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Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus. WEDNESDAY, Feb. 19, 2025 -- The U.S. Merilog is a rapid-acting human.
Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus.Merilog is a rapid-acting human. WEDNESDAY, Feb. 19, 2025 -- The U.S.
Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Biosimilars marketed in the U.S. for the treatment of diabetes.
Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe.
Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.
Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An
Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. That requirement would only be fulfilled if FDA agreed to such a change. But we digress. And indeed, after Pliva v.
Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” FDA thus disagrees that such differences are not clinically meaningful.
One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp.
This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class.
Last week Harm Reduction Therapeutics announced that it has entered into a commercial supply agreement with Catalent which will manufacture RiVive—if approved—at its facility in Morrisville, North Carolina. According to this announcement, FDAapproval of RiVive is anticipated in July 2023 and the U.S.
ENTRESTO was approved by FDA in July 2015 “to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.”
BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program.
Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDAapproval for often first-ever drugs to treat rare diseases (e.g., James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list.
For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. As AgencyIQ has previously discussed , developing biosimilars is an expensive process. FDAapproved 13 NMEs through the AA pathway in FY 2023, making up 25.5%
FDA has not approved an NDA for a drug containing botanical marijuana but notes that two drug products containing delta-9-tetrahydrocannabinol (“delta-9-THC”) (as dronabinol), the primary compound in marijuana have received FDAapproval: Marinol and Syndros. chemotherapy-induced), and pain.
Effect on FDAapprovals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update?
Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. Pipeline Information. billion.
FOOD AND DRUG ADMINISTRATION et al Challenge to FDAapproval of generic Hetlioz (tasimelteon) Pending 1:2023cv00629 (COFC) VANDA PHARMACEUTICALS, INC. FOOD AND DRUG ADMINISTRATION et al Challenge to FDAapproval of generic Hetlioz (tasimelteon) Pending ( Motion to Dismiss Denied-in Part/Granted-in-Part ) 1:2023cv02884 (D.D.C.)
156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. Another case of same-day (and same-time) FDAapprovals! To that end, 35 U.S.C. § 156(c)(4)
If an FDA-approved carve-out could support an intent to induce infringement claim, the use of the “section viii pathway would be substantially deterred.”
His unique background underscores his remarkable expertise as a cochlear implant researcher, a former FDA regulator, and his current role as a device attorney. The comprehensive agenda for the symposium can be accessed in its entirety here.
AUSTEDO is the first and only FDA-approved product to treat both tardive dyskinesia in adults and chorea associated with Huntingdon’s disease. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area.
Talazoparib is currently approved under the brand name TALZENNA ® for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Selection of patients for therapy is based on an FDA-approved companion diagnostic for TALZENNA.
Usually at this point in a post we would identify the date of approval of the relevant NDA. But that’s the controversy here: Did FDAapprove LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter , or on October 5, 2022 when FDA issued a corrected approval letter ?
1067, the “ Ensuring Timely Access to Generics Act of 2023 ,” and it would fundamentally transform the playing field for NDA, ANDA, BLA, and aBLA applicants seeking to preserve their rights in the wake of an adverse FDAapproval decision. That bill is S.
HPM is ably represented by seasoned drug product development and authorization attorney—and former FDA counsel— Deborah Livornese. Deb assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDAapproval and other paths to market, as well as on post-marketing regulatory requirements.
Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.
Very clearly, the brief states “In the FTC’s view, device patents that do not mention any drug in their claims do not meet the statutory criteria for Orange Book listing , and a device patent that is improperly listed in the Orange Book must be delisted” (emphasis added).
Rescheduling out of schedule I would allow for the medical use of FDA-approved prescription drugs dispensed by DEA-registered, state licensed pharmacies pursuant to prescriptions issued by similarly DEA-registered, state licensed practitioners.
The AAFCO OP includes FDAapproved feed and color additives, substances that are subject to GRAS notifications (AGRNs), etc. Most states treat the OP as a “positive list” of ingredients that may be included in animal foods.
As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C. Section II at 2.
Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDAapproved the NADA on May 15, 2014. In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.
Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDAapproval of applications to market drugs manufactured at the facility. Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S.
The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDAapproval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.
Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”
Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDAapproval so long as it adhered to pre-set terms under the monograph. The user fee program for OTC drugs is relatively young. Read AgencyIQ analysis here.]
Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.
As part of the Warning Letter, OPDP states, “To date, no drug has been shown to improve ACM in COPD” and includes a footnote that states, “Through the issuance of this letter, FDA does not intend to convey any views on whether data that did show that Breztri improved ACM in COPD would support a change to the FDA-approved labeling for Breztri.”
And, in fact, FDA muddied the waters itself when it stated in the 2003 implementing regulation preamble that “patents claiming devices or containers that are ‘integral’ to a drug product or require prior FDAapproval should be submitted and listed” and noting that patents claiming a finished dosage form of a product, which include “metered aerosols, (..)
Approximately six weeks after FDAapproved Lumryz and issued its clinical superiority decision , Jazz filed a Complaint against FDA in the District Court of D.C.
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