Herceptin, Trastuzumab Newswire

Herceptin, Trastuzumab Newswire

Comprehensive Real-Time News Feed for Herceptin, Trastuzumab (generic).

Results 1 - 20 of 369 in Herceptin, Trastuzumab (generic)

  1. Biocon Requests Withdrawal and Re-Submission of EMA Applications for...Read the original story w/Photo

    Friday Aug 18 | JD Supra

    As we've posted, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila and Ogivri , and have filed applications for marketing authorization in the European Union for those products. We also posted here that in July 2017, the French National Agency for Medicines and Health Products Safety , on behalf of the European Medicines Agency , inspected Biocon's Bengaluru product plant and issued a Statement of Non-Compliance based on good manufacturing practices deficiencies, and that Biocon indicated that it and Mylan would work with authorities with the goal of an early re-inspection.

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  2. Hospira Finds Mixed Results in Instituting IPRs Against Genentech Patents for HerceptinARead the original story w/Photo

    Wednesday Aug 16 | jdsupra.com

    Hospira filed five IPR petitions against Genentech patents that Genentech asserted were directed to Herpceptin . The PTAB has now instituted IPRs in three of the five petitions and denied the other two.

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  3. Puma Biotech Stock Offers Opportunity To Cash In On Its Maiden Product LaunchRead the original story w/Photo

    Tuesday Aug 15 | Seeking Alpha

    Puma Biotechnology Inc. stock showed strong momentum as it gained over 160 percent this year so far. However, the stock is currently taking a minor dip from is 52 weeks high of $98.85 and presents a strong opportunity to benefit from the company's latest foray into the market with its maiden product Neratinib.

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  4. Genentech to Defend 3 of 4 Herceptin Patents Challenged by HospiraRead the original story w/Photo

    Thursday Aug 10 | JD Supra

    At least 19 IPRs have been filed against seven of Genentech's patents covering its blockbuster antibody drug Herceptin . On July 27, 2017, the PTAB instituted IPRs filed by Hospira, Inc. against three Herceptin patents, and denied an IPR for a fourth Herceptin patent.

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  5. Analyzing OncobiologicsRead the original story w/Photo

    Thursday Aug 10 | IntersportsWire

    Oncobiologics and Editas Medicine are both small-cap healthcare companies, but which is the superior stock? We will compare the two businesses based on the strength of their dividends, valuation, profitabiliy, earnings, institutional ownership, analyst recommendations and risk. This is a breakdown of current ratings and price targets for Oncobiologics and Editas Medicine, as reported by MarketBeat.com.

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  6. Oncobiologics (NYSE:ONS) & Editas Medicine (EDIT) Critical ReviewRead the original story w/Photo

    Monday Aug 7 | Daily Political

    Oncobiologics and Editas Medicine are both small-cap healthcare companies, but which is the better investment? We will contrast the two businesses based on the strength of their institutional ownership, risk, valuation, analyst recommendations, dividends, earnings and profitabiliy. Oncobiologics currently has a consensus price target of $9.00, indicating a potential upside of 817.43%.

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  7. Cyclacel Pharma Announces Selection Of Recommended Phase II Dose For...Read the original story

    Sunday Aug 6 | BioSpace

    Cyclacel Pharmaceuticals, Inc. , a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases, announced today the selection of a recommended Phase 2 dose from part 1 of a dose-escalating, Phase 1, first-in-human, clinical study of CYC065, a Cyclin Dependent Kinase 2/9 inhibitor. RP2D was determined to be dosing level 6 which enrolled 9 evaluable patients with advanced cancers.

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  8. Stomach Cancer Market Intelligence Report Offers Growth ProspectsRead the original story w/Photo

    Sunday Aug 6 | PR-inside.com

    Future Market Insights has announced the addition of the " Stomach Cancer Market: Global Industry Analysis and Opportunity Assessment 2016-2026" report to their offering. Stomach Cancer is a fourth most common cancer globally in which malignant cells form in the lining of the stomach.

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  9. PTAB Splits on Instituting Challenges to Herceptin PatentsRead the original story w/Photo

    Friday Aug 4 | JD Supra

    On July 27th, the PTAB issued institution decisions in five IPRs brought by Hospira challenging four Genentech patents related to Herceptin . The patents are directed to various methods of treating cancer patients with combination therapies incorporating anti-ErbB2 antibodies.

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  10. Global Oncology Market Driven by Rising Prevalence and Increased...Read the original story w/Photo

    Friday Aug 4 | SBWire

    According to a precise analysis, there are 32.6 million people living with any type of cancer within the five years of diagnosis. The cancer type is generally incurable once they progress to the stage where they are unresectable, making Oncology an important part of medical science.

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  11. 3 Things In Biotech You Should Learn Today: August 3, 2017Read the original story w/Photo

    Thursday Aug 3 | Seeking Alpha

    Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep up with the rapid-moving world of biotech and pharmaceutical research. Biosimilars are coming to the US oncology field in a big way in the coming years, thanks to imminent patent expirations for trastuzumab and bevacizumab.

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  12. Puma Biotech Receives Day-180 List Of Outstanding Issues From...Read the original story

    Wednesday Aug 2 | BioSpace

    The CHMP has requested additional data analyses related to the safety and efficacy of neratinib and has instituted a clock stop in order to allow Puma time to respond to this List of Outstanding Issues. The CHMP has set a deadline of December 22, 2017 for Puma to respond to the list.

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  13. New compound boosts treatment for aggressive breast cancerRead the original story w/Photo

    Thursday Aug 3 | Medical News Today

    Although breast cancer survival rates are overall very high, some forms of cancer are more difficult to treat than others. However, a new compound proves highly effective against these types by targeting a protein that makes cancer cells resistant to treatment.

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  14. EMA requests additional data analyses on Puma's marketing application ...Read the original story w/Photo

    Wednesday Aug 2 | Seeking Alpha

    Puma Biotechnology eases 4% after hours on light volume on the news that the European Medicines Agency's Committee for Medicinal Products for Human Use has requested additional analyses of safety and efficacy data related to its marketing application seeking approval for neratinib for the treatment of patients with HER2-positive early-stage breast cancer who have been previously treated with Roche's Herceptin . CHMP has stopped the review clock in order to allow Puma to respond to its requests, contained in its Day-180 List of Outstanding Issues.

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  15. [Research Articles] Synergistic action of the MCL-1 inhibitor S63845...Read the original story

    Wednesday Aug 2 | Science

    BH3 mimetics are drugs that inhibit the BCL-2 family of prosurvival proteins in cancer cells and thereby promote cancer cell death. Unfortunately, MCL-1, a member of this prosurvival family, can interfere with treatment because it is not sensitive to currently available BH3 mimetics.

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  16. Celltrion/Teva and Amgen/Allergan Announce FDA Submissions for...Read the original story w/Photo

    Wednesday Aug 2 | JD Supra

    Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin , which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer. First, Celltrion and Teva announced that the FDA has accepted for review a BLA for CT-P6 , a proposed trastuzumab biosimilar.

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  17. Celltrion/Teva and Amgen/Allergan Announce FDA Submissions for Proposed Biosimilars of HerceptinARead the original story w/Photo

    Wednesday Aug 2 | jdsupra.com

    Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin , which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer. First, Celltrion and Teva announced that the FDA has accepted for review a BLA for CT-P6 , a proposed trastuzumab biosimilar.

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  18. Oddway International announces addition of herclon in their product catalougeRead the original story w/Photo

    Wednesday Aug 2 | PR Log

    DILSHAD GARDEN, India - Aug. 2, 2017 - PRLog -- Oddway International , an international distributor, dealer, exporter and wholesaler of pharmaceutical products introduces yet another effective drug; Herclon manufactured by Roche contains Trastuzumab as an injection, in their extensive distribution of product catalog. Trastuzumab is a cancer medication that interferes with the growth and spread of cancer cells in the body.

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  19. Puma Biotech Announces Availability Of NERLYNX??? (Neratinib) For...Read the original story

    Monday Jul 31 | BioSpace

    Puma Biotech Announces Availability Of NERLYNXa For Extended Adjuvant Treatment Of HER2-Positive Early Stage Breast Cancer In The United States NERLYNX is the first anti-HER2 treatment to be FDA-approved as extended adjuvant therapy for early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy. Treatment with NERLYNX resulted in a 34% reduction in the risk of invasive disease recurrence or death versus placebo after patients completed one year of therapy following a trastuzumab-based regimen.

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  20. Cascadian Therapeutics To Report Second Quarter 2017 Financial Results On August 8, 2017Read the original story

    Monday Jul 31 | BioSpace

    SEATTLE, Aug. 01, 2017 -- Cascadian Therapeutics, Inc. , a clinical-stage biopharmaceutical company, today announced that it will report its second quarter financial results after the close of the U.S. financial markets on Tuesday, August 8, 2017. Following the financial results announcement, members of management will host a conference call and live audio webcast to discuss the results and provide a general corporate update.

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