Drugs
Aquestive Therapeutics says that feedback from FDA has put it on a “clear path” to resubmit its NDA for Libervant (diazepam) Buccal Film for managing seizure clusters. The further guidance from the agency addressed a revised weight-based dosing regimen, modeling and simulations data that Aquestive provided 12/2020, the
Drugs
FDA has granted accelerated approval to Sarepta Therapeutics NDA for Amondys 45 (casimersen) injection for treating Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. Exons are DNA pieces that provide information for making proteins in a
Drugs
Three Hogan Lovells attorneys write that a 2/19 FDA announcement of Warning Letters sent to 10 companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders “signals that FDA labeling enforcement on health-related claims is on the rise under
Drugs
The FDA Office of Clinical Pharmacology (OCP) met or exceeded its 2020 organizational, scientific, and regulatory goals, according to the OCP annual report, while also being very involved in FDA’s pandemic response. OCP expanded its policy fellowship program and published six new guidances, with a major focus on the
Drugs
FDA has posted summaries of the 12/9/20 and 12/16/20 meetings of the FDA/industry pre-market subgroup that is part of discussions on the PDUFA 7 reauthorization. The 12/9 meeting covered: * further discussions about a real-world evidence pilot program to increase the use of
Drugs
Two consultants say that it usually is not FDA that slows the approval process for NDAs and BLAs. Writing in a Stat opinion piece, Certara CEO William Feehery and vice president Julie Bullock, a former FDA clinical pharmacology reviewer, say the main reason for delays and extensions is that sponsors
Drugs
FDA has revised its 9/1/20 guidance, Control of N-Nitrosamine Impurities in Human Drugs, to extend to 3/31 from 3/1 the recommended timeframe for completing risk assessments. FDA says manufacturers do not need to submit risk assessment documents to the agency, but should retain them so
Drugs
CDER has published a revised Manual of Policies and Procedures (MAPP) describing the organization, membership, responsibilities, and procedures for the Medical Policy Council (MPC). The MAPP says the MPC will provide senior support to CDER on medical policy development including: * leadership oversight and medical policy management for the Center; * attention
Drugs
The Sedgwick Brand Protection State of the Nation 2021 report predicts that by mid- to late-2021 FDA will start revoking medical device emergency use authorizations, reverting to unapproved status devices that were not approved by regular means. The report cautions that legal protections currently offered to manufacturers and distributors
Drugs
FDA has accepted for priority review a Pfizer BLA for TicoVac, its tick-borne encephalitis (TBE) vaccine for use in individuals one year of age and older. The company says it expects a user fee review action in August. TBE is a brain/spine viral infection that is transmitted to
Drugs
FDA has denied Sun Pharma’s appeal of the complete response letter the agency issued for Sun’s NDA for Taclantis (PICS), a novel formulation of paclitaxel under development to treat breast cancer. India’s Economic Times reports that FDA asked the company to conduct a new Phase 3 study
Drugs
An online FDA post says the agency is advising compounders and healthcare providers that it has concerns about the use of certain drugs prepared by compounders to treat patients with Covid-19. The post lists these concerns: * Thymosin-alpha 1 is not a component of an approved drug and thymosin
Drugs
Over-the-counter drug monograph reform will take more than a few years to implement, given some of the timeframes for publication of a non-binding list of OTC monographs discussed in a 1/27 agency Webinar on monograph reform. Attorney Carolina Wirth (Arnall Golden Gregory) says the agency also
Drugs
FDA has denied a 2/26/18 Synergy Pharmaceuticals petition asking that the agency require specified revisions to the approved package insert for Forest Laboratories’ Linzess (linaclotide) capsules. The petition asked that FDA: * convert the Trial 5 safety data for the Linzess 72 mcg dose in patients treated for chronic
Drugs
GlaxoSmithKline Consumer Healthcare says that a 12/9/20 FDA draft guidance, Best Practices in Developing Proprietary Names for Human Non-prescription Drug Products, does not reflect best practice as it pertains to over-the-counter (OTC) drugs and that implementation of the guidance as written “could significantly limit our
Drugs
AstraZeneca has withdrawn an Imfinzi (durvalumab) indication, treating previously treated adult patients with locally advanced or metastatic bladder cancer, after confirmatory data did not support the indication, which was granted accelerated approval 5/2017. The withdrawal does not impact the indication outside the U.S., and does not affect other
Drugs
FDA has issued a new guidance and revised another to assist vaccine, diagnostic and therapeutic product developers to address the emergence and potential future emergence of Covid-19 variants. The new guidance is entitled Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants,
Drugs
FDA has issued a updated guidance for currently authorized Covid-19 vaccines that could be modified with limited data to address emerging variants. In announcing the guidance, FDA acting commissioner Janet Woodcock said the document will allow FDA and developers to pivot as the virus adapts. “At this time, available
Drugs
Pfizer and BioNTech have submitted new stability data to FDA to permit their Covid-19 vaccine vials to be stored at warmer temperatures than their original authorization allowed for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer. The data demonstrate
Drugs
An FDA study of refuse-to-file (RTF) letters found that 4% of CDER submissions from 2008 to 2017 were issued an RTF. “Overall, 84.5% (544 of 644) of the refusal reasons were for scientific deficiencies; most reasons were related to drug efficacy and safety (196 [30.4%]) and
Drugs
Astellas and Seagen say they have completed submitting two sBLAs for Padcev (enfortumab vedotin-ejfv). The companies say that one submission, based on the Phase 3 EV-301 trial, seeks to convert Padcev’s accelerated approval to regular approval. The second submission, based on the pivotal trial EV-201’s
Drugs
CBER director Peter Marks says FDA is looking for ways to encourage cancer therapies to evolve quickly with enough information coming to the agency that it can be sure that patients are safe while still not holding back development. Marks spoke on a panel at a virtual meeting sponsored by