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04:43 EST 23rd January 2019 | BioPortfolio

Waters Expands Accessibility to High Resolution MS Data with the First SmartMS-Enabled LC-MS Biopharma System

As the Number of Analytical Monitoring Tests for Biopharmaceuticals Skyrockets, Waters Builds Intelligence into a Fit-for-Purpose System Waters Corporation (NYSE:WAT) today introduced the BioAccord™ System, a purposefully designed liquid chromatography-mass spectrometry (LC-MS) solution that will expand access to high-resolution time-of-flight mass ...

Bio-Thera Solutions Announces Initiation of Phase III Clinical Trial for BAT1806, a Proposed Biosimilar of Actemra® (Tocilizumab)

Bio-Thera Solutions, a clinical-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for its tocilizumab biosimilar, BAT1806. Bio-Thera’s Phase III clinical trial will compare the safety and efficacy of BAT1806 and the reference product, Genentech’s RoActemra® in patients with rheumatoid arthritis (RA). Act...

The Center for Biosimilars® Talks with Michael Kolodziej, M.D., About How Payers Are Preparing for Biosimilars

The interview was shared through the weekly e-newsletter of The Center for Biosimilars® The Center for Biosimilars®, an online resource for emerging therapies that focuses on improving patient outcomes,

Global Biosimilars Market Increasingly Lucrative Market Fueled by Constrained Payer Environment and Patent Expiries for BestSelling Biologics [Report Updated: 01012019] Prices from USD $2995

Global Biosimilars Market Increasingly Lucrative Market Fueled by Constrained Payer Environment and Patent Expiries for BestSelling BiologicsSummaryGBI Research's latest report: Biosimilars provides an indepth assessment of the current developments and trends in the global biosimilars market. This report also assesses the state of the biosimilar RD and commercial landscape through multilevel anal...

US FDA Approves ONTRUZANT® (trastuzumab-dttb), Samsung Bioepis’ First Oncology Medicine in the United States

Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved ONTRUZANT® (trastuzumab-dttb), a biosimilar referencing HERCEPTIN® 1 (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophag...

Literature Review: Advanced Biologic Therapies and Advanced Biologics Manufacturing

Two recent reports mark important milestones in the area of biologics development. The work by Crowell et al. provides a much-needed improvement in the ability to manufacture biopharmaceuticals in a modular benchtop fashion. Such a customizable production addresses a recently growing bottleneck, as many existing therapeutics are needed in new doses and formulations in order to enable […] T...

Top 10 most read GaBI Online articles in 2018

A review of the important events for biosimilars during 2018 are presented in this article. Some of the most memorable events for biosimilars in 2018 were the rejections by the US Food and Drug Administration (FDA) of four biosimilars and the agency’s update on its naming guideline for biologicals. Other subjects of interest for biosimilars were European Medicines Agency approvals, the US biosim...

EMA continues to be open to alternative clinical development strategies for biosimilars

In the European Union (EU) and other highly regulated markets, companies need to prove the similarity of proposed biosimilars to the established reference product for gaining market authorization. European regulators recommend using a step-wise approach whose first steps consist of a demonstration of similarity at the analytical level and via non-clinical studies. In addition, as a later step, cli...

Medicines for Europe 17th Biosimilar Medicines Conference; ‘Biosimilars: Shared Journey to Access’

Medicines for Europe 17th Biosimilar Medicines Conference; ‘Biosimilars: Shared Journey to Access’ 28‒29 March 2019 Hotel OkuraAmsterdam, The Netherlands

Xbrane Biopharma announces acceptance of initiation of Xlucane clinical trial in the US

Press release2019-01-18 The Food and Drug Administration (FDA) and the Central Ethics Committee in the United States have accepted Xbranes IND application for initiation of the Xplore trial, a phase III trial with Xlucane, a ranibizumab (Lucentis®) biosimilar candidate. "It is with great satisfaction we can announce acceptance from the FDA and the Central Ethics Committee...

Vaccinex Presented Previously Disclosed Data from Ongoing Phase 1/2 Trial of VX15/2503

Vaccinex (Nasdaq:VCNX), a clinical-stage biotechnology company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases and conditions with unmet medical needs, including cancer, neurodegenerative diseases, and autoimmune disorders, today announces vice president of preclinical research, Elizabeth Evans, Ph.D., provided a podium presentation at the Cambridge ...

Alder BioPharmaceuticals® Appoints Paul Streck, M.D. Chief Medical Officer

BOTHELL, Wash., Jan. 17, 2019 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced the appointment of Paul Streck, M.D., as chief medical officer (CMO), effective January 21, 2019.  He will report to Bob Azelby, Alder’s president and chief executive offi...

Bridge Biotherapeutics Announces FDA Orphan Drug Designation for BBT-877 in Idiopathic Pulmonary Fibrosis (IPF)

The U.S. FDA grants an orphan drug designation to BBT-877 in IPF The first-in-human clinical study is set to begin next month SEONGNAM, South Korea, Jan. 16, 2019 /PRNewswire/ -- Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea and a tenant company of JLABS@TMC in Houston, Texas, announced that the U.S. Food and Drug Administration (FDA)...

Samsung Bioepis partner brings biosimilars to China

Samsung Bioepis will expand into the Chinese market after agreeing to a deal with 3SBio to commercialise its biosimilar portfolio.

Thousand Oaks secures $45m to expand its CDMO, CMC service offerings

Thousand Oaks Biopharmaceuticals raised $45m in Series A financing, enabling the company to expand its CDMO and CMC services as well as its capabilities in global biologics development.

How a 'regulatory dead zone' may be holding up copycat insulin

The FDA has talked up biosimilars' potential impact on the insulin market, but changing regulations have complicated matters for would-be competitors.

How the FDA may be holding up insulin copies

FDA head Scott Gottlieb has talked up the idea of biosimilars coming to the insulin market, but changing regulations have complicated matters for would-be competitors.

AbSci Establishes New Collaboration with Sanofi

AbSci and Sanofi entered into a collaboration to improve the manufacturability for two of Sanofi’s biotherapeutics VANCOUVER, Wash., Jan. 9, 2019 /PRNewswire/ — AbSci, a global leader in biotherapeutic discovery and manufacturing technologies, today announced a collaboration with Sanofi.  Under the terms of the agreement, AbSci will apply its breakthrough E.coli manufacturing platform...

This from a panel at #JPMHC19 with @fiercepharma about improving patient access and affordability: https://www.fiercepharma.com/pharma/biosimilars-reference-index-are-among-challenges-drug-price-debate …

This from a panel at #JPMHC19 with @fiercepharma about improving patient access and affordability: https://www.fiercepharma.com/pharma/biosimilars-reference-index-are-among-challenges-drug-price-debate …

Biosimilars in the US: Rising applications and approval rates

Biosimilar approvals in the US have increased by 600% and with biologic patent expiration dates approaching, biosimilar applications are on the rise as well.

FDA releases guidances and proposed rule to advance biosimilars policy framework

The US Food and Drug Administration (FDA) announced on 11 December 2018 that it had released four guidance documents and a proposed rule on the definition of a ‘biological product’.

Trastuzumab and agalsidase beta biosimilars launched in Japan

Japanese firms have announced the launch of agalsidase beta and trastuzumab biosimilars in Japan on 28 November 2018.

Biosimilars makers in Canada to launch patient support programme

Biosimilars Canada, an association representing Canada’s biosimilar makers, announced on 22 November 2018 that it had chosen pharmaceutical service provider Innomar Strategies to be the preferred provider for the association’s Patient Support Program (PSP) platform.

Pharmalot.. Pharmalittle.. Good Morning.. Biologics makers using scare tactics to ward off biosimilars, insulin prices rise & more interesting news.. https://www.statnews.com/pharmalot/2019/01/10/biosimilars-insulin-drug-prices/ … #pharma #drugprices

Pharmalot.. Pharmalittle.. Good Morning.. Biologics makers using scare tactics to ward off biosimilars, insulin prices rise & more interesting news.. https://www.statnews.com/pharmalot/2019/01/10/biosimilars-insulin-drug-prices/ … #pharma #drugprices

/CORRECTION/ -- NapaJen Pharma, Inc./

TOKYO and BURLINGAME, Calif., Jan. 9, 2019 /PRNewswire/ -- In the news release, "NapaJen Pharma Closes $12.4 Million Series C Financing" issued on 9-Jan-2019 by NapaJen Pharma, Inc. over PR Newswire, we are advised by the company that one of the investors' name was incorrect. "P&D Directions Inc." should read "P&E Directions Inc." The full corrected release is...

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