FDA Law Blog: Biosimilars

AUGUST 8, 2024

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.

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FDA Law Blog: Biosimilars

JULY 5, 2023

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. 353b(a). Section II at 2. Draft Guidance III.B.2(e)

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New Drug Approvals

DECEMBER 16, 2023

Retrieved 10 December 2023. ^ “Novartis receives FDA approval for Fabhalta (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH” Novartis (Press release). 1 H NMR (400 MHz, methanol-d4) δ 10.73 (s, 1H), 8.23 (d, J = 8.2 Hz, 2H), 7.36−7.31

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

As FDA explains, Boehringer’s request would allow its “Cyltezo (adalimumab-adbm) injection, which contains the same total content of drug substance and same concentration as Original Concentration Humira (e.g., mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., mL) in addition to Original Concentration Humira.”

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

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Codon

APRIL 2, 2023

Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. Read Economic terms were compared for 239 biotechnology licenses issued to academic institutions and 916 similar licenses at commercial firms. 📰 News A blood test to detect about 50 different cancers.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Scott and colleagues focused on six genes that encode potential drug targets licensed or in development by GlaxoSmithKline for the treatment of obesity or diabetes. That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5].

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Codon

MAY 18, 2023

The company also has licensing deals with Tropic Biosciences to make bananas that don't brown as fast and coffee with naturally low caffeine & high solubility (for instant coffee). Wilson then went on to isolate AAV9 for the first time, and it was later used to develop one of the first FDA-approved gene therapies: Zolgensma.

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Codon

MAY 18, 2023

The company also has licensing deals with Tropic Biosciences to make bananas that don't brown as fast and coffee with naturally low caffeine & high solubility (for instant coffee). Wilson then went on to isolate AAV9 for the first time, and it was later used to develop one of the first FDA-approved gene therapies: Zolgensma.

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Codon

MARCH 28, 2023

Researchers used an off-the-shelf, FDA-approved machine, developed by Blackrock Neurotech ; the algorithms were the main advancement.) ” Another company, called Kernel , was also interested in the hippocampal memory prosthesis technology, according to Song, and licensed some of the IP.

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FDA Law Blog: Biosimilars

MAY 21, 2024

FDA analyzed anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, chemotherapy-induced nausea and vomiting, pain, and post-traumatic stress disorder. (Thirty-eight states authorize marijuana for specific qualifying medical conditions.) Basis at 63-64.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

4,631,286, where the PTO considered “whether Hoechst-Roussel is eligible to file an application for [PTE] based on a regulatory review conducted by its competitor, the marketing applicant Warner-Lambert, wherein Hoechst-Roussel was not associated with the regulatory review that led to FDA approval for commercial marketing of the approved product.”

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FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Cannabis in schedule III would require a prescription issued by a DEA-registered, state-licensed practitioner. FDA had not approved an NDA or ANDA for cannabis for any indication in 2016. FDA did approve Epidiolex , a cannabidiol oral solution derived from cannabis, in June 2018.

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FDA Law Blog: Biosimilars

MAY 5, 2024

OASH concluded “there is widespread current experience with medical use in the United States” by licensed healthcare providers for which “such medical use is recognized by entities that regulate the practice of medicine in these states.”

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

We blogged on the December 5, 2023, letter from six Democratic governors to President Biden). Rescheduling would eliminate a tax burden on cannabis companies, allowing licensed companies to expand investments into state programs and focus on public health in collaboration with law enforcement efforts.

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New Drug Approvals

JULY 10, 2023

If FDA approved, it will join other previously-approved “-gepant” drugs [ rimegepant ] and [ ubrogepant ] as an additional treatment alternative for patients with migraine, particularly those for whom traditional triptan therapy has proven ineffective. and > 300 mg/mL at lower pH pKa 4.8 2021 Jan 1;31:127624.

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FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

All DEA-registered practitioners may continue to prescribe via audio-visual telemedicine encounters schedule II-V controlled substances, and schedule III-narcotic controlled substances that are FDA-approved for opioid use disorder management and treatment.

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FDA Law Blog: Biosimilars

JANUARY 9, 2024

However, before the state can start importing drugs, it must first submit for FDA approval a pre-import request for each eligible prescription drug it plans to import into the United States. This must be a Health Canada-licensed wholesaler that is registered with FDA as a foreign seller. See 21 C.F.R. 251.5; § 251.6(c).

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Drug & Device Law

DECEMBER 29, 2023

This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. If any of these are your cases, the Blog congratulates you. So, there you have it.

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. In Bruesewitz v. Wyeth LLC , 562 U.S. at 237-38. Wyeth Laboratories, Inc. , 2d 397 (6th Cir. 2d at 401.

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Drug & Device Law

JUNE 2, 2022

For this post, however, all seven authors of the Blog are joining together. From its founding, the Blog has been addressing plaintiff attacks on medications and devices for contraception, state attempts to limit medical options for abortion, and other legal disputes affecting women’s health issues. As we discussed here , McCormack v.

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