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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Specialty Pharmacies Pharmacy Biosimilars Compliance 98

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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Biosimilars FDA Approval Treatment Therapies 52

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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Licensing Licensing Biosimilars Clinical Development 52

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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Treatment Therapies Disease FDA Approval 52

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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Biosimilars Therapies Disease Drugs 52

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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Vaccine Therapies Immune Response Disease 52

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.

Biosimilars 75

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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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Pharmacy Specialty Pharmacies Biosimilars Drugs 52

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.

Therapies 52

Therapies Production Government Disease 52

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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Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

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.

Biosimilars 52

Biosimilars Disease Therapies Treatment 52

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.

Biosimilars 52

Biosimilars Disease Therapies Treatment 52

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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Clinical Trials Trials Therapies Treatment 97

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.

Biosimilars 52

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.

Biosimilars 52

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.

Biosimilars 52

Biosimilars Disease Therapies Treatment 52

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 74

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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Biosimilars Pharmacokinetics FDA Approval Packaging 40

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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Drug Development Biosimilars Drugs Therapies 40

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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Trials Small Molecule Biosimilars Therapies 52

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.

Licensing 52

Licensing Licensing Biosimilars Disease 52

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.

Disease 52

Disease Small Molecule Engineering Biosimilars 52

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.

RNA 52

RNA Therapies Disease Biosimilars 52

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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Pharmacy Government Treatment Compliance 139

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 Treatment 59

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

Biosimilars 52

Biosimilars Clinical Trials Treatment Marketing 52

The Pharma Data

MAY 2, 2022

Zuranolone has been granted Fast Track and Breakthrough Therapy Designation for MDD and Fast Track Designation for PPD by the U.S. While antidepressants are widely used to treat MDD, large-scale studies have demonstrated the need for additional therapies with a differentiated profile. Food & Drug Administration.

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Treatment Drugs Clinical Pharmacology Clinical Development 52

The Pharma Data

APRIL 28, 2022

One of our immediate priorities following the NCD decision is to support patients on therapy who were uncertain whether they could receive their next infusion,” said Alisha Alaimo, President of Biogen’s U.S. Biogen’s program does not cover diagnostics and other potential fees associated with treatment administration and monitoring.

Clinical Trials 52

Clinical Trials Treatment Biosimilars Disease 52

The Pharma Data

MAY 2, 2022

AUSTEDO is also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine (Xenazine ® ) or valbenazine (Ingrezza ® ).

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Pharmaceuticals Production Treatment Disease 52

The Pharma Data

JUNE 7, 2022

Currently, there are no approved disease modifying therapies for PD, creating significant unmet needs for patients seeking to slow disease progression. At Biogen, we aim to advance therapies that serve people with movement disorders, enabling them to have greater independence and quality of life.”. “By

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Licensing Licensing Small Molecule Disease 40

The Pharma Data

JUNE 1, 2022

Zuranolone has been granted Fast Track and Breakthrough Therapy Designation for MDD and Fast Track Designation for PPD by the U.S. About Biogen As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies.

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Biosimilars Treatment Therapies Disease 52

The Pharma Data

MARCH 5, 2021

Novartis has also announced a collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19. The company is separately supporting COVID-19-related clinical investigations of several Novartis medicines.

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Vaccine Production Biosimilars Hospitals 52

Agency IQ

JUNE 9, 2023

High-priced cell and gene therapies are being increasingly developed for rare diseases. For example, a comparison of some gene therapy reimbursement shows that the single-treatment CAR-T cell therapy Kymriah (tisagenlecleucel) is reimbursed at 320,000 euros (based on outcome) in Italy, Germany, Spain and France.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

PPD

FEBRUARY 22, 2023

With the imminent need for new therapies to offset the expected losses to generic formulas and biosimilars, the environment will be ripe for new partnerships to emerge. Nearly two-thirds (64%) of our survey respondents reported that they have considered clinical co-development funding.

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Clinical Research Biosimilars Marketing Trials 52

The Pharma Data

DECEMBER 13, 2020

In addition, toripalimab for the treatment of recurrent/metastatic nasopharyngeal carcinoma was granted the Breakthrough Therapy designation by the US Food and Drug Administration in September 2020. SHANGHAI, China, Dec. Both supplemental NDAs received priority review status by the NMPA in July 2020.

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