2017, Biosimilars and Licensing - Drug Discovery Digest

Article FDA Thank You New FDA guidance on interchangeable biosimilar labeling heads to White House for review

Agency IQ

AUGUST 25, 2023

New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III) commitment.

Biosimilars

Biosimilars FDA Production Licensing

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

As to biosimilars, FDORA amends the statutory language regarding criteria for the demonstration of biosimilarity for a 351(k) biologic. The 2017 Predictive Toxicology Roadmap laid out some of the FDA’s thinking around the need for new toxicology methods driven in part by a desire to find alternatives to animal testing.

Animal Testing

Animal Testing Biosimilars Cell Based Assays FDA

BIOGEN TO WEBCAST ADUCANUMAB PRESENTATIONS FROM AD/PD 2021 VIRTUAL CONFERENCE ON MARCH 9-13, 2021

The Pharma Data

MARCH 5, 2021

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally. Source link:[link].

Licensing

Licensing Licensing Biosimilars Disease

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. for the years 2020 to 2022. Based on the E.U.

Biosimilars

Biosimilars FDA Production Treatment

OPQ’s State of Pharmaceutical Quality Report Is a Data Bonanza (with Cameos by Eye Drops and Hand Sanitizers)

FDA Law Blog: Biosimilars

JUNE 17, 2024

Of the 4,819 facilities in the Site Catalog, 60% manufacture drugs approved under a New Drug Application (NDA), Abbreviated NDA (ANDA), or Biologics License Application (BLA). The Quality Report includes a rundown of what the universe of FDA-registered drug manufacturing sites looks like as included in the CDER Site Catalog.

Pharmaceuticals

Pharmaceuticals FDA Production Drugs

Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease

The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

Disease

Disease FDA Clinical Trials Licensing

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

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. 8,128,929 [] for [PTE] request under 35 U.S.C. §

FDA

FDA Production FDA Approval Compliance

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Biosimilars

European Medicines Agency Accepts Biogen’s Aducanumab Marketing Authorization Application for Alzheimer’s Disease

The Pharma Data

OCTOBER 29, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai Co., If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s.

Disease

Disease Marketing Clinical Trials Treatment

Biogen Files New Drug Application for Aducanumab in Japan

The Pharma Data

DECEMBER 9, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai Co., If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s.

Clinical Trials

Clinical Trials Drugs Disease Licensing

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

Laboratories FDA Regulations Licensing

A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. 15, 2017), [link]. [18] 22] FDA, Financial Report to Congress: Medical Device User Fee Amendments of 2017 FY 2022, at 27, [link]. [23] 15, 2017), [link]. [18]

FDA

FDA Laboratories Regulations Production

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. Priority B List.

FDA

FDA Science Biosimilars Clinical Trials

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

The Pharma Data

NOVEMBER 9, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2017; 377 (10): 936-946. European Respiratory Journal 2017; 50: OA3189. Tezepelumab in Adults with Uncontrolled Asthma [published correction appears in N Engl J Med. 2019 May 23;380(21):2082]. N Engl J Med.

Trials

Trials Production Clinical Trials Government

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use.

FDA

FDA FDA Approval Production Regulations

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. 2017; 377 (10): 936-946. European Respiratory Journal 2017; 50: OA3189. Corren J, Parnes JR, Wang L, et al. 2019 May 23; 380 (21): 2082]. N Engl J Med. AstraZeneca plc. Available at: [link].

Trials

Trials Production Clinical Trials Therapies

Drug Discovery Digest

Article FDA Thank You New FDA guidance on interchangeable biosimilar labeling heads to White House for review

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

Trending Sources

BIOGEN TO WEBCAST ADUCANUMAB PRESENTATIONS FROM AD/PD 2021 VIRTUAL CONFERENCE ON MARCH 9-13, 2021

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

OPQ’s State of Pharmaceutical Quality Report Is a Data Bonanza (with Cameos by Eye Drops and Hand Sanitizers)

Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease

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)

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

European Medicines Agency Accepts Biogen’s Aducanumab Marketing Authorization Application for Alzheimer’s Disease

Biogen Files New Drug Application for Aducanumab in Japan

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

A Final LDT Rule in April!? Will FDA be prepared?

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

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

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