether a product is intended for use as a drug or medical device under the law and implementing regulations, including whether an approved or cleared medical product is intended
Drugs
FDA is alerting health care professionals and patients to a recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Co. due to possible clogging of the inhaler resulting in patients not receiving enough or any medicine. The albuterol inhalers are used to treat
Drugs
FDA has added content to a question-and-answer appendix in its guidance entitled Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The updated document includes a new question-and-answer regarding a clinical trial investigator’s responsibility to review all investigational new drug application
Drugs
Former FDA commissioner Scott Gottlieb says a recent move by HHS secretary Alex Azar to redirect his authority to prevent FDA and other health agencies from introducing any new rules on their own is a “distraction to FDA at the time that they should be focused on the Covid response.
Drugs
FDA has made “modernized” changes to its Phonetic and Orthographic Computer Analysis (POCA) program, the agency’s software tool that uses an advanced algorithm to determine the orthographic and phonetic similarity between two drug names. “The program can compare a drug name against multiple drug names found in several different
Drugs
Medimetriks Pharmaceuticals says it received a Type C Meeting written response from FDA on MM36 (difamilast) for the topical treatment of mild to moderate atopic dermatitis (AD). Based upon the response, Medimetriks says it is preparing to conduct a single pivotal trial in the U.S. for an NDA, which
Drugs
FDA has granted Junshi Biosciences an orphan drug designation for toripalimab and its use in treating soft tissue sarcoma. This is the third such designation granted to Toripalimab, with earlier designations for treating mucosal melanoma and nasopharyngeal carcinoma. Soft tissue sarcoma is a rare heterogeneous tumor with complex pathological types
Drugs
FDA has accepted for review a ChemoCentryx NDA for avacopan, an orally-administered selective complement 5a receptor inhibitor for treating antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The agency has set a 7/7 user fee review action target date. The company says ANCA-associated vasculitis is a systemic disease in
Drugs
The Justice Department says a 16-count indictment charges that two Florida men conspired to pay and receive kickbacks in connection with prescribing an Insys fentanyl spray. Those charged were pain management doctor Steven Chun and former Insys sales representative Daniel Tondre. A department statement says that Insys sales representatives
Drugs
FDA Office of Dietary Supplement Programs director Steven Tave told the 2020 Dietary Supplement Regulatory Summit 9/16 that while it is not correct to say that the dietary supplements industry is not regulated, “we can comfortably say at a minimum that the dietary supplement market isn’t perfectly regulated.
Drugs
FDA has accepted for priority review a CytRx NDA for arimoclomol for treating Niemann-Pick disease Type C. CytRx says that arimoclomol works by amplifying the production of heat-shock proteins, which can rescue defective misfolded proteins, clear protein aggregates, and improve the function of lysosomes. The agency has set
Drugs
President Trump and his administration’s “meddling for political purposes” in FDA and CDC activities related to Covid-19 puts the nation at risk, warns a Washington Post editorial board opinion piece. The Post looks at Trump’s touting of hydroxychloroquine and the expanded use of convalescent plasma as examples
Drugs
FDA says that stakeholders concerned about protecting proprietary information during the development of drugs containing cannabis and cannabis-derived compounds should consider using the drug master file (DMF) pathway. The agency explained the potential use of the DMF pathway for cannabis drug development during a recent Webinar that covered DMFs
Drugs
The California legislature has passed SB 852 that would require the state to partner with industry “to produce or distribute generic prescription drugs and at least one form of insulin, provided that a viable pathway for manufacturing a more affordable form of insulin exists at a price that results in