Meanings and history of the name Nova: | Edit. From Latin meaning 'new'. Hopi: food. Native American meaning "Chases Butterfly" In astronomy, a star that suddenly becomes thousands of times brighter and then gradually fades to its original intensity.
This is where we feature, organize and highlight key biotech or medtech products and their most recent NOVA , that is we will shed light and links to as much information as we can and with updates, clinical trials, expanded approvals, new indications and more.
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KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada
European Commission has granted a conditional marketing authorization to ERVEBO for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus
Since the middle of last year, the Congo Ebola outbreak has killed more than 2,100 people, making it the second-largest Ebola outbreak in history, after the 2013-16 epidemic in West Africa that killed more than 11,300.
After more than two decades of research, the world finally has an approved Ebola vaccine.
Opinion Supports Use of KEYTRUDA, as Monotherapy or in Combination with Platinum and 5-Fluorouracil Chemotherapy, in Patients Whose Tumors Express PD-L (CPS ≥1)
October 18, 2019 07:00 AM Eastern Daylight Time
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada
KEYTRUDA is the First Anti-PD-1 Therapy Approved in Europe for the First-Line Treatment of Head and Neck Cancer as Monotherapy or in Combination with Chemotherapy, in Patients Whose Tumors Express PD-L1 (CPS ≥1)Approval Based on Significant Overall Survival Findings from Phase 3 KEYNOTE-048 TrialNovember 20, 2019 06:45 AM Eastern Standard TimeKENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada
Wed November 20, 2019 6:45 AM|Business Wire|About: MRK
Published: Aug 13, 2019 By Alex Keown
The FDA also granted Opdivo plus Yervoy Breakthrough Therapy Designation for this potential indication
CORPORATE/FINANCIAL NEWSMONDAY, NOVEMBER 11, 2019 6:59 AM EST
Tue October 22, 2019 6:59 AM|Business Wire|About: BMY
Thu October 24, 2019 6:59 AM|Business Wire|About: BMY
YERVOY® (ipilimumab) is a prescription medicine used in adults and children 12 years of age and older to treat melanoma (a kind of skin cancer) that has spread (metastatic) or cannot be removed by surgery (unresectable).
It is not known if YERVOY is safe and effective in children less than 12 years of age.
YERVOY® (ipilimumab) is a prescription medicine used in adults to help prevent melanoma (a kind of skin cancer) from coming back after it and lymph nodes that contain cancer have been removed by surgery.
It is not known if YERVOY is safe and effective in children.
YERVOY will not work for every patient. Individual results may vary.
The ibrutinib clinical program is designed to fully explore the potential of this first-in-class molecule as a single or combination therapy for multiple cancers and other diseases. Fourteen Phase 3 company-sponsored studies are ongoing.
- Nearly half of all R/R MCL patients in the pooled analysis were able to survive their disease at three years and more than one quarter of patients had no progression in their disease
- Median PFS outcomes were observed to be higher in patients who received ibrutinib earlier and after only one prior therapy
- This analysis comprises of 3.5 years of R/R MCL follow-up data, the longest to date in Bruton's tyrosine kinase (BTK) inhibition
- This press release corresponds to abstract #151
- Milestone marks the 10th FDA approval for IMBRUVICA in six different disease areas since 2013
- FDA approval is based on positive Phase 3 iLLUMINATE (PCYC-1130) study results, which demonstrated IMBRUVICA plus obinutuzumab significantly prolonged progression-free survival versus the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines Category 1 treatment of chlorambucil plus obinutuzumab
- FDA also approved an updated IMBRUVICA label to include additional long-term efficacy data
NORTH CHICAGO, Ill., Jan. 28, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV),
Fri November 8, 2019 7:35 AM|PR NewswirePR Newswire
RARITAN, N.J., Nov. 8, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson
- Results from this interim analysis showed ibrutinib plus rituximab prolonged progression-free survival (PFS) compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR) at nearly 3 years of follow-up (abstract #LBA-4)
- The data also showed an improved overall survival (OS) for CLL patients treated with IMBRUVICA plus rituximab versus FCR
- First head-to-head trial of an IMBRUVICA-based, chemotherapy-free combination regimen versus FCR and dedicated to CLL patients aged 70 years or younger
- Study results were presented at the Late Breaking session at ASH 2018
NORTH CHICAGO, Ill., Dec. 4, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV)
On March 8, 2019, the FDA granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
ABRAXANE is a prescription medicine used to treat: advanced breast cancer in people who have already received certain other medicines for their cancer. advanced non-small cell lung cancer, in combination with carboplatin in people who cannot be treated with surgery or radiation. advanced pancreatic cancer, when used in combination with gemcitabine as the first medicine for advanced pancreatic cancer.
PUBLISHED30 September 2019
AstraZeneca and Merck’s LYNPARZA reduced the risk of disease progression or death by 51% in men with homologous recombination repair (HRR) gene mutations
First positive Phase III trial testing a targeted treatment in biomarker-selected prostate cancer patients
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada)
Mon September 30, 2019 10:59 AM|Business Wire|About: AZN
PUBLISHED28 September 2019
AstraZeneca and Merck’s LYNPARZA added to bevacizumab reduced the risk of disease progression or death by 41% in the overall trial population
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada
PUBLISHED28 October 2019
Mon September 9, 2019 7:00 AM|Business Wire|About: AZN
Mon October 28, 2019 3:14 PM|Business Wire|About: AZN
-First FDA-Approved Regimen in Frontline Peripheral T-Cell Lymphoma-
-FDA Approval Based on Results from the Phase 3 ECHELON-2 Clinical Trial; Data to be Presented at the 2018 ASH Annual Meeting-
-Application Approved Less Than Two Weeks After Submission Under FDA Real-Time Oncology Review Pilot Program-
November 16, 2018 10:52 AM Eastern Standard Time
-Four-Year Update of the ECHELON-1 Trial Continues to Support Superior Clinical Activity of ADCETRIS in Combination with Chemotherapy when Compared to ABVD in Frontline Advanced Hodgkin Lymphoma-
-Additional Data Analyses Highlight Activities Across Broad ADCETRIS Development Program-
November 07, 2019 08:00 AM Eastern Standard Time
Phase 3 '215 and Children's Oncology Group (COG) Studies Both Stopped Early Due to Treatment Benefit of BLINCYTO Over Chemotherapy
THOUSAND OAKS, Calif., Sept. 24, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN
Wed November 6, 2019 3:16 PM|Business Wire|About: AZN
Robust early-stage pipeline advancements and presentations across multiple scientific platforms demonstrate potential to improve treatment outcomes in blood cancers with high unmet need
WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca will present the first data from the Phase III ELEVATE-TN trial assessing CALQUENCE® (acalabrutinib), a next-generation selective Bruton’s tyrosine kinase (BTK) inhibitor,
- LIBRETTO-001 is the largest trial ever reported in RET-altered cancer patients
- 56 percent objective response rate (ORR) in the registration dataset (n=55) of RET-mutant medullary thyroid cancer (MTC) patients who had previously received cabozantinib and/or vandetanib
- 59 percent ORR in cabozantinib/vandetanib-naïve RET-mutant MTC patients
- 62 percent ORR in heavily pretreated RET fusion-positive thyroid cancer patients
- Sustained durability, measured by both Duration of Response and Progression-Free Survival
- Well-tolerated safety profile; low rate of discontinuation (1.7%) for treatment-related adverse events
- New Drug Application to be submitted by year-end
INDIANAPOLIS, Sept. 29, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)
At Lilly Oncology, some of us have been touched by cancer one way or another—either as a patient or as a caregiver, relative, or friend of a patient. Cancer disrupts life and changes its course, and we’re determined to provide support beyond treatment to you and your loved ones to help ease the difficult times and celebrate the good ones. Above all, we’re dedicated to creating a community where you and other cancer patients have a network of helpful resources.
Tue October 22, 2019 6:30 AM|GlobeNewswire|About: BIIB
New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified primary and secondary endpoints
Oct. 22, 2019 7:13 AM ET | About: Biogen Inc. (BIIB)
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (CLVS