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BiotecHEART™-Breakthrough

|About: AbbVie Inc. (ABBV), ALPMY, BMY, CELG, JNJ, MRK, PFE, RHHBY, SGEN
Summary

There is no impossible.

2019, has been a breakthrough year for all who need medicine.

many clinical tests involving combinations of successful medicines.

many approvals this year in China for successful medicines.

BiotecHEART™-Breakthrough

There is no impossible. And in 2019 the impossible is being topped as the year will prove to be one of the most successful years for biotech & medtech companies, irrespective of the on-going www.biotech-wars.com . In fact, the last 3 months of 2019 will go down as one of the most prolific times for biotech medicines.

This year, 2019, has been a magnificent year for all who need medicine. 2019 has been a breakthrough year for many biotech companies and their pipeline/lifelines are prepared for another successful year in 2020 – www.biotecHeart.com

There is also continued increased interest in biotech buy-outs as more companies seek out partners in product development.

Sanofi : Sanofi to acquire Synthorx to bolster its immuno-oncology pipeline for $2.5 Billion

Merck to Acquire ArQule, Advancing Leadership in Oncology

And there have been many clinical tests involving combinations of successful medicines and in many cases the combinations are with another biotech partner’s medicine. One example is = IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Data Show High Rates of Disease Clearance in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL) (ABBV) (JNJ) (OTCQX:RHHBY)

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

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

Patient Resources & Information for IMBRUVICA® (ibrutinib)

Another example is = Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer (OTCQX:RHHBY) (CELG)

FDA Approves Genentech's Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

Another example is = Seattle Genetics and Astellas Announce Clinical Trial Collaboration with Merck to Evaluate Enfortumab Vedotin in Combination with KEYTRUDA® (pembrolizumab) in Patients with Metastatic Urothelial Cancer

Mon December 2, 2019 8:00 AM|Business Wire|About: OTCPK:ALPMY, SGEN (MRK)

Seattle Genetics and Astellas Announce Clinical Trial Collaboration with Merck to Evaluate Enfortumab Vedotin in Combination with KEYTRUDA® (pembrolizumab) in Patients with Metastatic Urothelial Cancer

Merk & AstraZeneca continue to work together with their successful med =  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

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

here is another on 12/7/2019 

= Seattle Genetics Announces Updated Data of ADCETRIS® (Brentuximab Vedotin) in Combination with OPDIVO® (Nivolumab) in Frontline and Relapsed or Refractory Hodgkin Lymphoma at ASH Annual Meeting

Sat December 7, 2019 2:00 PM|Business Wire|About: SGEN (BMY)

Seattle Genetics Announces Updated Data of ADCETRIS® (Brentuximab Vedotin) in Combination with OPDIVO® (Nivolumab) in Frontline and Relapsed or Refractory Hodgkin Lymphoma at ASH Annual Meeting

https://www.adcetris.com/

11/11/2019 Single's Day/Veterans Day 

The most fascinating perspective on all this good biotech news is that it goes largely unnoticed, unless you’re a biotech investor like me or work within the biotech sector, much of this good news is rarely broadcast to a larger investing audience or potential user audience. So much business news broadcast time is devoted to Apple, Google, Facebook, Tesla, Netflix, Amazon, and Microsoft, that there is little time left to broadcast much of this great news. I’ve even heard comments by TV business news analyst’s that the healthcare sector will do well because lots of people are getting older? I guess they think the extraordinary clinical testing successes by so many biotech companies are an anomaly, they are not.

Basically, business news channels and business media sometimes bypass major biotech news almost every day as they did on 11/11/2019, Singles Day/Veterans Day depending on where you live. Regardless, Merck offered wonderful news that same day, for a product that will over time save many lives, many lives in Africa for sure, with little to no mention in the broadcast business news media. There was plenty of news and stories that day on Alibaba sales but nothing on Merck’s (MRK) press release that day? Info on many of these successful products are here = www.biotecNOVA.com

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

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

Remarkably, the success of Merck's KEYTRUDA® (pembrolizumab)  also goes largely unnoticed, even though Keytruda success stories and new indications come almost every week and Keytruda has become one of the best-selling drugs in the world 

Keytruda Approvals: A Timeline | BioSpace

 December 2019 to date has had significant positive and encouraging biotech news, a few noteworthy news posts are below;

Sesen Bio Initiates Rolling Submission of BLA for Vicinium to FDA

BeiGene Announces Clinical Data on BRUKINSA™ (Zanubrutinib) at the 61st American Society of Hematology (NYSE:ASH) Annual Meeting

Bristol-Myers Squibb Announces Studies Evaluating liso-cel in Multiple Additional Patient Populations, Site of Care and Disease Areas Presented at American Society of Hematology (ASH) Annual Meeting

Lilly Presents Interim Clinical Data from LOXO-305 Dose Escalation Trial in B-Cell Leukemias and Lymphomas at the American Society Hematology Annual Meeting

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)

Genentech: Press Releases | Sunday, Dec 8, 2019

Johnson & Johnson Announces Commitment to Support Republic of Rwanda's Preparedness Against Ebola Outbreak

First Clinical Data for REGN5458 (BCMAxCD3) Show Positive Preliminary Results in Multiple Myeloma | Regeneron Pharmaceuticals Inc.

Janssen Announces BCMA CAR-T Therapy JNJ-4528 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma

Findings Released from Real-World Data Analysis of Eliquis (apixaban) for the Treatment of Venous Thromboembolism in Patients with Active Cancer

Findings Released from Real-World Data Analysis of Eliquis (apixaban) for the Treatment of Venous Thromboembolism in Patients with Active Cancer

XBiotech out-licenses anti-inflammatory antibody to Janssen for up to $1.35B

Takeda to Present Results from the Phase 3 TOURMALINE-AL1 Trial of NINLARO in Patients with Amyloidosis

Takeda to Present Results from the Phase 3 TOURMALINE-AL1 Trial of NINLARO in Patients with Amyloidosis

Kite Announces Long-term Data From ZUMA-1 Showing Approximately Half of Refractory Large B-cell Lymphoma Patients Were Alive Three Years After Yescarta Treatment

Mallinckrodt Presents Data on a Novel Predictive Model to Identify Infants at Risk for Infantile Spasms (IS) at the 2019 Annual Meeting of the American Epilepsy Society (NYSE:AES)

Bristol-Myers Squibb Announces Liso-Cel Met Primary and Secondary Endpoints in TRANSCEND NHL 001 Study

bluebird bio Presents New Data from Ongoing Phase 1/2 HGB-206 Study of LentiGlobin™ Gene Therapy for Sickle Cell Disease (NYSE:SCD) at 61st ASH Annual Meeting and Exposition

Seattle Genetics Announces Updated Data of ADCETRIS® (Brentuximab Vedotin) in Combination with OPDIVO® (Nivolumab) in Frontline and Relapsed or Refractory Hodgkin Lymphoma at ASH Annual Meeting

Seattle Genetics Announces Updated Data of ADCETRIS® (Brentuximab Vedotin) in Combination with OPDIVO® (Nivolumab) in Frontline and Relapsed or Refractory Hodgkin Lymphoma at ASH Annual Meeting

More than Seven-Year Analysis of Early Treatment with IMBRUVICA® (ibrutinib) Monotherapy Showed Improved Progression-Free Survival in Patients with Mantle Cell Lymphoma (MCL) that Relapsed or Were Unresponsive to Prior Regimen

More than Seven-Year Analysis of Early Treatment with IMBRUVICA® (ibrutinib) Monotherapy Showed Improved Progression-Free Survival in Patients with Mantle Cell Lymphoma (MCL) that Relapsed or Were Unresponsive to Prior Regimen

Bristol-Myers Squibb Announces Liso-Cel Met Primary and Secondary Endpoints in TRANSCEND NHL 001 Study

Xenon Pharmaceuticals Provides Updates on Partnered Neurology Pipeline Programs at the 2019 American Epilepsy Society (AES) Annual Meeting

Xenon Pharma

Oncology

Extended Follow-up Phase 3 Data Underscore Sustained Efficacy and Safety of IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL)

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

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

CALQUENCE Significantly Prolonged the Time Patients Lived Without Disease Progression or Death in Previously Untreated Chronic Lymphocytic Leukemia

Bristol-Myers Squibb and bluebird bio Announce Positive Top-line Results from the Pivotal Phase 2 KarMMa Study of Ide-cel in Relapsed and Refractory Multiple Myeloma

Janssen Announces BCMA CAR-T Therapy JNJ-4528 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma

FDA Approves Amgen's AVSOLA™ (infliximab-axxq), For The Same Indications As Remicade® (infliximab)

Bristol-Myers Squibb and Acceleron Pharma Provide Update on FDA Advisory Committee for Reblozyl® (luspatercept-aamt)

https://www.novartis.com/sites/www.novartis.com/files/2019-12-05-novartis-r-d-day-investor-presentation.pdf

Novartis expects to sustain long-term growth with a robust pipeline of 25+ potential blockbusters highlighted at R&D Day

Intercept Announces Publication of Results from the Interim Analysis of the Phase 3 REGENERATE Study of OCA for the Treatment of Fibrosis Due to NASH in The Lancet

Novartis developing 25+ blockbusters - R&D Day

AbbVie reaches an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for SKYRIZI™ (risankizumab) for the Treatment of Moderate to Severe Plaque Psoriasis

ACADIA Pharmaceuticals Presents Positive Top-line Results from Pivotal Phase 3 HARMONY Trial of Pimavanserin in Patients with Dementia-Related Psychosis at 12th Clinical Trials on Alzheimer's Disease (CTAD) Meeting

Biogen's aducanumab showed mixed results in Alzheimer's studies

FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria

FDA OKs new MRSA test from Roche

Bayer enters into collaboration with Children's Hospital of Philadelphia to research novel small molecule therapies for the oral treatment of hemophilia

http://www.pharmexec.com/pd-1-race-china-heats

Takeda and Enzyre to Develop Diagnostic Device Allowing Hemophilia Patients to Determine their Coagulation Status at Home

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

Regeneron Announces Positive Topline Phase 2 Data with Anti-C5 Antibody Pozelimab in Patients with a Rare Blood Disorder

Sesen +9.2% after successful pre-BLA FDA meeting

Allergan Announces Positive Phase 3 ACHIEVE I Trial Results for Ubrogepant Published in The New England Journal of Medicine

https://www.nejm.org/doi/full/10.1056/NEJMoa1813049

Sesen Bio Completes Successful CMC Type B pre-BLA Meeting with FDA

 Biotech & China in 2019

And I am seeing more than ever before many approvals this year in China for successful medicines, all of these meds will be eagerly sought after = LYNPARZA® (olaparib) Approved in China as a First-Line Maintenance Therapy in BRCA-Mutated (BRCAm) Advanced Ovarian Cancer Thu December 5, 2019 6:45 AM|Business Wire|About: MRK

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

Merck’s KEYTRUDA® (pembrolizumab) Now Approved in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in Combination with Chemotherapy Tue November 26, 2019 6:45 AM|Business Wire|About: MRK

Merck's KEYTRUDA® (pembrolizumab) Now Approved in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in Combination with Chemotherapy

Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA) Mon November 25, 2019 7:00 PM|PR Newswire|About: OTCPK:ALPMY, PFE

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

This year so much wonderful and supportive medicines are being introduced that 2019 will no doubt match or exceed last year’s successful biotech products development gains.

Mack Brock - God Of Breakthrough (Acoustic Video)

Respectfully submitted to Seeking Alpha on December 9. 2019

As of December 9, 2019, I remain 100% invested in biotech/medtech companies.

thank you for visiting the heart of biotech™

it’s biotech or nothin’!™

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Disclosure: I am/we are long ABBV, AZN, AMGN, BMY, PFE, MRK, LLY, CELG, SGEN, RHHBY, NVS.