BioPharma Drive: Drug Pricing

JULY 2, 2025

Published July 2, 2025 By Kristin Jensen post share post print email license Endometriosis involves the outgrowth of womb lining tissue in the pelvis or abdomen. The company had hoped to kick off Phase 3 research in 2026 and launch the medicine around 2029. Organon acquired the drug in its purchase of Forendo Pharma in 2021.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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BioPharma Drive: Drug Pricing

JUNE 30, 2025

Published June 30, 2025 Jonathan Gardner Senior Reporter post share post print email license Moderna announced results from an influenza vaccine clinical trial on June 30, 2025. as early as the 2026-2027 flu season.

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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).

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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.

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New Drug Approvals

APRIL 27, 2025

Flurpiridaz F 18 WeightAverage: 367.84 3] Flurpiridaz ( 18 F) It is given by intravenous injection. [3] 3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3] 2008 ; Nagel 2014 ) Briefly, to a mixture of mucochloric acid ( 1 ) (1.18 mmol) and Na 2 CO 3 (0.33 Epub 2022 May 26.

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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.”

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