Agency IQ

APRIL 26, 2024

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promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.

Biosimilars 40

Biosimilars Science FDA Licensing 40

FDA Law Blog: Biosimilars

MARCH 3, 2024

3558 ) on January 25, 2024. Effect on FDA approvals— 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? House of Representatives ( H.B. 7085 ) and Senate ( S.B.

Government 102

Government Small Molecule FDA Approval Regulations 102

The Pharma Data

JUNE 24, 2021

The anticipated primary completion date is late-2024. 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. Source link:[link].

DNA 52

DNA Clinical Trials Trials Biosimilars 52

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. That did not happen.

FDA 59

FDA Production FDA Approval Compliance 59

FDA Law Blog: Biosimilars

MARCH 12, 2024

On March 6, 2024, the first antitrust suit arising from these letters was filed by the Massachusetts Laborers’ Health and Welfare Fund in the District Court of Massachusetts against Boehringer Ingelheim. FTC’s and Congress’s activities seem to have triggered litigation.

Drugs 59

Drugs FDA Regulations FDA Approval 59

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

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. Two PTE applications were submitted to FDA ( See FDA Docket Nos. Patent Nos.

FDA Approval 59

FDA Approval FDA Production Therapies 59

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. FDA, Basis for the Recommendation to Reschedule Marijuana Into Schedule III of the Controlled Substances Act, 3. chemotherapy-induced), and pain.

FDA 69

FDA FDA Approval Treatment Drugs 69

Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. Within 180 days, FDA will release a report on the proceedings of the public meeting and any recommendations.

FDA 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 29, 2023

AgencyIQ November 27 DSCSA Technically goes into full effect While the FDA has technically extended enforcement of certain provisions under the Drug Supply Chain Security Act until November 2024, certain provisions of the law are still due to come into effect in late November.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

Production 52

Production International Clinical Trials Small Molecule 52

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). 21 U.S.C. § Basis at 63-64.

Regulations 69

Regulations FDA Licensing Licensing 69

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Vaccine 40

Vaccine Production FDA Biosimilars 40

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Few would oppose FDA-approved marijuana-derived medications if marijuana compounds are found to have medical value; the National Institute of Health should continue to fund research on any potential medical value of marijuana and on the harms of highly potent products. January 29, 2024).

Regulations 59

Regulations Production FDA Approval Marketing 59

FDA Law Blog: Biosimilars

MAY 5, 2024

FDA/HHS next reviewed studies investigating safety and efficacy/effectiveness of marijuana, professional societies’ position statements, data from state medical marijuana programs and national surveys, and labeling of relevant FDA-approved products. treaty obligations in rescheduling. 21 U.S.C. § 812(b)(1).

FDA 95

FDA Regulations Treatment Licensing 95