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Welcome to BIOTECNOVA™


 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. 


 

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Thank you for visiting

Welcome to BIOTECNOVA™

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.   

Thank you for visiting 


REVLIMID® (lenalidomide) in combination with rituximab (R²

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REVLIMID® (lenalidomide) in combination with rituximab (R²)

 

INDICATIONS

  • REVLIMID is a prescription medicine used to treat adults with follicular lymphoma (FL) or marginal zone lymphoma (MZL) in combination with a rituximab product, and who have previously been treated for their FL or MZL
  • FL and MZL are types of cancer of white blood cells called B-cell lymphocytes that are found in the lymph nodes and spleen
  • REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial
  • It is not known if REVLIMID is safe and effective in children
  • REVLIMID is only available through a restricted distribution program, REVLIMID REMS®

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ERVEBO®

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Merck’s ERVEBO® [Ebola Zaire Vaccine Granted Conditional Approval in the European Union

 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 

Ervebo

 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. 

Home/Emergencies/Diseases/Ebola/Ebola health update - DRC, 2019

KEYTRUDA® (pembrolizumab) KEYTRUDA® +LENVIMA® (lenvatinib

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KEYTRUDA® (pembrolizumab)= Metastatic or Unresectable Recurrent Head & Neck Squamous Cell Carcinoma

 

Merck Receives Positive EU CHMP Opinion for Two New Regimens of KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma

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
https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf
https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
https://www.merck.com/clinical-trials/index.htm 


 

European Commission Approves Two New Regimens of Merck’s KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

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 


https://www.businesswire.com/news/home/20191120005267/en/ 


https://www.merck.com/research/index.html#IntroVideo 


https://www.merck.com/clinical-trials/index.html 


https://www.keytruda.com/ 


https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.p 


 

European Commission Approves Two New Regimens of Merck’s KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

Wed November 20, 2019 6:45 AM|Business Wire|About: MRK 

 https://seekingalpha.com/pr/17705201-european-commission-approves-two-new-regimens-merck-s-keytruda-pembrolizumab-first-line 


Keytruda Set to Become World’s Top-Selling Drug,

 

Keytruda Approvals: A Timeline

Published: Aug 13, 2019 By Alex Keown

 https://www.biospace.com/article/keytruda-approvals-a-timeline/ 

Marks First Approval for KEYTRUDA in SCLC

 

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Monotherapy for Patients with Metastatic Small Cell Lung Cancer (SCLC) with Disease Progression on or After Platinum-Based Chemotherapy and at Least One Other Prior Line of Therapy

Opdivo (nivolumab) OPDIVO + YERVOY® (ipilimumab)

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European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab)

 

Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) Four-Week Dosing Schedule for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease


 https://www.businesswire.com/news/home/20190924005279/en/ 


 https://www.bms.com/search-results.html?q=Opdivo 


 https://www.bms.com/ 


  PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) 

U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination for Patients with Previously Treated Advanced Hepatocellular Carcinoma

The FDA also granted Opdivo plus Yervoy Breakthrough Therapy Designation for this potential indication

CATEGORY: 

CORPORATE/FINANCIAL NEWSMONDAY, NOVEMBER 11, 2019 6:59 AM EST 

 https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-accepts-priority-review-bris-0 

Data exploring potential of Opdivo & Opdivo plus Yervoy in esophageal, cervical and prostate cancer

 

CheckMate -9LA, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Combined with Chemotherapy, Meets Primary Endpoint Demonstrating Superior Overall Survival Compared to Chemotherapy Alone in First-Line Lung Cancer

Tue October 22, 2019 6:59 AM|Business Wire|About: BMY 


 https://www.businesswire.com/news/home/20191022005425/en/ 


 https://packageinserts.bms.com/pi/pi_yervoy.pdf 


 https://packageinserts.bms.com/pi/pi_opdivo.pdf 


 https://seekingalpha.com/pr/17669553-checkmate-minus-9la-phase-3-trial-evaluating-opdivo-nivolumab-plus-low-dose-yervoy-ipilimumab  


 https://www.opdivohcp.com/home 



Bristol-Myers Squibb Research at ESMO Demonstrates Breadth of Oncology Development Program and Focus on Improving Overall Survival Across Multiple Cancers


 https://www.businesswire.com/news/home/20190919005148/en/ 


 https://www.opdivohcp.com/home 



European Commission Approves Opdivo (nivolumab)

 

European Commission Approves Opdivo (nivolumab) Four-Week Dosing Schedule for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease Who Have Undergone Complete Resection

Thu October 24, 2019 6:59 AM|Business Wire|About: BMY

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY)


 https://seekingalpha.com/pr/17673364-european-commission-approves-opdivo-nivolumab-four-week-dosing-schedule-adjuvant-treatment  


 https://news.bms.com/press-release/corporatefinancial-news/european-commission-approves-opdivo-nivolumab-four-week-dosing 


 https://news.bms.com/press-release/corporatefinancial-news/european-commission-approves-opdivo-nivolumab-four-week-dosing 


 https://www.opdivo.com/ 


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.

BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) & Cetuxima

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BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab

 

PFIZER PRESENTS INTERIM ANALYSIS RESULTS FROM PHASE 3 BEACON CRC TRIAL OF BRAFTOVI® (ENCORAFENIB), MEKTOVI® (BINIMETINIB) AND CETUXIMAB FOR THE TREATMENT OF BRAFV600E-MUTANT METASTATIC COLORECTAL CANCER


 https://www.businesswire.com/news/home/20190929005046/en/ 

 https://seekingalpha.com/pr/17646946-pfizer-presents-interim-analysis-results-phase-3-beacon-crc-trial-braftovi-encorafenib 

 https://www.arraybiopharma.com/documents/Mektovi_Prescribing_information.pdf 

 https://www.arraybiopharma.com/documents/Braftovi_Prescribing_information.pdf 

IMBRUVICA® (ibrutinib)

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Phase 3 study of ibrutinib (IMBRUVICA®) in untreated (treatment-naïve) diffuse large B-cell lympho

 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. 



IMBRUVICA® (ibrutinib)

 

- 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


 https://www.nejm.org/doi/full/10.1056/NEJMoa1306220#t=article 


 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00667-4/fulltext 

U.S. FDA Approval of IMBRUVICA® (ibrutinib) Plus Obinutuzumab (GAZYVA®)

 - 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),


 https://www.hematology.org/Patients/Cancers/Leukemia.aspx 


 https://www.leukaemia.org.au/disease-information/lymphomas/non-hodgkin-lymphoma/other-non-hodgkin-lymphomas/small-lymphocytic-lymphoma/ 


 https://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency 


 https://www.gazyva.com/ 

IMBRUVICA® (ibrutinib) Combination Regimen

 
- 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)

Tecentriq® (atezolizumab) Tecentriq® +Avastin® (bevacizumab

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FDA granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane®

 

GENENTECH MEDICINE FDA APPROVED AS FIRST CANCER IMMUNOTHERAPY FOR A TYPE OF BREAST CANCER

March 8th, 2019

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).


 https://www.tecentriq-hcp.com/ 


 https://www.abraxane.com/ 


 https://media.celgene.com/content/uploads/abraxane-pi.pdf 

 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.  

LYNPARZA® (olaparib)

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LYNPARZA® (olaparib)

 

LYNPARZA (olaparib) more than doubled the time without radiographic disease progression in patients with BRCA1/2- or ATM-mutated metastatic castration-resistant prostate 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)


 

LYNPARZA (olaparib) More Than Doubled the Time Without Radiographic Disease Progression in Patients With BRCA1/2- or ATM-Mutated Metastatic Castration-Resistant Prostate Cancer

Mon September 30, 2019 10:59 AM|Business Wire|About: AZN 

 https://seekingalpha.com/pr/17647768-lynparza-olaparib-doubled-time-without-radiographic-disease-progression-patients-brca1-2-atm 


 https://www.businesswire.com/news/home/20190930005570/en/ 


 https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf#page=1 


 https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/lynparza-olaparib-more-than-doubled-the-time-without-radiographic-disease-progression-in-patients-with-brca12-or-atm-mutated-metastatic-castration-resistant-prostate-cancer-09302019.html 


 https://www.lynparza.com/ 

LYNPARZA (olaparib)

 

LYNPARZA (olaparib) improved the time women lived without disease progression to 22 months in the broad population and to 37 months in hrd-positive patients as 1st-line maintenance treatment with bevacizumab for newly diagnosed advanced ovarian cancer

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


 https://www.astrazeneca-us.com/ 


 https://www.astrazeneca.com/search-results.s.html?q=LYNPARZA+ 


 https://www.astrazeneca.com/our-therapy-areas/oncology.html 


 https://www.lynparza.com/ovarian-cancer/ovarian-cancer-treatment.html 

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IMFINZI® (durvalumab) & IMFINZI plus chemotherapy

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IMFINZI plus chemotherapy

 

IMFINZI Is First Immunotherapy to Show Both Significant Survival Benefit and Improved, Durable Responses in Extensive-Stage Small Cell Lung Cancer

Mon September 9, 2019 7:00 AM|Business Wire|About: AZN 


 https://www.businesswire.com/news/home/20190909005297/en/ 


 https://www.azpicentral.com/imfinzi/imfinzi.pdf#page=1 


 

IMFINZI® (durvalumab) and IMFINZI Plus Tremelimumab Delayed Disease Progression in Phase III POSEIDON Trial for 1st-Line Treatment of Stage IV Non-Small Cell Lung Cancer

Mon October 28, 2019 3:14 PM|Business Wire|About: AZN 

 https://seekingalpha.com/pr/17677111-imfinzi-durvalumab-imfinzi-plus-tremelimumab-delayed-disease-progression-phase-iii-poseidon 


 https://www.astrazeneca.com/ 

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ADCETRIS® (brentuximab vedotin)

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FDA Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy

 

Seattle Genetics Announces FDA Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas

-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

BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN


 https://www.businesswire.com/news/home/20181116005332/en/ 


 https://seagendocs.com/adcetris/pi/734371533_80542-10_Adcetris_Full_Ltr_Master.pdf 


 https://www.cancer.org/cancer/non-hodgkin-lymphoma.html 


 https://www.seattlegenetics.com/ 


 https://www.seattlegenetics.com/products/adcetris-us 

ADCETRIS® (Brentuximab Vedotin)

 

Seattle Genetics Announces Multiple ADCETRIS® (Brentuximab Vedotin) Presentations at the ASH Annual Meeting

-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

BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN)


 https://www.businesswire.com/news/home/20191107005424/en/ 


 https://www.seattlegenetics.com/products/adcetris-us 

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Blincyto (blinatumomab)

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BLINCYTO® (blinatumomab) Studies In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia

 

Amgen Announces Positive Results From Two Phase 3 BLINCYTO® (blinatumomab) Studies In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia

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


 https://www.amgen.com/products/ 


 https://www.prnewswire.com/news-releases/amgen-announces-positive-results-from-two-phase-3-blincyto-blinatumomab-studies-in-pediatric-patients-with-relapsed-acute-lymphoblastic-leukemia-300924297.html 


 https://www.blincyto.com/ 


 https://www.blincyto.com/patient/mrd/ 

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CALQUENCE® (acalabrutinib)

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CALQUENCE® (acalabrutinib)

 

CALQUENCE® Data To Show Improved Progression-Free Survival In Phase III Front-Line Chronic Lymphocytic Leukemia At ASH 2019 Annual Meeting

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, 


 https://www.azpicentral.com/calquence/calquence.pdf#page=1 


 https://www.businesswire.com/news/home/20191106005922/en/ 


 https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/calquence-data-to-show-improved-progression-free-survival-in-phase-iii-front-line-chronic-lymphocytic-leukaemia-trial-at-ash-2019-annual-meeting.html 


 https://www.astrazeneca-us.com/ 


 https://www.calquence.com/ 



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Selpercatinib (LOXO-292)

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Selpercatinib (LOXO-292) in Heavily Pretreated RET-Altered Thyroid Cancers

 

Lilly Announces Positive Registrational Data for Selpercatinib (LOXO-292) in Heavily Pretreated RET-Altered Thyroid Cancers

09/29/2019 

 - 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)


 https://www.prnewswire.com/news-releases/lilly-announces-positive-registrational-data-for-selpercatinib-loxo-292-in-heavily-pretreated-ret-altered-thyroid-cancers-300926842.html 


I https://investor.lilly.com/news-releases/news-release-details/lilly-announces-positive-registrational-data-selpercatinib-loxo 


 https://www.lilly.com/newsroom 

Care Beyond Treatment

 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. 

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aducanumab, an investigational treatment for early Alzheimer

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aducanumab reduced clinical decline in patients with early Alzheimer’s disease

 

Biogen Plans Regulatory Filing for Aducanumab in Alzheimer’s Disease Based on New Analysis of Larger Dataset from Phase 3 Studies

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


 https://seekingalpha.com/pr/17669521-biogen-plans-regulatory-filing-aducanumab-alzheimer-s-disease-based-new-analysis-larger 


 https://biogenalzheimers.com/ 


 http://investors.biogen.com/news-releases/news-release-details/biogen-plans-regulatory-filing-aducanumab-alzheimers-disease 


 https://www.eisai.com/news/2019/news201979.html 


 https://www.biogen.com/ 


 https://www.usagainstalzheimers.org/press/usagainstalzheimers-applauds-positive-news-alzheimers-drug-aducanumab 


 https://www.biospace.com/article/a-stunning-surprise-biogen-and-eisai-s-aducanumab-works-in-alzheimer-s/ 

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Biogen Inc. 2019 Q3 - Results - Earnings Call Presentation

Oct. 22, 2019 7:13 AM ET | About: Biogen Inc. (BIIB) 

Rubraca® (rucaparib)

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Rubraca® (rucaparib)

 

  • Rubraca® (rucaparib) offers a new monotherapy maintenance treatment option for eligible women with relapsed, platinum-sensitive ovarian cancer, who harbor either a BRCA1/2 mutation or are BRCA wild-type
  • Rucaparib provided statistically significant improvement in progression-free survival (PFS) versus placebo in all ovarian cancer patients studied1
  • Some patients with residual disease at ARIEL3 study entry who were treated with rucaparib showed further reduction in tumor burden, including complete responses1
  • Most common Grade ≥3 adverse reaction was anemia; the only serious adverse reaction occurring in >2 percent of patients was anemia2
  • Rucaparib now reimbursed in several countries in Europe with additional countries to follow in 2020

BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (CLVS

 https://www.businesswire.com/news/home/20191113005122/en/ 


 https://www.ema.europa.eu/en/documents/product-information/rubraca-epar-product-information_en.pdf 

 

Pipeline Overview

 https://www.clovisoncology.com/pipeline/pipeline-overview/ 


 https://www.clovisoncology.com/ 

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CLVS - Clovis Oncology, Inc.

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