Drug Discovery World

DECEMBER 13, 2023

It demonstrated superior activity to a pembrolizumab biosimilar antibody and a matched CD73 DFC at one third the dose of the respective monotherapies. The in vitro potency, multiple mechanisms of action and favourable pharmacokinetics profile of CBO421 translated to antitumor efficacy in monotherapy and in combination with PD-1 therapy.

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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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Drug Channels

JANUARY 27, 2023

Saket discusses market access and contracting strategies for medical benefit products when pharmacy benefit biosimilar therapies launch. Today’s guest post comes from Saket Patel, Consultant, Advisory Services at MMIT. He then describes how to automate formulary and medical policies to protect manufacturers from overpayment.

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Drug Discovery World

FEBRUARY 22, 2024

in 2023, fuelled by the FDA approval of its CRISPR-based ex vivo cell therapy Casgevy. Regeneron’s market capitalisation growth was attributed to the FDA approval of its high-dose Eylea – a VEGF fusion protein – for eye diseases, which may likely offset standard Eylea’s expected sales decline following looming biosimilar competition.

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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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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

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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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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Drug Hunter

APRIL 24, 2023

A landmark part of the act is the requirement of Medicare to negotiate the prices for the 15 drugs with highest Medicare spend without generic and/or biosimilar substitutions across Part B (hospital drugs) and D (at-home drugs), with negotiated price implementation starting in 2026.

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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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Treatment Therapies Disease FDA Approval 52

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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Biosimilars FDA FDA Approval Small Molecule 52

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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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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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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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

MAY 14, 2021

Gene therapy player turned kidney specialist Vera drops a dud in leadup to Nasdaq, pricing well below range ( Endpoints ). Lupin Pursues India Approval For Lucentis Biosimilar, COVID-19 Opportunities ( Scrip ). Lupin Pursues India Approval For Lucentis Biosimilar, COVID-19 Opportunities ( Scrip ).

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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

Drug Discovery World

MARCH 29, 2023

What of the increased possibilities for ‘replacement pharmacy compounding’ for weekly hospital supplies, and for routine manufacturing of cell and gene therapies without a marketing authorisation? He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

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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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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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FDA Law Blog: Biosimilars

JUNE 23, 2024

However, the well-intentioned statutory language enacted in 1970 did not anticipate important changes in clinical therapies and advances in medical technology, and in some cases has created obstacles both to ensuring needed patient access and successful medical outcomes. 2] Why is this an issue? Highly concentrated opioid formulations (e.g.,

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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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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 Doctors 52

Drug Discovery World

NOVEMBER 9, 2023

These include: Samantha Bailey-Bucktrout, PhD, Senior Vice President, Akamis Bio, on: ‘Tumour specific immunogene therapy to deliver protein therapeutics to solid tumour microenvironments’. Chairperson Klampatsa on: ‘Overcoming tumour antigen heterogeneity in the context of car t cell therapy for solid tumours’.

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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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Drug Discovery World

MAY 1, 2023

The EC also says that earlier availability of generic and biosimilar medicines will be facilitated, and market authorisation procedures simplified. Speeding up procedures The reform hopes to create an innovation-friendly regulatory environment, with the European Medicines Agency (EMA) providing better early regulatory and scientific support.

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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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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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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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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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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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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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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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The Pharma Data

AUGUST 21, 2020

Poseida suspends CAR T therapy trial in prostate cancer due to patient death. Poseida’s Phase 1 trial that used an investigational CAR T therapy for treating prostate cancer has been suspended due to a patient death. China approves its first biosimilar of Roche’s Herceptin in HER2+ cancers.

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Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

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The Pharma Data

MAY 3, 2021

Six patients with dementia went to Mexico for an unproven gene therapy, a biotech CEO claims ( STAT ). Avrobio changes course after FDA closes path for speedy gene therapy approval ( BioPharmaDive ). UK Could Become ‘World Leader’ On Biosimilar Regulation ( Pink Sheet ). Medtech.

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