Search Results for “antibody” – Page 65 – media

RubrYc Therapeutics Completes $10M Million Series A Financing

RubrYc Therapeutics, Inc., a biotherapeutics discovery business, announced today it has closed a $10 million Series A Preferred Equity financing round led by Third Point Ventures, with participation by Paladin Capital Group and Vital Venture Capital.
- Source: prnewswire
- 929
- April 16, 2018
antibody biotherapeutics Series
Boehringer Ingelheim and OSE Immunotherapeutics Ink $1.4B Deal

Boehringer Ingelheim, headquartered in Ingelheim, Germany, and OSE Immunotherapeutics, based in Nantes, Frances, signed a collaboration and license deal to jointly develop OSE-172 for myeloid cancers.
- Source: Pharmalive
- 451
- April 10, 2018
Market Views myeloid cancers OSE-172
KEYTRUDA® (pembrolizumab) Monotherapy Met Primary Endpoint in Phase 3 KEYNOTE-042 Study, Significantly Improving OS as First-Line Therapy in Locally Advanced or Metastatic NSCLC Patients Expressing PD-L1 in at Least 1 Percent of Tumor Cells

Based on the recommendation of the DMC, the trial will continue to evaluate progression-free survival (PFS), which is a secondary endpoint. Results from KEYNOTE-042 will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.
- Source: finance.yahoo
- 679
- April 10, 2018
Clinical Trials keytruda Merck NSCLC
Rejection–FDA Issues CLRs for Two Celltrion and Teva Biosimilars

The U.S. Food and Drug Administration (FDA) issued two Complete Response Letters (CRLs) to South Korean manufacturer Celltrion. One was for a proposed biosimilar for Genentech and Biogen’s Rituxan for lymphomas and leukemias, and a proposed biosimilar to AbbVie’s Humira for rheumatoid arthritis, plaque psoriasis, Crohn’s disease and other autoimmune disorders.
- Source: biospace
- 642
- April 9, 2018
AbbVie biosimilar FDA Genentech
Sanofi’s PD-1 inhibitor starts EU review for skin cancer

The EMA has kicked off its review of Sanofi and Regeneron’s immuno-oncology drug cemiplimab, which is aiming to become the sixth drug in the PD-1/PD-L1 inhibitor class to reach the market.
- Source: Pmlive
- 552
- April 8, 2018
cemiplimab immuno-oncology New Approvals
EU reviews for Sanofi’s Dupixent, cemiplimab

European regulators have agreed to review Sanofi and Regeneron’s Dupixent for asthma and cemiplimab for advanced cutaneous squamous cell carcinoma.
- Source: pharmatimes
- 950
- April 4, 2018
asthma FDA New Approvals Sanofi
Shire Reports Regulatory Milestones for Investigational Hereditary Angioedema (HAE) Treatment Lanadelumab

Shire plc (LSE: SHP, NASDAQ: SHPG) announced today the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for lanadelumab (SHP643) and also reports that Health Canada has completed screening and accepted the New Drug Submission (NDS) under Priority Review for this investigational compound.
- Source: Shire
- 613
- April 2, 2018
angioedema HAE lanadelumab New Approvals
China’s Adagene raises $50M to take anticancer antibodies into the clinic

Sequoia China has powered Adagene to a $50 million series C round. The investment positions the Chinese antibody discovery shop to move the most advanced assets in its oncology pipeline into human testing.
- Source: FierceBioTech
- 601
- March 30, 2018
Clinical Trials Company Insights oncology
Amgen And Allergan Receive Positive CHMP Opinion For ABP 980 (Biosimilar Herceptin®) For The Treatment Of Three Types Of Cancer

Recommended for Approval for the Same Indications as Herceptin® (Trastuzumab) Positive Opinion for ABP 980 is Supported by Phase 3 Data in Patients With HER2-Postive Early Breast Cancer
- Source: finance.yahoo
- 608
- March 28, 2018
Allergan Amgen biosimilar herceptin New Approvals
Astellas and Seattle Genetics Announce Updated Enfortumab Vedotin Phase 1 Data in Metastatic Urothelial Cancer at 2017 ASCO Annual Meeting -Pivotal Monotherapy Phase 2 Trial Initiation Planned for 2017-

Astellas and Seattle Genetics, Inc. (NASDAQ: SGEN) highlighted updated phase 1 data for enfortumab vedotin (ASG-22ME) studied as monotherapy treatment for metastatic urothelial cancer (mUC) in an oral presentation at the American Society of Clinical Oncology (ASCO) 52nd Annual Meeting in Chicago. Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a cell surface protein expressed in multiple solid tumors including mUC, ovarian cancer, and non-small cell lung cancer (NSCLC). Based on the data from the ongoing phase 1 clinical trial, the companies this year plan to initiate a registrational monotherapy phase 2 trial for locally advanced or mUC patients who have been previously treated with checkpoint inhibitor (CPI) therapy. A trial evaluating enfortumab vedotin in combination with CPIs is also planned for later this year as part of a broad clinical development program.
- Source: newsroom.astellas.us
- 546
- March 28, 2018
Astellas monotherapy mUC Seattle Genetics

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