Drugs
FDA has accepted for review an Incyte NDA seeking approval of parsaclisib for treating patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL). The submission is based on data from three Phase 2 studies (CITADEL-203, -204 and -205) evaluating parsaclisib as a
Drugs
A former Aegerion Pharmaceuticals sales rep has been sentenced to 54 months in prison for using the identities of physicians to carry out insurance fraud to help meet his performance bonuses. Mark Moffett (Springfield, IL) had been convicted 12/2019 by a federal jury of nine counts of wire fraud
Drugs
Johnson & Johnson says it has settled substantially all outstanding cases against its Risperdal (risperidone) over personal injury claims that the drug can cause young men to grow breasts. Risperdal is indicated for treating schizophrenia, acute manic or mixed episodes associated with Bipolar I disorder and irritability associated with autism.
Drugs
Beginning 11/15, new requirements under the FDA-approved Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program become effective to require all patients, prescribers, and pharmacies to recertify and re-enroll in the new system to prevent treatment interruptions. FDA 7/29 approved modifications to the clozapine REMS and prescribers
Drugs
FDA has announced the availability of a “NextGen Portal” for reporting the annual amount of listed human and animal drugs and human biological products that an establishment manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for commercial distribution. All registrants of drug establishments or their authorized agents should
Drugs
In a sweeping HHS announcement of the Biden administration’s strategy for curbing drug overdoses, secretary Xavier Becerra said one element in the plan is to expand the number of doctors who can prescribe buprenorphine to treat addiction, bypassing rules requiring hours of training for the physicians. The Washington Post
Drugs
CDER associate director for controlled substances Marta Sokolowska describes in an online post a variety of Center actions focused on the safe use of benzodiazepines. “One critical element of increasing our understanding of their benefits and risks is through collaborations and stakeholder outreach,” she writes. “One of the agency’s
Drugs
The Alliance for Regenerative Medicine says it supports tools outlined in FDA’s PDUFA 7 commitment letter to share information and help improve communication between the agency and sponsors. In its comment letter, it raises a concern about the increasing reliance on written responses to requests to discuss important and
Drugs
FDA has awarded Cardinal Health a $750,000 contract to implement an 18-month real world evidence (RWE) study to help the agency advance RWE in regulatory decision-making. The grant is intended to support FDA’s Assessment of a Novel Methodology for Endpoints Assessing Response to Lymphoma Treatment in
Drugs
The Covid-19 pandemic forced FDA to take a much closer look at the use of real-world data and it will likely play a bigger role in agency drug reviews as it adopts lessons learned from the pandemic. That’s the view in a 10/26 Bloomberg Law report.
Drugs
FDA has approved a labeling modification on Impulse Dynamics’ Optimizer Smart medical device, allowing the removal of a “normal sinus rhythm (NSR)” limitation from the indications for use statement. “Since patients are no longer required to be in NSR at the time of Optimizer implant, heart rhythm does not impose
Drugs
In its 30th anniversary report, the International Council for Harmonization (ICH) reviews past successes and then looks to the future in a rapidly changing environment. Presenting what the report calls a “pragmatic vision,” ICH says its guidelines “should enable more streamlined drug development of both innovative and generic/biosimilar medicines
Drugs
CDER director Patrizia Cavazzoni has named M. Khair ElZarrad as the permanent director for the Office of Medical Policy (OMP). ElZarrad joined the agency late in 2017 as the OMP deputy director. Cavazzoni says he led and successfully advanced multiple workstream-spanning areas such as clinical trial design and conduct,
Drugs
Public Citizen says the FDA Bone, Reproductive, and Urologic Drugs Advisory Committee that will consider whether Covis Pharma’s Makena (hydroxyprogesterone), indicated to reduce the risk of pre-term birth, should be withdrawn from the market must be fairly balanced to ensure hearing process integrity. In a statement (contains a
Drugs
[Review by Jim Dickinson] “Dopesick,” a compelling and hard-hitting, eight-part Hulu series on Purdue Pharma’s Oxycontin that was launched this month lambastes the company but goes easy on FDA while nevertheless charging that it corruptly relaxed the drug’s labeling without science. Unique among opioids, this was
Drugs
FDA, the National Institutes of Health (NIH), 10 drug companies, and five non-profit organizations are partnering to accelerate the development of gene therapies for the 30 million Americans who suffer from rare diseases. An NIH statement says the new Bespoke Gene Therapy Consortium “aims to optimize and streamline the
Drugs
During the Covid-10 pandemic, more than 70 bioresearch monitoring remote regulatory assessments have been conducted in lieu of physical FDA inspections to verify the clinical data that support regulatory applications, according to CDER Office of Compliance director Don Ashley. Speaking at a Pharmaceutical Quality Symposium 10/26, Ashley reflected
Drugs
Genentech says it commends FDA for leveraging scientific and regulatory experience to develop guidance for sponsors on how PK-based criteria can be used to support registration of alternative dosing regimens beyond those studied in dedicated clinical trials. Responding to an agency draft guidance, Pharmacokinetic-Based Criteria for Supporting Alternative
Drugs
Novartis says the CANOPY-1 Phase 3 study of canakinumab in lung cancer did not meet its primary endpoints of overall survival and progression-free survival in patients with previously untreated locally advanced or metastatic non-small cell lung cancer. The company says patients in the treatment arm received canakinumab
Drugs
[Report by David McFarland] FDA’s need to conduct preapproval inspections was reduced by 55% during the Covid-19 pandemic by the agency’s use of alternative tools, CDER Office of Pharmaceutical Manufacturing Assessment director Stelios C. Tsinontides told an online Pharmaceutical Quality Symposium 10/26. Historically, about 20% of
Drugs
Washington Legal Foundation (WLF) has asked the 9th Circuit Court of Appeals to affirm a lower court ruling that federal law preempts the plaintiffs’ state law failure-to-warn claim because it was impossible for the drug’s manufacturer to change the drug’s label under federal law. Adams v.
Drugs
Three Sidley attorneys say a new FDA final rule amending the agency’s regulations defining intended use opens many consumer products without therapeutic claims to regulatory oversight as drugs or medical devices. In their analysis, the attorneys say the rule provides that the agency can find a product subject to