FDA Law Blog: Biosimilars

MARCH 5, 2024

AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program for Price Applicability Year 2026 (“Guidance”) interpreted the IRA in two very faulty ways, which violated the Administrative Procedure Act (APA) and harmed and will continue to harm the company. The court found numerous flaws with this argument.

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Agency IQ

MARCH 25, 2024

BY SCOTT STEPHENS, MPA This week, ECHA finalized its annual update to the Community Rolling Action Plan (CoRAP), listing 28 substances that will be assessed under the REACH Regulation’s substance evaluation procedure during the 2024-2026 period.

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New Drug Approvals

MAY 9, 2025

2] [4] Pharmacology Pharmacodynamics Elacestrant is an antiestrogen that acts as an antagonist of estrogen receptors , specifically targeting the estrogen receptor alpha (ER), which is the biological target of endogenous estrogens like estradiol. [1] 1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1]

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PPD

OCTOBER 31, 2024

Small/mid-size participants in particular indicate greater use of DCTs, expecting higher use by 2026. As DCTs become standard across toolkits, there is greater opportunity to implement decentralized approaches when needed.

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FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

Regarding CDER’s ETP, the current ETP guidance document, originally published in 2017, will be updated by the end of 2026, and will include details on communicating the type of products and stages of development for which a requestor can approach the ETP.

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Perficient: Drug Development

MAY 30, 2024

.” – Marybeth Wrabel How We’re Approaching Transformation, Modernization, and Mandates There’s plenty of discussion and investment happening already among insurers, as they address interoperability and prepare for a Prior Authorization mandate in 2026.

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The Pharma Data

SEPTEMBER 27, 2021

7.125% Notes due 2025 532457 AM0 3 0.750% due August 31, 2026 0.820% 15 bps $1,222.65 5.500% Notes due 2027 532457 AZ1 7 0.750% due August 31, 2026 0.820% 40 bps $1,226.23 3.100% Notes due 2027 532457 BP2 13 0.750% due August 31, 2026 0.820% 35 bps $1,100.66

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Perficient: Drug Development

AUGUST 22, 2023

According to Gartner’s 2022 Industry Cloud Survey , about 40% of IT leaders say they have started to adopt industry cloud platforms, with another 15% in pilots; another 15% are considering deployment by 2026. One of the ways healthcare and life sciences organizations are moving to the cloud is by adopting digital health platforms (DHP).

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Drug Channels

SEPTEMBER 25, 2024

ET on the following dates: April 4, 2025 June 20, 2025 December 12, 2025 (Drug Channels Outlook 2026) For 2025, we are offering a Corporate Pricing option that will allow larger organizations to register hundreds of colleagues for one fixed price. The three events are scheduled for 12:00 p.m. to 1:30 p.m.

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FDA Law Blog: Biosimilars

JUNE 26, 2023

September 1, 2023 will be the selection date for the 10 drugs that will be subject to “maximum fair price” ceilings under Medicare Part D starting in 2026. Chamber of Commerce makes all the arguments that the other plaintiffs have made, and also alleges that Congress has no power to levy the excise tax because it “compels” commerce.

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Pharmaceuticals Drugs Research Government 59

Agency IQ

MARCH 25, 2024

ECHA flags 28 substances for evaluation over next three years This week, ECHA finalized its annual update to the Community Rolling Action Plan (CoRAP), listing 28 substances that will be assessed under the REACH Regulation’s substance evaluation procedure during the 2024-2026 period.

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The Premier Consulting Blog

APRIL 27, 2023

How can you prepare?

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Packaging FDA International Pharmaceuticals 52

Agency IQ

JULY 22, 2024

According to that version of the plan, the actor and market surveillance modules would be complete as of Q4 2023, the certificates module by Q1 2024, the device and vigilance modules by the end of Q2 2024, and the CI/PS module estimated to be ready for Q3 2026. The announcement that the vigilance module is ready is projected for January 2026.

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Broad Institute

OCTOBER 24, 2024

The GEDMex team — comprising researchers, clinicians, project managers, and others at Harvard, the Broad Institute, INPRFM, and participating institutions — aims to collect and genetically analyze samples from 6,000 people with eating disorders and 3,000 controls by 2026.

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Drug Target Review

JULY 4, 2023

The global ADC market is expected to continue this steep upward trajectory and is anticipated to exceed $16 Billion by 2026. 1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments.

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The Pharma Data

OCTOBER 31, 2020

billion USD by 2026 at a CAGR of 11.5%. With the IND approval in place, we are ready and eager to extend the clinical study of TG-1000 to the U.S. in the near future.” ” According to Global Data, the global market for influenza antivirals reached 2.34 billion USD in 2019 and is estimated to reach 5.03

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National Institute on Drug Abuse: Nora's Blog

NOVEMBER 4, 2024

Participants will meet virtually three or four times during 2025 and potentially early 2026 and will be compensated for their time during the meetings. For that group, we are seeking individuals who identify as having experience with substance use or a substance use disorder or as a family or caregiver of someone who does.

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Science Treatment Research Drugs 85

Broad Institute

OCTOBER 25, 2024

El equipo del GEDMex cuenta con investigadores, clínicos, coordinadores de proyectos y otros profesionales del INPRFM, Harvard, el Instituto Broad y las instituciones participantes, y tiene como objetivo recoger y analizar genéticamente muestras de 6.000 persons con trastornos de la conducta alimentaria y 3.000 controles hasta el 2026.

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LifeSciVC

APRIL 2, 2024

We have milestones on the horizon, and we want investors to stay close to the Sionna story even if we don’t need capital until 2026. As an example of the continued engagement, we headed to the TD Cowen healthcare conference in early March before the ink was dry on the Series C closing.

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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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Licensing Licensing Marketing 52

Advarra

AUGUST 8, 2024

While some of the AI Act’s compliance dates are set for August 2024, the full Act will be enforced in March 2026. Unacceptable risk AI systems are banned outright, while high-risk systems must comply with stringent requirements, including transparency, data governance, registration with the central competent authorities, and human oversight.

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Drug Target Review

JANUARY 4, 2024

Then it’s on to dosing and administration studies in animals, pivotal toxicology studies, and, following a successful funding round, first-in-human studies in 2026. We’ve made great progress to date and have every faith that the program will continue to progress with remarkable promise.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

One of the major changes is the extension of the transition period from one to two years, with FDA now planning to enforce the QMSR requirements upon the effective date of the final rule on February 2, 2026.

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The Pharma Data

DECEMBER 8, 2020

Ionis projects having the opportunity to launch six or more new products through 2026, with each being ready for launch in a close window, ranging from 18 to 24 months between each new product launch. The expectation is that the implementation of this strategy will drive double-digit revenue growth and substantial earnings growth. .

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Alta Sciences

JANUARY 31, 2025

Ria is currently an industry member of the STCs Scientific Program Committee and will serve in this role until 2026, after which she will transition to Committee Chair until 2027. She also contributed extensively to quality assurance and study design processes, fostering collaboration and consistency across teams.

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Cell Biology Pharmaceutical Companies Clinical Research Government 52

Perficient: Drug Development

DECEMBER 27, 2023

The effective date of the new rule is April 1, 2024, with key provisions taking effect on January 1, 2026, and January 1, 2027. Banks Additionally, the recent rule by the OCC, the Federal Reserve, and the FDIC strengthens and modernizes Community Reinvestment Act (CRA) regulations.

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Compliance Regulations Production 52

FDA Law Blog: Biosimilars

OCTOBER 12, 2023

Priority is given to Suitability Petitions that could mitigate or resolve a drug shortage; address a public health emergency declared by HHS; mitigate waste by way of new strengths for parenteral products; or subject to special review under the President’s Emergency Plan for Aids Relief.

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FDA Drugs Production 59

FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026.

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FDA Laboratories Regulations Compliance 64

The Pharma Data

APRIL 14, 2021

The five-year project will see the site fully operational in Q1 2026 once all qualifications and validations of the first manufactured vaccine have been completed. The project is currently entering its design phase with construction expected to begin in Q3 2021.

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The Pharma Data

APRIL 29, 2022

The site, scheduled for completion in 2026, will be in close proximity to several major academic, pharma and biotech institutions, inspiring greater collaboration and innovation potential, and providing access to future talent.

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Science International Disease 40

Perficient: Drug Development

OCTOBER 15, 2024

A recent study from IDC suggests that by 2026, 70% of financial institutions will have formalized data governance frameworks in place. With the rise of AI, machine learning, and real-time data analytics, banks will need to be even more diligent in how they manage and govern their data.

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FDA Law Blog: Biosimilars

OCTOBER 4, 2023

Note that Astellas withdrew its lawsuit after none of its drugs were selected for price reduction in 2026—potentially because that fact cut against its argument for standing. Harm The Court reviewed the parties’ arguments on “irreparable harm to Plaintiffs.”

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Pharmaceuticals Drugs Government Regulations 59

The Pharma Data

MAY 2, 2023

Starting in 2026, this facility will develop manufacturing processes for active pharmaceutical ingredients and produce drugs for use in clinical trial phases. This step is crucial for Boehringer Ingelheim to rapidly advance new drug candidates from the company’s vast research pipeline to clinical trials and ultimately to market approval.

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The Pharma Data

JUNE 26, 2021

Those taking up this offer will be required to hold the Shares or the corresponding FCPE units for a period of approximately five years, i.e. until 31 May 2026, except upon the occurrence of an early release event provided for under Article R. The voting rights attached to the subscribed Shares will be exercised directly by the employees.

Regulations 52

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Perficient: Drug Development

NOVEMBER 21, 2024

The first compliance deadline of April 1, 2026, impacts the largest organizations. Under this ruling, banks, credit unions, credit card issuers, and other financial service providers must enhance consumer access to personal financial data. The ruling demands action from all non-depository firms (e.g.,

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Compliance Engineering Regulations Production 52

The Pharma Data

JUNE 28, 2023

3 The Company is on track to reduce greenhouse gas emissions (GHGs) from its operations and fleet by 98% by 2026 * and halve its entire value chain footprint by 2030, on the way to a 90% absolute emissions reduction and becoming science-based net zero by 2045 ** at the latest.

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ACTO

DECEMBER 19, 2023

The number of new launches and products is expected to increase in the near future, with more than 85% of launches through 2026 expected to be nano- and micro-launches (under $500M in sales) as opposed to blockbuster drugs. It is clear why the number of accessible customers is declining and that only 50% of providers are fully accessible.

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