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BiotecNOVA™ All That Matters

|About: AbbVie Inc. (ABBV), ABMD, AMGN, AMRN, AZN, BGNE, BIIB, BLUE, BMRN, BMY, GILD, ISRG, JNJ, LLY, MDT, MRK, NVS, PFE, REGN, RHHBY, SGEN, SRPT, VRTX, ABT
Summary

this has been the BIOTECH Decade.

10 years of phenomenal clinical success stories in many areas and that is “All That Matters".

And this year 2019 has been a great year for the entire biotech sector.

BiotecNOVA™ -All That Matters

I see that many think we have been in the TECH decade – with the success of Apple and Google and Amazon and Microsoft no wonder. Nevertheless, it is my view that this has been the BIOTECH Decade. There will be an explosion of biotech successes in 2020, but the biotech foundation was built these last 10 years. 10 years of phenomenal clinical success stories in many areas and that is “All That Matters”. And this year 2019 has been a great year for the entire biotech sector.  Just a few notable success stories are below; 

VENCLEXTA® (venetoclax tablets)

New Long-Term Data Continues to Demonstrate Progression-Free Survival and Overall Survival Benefits with VENCLEXTA®/ VENCLYXTO® (venetoclax) Combination in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

New Data Demonstrate the Continued Clinical Benefit of Fixed-duration, Chemotherapy-free Venclexta-based Treatments in Chronic Lymphocytic Leukemia

Advanced Prostate Cancer Treatment | XTANDI® (enzalutamide) Safety Info

Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA)

XTANDI® (enzalutamide) Approved by U.S. FDA for the Treatment of Metastatic Castration-Sensitive Prostate Cancer

https://www.vumerity.com/en_us/home.html

Biogen Presents Data Demonstrating Improved Gastrointestinal Tolerability With VUMERITY™ (diroximel fumarate) Compared to TECFIDERA® (dimethyl fumarate)

Biogen Presents Data Demonstrating Improved Gastrointestinal Tolerability With VUMERITY™ (diroximel fumarate) Compared to TECFIDERA® (dimethyl fumarate) | Biogen

Patient Resources & Information for IMBRUVICA® (ibrutinib)

VENCLEXTA® (venetoclax) Official HCP Site | Treatment for CLL/SLL

AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting

AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Data Show High Rates of Disease Clearance in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL)

REVLIMID® (lenalidomide) Plus rituximab for Patients with Previously Treated FL or MZL

REVLIMID® (lenalidomide) Treatment for Multiple Myeloma | Mantle Cell Lymphoma | Deletion 5q Myelodysplastic Syndromes

What is RITUXAN® (rituximab)

Celgene Receives CHMP Positive Opinion for REVLIMID® (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously Treated Follicular Lymphoma

Celgene Receives CHMP Positive Opinion for REVLIMID® (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously Treated Follicular Lymphoma

Bristol-Myers Squibb Receives European Commission Approval for Revlimid® (lenalidomide) in Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma

BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID® in Relapsed or Refractory Indolent Lymphoma

Merck's ERVEBO® [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Granted Conditional Approval in the European Union

Merck wins European approval for first-ever Ebola vaccine

Ebola vaccine approved in Europe, in landmark moment for global health

First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

Ebola health update - DRC, 2019

Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live)

KEYTRUDA® (pembrolizumab)

LENVIMA® (lenvatinib) capsules | HCP Website

FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Merck's R&D Journey

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)

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

Merck's KEYTRUDA® (pembrolizumab) Now Approved as Monotherapy in China for First-Line Treatment of Certain Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express PD-L1

FDA Approves LENVIMA® (lenvatinib) plus KEYTRUDA® (pembrolizumab) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma | News Release:2019 | Eisai Co., Ltd.

FDA Grants Priority Review to Merck's Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Study of Pembrolizumab (MK-3475) in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057) - Full Text View - ClinicalTrials.gov

FDA Approves KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma

Merck's KEYTRUDA® (pembrolizumab) Plus Chemotherapy Showed Statistically Significant Increase in Pathological Complete Response Versus Chemotherapy as Neoadjuvant Therapy in Early-Stage Triple-Negative Breast Cancer (TNBC)

Keytruda Approvals: A Timeline | BioSpace

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)

YERVOY®(ipilimumab) | Consumer | Gateway

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 who have...

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 who have...

Opdivo (nivolumab) Demonstrates Statistically Significant Overall Survival Benefit Versus Chemotherapy in Patients with Advanced Esophageal Cancer

Bristol-Myers Squibb Announces Pooled Five-Year Survival Results for Opdivo (nivolumab) in Previously-Treated Advanced Non-Small Cell Lung Cancer Patients

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

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

Bristol-Myers Squibb Announces Pooled Five-Year Survival Results for Opdivo (nivolumab) in Previously-Treated Advanced Non-Small Cell Lung Cancer Patients

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

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

Patient Information | BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib)

INLYTA® (axitinib) tablets | 2nd-Line mRCC Treatment | Safety Info

Home Page | IBRANCE® (palbociclib) Capsules | Safety Info

Metastatic Colorectal Cancer and Head & Neck Cancer Treatments | ERBITUX (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

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

Pfizer Oncology Press Kit

U.S. FDA Accepts and Grants Priority Review to sNDA for BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer After Prior Therapy

U.S. FDA Accepts and Grants Priority Review to sNDA for BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer After Prior Therapy

Patient Resources & Information for IMBRUVICA® (ibrutinib)

What is RITUXAN® (rituximab)

AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Metastatic Pancreatic Cancer

Search

https://seekingalpha.com/pr/17721323-extended-follow-up-phase-3-data-underscore-sustained-efficacy-and-safety-of-imbruvica

AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Blood Cancer Diffuse Large B-Cell Lymphoma (DLBCL) and Ongoing Ibrutinib Clinical Program

IMBRUVICA® (ibrutinib) Pooled Analysis Suggests Benefit in Progression-Free Survival (NYSE:PFS) at 3.5 Years in Patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL)

Small lymphocytic lymphoma

AbbVie Announces U.S. FDA Approval of IMBRUVICA® (ibrutinib) Plus Obinutuzumab (GAZYVA®) - First Chemotherapy-Free, Anti-CD20 Combination Regimen Approved for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) in Previously Untreated Patients

Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA Seeking Approval of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia

IMBRUVICA® (ibrutinib) Combination Regimen Significantly Improved Survival Versus the Chemoimmunotherapy FCR (Fludarabine, Cyclophosphamide and Rituximab) in Previously Untreated and Younger Chronic Lymphocytic Leukemia (CLL) Patients; Late-Breaking Phase 3 Data at ASH 2018

https://www.nejm.org/doi/full/10.1056/NEJMoa1817073

TECENTRIQ® (atezolizumab) Efficacy, Safety, Dosing & Prescribing Information

Avastin® (bevacizumab) Efficacy, Safety, Dosing & Prescribing Information

Genentech: Topics | Cancer Immunotherapy

Genentech Presents Pivotal Data Demonstrating Tecentriq in Combination With Avastin Improves Overall Survival in People With the Most Common Form of Liver Cancer

Genentech Presents Pivotal Data Demonstrating Tecentriq in Combination With Avastin Improves Overall Survival in People With the Most Common Form of Liver Cancer

Genentech's Tecentriq in Combination With Avastin Increased Overall Survival and Progression-free Survival in People With Unresectable Hepatocellular Carcinoma

Genentech's Tecentriq in Combination With Avastin Increased Overall Survival and Progression-free Survival in People With Unresectable Hepatocellular Carcinoma

Genentech: Press Releases | Monday, Sep 30, 2019

https://www.tecentriq-hcp.com/

Patient & Caregiver Website | ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)

Genentech: News Features | Genentech Medicine FDA Approved as First Cancer Immunotherapy for a Type of Breast Cancer

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

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

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

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

LYNPARZA® (olaparib) Approved in China as a First-Line Maintenance Therapy in BRCA-Mutated (BRCAm) Advanced Ovarian Cancer

LYNPARZA® (olaparib) Approved in China as a First-Line Maintenance Therapy in BRCA-Mutated (BRCAm) Advanced Ovarian Cancer

LYNPARZA® (olaparib) Recommended by FDA Advisory Committee for First-Line Maintenance Therapy in Germline BRCA-Mutated Metastatic Pancreatic Cancer That Has Not Progressed on Platinum-Based Chemotherapy

Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer

LYNPARZA® (olaparib) Recommended by FDA Advisory Committee for First-Line Maintenance Therapy in Germline BRCA-Mutated Metastatic Pancreatic Cancer That Has Not Progressed on Platinum-Based Chemotherapy

LYNPARZA (Olaparib) Approved in the US as a 1st-line Maintenance Treatment of Germline BRCA-mutated Metastatic Pancreatic Cancer

Treatment for CLL/SLL and MCL | CALQUENCE® (acalabrutinib)

Calquence data to show improved progression-free survival in Phase III front-line chronic lymphocytic leukaemia trial at ASH 2019 Annual Meeting

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

Calquence approved in the US for adult patients with chronic lymphocytic leukaemia

CALQUENCE significantly prolonged the time patients lived without disease progression or death in previously untreated chrnic lymphocytic leukemia

IMFINZI® (durvalumab)

AstraZeneca's Imfinzi extends progression-free survival in first-line lung cancer

Imfinzi granted FDA Priority Review for the treatment of patients with extensive-stage small cell lung cancer

Imfinzi and Imfinzi plus tremelimumab delayed disease progression in Phase III POSEIDON trial for 1st-line treatment of Stage IV non-small cell lung cancer

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

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

https://www.adcetris.com/

ADCETRIS® (brentuximab vedotin) | U.S. | Seattle Genetics

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

Seattle Genetics Announces Health Canada Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy in Frontline CD30-Expressing Peripheral T-Cell Lymphoma

Seattle Genetics Announces Progress in Expanding ADCETRIS® (Brentuximab Vedotin) Indications in Canada

ADCETRIS® (brentuximab vedotin) | U.S. | Seattle Genetics

Seattle Genetics, Inc. 2019 Q3 - Results - Earnings Call Presentation

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

Seattle Genetics and Takeda Announce Additional Analyses of ADCETRIS® (Brentuximab Vedotin) ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials at the 2019 ASH Annual Meeting

Seattle Genetics and Takeda Announce Additional Analyses of ADCETRIS® (Brentuximab Vedotin) ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials at the 2019 ASH Annual Meeting

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

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

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

Life With Cancer, Support & Resources | Lilly Oncology

Lilly Opens First Ever Randomized Phase 3 Clinical Trial in Treatment-Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

Lilly Opens Phase 3 Clinical Trial in RET-Mutant Medullary Thyroid Cancer | Eli Lilly and Company

Lilly Opens Phase 3 Clinical Trial in RET-Mutant Medullary Thyroid Cancer

Lilly launches late-stage study of LOXO-292 in medullary thyroid cancer

Homepage - Biogen

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

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

UsAgainstAlzheimer's Applauds Positive News on Alzheimer's Drug Aducanumab

A New Hope: Biogen's Aducanumab Headed To Regulators for Treating Alzheimer's Disease | BioSpace

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

221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease - Full Text View - ClinicalTrials.gov

Respectfully submitted to Seeking Alpha on December 31, 2019.  I am very grateful to all at Seeking Alpha for allowing these lengthy blogs on their site. 

I am 100% invested in biotech/medtech companies noted below; 

(MRK)(BMY)(JNJ)(AMGN)(GILD)(PFE)(AZN)(BGNE)(VRTX)(BMRN)(SGEN)(LLY)(NVS)(MDT)(ISRG)(ABBV)(ABT)(AMRN)(ABMD)(SRPT)(OTCQX:RHHBY)(BLUE)(BIIB)(REGN)(BIIB)(REGN)

seeking biotech alpha 12/31/2019 the heart of biotech™

seeking biotech alpha 12/31/2019 the heart of biotech™ 

seeking biotech alpha 12/31/2019 the heart of biotech™ 

  GLTA

Dan Watson

Colton Dixon - All That Matters (Lyric Video)

Colton Dixon - All That Matters (Lyric Video)

Disclosure: I am/we are long ABBV, BMY, PFE, MRK, LLY, AMRN, AZN, SGEN, BIIB, GILD, AMGN.