Fierce BioTech

MARCH 28, 2024

How Medical Affairs is Charting the Course for Pre- and Post-Launch Strategies Early involvement of Medical Affairs in advanced therapies is pivotal. dfarris Thu, 03/28/2024 - 15:39 Early involvement of Medical Affairs in advanced therapies is pivotal.

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The Pharma Data

JANUARY 12, 2021

In exchange for exclusive rights to selected autoimmune programs, Amgen will make upfront and milestone payments potentially totaling more than $240 million , as well as pay royalties on sales of resulting therapies. EVOQ Therapeutics today announced a license and collaboration agreement with Amgen.

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The Pharma Data

APRIL 7, 2022

This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. About Biogen.

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Drug Channels

JULY 11, 2022

Director, Cell Therapy Operations and Patient Services, Gamida Cell Austin Fisher, Executive Director, CART Patient Support and Distribution, Autolus Chris Boneham, Vice President Market Access U.S.,

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The Pharma Data

DECEMBER 13, 2020

About 15 to 20% of breast cancers cases are HER2+, and antibody-based therapies targeting HER2 have significantly improved outcomes of patients with HER2+ breast cancer. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. That collaboration was to develop and commercialize four oncology antibody biosimilar therapies.

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The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

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Drug Channels

OCTOBER 17, 2022

Don’t miss the chance to unite with colleagues and master the complexities of pharmacy and distribution models to accelerate patient access!

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Drug Channels

NOVEMBER 24, 2020

My recent tweets have highlighted: doctors against step therapy, distribution of COVID-19 therapies, biosimilar savings, copay accumulator data, prospects for smaller PBMs, the new transparency rule, specialty pharmacy profit metrics, the future of oncology practices, and an update on Diplomat founder Phil Hagerman.

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The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif.

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thought leadership

SEPTEMBER 29, 2023

Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs (including small molecules, vaccines, cell and gene therapy products, biologics, etc.), Generic Drugs, Biosimilars, and Medical Devices.

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The Pharma Data

JUNE 25, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. An archived version of the webcast will be available following the presentation.

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The Pharma Data

MARCH 22, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. An archived version of the webcast will be available following the presentation. About Biogen.

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Quanticate

SEPTEMBER 25, 2024

By evaluating improvements in joint symptoms and overall disease activity, the ACR criteria provide a clear and consistent framework for determining the efficacy of RA therapies.

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The Pharma Data

SEPTEMBER 1, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. An archived version of the webcast will be available following the presentation. About Biogen.

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Biosimilars Disease Therapies Treatment 52

The Pharma Data

JULY 8, 2021

Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Following the live webcast, an archived version of the call will be available on the website.

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Biosimilars Disease Therapies Treatment 52

The Pharma Data

APRIL 9, 2021

Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Following the live webcast, an archived version of the call will be available on the website. About Biogen.

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Biosimilars Disease Therapies Treatment 52

The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development.

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Drug Channels

JUNE 26, 2023

View the agenda for Health Systems & Pharma Partnering 2023 to see the complete picture – the program, speakers, and more, and visit www.informaconnect.com/health-systems-partnering for further details and to register.

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FDA Law Blog: Drug Discovery

DECEMBER 15, 2024

Valentine We recently published the first part of our review of FDAs draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. If you make a tissue product you may produce one lot per patient where a gene therapy may only need a handful of lots through Phase 3.

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Vial

APRIL 24, 2024

In addition to the areas above (aside from DTx), Syneos Health offers biosimilars , cell and gene therapy , endocrine and metabolic, immunology and inflammation, infectious diseases, pediatrics, respiratory, and women’s health services. Dermatology Phase I Units are critical to advancing care and validating treatments.

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DrugBank

OCTOBER 4, 2024

Gilead's assessment of the IP portfolio would have involved a detailed analysis of the patent claims, the remaining patent life, the potential for generic or biosimilar competition, and the expected revenue streams from Trodelvy in various markets. However, such acquisitions also entail significant risks for biotech firms.

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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The Pharma Data

MAY 26, 2023

Abstracts include new data from pivotal trials supporting ongoing regulatory reviews for three potential therapies, if approved, and new clinical data for six early pipeline assets.

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Biosimilars Clinical Development Science Therapies 52

Alta Sciences

JULY 20, 2023

With Altasciences, your entire program is managed by one organization and overseen by a single, cross-functional program manager to quickly and seamlessly advance your large molecule, and help you get your therapies to the people who need them, faster. Fact Sheet: Biologics/Biosimilars. Download now.

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The Pharma Data

MARCH 23, 2022

“These positive results demonstrate that etrasimod, if approved, could be a potential breakthrough option for patients with ulcerative colitis who aren’t able to experience improvement on current therapies,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.

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Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules.

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The Pharma Data

MARCH 5, 2021

Biogen (Nasdaq: BIIB) today announced it will host webcasts of its pre-recorded presentations and live discussions related to its Alzheimer’s disease investigational therapy, aducanumab, at the upcoming AD/PDTM 2021 Virtual Conference. AD/PD Webcast Schedule Details: Wednesday, March 10, 2021, 6:45 a.m. About Biogen.

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Drug Channels

JUNE 5, 2023

Hear directly from specialty pharmacies, payers, PBMs, government agencies, health systems, and industry leaders to: Gain insights into patient perspectives Explore specialty trade and distribution trends and the state of the channel Discover policy and regulatory reform impacting trade and channel distribution Analyze patient service programs that (..)

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Specialty Pharmacies Pharmacy Biosimilars Compliance 55

The Pharma Data

MARCH 13, 2022

NYSE: PFE) announced today the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Pfizer Inc. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents.

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Conversations in Drug Development Trends

JULY 9, 2024

The discussions at the conference shed light on innovative approaches to enhance long-term outcomes for patients, focusing on combination therapies that not only aid in weight loss but also help preserve muscle mass, an essential component of healthy body composition.

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Clinical Research Treatment Research Clinical Trials 52

The Pharma Data

MAY 31, 2022

“More than 10 million people worldwide are affected by Parkinson’s disease, and there is a significant medical need for therapies to slow or stop the progression of this devastating neurodegenerative disease,” said Carole Ho, M.D., Chief Medical Officer at Denali. For additional information, please visit www.denalitherapeutics.com.

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The Pharma Data

MARCH 28, 2022

While these were not the results we were hoping for, they are clear and will inform future research across our broad pipeline of investigational ALS therapies. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology. Biogen Inc.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Lack of Individual Drug Therapy Pattern prescribing can occur when physicians prescribe the same drugs, in the same quantities, in the same strengths to their patients, or a patient receives the same controlled substances repeatedly with no adjustment or change in therapy. Complaint ¶ 58.

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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). percentage points (-3.6

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FDA Law Blog: Biosimilars

APRIL 10, 2023

Booker opined that the Act would expedite rescheduling schedule I substances that receive breakthrough therapy designation to schedule II that “with DEA oversight-will enable patient access and reduce the burden on further clinical investigation.” Booker & Paul introduce the Breakthrough Therapies Act for Veterans and Patients, Mar.

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Research Therapies Clinical Trials FDA 59

The Pharma Data

SEPTEMBER 10, 2020

(NYSE:PFE) announced today that more than 50 abstracts representing data from nine approved and investigational Pfizer medicines, including several biomarker-driven and immuno-therapies, will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 being held from September 19-21, 2020. Mayer E. . Pfizer Inc.:

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