Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. Halfway through 2024: how are novel drug approvals shaping up?

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Perficient: Drug Development

JANUARY 24, 2024

Before I begin, I just want to caveat everything with the fact that HIPAA is a complex regulation open to interpretation, and in the end your legal and compliance teams need to be comfortable with how you handle data and the risk associated with those methods. This is because under the covers it is actually using the same instance.

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Licensing Licensing Production Regulations 96

Perficient: Drug Development

SEPTEMBER 19, 2023

Increased Capabilities for Marketing Cloud and Commerce Cloud Salesforce introduced 26 generative AI capabilities between Marketing Cloud and Commerce Cloud, 14 of which are in GA now, with an additional 14 to arrive by the end of 2024.

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The Pharma Data

DECEMBER 13, 2020

With the execution of this collaboration, Relay Therapeutics anticipates it will have cash and investments to sustain its operations through 2024. Relay Therapeutics retains the right to combine RLY-1971 with its selective FGFR2 and mutant-selective PI3K? Conference Call Information. ET to discuss the collaboration. About RLY-1971.

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Licensing Licensing Clinical Trials Small Molecule 40

Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. But one can only train a phage so much before it has changed, genetically, to the point where it is now considered a different phage to the one the regulator initially approved.

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FDA Law Blog: Biosimilars

APRIL 25, 2024

While the Federal Food, Drug & Cosmetic Act does not explicitly define “advertisement,” FDA provides several examples in its regulations at 21 CFR § 201.1(l)(1) Comments to the revised draft guidance are due to the docket by June 25, 2024. l)(1) (e.g.,

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Biosimilars Production FDA Licensing 59

SugarCone Biotech

JUNE 10, 2024

This is where things get interesting due to the complexity of the immune system and its regulation. 124507 and references within this excellent 2024 review: [link]. Orchestration of immune responses therein is highly complex and fiercely regulated. Let’s back up a bit.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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Agency IQ

JUNE 28, 2024

FDA draft guidance on addressing misinformation clears White House review A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products.

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Agency IQ

MAY 28, 2024

New FDA guidance on addressing misinformation under White House review A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

On 28 August, 2024, almost a year after FDA’s interim response to the CP, NPA filed a complaint in US District Court for the District of Columbia seeking preliminary and permanent injunction prohibiting FDA from taking any regulatory action against firms producing or marketing NMN.

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Production FDA Licensing Licensing 59

Agency IQ

FEBRUARY 15, 2024

MHRA selects eight technologies to help it test its new innovative devices pathway The British regulator and its partners just released the list of products and companies chosen to participate in the pilot of its Innovative Device Access Pathway (IDAP). BY COREY JASEPH, MS, RAC | FEB 14, 2024 6:11 PM CST Quick background on the future U.K.

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Agency IQ

JANUARY 4, 2024

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. Read more about what the regulator plans for its database here.]

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Marketing Regulations Clinical Trials International 40

Drug Target Review

FEBRUARY 28, 2024

Normality sensing licenses local T cells for innate-like tissue surveillance. Regulation of cutaneous malignancy by gammadelta T cells. Nat Cancer (2024 January 3). Kabelitz D, Serrano R, Kouakanou L, et al. Cancer immunotherapy with γδ T cells: many paths ahead of us. Cell Mol Immunol 17:925-939 (2020).

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Therapies Engineering Molecular Biology Science 105

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

FDA 40

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Codon

JULY 14, 2024

In 1940, Charles Drew—the first African-American researcher to earn a doctor of medical science degree at Columbia University—developed an ingenious method for separating and storing plasma , the liquid part of blood that contains essential proteins that promote clotting and regulate blood pressure. ” Asimov Press (2024).

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Production Clinical Trials Trials Therapies 138

Agency IQ

MARCH 7, 2024

flu vaccines Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) weighed in on strains for seasonal influenza vaccines for the Northern hemisphere 2024-2025 season. Vaccines advisory panel endorses move to trivalent formulation for U.S.

Vaccine 40

Vaccine FDA Virus Licensing 40

Agency IQ

APRIL 26, 2024

BY RACHEL COE, MSC | APR 24, 2024 10:56 PM CDT Biosimilars and interchangeable products The FDA was first authorized to develop a pathway for the approval of biosimilar products in 2010 under the Biologics Price Competition and Innovation (BPCI) Act.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S. That did not happen.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. In regulation, intended use is defined at 21 CFR 201.128 for drugs and 21 CFR 801.4 sponsors, developers and manufacturers] to disseminate information about drugs and devices.”

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. This is what OIRA is currently reviewing.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.

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FDA Law Blog: Biosimilars

JUNE 27, 2024

50,372 , 50,377 (June 13, 2024). DEA regulations also establish that “[t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” 21 C.F.R. §§ 1306.04(a), a), 1306.06.

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Pharmacy Drugs Regulations Licensing 52

Codon

FEBRUARY 27, 2024

A startup that makes such a spray has gained an EPA license to sell its product to customers in the consumer, commercial, and healthcare sectors. Whether new sprays are made using copper, carbon nanotubes, or cellulose, though, they will have to vault two hurdles: testing outside of the laboratory, and regulation. Asimov Press (2024).

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Virus Hospitals Production Regulations 73

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Rescheduling Recommendation, 2024 FDA’s 2023 analysis and recommendation finally came to light when Texas attorney Matt Zorn posted it on his website a week ago. DEA found in 2016 that marijuana met none of the of elements and therefore did not have a currently accepted medical use in treatment in the U.S.

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Agency IQ

MAY 31, 2024

BY RACHEL COE, MSC | MAY 28, 2024 10:34 PM CDT Quick recap on platform technologies As part of the 2023 Consolidated Appropriations Act (Section 2503), Congress directed FDA to establish a new “Platform Technologies Designation” program. AgencyIQ breaks down what the designation means for sponsors and its limits for product sponsors.

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Agency IQ

JUNE 21, 2024

BY ALEXANDER GAFFNEY, MS, RAC | JUN 20, 2024 10:53 AM CDT Peter Marks on the START Pilot Program: Goals and future PDUFA plans The Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot was formally unveiled in September 2023. Read AgencyIQ’s analysis of these CRLs here.]

Disease 40

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Agency IQ

MARCH 25, 2024

This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes. BY CHELSEY MCINTYRE, PHARMD | MAR 20, 2024 10:32 PM CDT Background: Drug compounding in the U.S. Now, the proposed list is out, and its limited length may be a surprise to stakeholders.

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Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

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LifeSciVC

SEPTEMBER 15, 2022

Generating robust preclinical data to share with global regulators supports alignment on your trial design. Yet, capital is not just equity or debt financings, it could mean pulling other levers such as portfolio optimization, licensing or partnership opportunities.

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Trials Clinical Trials Clinical Development Therapies 40

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. BY CHELSEY MCINTYRE, PHARMD | JAN 24, 2024 4:09 PM CST Back to the beginning: What does an expiration date mean to the FDA? Enter the beyond-use date.

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The Pharma Data

FEBRUARY 4, 2021

AbbVie expects total company sales to decline in 2023, following the LOE, with modest top-line growth expected in 2024. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties. Humira (adalimumab) loss of exclusivity (LOE) in 2023.

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Production Clinical Trials International Small Molecule 52

Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K.

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FDA Law Blog: Biosimilars

MAY 21, 2024

On Thursday, May 16, 2024 , the Attorney General issued a Notice of Proposed Rulemaking (“NPRM”) to initiate rulemaking proceedings to reschedule marijuana. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). 802(16)) and regulated by 21 C.F.R.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

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