GSK wins speedy FDA Zejula review in ovarian cancer niche

fiercepharma | June 24, 2019

GlaxoSmithKline has been working to restrengthen in cancer, particularly through a multibillion-dollar purchase of Tesaro. The main drug from the buyout, Zejula, is now up for a priority review in late-stage ovarian cancer, where it's working to pick up a niche nod its rivals don't have. The FDA has accepted GSK's application for the drug to treat patients with advanced ovarian, fallopian tube or primary peritoneal cancer who have had at least three prior chemo regimens. The patients must also have a BRCA mutation or homologous recombination deficiency for their cancers, and in the case of HRD cancers, must have progressed at least half a year from their last chemo treatment. The application is based on data in a trial called Quadra that found “clinically relevant activity” for the patients when treated with the drug. Investigators noted that the patients have few options, and that survival after the third line of treatment ranges from 5 months to 9 months. Now, the FDA expects to hand down a decision by October 24, and if Zejula can secure an approval, it'll be the only drug in its class of PARP inhibitors—a group that includes AstraZeneca and Merck's Lynparza as well as Clovis Oncology's Rubraca—that can tout the specific indication.  While Lynparza and Rubraca are also approved for BRCA-positive patients who have had multiple rounds of chemo, they're not cleared for those with HRD. Zejula is an oral PARP inhibitor currently approved as a maintenance treatment for women with recurrent ovarian, fallopian tube, or primary peritoneal cancer whose cancer returns. In that market, its jockeying with both Lynparza and Rubraca for positioning. Pfizer also last year won an approval for Talzenna, a fourth PARP inhibitor, to treat patients with germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer.

Spotlight

To start our series on the fruitful benefits of collaboration in the Pharma industry, we chose to discuss a well-familiar, in-house, long-existing, dichotomous relationship between brands and sales, and how a reconciliation between them, based on a shared platform of data analytics and communication, can truly save the day when it comes to success in the Pharma market.


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BUSINESS INSIGHTS

Labcorp Completes Acquisition of Personal Genome Diagnostics

Labcorp | February 21, 2022

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PHARMACY MARKET

Veneno Technologies, a Novel DRP Drug Discovery Company, Raises $2Million (¥200M Yen) in Seed Funding Round

Veneno Technologies Co. Ltd. | January 27, 2022

Veneno Technologies Co. Ltd. is pleased to announce that it has completed fundraising of 200 million yen through a third-party allocation of new shares to SBI Investment Co., Ltd., Tsukuba Institute of Research, Ltd., and SBI regional activation support Co., Ltd. The funds raised will be used to strengthen the recruitment and organizational structure, to further develop the Company's proprietary peptide drug discovery platform technology, and invest in the research and development of the Company's own drug discovery pipeline using DRP functional peptides as basic molecules to further promote DRP drug discovery. Objective of the Fund Procurement Veneno Suite™ is the Company's proprietary integrated DRP drug discovery technology. The Veneno Suite™ consists of a large gene library that is created by artificially accelerating the evolution of natural DRPs using them as templates, a screening system that enables the search for target DRPs from the library in a fast and efficient manner, and technology that enables the efficient production of various DRPs in a short period of time. With this funding, we will further refine these technologies and accelerate DRP drug discovery. Our mission is to contribute to the advancement of medicine by providing new drugs for targets such as membrane proteins that have been difficult to discover, and for intractable diseases related to these targets. In order to fulfill this mission, we will strengthen the following points through this fundraising. Appointment of high-level researchers and opening of new laboratories to advance DRP drug discovery. Expansion of the DRP focused library (DRP Space™). Strengthen and expand the pipeline of the DRP rapid search system (PERISS™) (promote joint research). Development of DRP manufacturing technology (Super Secrete™) including establishment of high-efficiency, low-volume, high-mix manufacturing technology. This funding will enable us to further refine our proprietary large-scale library, high-speed screening technology, and high-efficiency DRP manufacturing technology to accelerate our goal of DRP drug discovery. We expect that we will be able to take a concrete step toward the establishment of a new paradigm using DRP as a new drug discovery platform molecule following antibody drugs. Investor Comments Mr. Makoto Hasegawa, Manager, Investment Division, SBI Investment Co. noted, "Veneno Technologies has developed an innovative technology to turn functional peptides, called DRPs, into pharmaceuticals. We have decided to invest in Veneno Technologies because we see the potential in their technology and want to take on the challenge of developing new modalities together. We hope that our technology will lead to the development of many innovative new drugs in the future." "Veneno Technologies is a drug discovery venture that uses this technology to develop drugs that target ion channels, which remain untapped as drug targets." Mr. Masato Suzuki, Senior Researcher, Consulting Department, Tsukuba Research Institute, Inc About Veneno Technologies, Inc. Veneno Technologies was established to accelerate the research and development of DRP functional peptides and to contribute to advanced and sustainable medicine and society. The company was established to accelerate the research and development of DRP functional peptides and to contribute to advanced and sustainable medicine and society. By integrating innovative DRP discovery technologies that have been researched for many years at the National Institute of Advanced Industrial Science and Technology (AIST) and DRP manufacturing technologies that are currently being researched and developed, we will lead the research and development of various DRP drug discovery technologies such as new drugs, research reagents, agrochemicals and biostimulants.

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BUSINESS INSIGHTS

Acorda Therapeutics and Biopas Laboratories Announce Agreement to Commercialize INBRIJA® in Latin America

Acorda Therapeutics, Inc. | May 12, 2022

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PHARMACY MARKET

KromaTiD Announces Launch of KromaTiD Pinpoint FISH TP53/CEP17 Kit for Synthetic Oligonucleotide-Based FISH Assay

KromaTiD Inc | January 14, 2022

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Spotlight

To start our series on the fruitful benefits of collaboration in the Pharma industry, we chose to discuss a well-familiar, in-house, long-existing, dichotomous relationship between brands and sales, and how a reconciliation between them, based on a shared platform of data analytics and communication, can truly save the day when it comes to success in the Pharma market.

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