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.

Engineering 105

Engineering Regulations 105

The Pharma Data

JUNE 15, 2025

Furthermore, Intellia plans to submit a biologics license application (BLA) in 2026 in support of a potential U.S. This data further highlights the strong value we believe this approach can bring to patients, physicians, and payers.”

Treatment 40

Treatment Therapies Licensing Licensing 40

The Pharma Data

JUNE 6, 2025

Ongoing Study and Future Outlook The VISIONARY study remains ongoing, with full results expected upon completion in early 2026. This is very exciting news for patients and offers a therapeutic option with a novel mechanism of action targeting the immunologic pathogenesis of IgAN.”

Trials 40

Trials Treatment Therapies FDA 40

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.

Regulations 59

Regulations FDA Drugs 59

FDA Law Blog: Drug Discovery

DECEMBER 23, 2024

This means that, at the current moment, FDA cannot award any priority review vouchers for rare pediatric disease product applications unless it is for a drug that was designated as a drug for a rare pediatric disease not later than December 20, 2024, and such application is approved not later than September 30, 2026.

Disease 59

Disease Government FDA Production 59

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.

Government 64

Government Marketing Production Drugs 64

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.

59

59

Conversations in Drug Development Trends

APRIL 29, 2025

It was a fantastic forum to encourage collaboration between advocates and researchers, and we look forward to the potential of organizing again in 2026! The response to this event from the rare disease community has been overwhelming and positive.

Disease 69

Disease Clinical Trials FDA Trials 69

FDA Law Blog: Drug Discovery

FEBRUARY 11, 2025

However, as we suggested in a recent blog post , the statute did not actually provide any limitations on FDAs authority to grant rare pediatric disease designations , only its authority to grant vouchers.

Disease 59

Disease FDA Therapies Drugs 59

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.

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

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.

Disease 64

Disease FDA Approval FDA Government 64

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]

FDA 62

FDA Pharmacokinetics Therapies Treatment 62

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.

FDA 59

FDA International Production Drugs 59

The Pharma Data

JUNE 9, 2025

Merck has indicated that ordering of ENFLONSIA is expected to begin in July, with commercial shipments scheduled for delivery ahead of the 2025-2026 RSV season. These guidelines will be essential in shaping how the therapy is adopted within public and private pediatric care programs.

FDA Approval 40

FDA Approval FDA Hospitals Clinical Trials 40

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

Disease 52

Disease Marketing 52

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).

Science 98

Science Marketing Production 98

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.

Drugs 52

Drugs Marketing 52

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.

Pharmaceuticals 59

Pharmaceuticals Drugs Research Government 59

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.

Regulations 88

Regulations Science Marketing 88

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.

Compliance 40

Compliance Production Regulations 40

The Premier Consulting Blog

APRIL 27, 2023

How can you prepare?

Packaging 52

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.

Regulations 40

Regulations Marketing Clinical Trials Trials 40

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.

Research 52

Research 52

Perficient: Drug Development

APRIL 15, 2025

Were already looking forward to Perfathon 2026. Huge thanks to our leadership and HR team for their continuous support and encouragement, and to every participant who made the event what it was memorable, meaningful, and magical. Until then, lets keep the hacker spirit alive and continue being the solution-makers our organization needs.

International 52

International Packaging Production 52

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.

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

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

FDA Approval 52

FDA Approval FDA Virus Clinical Development 52

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.

Science 85

Science Research Treatment 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.

52

52

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.

Science 80

Science Small Molecule International Clinical Development 80

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 52

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.

Clinical Research 98

Clinical Research Research Clinical Trials Compliance 98

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.

Therapies 98

Therapies Small Molecule Production Disease 98

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.

FDA 59

FDA Regulations Packaging Compliance 59

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. .

RNA 52

RNA Pharmaceuticals Disease Production 52

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.

Cell Biology 52

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.

Compliance 52

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.

FDA 59

FDA Drugs Production 59