2026 and Licensing - Drug Discovery Digest

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner.

Compliance

Compliance Drugs Pharmacy Licensing

Lilly Announces Cash Tender Offer for Up to $1.5 Billion.

The Pharma Data

SEPTEMBER 7, 2021

0.750% due August 31, 2026. 0.750% due August 31, 2026. 0.750% due August 31, 2026. 0.750% due August 31, 2026. 3.950% Notes due 2049. 532457 BT4. 1,500,000,000. 2.375% due May 15, 2051. 7.125% Notes due 2025. 532457 AM0. 229,692,000. 6.770% Notes due 2036. 532457 AP3. 174,445,000. 1.250% due August 15, 2031. 532457 BC1.

Licensing

Licensing Licensing Marketing

Sanofi to build new facility in Canada to increase global availability of high-dose influenza vaccine

The Pharma Data

APRIL 1, 2021

Sanofi expects this new facility to be operational in 2026, following design, construction, testing and qualification of the facility and equipment. License approval for the United States and Canada is expected in 2024 for the five-component-pertussis and in 2025 for diphtheria and tetanus.

Vaccine

Vaccine Government Science Production

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Models of Life

Codon

SEPTEMBER 29, 2024

2026 Another lab, one with a greater appreciation for what machine learning could pull from noisy, high-throughput biological data, stumbled across the 2025 paper and discussed it in a Monday morning lab meeting. At best, the corporations with the best models released weak versions to the public under non-commercial licenses.

Engineering

Engineering Virus DNA Therapies

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

JULY 26, 2024

The guidance “is intended to inform prospective and current applicants of the nature and type of information that applicants should provide in support of manufacturing changes to licensed biosimilars and licensed interchangeable biosimilars in different reporting categories.” Comments are due September 23, 2024.

Biosimilars

Biosimilars Science FDA Production

Article EMA Thank You Swissmedic reorg adds new focus on medical device market surveillance

Agency IQ

JANUARY 4, 2024

The current approved objectives cover the years 2023 – 2026, laying out the regulator’s approach to surveillance, international cooperation, support of innovation, and how its activities will be funded. The TPA requires the Swissmedic Agency Council to create strategic objectives for approval by the Federal Council.

Marketing

Marketing Regulations Clinical Trials International

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. The study is planned to begin in 2026 and conclude in 2028.

FDA

FDA Trials Therapies Regulations

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure.

Vaccine

Vaccine Therapies Trials Clinical Trials

AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

The Pharma Data

DECEMBER 12, 2020

2 EvaluatePharma, World Preview 2020, Outlook to 2026. AstraZeneca PLC. _. 1 A rare disease is a disease impacting less than 200,000 patients (as defined in the US Orphan Drug Act 1983). This announcement contains inside information.

Regulations

Regulations International Disease Small Molecule

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

Agency IQ

AUGUST 2, 2024

While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. FDA September 30 Deadline for submission of Advancing RWE Pilot Program projects A semi-annual deadline for FDA’s Advancing Real-World Evidence Program is set for the end of the fiscal year.

FDA

FDA Science Regulations Biosimilars

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

Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2026 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Patient-Focused Drug Development FDA must issue or update guidance regarding the Agency’s collection of information from medical device facilities prior to inspection. Priority B List.

FDA

FDA Science Biosimilars Clinical Trials

Pharmacy Law and Licensing Highlights 2025

FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

The Massachusetts Board of Registration in Pharmacy published its heavily anticipated licensure requirements for nonresident pharmacies, with licensing applications being accepted starting on January 1, 2025. Now, all nonresident pharmacies will need to be licensed in order to dispense prescription drugs to patients in Massachusetts.

Licensing

Licensing Licensing Pharmacy Packaging

Abelacimab: the next frontier in safer anticoagulation therapy

Drug Target Review

MARCH 20, 2025

“This study will be the basis of a Biologics License Application (BLA) submission to the FDA for the approval of abelacimab, Bloomfield noted. LILAC is an event-driven study so we do not know exactly when the study will end, but we anticipate having final data in 2026.”

Therapies

Therapies Trials Clinical Development FDA

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Regulations

Regulations FDA Science Production

Drug Discovery Digest

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

Lilly Announces Cash Tender Offer for Up to $1.5 Billion.

Webinars

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Sanofi to build new facility in Canada to increase global availability of high-dose influenza vaccine

Webinars

Models of Life

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Article EMA Thank You Swissmedic reorg adds new focus on medical device market surveillance

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

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

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

Pharmacy Law and Licensing Highlights 2025

Abelacimab: the next frontier in safer anticoagulation therapy

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

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