Agency IQ

JULY 13, 2023

As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products). AgencyIQ’s analysis of how the FDA is doing.

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FDA Law Blog: Biosimilars

JUNE 27, 2023

James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list. Karst Awarded WWL: Life Sciences 2023 Global Elite Thought Leader HP&M Director Kurt R. Karst was named by Who’s Who Legal: Life Sciences 2023 as one of only 14 “Global Elite Thought Leaders.” HP&M’s Kurt R.

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FDA Law Blog: Biosimilars

MAY 15, 2025

is pleased to announce that Sophia Gaulkin will be presenting and speaking on an expert panel at Informa Connectsannual Life Sciences Pricing & Contracting USA Summit , which is being held virtually and in-person in Philadelphia on May 19-21. Hyman, Phelps & McNamara, P.C.

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FDA Law Blog: Biosimilars

APRIL 8, 2025

About one third of these PSGs are for complex products and many reflect what OGD and DPD learned about the science of equivalence from GDUFA-funded regulatory science research. the ICH M13A batch ), totaling more than 3,000 PSGs (includingPSG revisions). Leading FDAs implementationof the Drug Competition Action Plan (DCAP).

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Agency IQ

AUGUST 25, 2023

New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III) commitment.

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The Pharma Data

MAY 3, 2021

DARS also greatly expanded its clinical trials operations, running three clinical trials related to streamlining biosimilars development and studying safety questions related to opioids and over-the-counter drugs,” Strauss wrote.

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The Pharma Data

NOVEMBER 23, 2020

have partnered with Yangtze River Pharmaceutical Group, a leading Chinese pharmaceutical company, to form an exclusive strategic partnership for the commercialization of eight biosimilar medicines in China. is an attempt on international collaboration of biosimilar medicines. and Alvotech & CCHT Biopharmaceutical Co.,

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FDA Law Blog: Biosimilars

JULY 30, 2024

By Sara M Keup & Véronique Li, Senior Medical Device Regulation Expert — The American Conference Institute (“ACI”) held its 11th Annual Summit for Women Leaders in Life Sciences Law at the Seaport Hotel in Boston, Massachusetts on July 25th & 26th of last week. Advertising Challenges in Life Sciences.

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The Pharma Data

MAY 31, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced the launch of a new global initiative called ‘Act4Biosimilars’ to help address health inequity and inequality worldwide. Biosimilars match their respective reference medicine in terms of quality, safety and efficacy.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. 42 U.S.C. § 262(k)(2)(A)(i)(I). FDORA § 3209(b).

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Drug Channels

NOVEMBER 8, 2021

Year after year, the life science industry marks Informa Connect’s Trade and Channel Strategies as the “go-to” event for trade, channel, market access, account strategy and brand professionals. The full agenda for this year’s Trade and Channel Strategies conference is available now!

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FDA Law Blog: Biosimilars

MAY 27, 2025

How does he plan on implementing AI in regulatory science and application reviews? How does he plan on implementing the framework for his proposal of a regulatory pathway based on a scientifically plausible mechanism? How does he plan to remedy widely reported low morale among review teams?

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The Pharma Data

JUNE 2, 2022

BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.

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Drug Channels

JUNE 26, 2023

This is a critical opportunity to navigate these complex yet beneficial partnerships with both health systems and life science companies together.

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FDA Law Blog: Biosimilars

MAY 25, 2023

Join attendees from around the globe at the IBA’s World Life Sciences Conference in Washington, DC. The conference will highlight hot topics affecting the healthcare and life sciences industries. ONE WEEK AWAY! We are honored to have keynote addresses from DOJ and FDA officials. Hyman Phelps & McNamara, P.C.

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Agency IQ

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

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Agency IQ

AUGUST 2, 2024

Title Type Comments Close Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance Draft Guidance August 5 Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research (..)

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Drug Channels

OCTOBER 23, 2023

Eduardo De La Calle, Director of Regional Supply, AstraZeneca Shefali Shah, Global VP, Market Value and Commercial Effectiveness, MindMaze And more !

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FDA Law Blog: Biosimilars

NOVEMBER 5, 2023

The 14th Asia Pacific Symposium on Cochlear Implant and Related Sciences is poised to captivate the global scientific community from November 8-11, 2023, as it convenes in Seoul, Korea.

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The Pharma Data

NOVEMBER 10, 2020

Yong-Jun Liu , senior executives of Innovent R&D team, including Dr. Junjian Liu , vice president (VP) of new drug research, Dr. Wei Xu , VP of translational medicine, Dr. Hui Zhou , VP of medical science, and Dr. Lei Qian, senior director of medical science, discussed the key pipeline and R&D strategy of Innovent in detail.

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Pharmaceutical Development Group

JANUARY 7, 2022

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience. Spanogle, Ph.D.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. life sciences industry. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

These are condensed thoughts from his speech Communicating Regulatory Impact to Your Organization: Advanced Procedures for Compliance Success, which he delivered at the 2025 Q1 Productions Life Science Regulatory Intelligence & Strategy Conference.

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The Pharma Data

MAY 26, 2023

Today, Pfizer Oncology has a comprehensive portfolio of 24 approved innovative cancer medicines and biosimilars to treat more than 30 cancer types and an extensive pipeline of more than 30 programs in clinical development. Oncology Chief Medical Affairs Officer, Pfizer. “At

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

The conference equips legal professionals without prior regulatory experience, as well as life sciences executives involved with FDA-regulated products, with a comprehensive understanding of fundamental FDA principles. And it is exactly that!

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Agency IQ

JULY 8, 2024

In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document. Medical Misinformation : FDA Commissioner ROBERT CALIFF has been heavily focused for much of the last two years on what he calls the negative health effects of medical misinformation.

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Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

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The Pharma Data

MARCH 5, 2021

Senior Medical Director, Global Safety and Regulatory Sciences at Biogen. ET – Pre-recorded presentation: Evaluation of aducanumab safety in early Alzheimer’s disease, Spyros Chalkias, M.D., Saturday, March 13, 2021, 11:30 a.m. ET – Live discussion including Samantha Budd Haeberlein, Ph.D.,

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DrugBank

OCTOBER 4, 2024

For example, Gilead Sciences' acquisition of Immunomedics in 2020 included Trodelvy, an antibody-drug conjugate approved for treating triple-negative breast cancer. The IP surrounding Trodelvy , including patents covering the drug's composition, manufacturing process, and clinical use, was a significant valuation component.

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The Pharma Data

OCTOBER 26, 2021

Sandoz is a global leader in generic pharmaceuticals and biosimilars. Its global portfolio covers all major therapeutic areas with a global market leadership position in biosimilars, generic antibiotics and oncology medicines. Innovative Medicines net sales were USD 10.6 billion (+8%, +7% cc). About Novartis.

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The Pharma Data

MAY 2, 2022

Head of Global Safety and Regulatory Sciences and Interim Head of R&D at Biogen. “We We are committed to advancing the science and developing new approaches to treating mental health, a major public health challenge that was exacerbated by the COVID-19 pandemic.”. Source link: [link].

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FDA Law Blog: Biosimilars

AUGUST 27, 2024

Everyone in the life sciences industry must be well-versed in the regulatory components and intellectual property nuances integral to patenting products. Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials—critical competencies for legal and business professionals in the biopharmaceutical sector.

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FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO). Hyman, Phelps & McNamara, P.C. (HP&M),

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The Pharma Data

MARCH 23, 2022

With a focus on immuno-inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars.

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FDA Law Blog: Biosimilars

APRIL 10, 2025

Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. Walsh The recent and drastic Reduction In Force (RIF) at the U.

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The Pharma Data

MAY 31, 2022

Biogen is also commercializing biosimilars and focusing on advancing the industry’s most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need. Source link: [link].

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The Pharma Data

APRIL 7, 2022

Biogen is also commercializing biosimilars and focusing on advancing the industry’s most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need. Source link: [link].

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