2016, Biosimilars and Licensing - Drug Discovery Digest

FDA Knows Its Own Strength—and It Includes Concentration

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

FDA

FDA Biosimilars Production Regulations

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing? He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

8,128,929 was submitted on December 8, 2016 (Docket No. FDA-2017-E-5106 ), and concerns FDA’s October 19, 2016 Accelerated Approval of BLA 761038 for LARTRUVO (olaratumab). 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application.

FDA

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Federal Marijuana Rescheduling: States Get Ready

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. 12, 2016); Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed.

Regulations

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Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

FDA Law Blog: Biosimilars

JANUARY 18, 2024

FDA conducted the eight-factor scheduling analysis required by the CSA in 2016 and found that marijuana continued to meet the scheduling criteria for remaining in schedule I. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

FDA

FDA FDA Approval Treatment Drugs

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

Laboratories

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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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

FDA Science Regulations Production

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

The Pharma Data

DECEMBER 21, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2016; 71 (4): 339-346. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. J Allergy Clin Immunol.

Trials

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Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog: Biosimilars

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

Regulations

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HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises Questions

FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Cannabis in schedule III would require a prescription issued by a DEA-registered, state-licensed practitioner. DEA and HHS last considered rescheduling cannabis in 2016. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. 53,688 (Aug. 53,688 (Aug. 53,767 (Aug. 21 U.S.C. § at 53,689, 53,768.

FDA

FDA Treatment FDA Approval Drugs

Article EMA Thank You MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway

Agency IQ

SEPTEMBER 1, 2023

The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” In May 2023, the MHRA revealed which regulators will be included in the scheme: Australia, Canada, the E.U., or E.A.A.

International

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Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

There has been no evidence that marijuana’s schedule should change since the last rescheduling review in 2016. 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.

Regulations

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DEA Concurs: Marijuana Meets Schedule III Criteria

FDA Law Blog: Biosimilars

MAY 5, 2024

FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. 53,688 (Aug.

FDA

FDA Regulations Treatment Licensing

Drug Discovery Digest

FDA Knows Its Own Strength—and It Includes Concentration

European Commission vs Big Pharma, or profit vs access?

Trending Sources

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

Federal Marijuana Rescheduling: States Get Ready

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises Questions

Article EMA Thank You MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

DEA Concurs: Marijuana Meets Schedule III Criteria

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