Breakthrough therapy Press Release
|06/09/2020 - 09:07||
OncoSec Expands KEYNOTE-890 Trial into First-Line Metastatic Triple Negative Breast Cancer (mTNBC) with TAVO and KEYTRUDA Plus Chemotherapy
|06/04/2020 - 13:36||
Halozyme Announces Janssen Receives European Marketing Authorization For Subcutaneous DARZALEX Utilizing Halozyme's ENHANZE Technology For The Treatment Of Patients With Multiple Myeloma
The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV DARZALEX ® , which is given over several hours. Patients currently on IV DARZALEX ® will have the choice to switch to the SC formulation.
|06/04/2020 - 05:49||
OncoSec to Present at Virtual Summer Investor Summit
PENNINGTON, N.J. and SAN DIEGO, June 4, 2020 / / -- OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, today announced that Daniel J. O'Connor, President and Chief Executive Officer of OncoSec, will present a company overview at the Virtual Summer Investor Summit on Tuesday, June 9 th at 9:45 a.m.
|06/02/2020 - 17:33||
Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
Basel, June 2, 2020 — Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Regulatory action is now expected in September 2020.
|05/18/2020 - 11:59||
Agilent PD-L1 Assay Receives FDA Approval for Use as a Companion Diagnostic
Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration has approved the company?s PD-L1 IHC 28-8 pharmDx for expanded use in non-small cell lung cancer (NSCLC).
|05/13/2020 - 20:47||
EISAI TO PRESENT DATA ON ONCOLOGY PIPELINE AND PRODUCTS AT ASCO ANNUAL MEETING
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that presentations on a series of abstracts regarding its in-house discovered lenvatinib mesylate (multikinase inhibitor, product name: LENVIMA®, “lenvatinib”) and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: HALAVEN®, “eribulin”) will be given at the American Society of Clinical Oncology (ASCO20 Virtual Scientific Program*), from May 29 to 31, 2020.
|05/13/2020 - 12:53||
Gilead and Kite Continue to Advance Next Generation Cancer Therapies at 2020 American Society of Clinical Oncology Annual Meeting
Nine Abstracts, Including Three Oral Presentations, Highlight Leadership in Hematologic Malignancies and Early Progress in Solid Tumors --
|05/12/2020 - 12:50||
New Data from 18 Approved and Investigational Pfizer Medicines to be Showcased at ASCO20 Virtual Scientific Program
JAVELIN Bladder 100 Study to be presented in Plenary Session and featured in the official Press Program.
|05/11/2020 - 10:52||
Heat Biologics Provides Clinical Update; Reports Continued Progress Advancing HS-110
American Society of Clinical Oncology (ASCO) poster presentation on "Tumor antigen expression and survival of patients with previously treated advanced non-small cell lung cancer (NSCLC) receiving viagenpumatucel-L (HS-110) plus nivolumab" on May 29th presenting latest survival data of HS-110 in combination with nivolumab in previously treated, immunotherapy naïve patients with advanced non-small cell lung cancer (NSCLC) Established partnership for biomarker development with Earle A.
|05/06/2020 - 06:36||
OncoSec's TAVO in Combination with KEYTRUDA Demonstrated 41% Overall Response Rate and 36% Complete Response in a Late-Stage Metastatic Melanoma Study Featured in 'Clinical Cancer Research'
Press Release Issued by The American Association for Cancer Research (AACR) Highlights Strong Response Data from Now Published Study, Citing TAVO's Capability to Convert Melanomas Into "Hot" Tumors.
|05/06/2020 - 06:07||
Interleukin-12 Electroporation May Sensitize Immunologically Cold Melanomas to Immune Checkpoint Inhibition
PHILADELPHIA – Combining intratumoral electroporation of interleukin-12 (IL-12) DNA (tavokinogene telseplasmid, or TAVO) with the immune checkpoint inhibitor pembrolizumab (Keytruda) led to clinical responses in patients with immunologically quiescent advanced melanoma, according to results from a phase II trial published in Clinical Cancer Research, a journal of the American Association for Cancer Research.
|05/01/2020 - 19:33||
Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO Utilizing Halozyme's ENHANZE Technology For The Treatment Of Patients With Multiple Myeloma
Innovative, fixed-dose formulation demonstrates consistent efficacy to intravenous DARZALEX® with lower rate of infusion-related reactions - - Can be administered in three to five minutes compared to multi-hour infusions with intravenous DARZALEX® - SAN DIEGO, May 1, 2020 / / -- Halozyme Therapeutics, Inc.
|04/29/2020 - 18:41||
Halozyme Announces Janssen's Receipt Of CHMP Positive Opinion For DARZALEX Subcutaneous Formulation Utilizing Halozyme's ENHANZE Technology For Patients With Multiple Myeloma
The DARZALEX® SC formulation utilizes Halozyme's ENHANZE® drug delivery technology and reduces the treatment time from several hours to approximately five minutes with comparable efficacy to intravenous DARZALEX® and lower rates of infusion-related reactions.
|04/26/2020 - 01:34||
Halozyme Announces Janssen Submits New Drug Application In Japan For Daratumumab Subcutaneous Formulation Utilizing Halozyme's ENHANZE Technology For Patients With Multiple Myeloma
The NDA is supported by pivotal data from the Phase 3 COLUMBA (MMY3012) study – a randomized open label study – that included a non-inferiority comparison of daratumumab SC formulation versus daratumumab IV administration in patients with multiple myeloma who had received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease was refractory to both PI and IMiD.
|04/23/2020 - 15:28||
Agilent Receives FDA Approval for PD-L1 Companion Diagnostic on Dako Omnis
Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration has approved the company’s PD-L1 IHC 22C3 pharmDx as a companion diagnostic (CDx) to identify patients with non-small cell lung cancer who are appropriate for first-line monotherapy with KEYTRUDA (pembrolizumab) on the Dako Omnis platform.
|04/22/2020 - 17:46||
FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments
Today, the U.S. Food and Drug Administration granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread to other parts of the body. Patients must have received at least two prior therapies before taking Trodelvy.
|04/22/2020 - 08:01||
Novartis Kymriah receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma
If approved, relapsed or refractory (r/r) follicular lymphoma would become the third B-cell malignancy indication for Kymriah, joining approvals in children and young adults with r/r ALL, and adults with r/r DLBCL.
|04/21/2020 - 15:02||
U.S. FDA Approves IMBRUVICA (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
U.S. FDA Approves IMBRUVICA® (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
|04/21/2020 - 06:19||
European Commission approves nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Approval is based on the SENSCIS® study which showed nintedanib slows the loss of pulmonary function in people living with systemic sclerosis-associated ILD (SSc-ILD)1 Following the FDA’s approval in September 2019, nintedanib in SSc-ILD has so far been approved in 15 countries including Canada, Japan and Brazil Being the first and only approved treatment option available for people living with SSc-ILD, the approval constitutes a breakthrough in an area of high unmet need.
|04/19/2020 - 22:22||
How cancer cells don their invisibility cloaks
Researchers uncover a key mechanism that regulates PD-L1, a protein that helps tumors evade the immune system and is the target of several immunotherapy drugs.
|04/03/2020 - 04:34||
Dupixent (dupilumab) Phase 3 data show significant improvement in severe atopic dermatitis for children aged 6 to 11 years
Data further reinforce consistent safety and tolerability profile observed across adult and adolescent atopic dermatitis trials, including a numerically lower rate of skin infections compared to placebo.
|03/31/2020 - 23:13||
Blueprint Medicines Announces the Achievement of Key Portfolio Milestones
Top-line ARROW trial data for pralsetinib show 60% overall response rate and 18-month duration of response rate of 90% in previously treated RET-mutant medullary thyroid cancer; plan to submit NDA to FDA in Q2 2020 --
|03/25/2020 - 11:23||
Regeneron to Extend Payment Terms for Eylea (aflibercept) Injection
Company works with American Academy of Ophthalmology to support ophthalmologists during COVID-19 crisis
|03/18/2020 - 15:55||
Pfizer Announces Positive Top-Line Results from Third Phase 3 Trial of Abrocitinib for Moderate to Severe Atopic Dermatitis, Which Showed Improvements in Skin Clearance, Disease Extent and Severity, and Itch
NEW YORK--( )--Pfizer Inc. (NYSE:PFE) announced today that JADE COMPARE (B7451029) met its co-primary efficacy endpoints. The Phase 3 study evaluated the safety and efficacy of abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, in adults with moderate to severe atopic dermatitis who were also on background topical therapy. The study also included an active control arm, dupilumab, a biologic treatment administered by subcutaneous injection, compared with placebo.
|03/17/2020 - 11:53||
OncoSec Announces Publication of Positive TAVO Monotherapy Results in Metastatic Melanoma Patients in Annals of Oncology
High Impact Peer-Reviewed Medical Journal Highlights Overall Response Rate of 35.7% and Complete Response of 17.9% with Demonstrable Abscopal Responses When Using TAVO as a Monotherapy in Patients with Advanced Melanoma.