Drug Channels

JUNE 27, 2021

on generic and biosimilar trends Some hospitals seem to be gaming their 340B eligibility Plus, tips on effective hospital marketing. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. P.S. Please join the nearly 12,000 consumers of my daily commentary and links to neat stuff at @DrugChannels on Twitter.

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Drug Discovery World

APRIL 13, 2023

Created by DDW and sponsored by Bio-Rad, The future of antibody-based drugs: Where are the opportunities and what does the future hold? is a free In Focus report, available here.

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Drug Channels

SEPTEMBER 8, 2021

Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for his latest video webinar: Drug Channels Update: Buy-and-Bill Market Trends. Friday, September 24, 2021, from 12:00 p.m. This event is part of The Drug Channels 2021 Quarterly Video Webinar Series. to 1:30 p.m.

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The Pharma Data

JUNE 17, 2022

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe. billion.

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New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III)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

JULY 8, 2021

Nasdaq:BIIB) today announced it will report second quarter 2021 financial results Thursday, July 22, 2021, before the financial markets open. Biogen Inc. Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

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Drug Channels

OCTOBER 5, 2021

I am pleased to announce our new 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. The notable new material in this 2021-22 edition includes three new sections: Section 4.2.5. reviews AmerisourceBergen’s entry into the European distribution market. (We

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The Pharma Data

APRIL 9, 2021

today announced it will report first quarter 2021 financial results Thursday, April 22, 2021, before the financial markets open. Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m.

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The Pharma Data

APRIL 9, 2021

Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA ® (tocilizumab). Biosimilars have the potential to enable greater access to marketed biologic therapies while generating cost savings and healthcare sustainability.

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The Pharma Data

JULY 29, 2021

Second-Quarter 2021 Revenues of $19.0 Billion The 10% Operational Growth Excluding BNT162b2(1) in Second-Quarter 2021 Builds on the 6% Operational Growth Delivered by the Comparable Business in Second-Quarter 2020 Second-Quarter 2021 Reported Diluted EPS(2) of $0.98, Adjusted Diluted EPS(3) of $1.07

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept.

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The Pharma Data

AUGUST 3, 2021

Revenue in the second quarter of 2021 increased 23 percent, driven by volume growth of 22 percent. – Revenue from all key products grew in the quarter and 2021 year-to-date. . – Revenue from all key products grew in the quarter and 2021 year-to-date. – 2021 EPS guidance updated to be in the range of $6.73

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The Pharma Data

AUGUST 3, 2021

today announced financial results for the second quarter of 2021. Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). on a non-GAAP basis.

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Drug Discovery World

SEPTEMBER 23, 2022

UK’s Drug Discovery 2022 in London, October 4-5, 2021.? . How can automation help the discovery of biologics and biosimilars? ELRIG UK supplement?. This issue?is is accompanied?by?an?exclusive?DDW DDW & ELRIG UK?supplement?ahead supplement?ahead ahead of ELRIG?UK’s The DDW and ELRIG UK supplement, available as a flipbook?here,

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Drug Channels

NOVEMBER 8, 2021

Delivered as a Hybrid Event In-Person: December 13-14, 2021, Hilton Philadelphia at Penn’s Landing, Philadelphia, PA Virtual: December 16-17, 2021 [link]. Copyright © 2006-2021 Pembroke Consulting, Inc. The full agenda for this year’s Trade and Channel Strategies conference is available now! Meet The Expert Faculty.

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Drug Channels

NOVEMBER 15, 2021

Broadcast live on December 17, 2021. This event is part of The Drug Channels 2021 Quarterly Video Webinar Series. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. to 1:30 p.m. ET This page describes the event and explains how to purchase a registration. Read on for full details on pricing and registration.

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Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Eight products received recommendations for conditional marketing authorization and one product was reviewed “under exceptional circumstances.” This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021.

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Drug Discovery World

AUGUST 22, 2023

This will continue to be the case going forward, but the nature of the off-patent landscape will evolve in line with ongoing changes in the segment’s ‘pipeline’: the originator products of today, which will become the generic and biosimilar medicines of tomorrow. There is significant need for more cost-effective generic versions.

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Drug Discovery World

OCTOBER 20, 2022

Japan continues to be one of the largest pharmaceutical markets in the world, despite what the International Trade Administration described as ‘a challenging business landscape due to demographics’ 1. According to the International Trade Administration’s market overview, anti-tumour agents brought in the largest sales in 2020 in Japan.

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FDA Law Blog: Biosimilars

MARCH 16, 2023

This announcement is the first traditional marketing authorization for a non-PCR based test to detect SARS-CoV-2. We are aware through public statements that companies have been pursuing traditional marketing authorizations since at least late 2021.

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The Pharma Data

OCTOBER 29, 2020

Tokyo, Japan) today announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. . CAMBRIDGE, Mass. and TOKYO, Oct. About Aducanumab.

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The Pharma Data

SEPTEMBER 8, 2020

million and Mylan expects to pay the remainder of the deal from profits generated from their operations by 25 June 2021. . By adding to our highly experienced sales and marketing team, we will further strengthen our current reach in hospitals and enhance the future growth of our biosimilars franchise in Europe.”

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The Pharma Data

OCTOBER 26, 2021

Commencing a strategic review of Sandoz to maximize shareholder value , options range from retaining the business to separation 2021 Group guidance² unchanged. Sandoz is a global leader in generic pharmaceuticals and biosimilars. billion) and Entresto (at least USD 5.0 billion) and Entresto (at least USD 5.0 billion (+8%, +7% cc).

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Vial

MARCH 1, 2024

By geographical region, the global CRO services market in 2023 was dominated by North America. Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. We should explain what RIEs are. Comments on the guidance are invited.

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The Pharma Data

JANUARY 20, 2021

21, 2021 09:41 UTC. The suite is now under validation and will be suitable for the manufacture of clinical and commercial mammalian products, it is expected to be ready for its first production run in mid-2021. This press release features multimedia. View the full release here: [link]. About Polpharma Biologics.

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The Pharma Data

NOVEMBER 17, 2021

Tokyo, Japan) blazoned moment an update on the ongoing review of the Marketing Authorization Operation for aducanumab 100 mg/ mL concentrate result for infusion for the treatment of Alzheimer’s complaint by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). and EisaiCo.,Ltd.

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Clinical Trials Biosimilars Treatment Trials 52

The Pharma Data

MAY 18, 2021

Basel, May 18, 2021 — Sandoz, a Novartis division, today announces plans to further strengthen its European antibiotics manufacturing network by further expanding production capabilities in Kundl, Austria and in Palafolls, Spain. Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. About Sandoz.

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The Pharma Data

NOVEMBER 17, 2021

In connection with the accession, Trillium’s common shares will be excluded from the Nasdaq Capital Market. Trillium’s common shares will be excluded from the Toronto Stock Exchange on or before November 19, 2021. For fresh background on the accession, please read the advertisement press release then. About Pfizer Oncology.

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The Pharma Data

MAY 15, 2023

Huebscher , non-executive board member in companies, institutions and former CEO of Solvias Group, a Swiss contract research firm, which she led between 2014 and 2021. Before joining EMMI Group as CEO, he was a Member of the Executive Board and Head of the Marketing Department at Migros-Genossenschafts-Bund. Gallen (HSG), Switzerland.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

As background, FDC Act § 505(q) states that FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. And in December 2021, we saw FDA apply those factors in responding to a citizen petition (Docket No.

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The Pharma Data

APRIL 8, 2021

The notes offering is expected to close on April 22, 2021, subject to customary closing conditions. Manufacturer target market (MiFID II product governance / UK MiFIR product governance) is eligible counterparties and professional clients only (all distribution channels).

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FDA Law Blog: Biosimilars

NOVEMBER 29, 2023

Total Product Lifecycle (TPLC) This guiding principle reminds manufacturers that PCCPs and MLMD changes should be integrated into the lifecycle management of the device and be part of their existing quality system processes including but not limited to risk management and post market monitoring.

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The Pharma Data

MARCH 17, 2021

If all conditions are met, the separation is on track for completion late in the second quarter of 2021. In addition, Organon will pursue opportunities to partner with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

of Miami, Florida, a contract manufacturer of over-the-counter (OTC) drug products, including oral cough and cold drug products marketed for both adults and children, was also advised in a Warning Letter to retain an independent expert on good manufacturing practices. Dextrum Laboratories Inc. Terragene S.A.,

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FDA Law Blog: Biosimilars

MAY 8, 2023

The purpose of a predetermined change control plan (PCCP) is to avoid the need for such post-market assessments – and the delay and expense entailed when it is determined that a new submission is needed – through prospectively defining a process for making post-market changes. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a)

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