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2026 Related Topics 
BioPharma Drive: Drug Pricing
OCTOBER 18, 2024
Detailed data from a Phase 2b/3 study of Merck’s treatment clesrovimab should support the company’s efforts to win approval by the 2025-2026 season.
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BioPharma Drive: Drug Pricing
NOVEMBER 5, 2024
Rallybio is headed into a mid-stage trial with enough cash to last it through 2026, but biotech's down market has made the company's journey difficult.
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FDA Law Blog: Biosimilars
MARCH 19, 2024
Hyman, Phelps & McNamara, P.C. (HP&M), HP&M), the largest dedicated food and drug law firm in the U.S., is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). This prestigious appointment recognizes Ms.
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BioPharma Drive: Drug Pricing
OCTOBER 24, 2024
As Sanofi prepares to halt production on its dengue vaccine in 2026, locally acquired infections in the U.S. are raising the alarm.
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BioPharma Drive: Drug Pricing
OCTOBER 7, 2024
The company is committing to make at least 2 million doses of its long-acting PrEP therapy available in low- and middle-income countries next year and in 2026.
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BioPharma Drive: Drug Pricing
OCTOBER 9, 2023
The purchase agreement with Chongqing Zhifei Biological Products is part of GSK’s plan to double sales of the shingles vaccine by 2026.
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BioPharma Drive: Drug Pricing
MARCH 18, 2024
The funding could extend the cash-strapped gene therapy maker’s financial runway to 2026, but only if the company successfully hits certain milestones.
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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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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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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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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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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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FDA Law Blog: Biosimilars
NOVEMBER 11, 2024
That means almost certainly no sooner than the second half of 2026. Notably, the proposed order provides that the order, if finalized, will become effective one year after the final rule is published.
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Perficient: Drug Development
NOVEMBER 12, 2024
Prior Authorization, In a Nutshell The CMS Prior Authorization mandate , which goes into effect on January 1, 2026, aims to reduce guesswork for healthcare consumers and the administrative burden on care teams, and to improve patient/member care by streamlining processes and enhancing the exchange of health information.
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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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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.
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
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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Common Sense for Drug Policy Blog
JUNE 10, 2023
At the time of writing, the City of San Francisco funds naloxone distribution in seven of its approximately 75 supportive housing SROS, and has committed to making naloxone available in all its supportive housing facilities by 2026 ( San Francisco Department of Public Health 2022 ; Thadani & Palomino, 2022 ). 2017 ; Rowe et al.,
FDA Law Blog: Biosimilars
OCTOBER 13, 2024
No rare pediatric disease vouchers could be awarded even to designated applications after September 30, 2026. After this date, without action by Congress, FDA’s authority to grant rare pediatric disease designations would expire, and no vouchers could be granted unless previously granted such a designation.
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The Pharma Data
JULY 6, 2021
Adjusted operating margins are expected to improve from the current mid-20s level to over 30% by 2026. Cash generated from operations is expected to exceed £10 billion by 2026. 2021-2026 outlook refers to the 5 years to 2026 with 2021 as the base year.
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FDA Law Blog: Biosimilars
JUNE 14, 2023
In FY 2026 – FY 2027, continue to support products enrolled in previous fiscal years and expand to enroll up to 100 additional products each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from FY 2023 – FY 2025 experience (i.e., up to 125 total products enrolled through FY 2025).
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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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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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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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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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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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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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The Pharma Data
MARCH 31, 2023
This would support extension of the regulatory data protection to November 2026. If approved, Entresto will become available to children with a new age-appropriate formulation to enable accurate and convenient administration for these patients and their caregivers.
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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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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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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.
52 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.
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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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.
Agency IQ
JULY 22, 2024
EPA’s regulatory agenda for Spring 2024 Agenda Stage of Rulemaking Title Estimated Publication Former Estimated Date First on Agenda Proposed Rule Stage Removal of Affirmative Defense Provisions from Specified CAA Section 111 and 112 Regulations July 2024 Spring 2024 Final Rule Stage Standards of Performance for New, Reconstructed, and Modified Sources (..)
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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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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
MARCH 31, 2022
million patients, provided with essential medicines by the global health unit, for the treatment of non-communicable diseases in 40 of the world’s poorest countries, between 2022 and 2026. The coupon amounts are linked to the achievement of a sustainability performance target defined as the cumulative number of patients, being at least 1.5
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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
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. .
52 Agency IQ
MAY 28, 2024
Transitional conditions are given in Article 25 , which set January 12, 2026 as the deadline for member states to ensure compliance with the parametric values for bisphenol A, chlorate, chlorite, haloacetic acids, microcystin-LR, uranium, and total and sum values of per- and polyfluoroalkyl substances (PFAS).
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