MERCK

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 European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and platinum chemotherapy for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults whose tumors have no EGFR or ALK positive mutations.  


KEYTRUDA, the company’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and platinum chemotherapy
image30

Selumetinib Granted Orphan Designation in Europe for Neurofibromatosis Type 1

selumetinib, a MEK 1/2 inhibitor

KEYTRUDA® (pembrolizumab)

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Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Improved Overall Survival as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma at Final Analysis of Pivotal Phase 3 KEYNOTE-048 Trial

Survival Benefit Now Observed with KEYTRUDA in Combination with Chemotherapy in All Patient Populations (Regardless of PD-L1 Expression) and with KEYTRUDA Monotherapy in Patients Whose Tumors Expressed PD-L1 at CPS ≥1

Data Presented Today at 2019 ASCO Annual Meeting

Friday, May 31, 2019 6:45 am EDT 

KEYTRUDA®
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Eisai and Merck Announce FDA Grants Breakthrough Therapy Designation for LENVIMA® (lenvatinib) in Combination with KEYTRUDA® (pembrolizumab) as Therapy for Previously Treated Patients with Advanced and/or Metastatic non-MSI-H/pMMR Endometrial Carcinoma 

LENVIMA®
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KEYTRUDA® (pembrolizumab) Monotherapy Met a Primary Endpoint in the Phase 3 KEYNOTE-048 Trial, Significantly Improving OS as First-Line Therapy in Head and Neck Squamous Cell Carcinoma Patients Whose Tumors Expressed PD-L1 (CPS ≥20) 

KEYTRUDA®
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Merck's doravirine shows treatment effect in late-stage HIV study

non-nucleoside reverse transcriptase inhibitor doravirine

Lilly

Taltz® (ixekizumab)

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Lilly to Present 5-Year Sustained Efficacy and Safety Results for Taltz® (ixekizumab) in Patients with Plaque Psoriasis at the World Congress of Dermatology

Tue June 11, 2019 3:00 AM|PR Newswire|About: LLY

INDIANAPOLIS, June 11, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY

INDIANAPOLIS, June 11, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) Lilly to Present 5-Year Sustained Efficacy and Safety Results for Taltz® (ixekizumab) in Patients with Plaque Psoriasis at the World Congress of Dermatology NEWS PROVIDED BY Eli Lilly and Company Jun 11, 2019, 03:00 ET

mirikizumab

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Lilly's Mirikizumab Met Primary Endpoint and Key Secondary Endpoints in Phase 2 Study, Including Reductions of Gastrointestinal Lesions

05/21/2019Download PDFThe safety and efficacy data from the induction period of the Phase 2 trial encourage Lilly to initiate a Phase 3 trial for mirikizumab for the treatment of Crohn's disease later this year

INDIANAPOLIS, May 21, 2019 /PRNewswire/ 

Lilly's Mirikizumab Met Primary Endpoint and Key Secondary Endpoints in Phase 2 Study, Including Reductions of Gastrointestinal Lesions The safety and efficacy data from the induction period of the Phase 2 trial encourage Lilly to initiate a Phase 3 trial for mirikizumab for the treatment of Crohn's disease later this year NEWS PROVIDED BY Eli Lilly & Company May 21, 2019, 13:15 ET INDIANAPOLIS, May 21, 2019 /PRNewswire/

investigational dual GIP and GLP-1 receptor agonist (RA), tirzepatide

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Lilly's tirzepatide demonstrates benefits in data presented at the American Diabetes Association's® 79ᵗʰ Scientific Sessions®

 

NEWS PROVIDED BY

Eli Lilly and Company 

Jun 08, 2019, 20:30 ET

 INDIANAPOLIS, June 8, 2019 /PRNewswire/ -- Results from several studies of Eli Lilly and Company's (NYSE: LLY)  

Lilly's tirzepatide demonstrates benefits in data presented at the American Diabetes Association's® 79ᵗʰ Scientific Sessions® Sat June 8, 2019 8:30 PM|PR Newswire|About: LLY INDIANAPOLIS, June 8, 2019 /PRNewswire/

Emgality® (galcanezumab-gnlm)

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 INDIANAPOLIS, June 4, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)  FDA Approves Emgality® (galcanezumab-gnlm) as the First and Only Medication for the Treatment of Episodic Cluster Headache that Reduces the Frequency of Attacks

-With this approval, Emgality is the only calcitonin gene-related peptide (CGRP) antibody indicated for the preventive treatment of migraine and the treatment of episodic cluster headache[1]

 

NEWS PROVIDED BY

Eli Lilly and Company 

Jun 04, 2019, 21:01 ET


 https://www.emgality.com/  


 https://seekingalpha.com/pr/17534670-fda-approves-emgality-galcanezumab-gnlm-first-medication-treatment-episodic-cluster-headache 

FDA Approves Emgality® (galcanezumab-gnlm) as the First and Only Medication for the Treatment of Episodic Cluster Headache that Reduces the Frequency of Attacks 06/04/2019 With this approval, Emgality is the only calcitonin gene-related peptide (CGRP) antibody indicated for the preventive treatment of migraine and the treatment of episodic cluster headache[1] INDIANAPOLIS, June 4, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

CYRAMZA® (ramucirumab)

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Lilly's CYRAMZA® (ramucirumab) Becomes First FDA-Approved Biomarker-Driven Therapy in Patients with Hepatocellular Carcinoma

05/13/2019 

 This new indication - the fifth FDA approval for CYRAMZA in an advanced or metastatic cancer - is for the second-line treatment of patients with hepatocellular carcinoma (HCC) who are AFP-High (AFP ≥400 ng/mL)
Approximately forty percent of all patients with advanced HCC are AFP-High and are a patient population that can have more aggressive disease and a poorer prognosis
Concurrent with this approval, the FDA has also removed the boxed warning from the CYRAMZA labeling

INDIANAPOLIS, May 13, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

Lilly's CYRAMZA® (ramucirumab) Becomes First FDA-Approved Biomarker-Driven Therapy in Patients with Hepatocellular Carcinoma NEWS PROVIDED BY Eli Lilly and Company May 13, 2019, 06:45 ET

Jardiance® (empagliflozin)

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New analysis shows cardiorenal risk reductions of Jardiance® are consistent in adults with type 2 diabetes, cardiovascular disease and kidney disease without overt proteinuria

Mon June 10, 2019 1:00 PM|PR Newswire|About: LLYPR Newswire

RIDGEFIELD, Conn. and INDIANAPOLIS, June 10, 2019 /PRNewswire/


 https://www.jardiance.com/ 

New analysis shows cardiorenal risk reductions of Jardiance® are consistent in adults with type 2 diabetes, cardiovascular disease and kidney disease without overt proteinuria - Findings from an EMPA-REG OUTCOME® post-hoc analysis of adults with chronic kidney disease without overt proteinuria presented at American Diabetes Association's 79th Scientific Sessions® NEWS PROVIDED BY Eli Lilly and Company Jun 10, 2019, 13:00 ET

Pfizer

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 U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)

XTANDI® (enzalutamide)
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PFIZER AND LILLY ANNOUNCE POSITIVE TOP-LINE RESULTS FROM PHASE 3 TRIAL OF TANEZUMAB FOR THE TREATMENT OF OSTEOARTHRITIS (OA) PAIN

Tanezumab is the first NGF inhibitor to receive Fast Track designation
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 XELJANZ® (tofacitinib citrate) Receives Marketing Authorization in the European Union for Moderately to Severely Active Ulcerative Colitis 

XELJANZ® (tofacitinib citrate)
image45

 Pfizer’s XALKORI® (crizotinib) Receives FDA Breakthrough Therapy Designation in Two New Indications 

XALKORI® (crizotinib)

Bristol-Myers Squibb

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 U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma 

Empliciti® (elotuzumab)
image48

 European Commission Approves Bristol-Myers Squibb’s Opdivo (nivolumab) for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease Who Have Undergone Complete Resection 

Opdivo® (nivolumab)
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 Bristol-Myers Squibb’s Opdivo® (nivolumab) + Low-Dose Yervoy® (ipilimumab) is the First Immuno-Oncology Combination Approved for MSI-H/dMMR mCRC Patients Who Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin and Irinotecan 

Yervoy® (ipilimumab)
image50

 U.S. Food and Drug Administration (FDA) Accepts Application for Opdivo Plus Low-Dose Yervoy for Treatment of First-Line Non-Small Cell Lung Cancer in Patients with Tumor Mutational Burden ≥10 mut/Mb 

Opdivo® Plus Low-Dose Yervoy®
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 Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) for the Adjuvant Treatment of Adult Patients with Melanoma 

Opdivo®
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 China National Drug Administration Approves Country’s First Immuno-Oncology Agent, Opdivo (nivolumab injection), for Previously Treated Non-Small Cell Lung Cancer (NSCLC) 

Opdivo® (nivolumab injection)

Amgen

BiTE® Immuno-Oncology Platform

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 Amgen Highlights the Versatility of the BiTE® Immuno-Oncology Platform in Multiple Tumour Types at ASCO 2019

Wed June 5, 2019 7:00 AM|Canada Newswire|About: AMGN 


 

Updated Phase 1 Data of Investigational AMG 420 in Relapsed and/or Refractory Multiple Myeloma Highlighted in Oral Presentation and Accepted for Best of ASCO®

Investigational AMG 212 (Pasotuxizumab) Phase 1 Study Explores Use of BiTE Platform in a Solid Tumour

MISSISSAUGA, ON, June 5, 2019 /CNW/ - Amgen (AMGN)

About BiTE® Technology BiTE® (Bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patients' own T cells to any tumour-specific antigen, activating the cytotoxic potential of T cells with the goal of eliminating detectable cancer. AmgenTrials.com is dedicated to bringing information about Amgen's clinical trials to patients and healthcare communities.
image54

 FDA Approves Aimovig™ (erenumab-aooe), A Novel Treatment Developed Specifically For Migraine Prevention 

Aimovig™ (erenumab-aooe)
image55

 European Commission Approves Prolia® (denosumab) for Patients With Glucocorticoid-Induced Osteoporosis 

Prolia® (denosumab)

AMG 510, the first KRASG12C inhibitor

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AMG 510 is the First KRASG12C Inhibitor to Reach Clinical Stage After Three Decades of RAS Research

First-In-Human Results Show Preliminary Safety, Tolerability Data and Anti-Tumor Activity in KRAS Mutant Solid Tumors

FDA Grants AMG 510 Orphan Drug Designation for KRASG12C-Positive Non-Small Cell Lung and Colorectal Cancers

THOUSAND OAKS, Calif., June 3, 2019 /PRNewswire/ -- Amgen (NASDAQ: AMGN) Amgen Announces First Clinical Data Evaluating Novel Investigational KRASG12C Inhibitor AMG 510 At ASCO 2019

 

NEWS PROVIDED BY

Amgen 

Jun 03, 2019, 09:00 ET


Amgen Announces First Clinical Data Evaluating Investigational KRAS(G12C) inhibitor AMG 510 at ASCO 2019 Wed June 5, 2019 7:00 AM|Canada Newswire|About: AMGN AMG 510 is the First KRASG12C Inhibitor to Reach Clinical Stage After Three Decades of RAS Research First-In-Human Results Show Preliminary Data and Anti-Tumour Activity in KRAS Mutant Solid Tumours MISSISSAUGA, ON, June 5, 2019 /CNW/ - Amgen (AMGN)
image57

 Neulasta is used to reduce the risk of infection during chemotherapy treatment. 

Neulasta®, (Pegfilgrastim)
image58

 FDA Panel Recommends Enbrel for Pediatric Patients

ENBREL® (etanercept)

AstraZeneca

image59

 Lokelma approved in the US for the treatment of adults with hyperkalaemia 

Lokelma (sodium zirconium cyclosilicate), formerly ZS-9

trastuzumab deruxtecan (DS-8201)

image60

 Trastuzumab deruxtecan demonstrated clinically-meaningful response in patients with refractory HER2-positive metastatic breast cancer, a population with high unmet need 

Daiichi Sankyo Confirms Plans to Accelerate BLA Submission to U.S. FDA for [Fam-] Trastuzumab Deruxtecan (DS-8201) in HER2 Positive Metastatic Breast Cancer Post T-DM Tokyo, Munich, and Basking Ridge, NJ – (March 28, 2019) – Daiichi Sankyo Company, Limited

Calquence (acalabrutinib)

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Calquence Phase III ELEVATE-TN trial met primary endpoint at interim analysis in previously-untreated chronic lymphocytic leukaemia

  • PUBLISHED6 June 2019
  • 06 June 2019 07:00 GMT
  • Calquence alone or in combination significantly increased
    the time patients lived without disease progression

 https://seekingalpha.com/news/3469459-astrazenecas-calquence-successful-2nd-pivotal-cll-study-shares-1-percent-premarket 


 Jun. 6, 2019 7:28 AM ET|About: AstraZeneca PLC (AZN) 

CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.
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 IMFINZI® (Durvalumab) Significantly Improves Overall Survival in the Phase III Pacific Trial for Unresectable Stage III Non-Small Cell Lung Cancer 

IMFINZI® (Durvalumab)
image63

 Lynparza significantly delays disease progression in Phase III 1st-line SOLO-1 trial for ovarian cancer 

Lynparza™(olaparib) tablets
image64

 Bydureon receives positive EU CHMP opinion for new BCise device for patients with type-2 diabetes 

Bydureon® (2mg prolonged-release suspension for injection)

Gilead

image65

 European CHMP Adopts Positive Opinion for Yescarta® (axicabtagene ciloleucel) for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy 

Yescarta® (axicabtagene ciloleucel)
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China National Drug Administration Approves Gilead’s Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), a Single Tablet Regimen for the Treatment of HIV-1 Infection

Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide)
image67

 European Commission Grants Marketing Authorization for Gilead’s Biktarvy®(Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection 

Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide)

KTE-X19, an investigational CD19 chimeric antigen receptor T (CAR T) cell therapy

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Kite Announces End of Phase 1 ZUMA-3 Results for KTE-X19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia

-- Data Show High Rates of Response to Single Infusion of KTE-X19 --

-- Phase 2 Portion of ZUMA-3 is Ongoing and Includes Dosing and Revised Safety Management Protocol Studied in Phase 1 --

 CHICAGO--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD) 

Kite Announces End of Phase 1 ZUMA-3 Results for KTE-X19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia Sat June 1, 2019 6:00 PM|Business Wire|About: GILD
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Gilead, Galapagos hit goal in psoriatic arthritis phase 2 -

​Gilead and Galapagos disclosed the data alongside news that filgotinib has cleared a phase 2b futility analysis in ulcerative colitis. (Gilead China)

filgotinib
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 Gilead Sciences: Still My Top Biotech Pick For The Next Decade

the company is sitting billions of dollars.

Celgene

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 Celgene Announces Phase III ‘AUGMENT’ Study of REVLIMID® in Combination with Rituximab (R²) for the Treatment of Patients with Relapsed/Refractory Indolent Lymphoma Met Primary Endpoint 

REVLIMID® in Combination with Rituximab (R²)
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 Anti-PD-L1 Immunotherapy Plus ABRAXANE® Significantly Reduced the Risk of Disease Worsening or Death in Patients with Metastatic or Locally Advanced Triple Negative Breast Cancer in Phase III IMpassion130 Study

ABRAXANE®
image73

 Celgene and Acceleron Announce Luspatercept Achieved Primary and Key Secondary Endpoints in Phase III ‘MEDALIST’ Study in Patients with Low-to-Intermediate Risk Myelodysplastic Syndromes 

Luspatercept
image74

 Celgene Announces Updated Safety and Efficacy Data from the TRANSCEND Trial of liso-cel (JCAR017) in Patients with Relapsed or Refractory B-cell non-Hodgkin Lymphoma at ASCO 

lisocabtagene maraleucel (liso-cel; JCAR017), an investigational CD19-directed CAR T cell therapy
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 Bluebird bio and Celgene Corporation Enter into Agreement to Co-Develop and Co-Promote Anti-BCMA CAR T Cell Therapy bb2121 in the United States

Co-Develop and Co-Promote Anti-BCMA CAR T Cell Therapy bb2121 in the United States

POMALYST® (pomalidomide)

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Celgene Corporation Announces POMALYST® Granted Breakthrough Therapy Designation from FDA for HIV-Positive and Negative Kaposi Sarcoma

May 13, 2019

Celgene plans to submit sNDA by end of 2019

Celgene plans additional studies with the AIDS Malignancy Consortium in U.S. and sub-Saharan Africa

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG)

Celgene Corporation Announces POMALYST® Granted Breakthrough Therapy Designation from FDA for HIV-Positive and Negative Kaposi Sarcoma Celgene plans to submit sNDA by end of 2019 Celgene plans additional studies with the AIDS Malignancy Consortium in U.S. and sub-Saharan Africa May 13, 2019 07:30 AM Eastern Daylight Time SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG

abbvie

image77

 AbbVie's elagolix shows positive effect in late-stage extension study in uterine fibroids

ORILISSA™ (elagolix)
image78

 IMBRUVICA® (ibrutinib) Plus GAZYVA® (obinutuzumab) Phase 3 iLLUMINATE Trial for First-Line Therapy of Chronic Lymphocytic Leukemia (CLL) Patients Met Primary Endpoint

IMBRUVICA® (ibrutinib) Plus GAZYVA® (obinutuzumab)

VENCLEXTA® (venetoclax) in combination with rituximab

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AbbVie Receives Positive Recommendation from the pan-Canadian Oncology Drug Review Expert Review Committee for the Combination VENCLEXTA® With Rituximab as a Treatment for Patients With Chronic Lymphocytic Leukemia

Thu June 6, 2019 9:00 AM|Canada Newswire|About: ABBV 

How does VENCLEXTA® + rituximab work?
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 AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Blood Cancer Diffuse Large B-Cell Lymphoma (DLBCL) and Ongoing Ibrutinib Clinical Program 

Ibrutinib (IMBRUVICA®)

HUMIRA® (adalimumab)

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AbbVie Resolves HUMIRA® (adalimumab) U.S. Patent Litigation with Boehringer Ingelheim

Tue May 14, 2019 8:34 AM|PR Newswire|About: ABBV

NORTH CHICAGO, Ill., May 14, 2019 /PRNewswire/ -- AbbVie (ABBV) n

NORTH CHICAGO, Ill., May 14, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV) May 14, 2019 AbbVie Resolves HUMIRA® (adalimumab) U.S. Patent Litigation with Boehringer Ingelheim
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 AbbVie Announces Submission of Supplemental New Drug Application to US FDA for Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

venetoclax in combination with an HMA (azacitidine or decitabine), and M14-387, a Phase 1/2 trial of venetoclax in combination with LDAC.

Johnson & Johnson

image83

 Janssen Submits U.S. & EU Regulatory Applications Seeking Approval of DARZALEX® (daratumumab) Split Dosing Regimen 

DARZALEX® (daratumumab)
image84

New Real-World Study Finds Long-Term XARELTO® (rivaroxaban) Use Resulted in Fewer Strokes and Systemic Emboli Compared to Warfarin in Frail Patients with Non-Valvular Atrial Fibrillation 

XARELTO® (rivaroxaban)
image85

 Johnson & Johnson enlists diabetes veteran Merck KGaA to market Invokana in China 

Invokana™

UPTRAVI® (selexipag)

image86

 

New Post-hoc Analysis Shows Adding UPTRAVI® (selexipag) Versus Placebo Improved Long-Term Clinical Outcomes Regardless of Time of Treatment Initiation, and Demonstrated an Even More Pronounced Treatment Effect When Initiated Early

Actelion presents latest post-hoc analysis from the GRIPHON study - the largest randomized, controlled, outcome trial ever conducted in patients with pulmonary arterial hypertension (PAH)

 ALLSCHWIL, Switzerland, May 20, 2019 /PRNewswire/ -- Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson 

UPTRAVI® (selexipag) is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1), which is high blood pressure in the arteries of your lungs. UPTRAVI can help delay (slow down) the progression of your disease and lower your risk of being hospitalized for PAH.
image87

 Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression

esketamine nasal spray
image88

 Janssen Announces U.S. FDA Breakthrough Therapy Designation for Erdafitinib in the Treatment of Metastatic Urothelial Cancer 

Erdafitinib, an oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor

BeiGene

image89

 BeiGene Initiates New Phase 3 Trial of Anti-PD-1 Antibody Tislelizumab Combined with Chemotherapy as First-line Treatment for Patients with Advanced Squamous Non-Small Cell Lung Cancer in China

Tislelizumab (BGB-A317)
image90

 BeiGene Announces Plan to Pursue Accelerated Approval in the U.S. of BTK Inhibitor Zanubrutinib in Waldenström Macroglobulinemia (WM) 

BTK Inhibitor Zanubrutinib
image91

 BeiGene Announces Preliminary Topline Results of Pivotal Trial in China for Anti-PD-1 Antibody Tislelizumab in Hodgkin’s Lymphoma 

Tislelizumab (BGB-A317), a PD-1 inhibitor,
image92

 BeiGene's NDA for anti-pd-1 antibody tislelizumab in hodgkin’s lymphoma accepted in China

tislelizumab, an investigational anti-PD-1 antibody
image93

 BeiGene's first NDA for zanubrutinib approved in China for the treatment of relapsed/refractory MCL

zanubrutinib, an investigational Bruton's tyrosine kinase (BTK) inhibitor,
image94

 BeiGene Announces Approval of REVLIMID® for Newly Diagnosed Multiple Myeloma in China 

REVLIMID® (lenalidomide) is currently marketed in China by BeiGene under an exclusive license from Celgene Corporation.

Novartis

image95

Novartis Kisqali® now first and only CDK4/6 inhibitor indicated in US as first-line therapy specifically for premenopausal women; and as initial therapy with fulvestrant in postmenopausal women

KISQALI® (ribociclib)
image96

 FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients

GILENYA™ is a sphingosine 1-phosphate receptor modulator
image97

 FDA expedites review of Novartis drug Promacta® for first-line severe aplastic anemia (SAA)

PROMACTA® is a thrombopoietin receptor
image98

 Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah® (tisagenlecleucel)

Kymriah® (tisagenlecleucel)

Gilenya® (fingolimod)

image99

Novartis announces EU approval of Gilenya® for children and adolescents with MS, making it the first and only oral disease-modifying treatment for these patients in Europe

 Basel, November 29, 2018  

Novartis today announced that the European Commission (EC) has approved Gilenya® (fingolimod) for the treatment of children and adolescents 10 to 17 years old with relapsing-remitting forms of multiple sclerosis (RRMS).

Tafinlar® + Mekinist®

image100

Long-term survival benefit shown for metastatic melanoma patients treated with Novartis Tafinlar® + Mekinist®

Jun 04, 2019

  • Five-year Tafinlar + Mekinist survival data presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in The New England Journal of Medicine
     
  • Results are from the largest dataset and longest follow-up of more than 500 patients with BRAF-mutated metastatic melanoma, a genetic mutation common for this aggressive skin cancer 

 Basel, June 4, 2019 

Long-term Survival Benefit Shown for Metastatic Melanoma Patients Treated with Novartis Tafinlar® + Mekinist® Tue June 4, 2019 1:03 PM|PR Newswire|About: NVS PR Newswire BASEL, Switzerland, June 4, 2019 /PRNewswire/

Biogen

image101

 Biogen and Eisai's BAN2401 shows positive effect in mid-stage Alzheimer's study

BAN2401 (Aβ mAb) Alzheimer’s disease
image102

 SAMSUNG BIOEPIS AND BIOGEN ANNOUNCE POOLED ANALYSIS RESULTS OF ANTI-TNF BIOSIMILARS BENEPALI™ (ETANERCEPT), FLIXABI™ (INFLIXIMAB), AND IMRALDI™ (ADALIMUMAB) AT EULAR 2018 

three anti-tumor necrosis factor (anti-TNF) biosimilars – BENEPALI™ (SB4, etanercept biosimilar), FLIXABI™ (SB2, infliximab biosimilar), and IMRALDI™ (SB5, adalimumab biosimilar)
image104

 In a partnership with Japanese pharmaceutical company Eisai Co. Ltd. (TSE:4523), the Cambridge, Massachusetts-based biotech company treated 856 patients who had early-stage Alzheimer’s disease with varying dosages of BAN2401. 

BAN2401 is an anti-amyloid beta protofibril antibody

Roche

image107

 FDA Grants Breakthrough Therapy Designation for Genentech’s TECENTRIQ in Combination With Avastin as First-Line Treatment for Advanced or Metastatic Hepatocellular Carcinoma (HCC)

Avastin® (bevacizumab) is a tumor-starving (anti-angiogenic) therapy
image108

 Roche reveals that TECENTRIQ in combination with Celgene's Abraxane improves progression-free survival in patients with front-line metastatic triple-negative breast cancer. 

TECENTRIQ® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel])
image110

 Roche's antiviral balovavir marboxil successful in late-stage study

Baloxavir marboxil – an investigational oral, single-dose antiviral
image111

 Genentech Announces Submission of Supplemental New Drug Application for Venclexta for People With Previously Untreated Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Venclexta® (venetoclax), in combination with a hypomethylating agent or in combination with low dose cytarabine (LDAC

Gazyva (Obinutuzumab)

image112

Genentech’s Gazyva (Obinutuzumab) Delivers Positive Topline Results for Phase II Lupus Nephritis Study

Tue June 11, 2019 1:00 AM|Business Wire|About: RHHBY

  • NOBILITY showed that Gazyva helped more patients achieve a complete renal response when added to standard of care
  • The Phase II study met both primary and key secondary endpoints
  • There are currently no FDA-approved therapies for lupus nephritis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)


 https://www.businesswire.com/news/home/20190610005836/en/ 

GAZYVA® (obinutuzumab) is a prescription medicine used in combination with chemotherapy, followed by GAZYVA alone in those who responded, to treat stage II bulky, III or IV follicular lymphoma (FL) in adults who have not had previous FL treatment. GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, bendamustine, followed by GAZYVA alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment. GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.

Vertex

image113

 Sep 6, 2018

Vertex Completes Enrollment of Two Phase 3 Studies of VX-659 in Triple Combination with Tezacaftor and Ivacaftor for the Treatment of Cystic Fibrosis

SYMDEKO™ (tezacaftor/ivacaftor and ivacaftor)
image114

  Sep 3, 2018 

Vertex Announces Reimbursement Agreement in Australia for ORKAMBI® (lumacaftor/ivacaftor) for People with Cystic Fibrosis Ages Six Years and Older with Two Copies of the F508del Mutation

ORKAMBI® (lumacaftor/ivacaftor)
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  Aug 7, 2018 

FDA Approves ORKAMBI® (lumacaftor/ivacaftor) as First Medicine to Treat the Underlying Cause of Cystic Fibrosis for Children Ages 2-5 Years with Most Common Form of the Disease 

ORKAMBI® (lumacaftor/ivacaftor)
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 Aug 15, 2018 

 FDA Approves KALYDECO® (ivacaftor) as First and Only Medicine to Treat the Underlying Cause of CF in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene

KALYDECO® (ivacaftor)
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 Jun. 28, 2018

- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada approved PrSYMDEKO™ (tezacaftor/ivacaftor and ivacaftor) for treating the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene 

PrSYMDEKO™ (tezacaftor/ivacaftor and ivacaftor)
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  Jun 18, 2018 

Vertex Announces Long-Term Access Agreement in Sweden for Cystic Fibrosis Medicine ORKAMBI® (lumacaftor/ivacaftor)

ORKAMBI® (lumacaftor/ivacaftor

Regeneron

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TARRYTOWN, N.Y. and PARIS, Sept. 28, 2018 /PRNewswire/ -- 

Libtayo is the third anti-PD-1 approved in the U.S.

CSCC is the second most common skin cancer in the U.S.

Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Libtayo®  

FDA Approves Libtayo® (cemiplimab-rwlc) as First and Only Treatment for Advanced Cutaneous Squamous Cell Carcinoma 

September 28, 2018 at 4:39 PM EDT Back FDA APPROVES LIBTAYO® (CEMIPLIMAB-RWLC) AS FIRST AND ONLY TREATMENT FOR ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA TARRYTOWN, N.Y. and PARIS, Sept. 28, 2018 /PRNewswire/ --
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 June 4, 2018 

NEW ENGLAND JOURNAL OF MEDICINE PUBLISHES PIVOTAL CEMIPLIMAB TRIALS SHOWING POSITIVE RESULTS IN ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA

CEMIPLIMAB
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 May 21, 2018 

NEW ENGLAND JOURNAL OF MEDICINE PUBLISHES TWO POSITIVE PHASE 3 TRIALS SHOWING DUPIXENT® (DUPILUMAB) IMPROVED MODERATE-TO-SEVERE ASTHMA

DUPIXENT® (DUPILUMAB)
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  May 16, 2018   

POSITIVE PHASE 3 TRIAL OF DUPIXENT® (DUPILUMAB) IN ADOLESCENTS WITH INADEQUATELY CONTROLLED MODERATE-TO-SEVERE ATOPIC DERMATITIS 

DUPIXENT® (DUPILUMAB)
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  March 10, 2018  

PRALUENT® (ALIROCUMAB) INJECTION SIGNIFICANTLY REDUCED RISK OF CARDIOVASCULAR EVENTS IN HIGH-RISK PATIENTS, AND WAS ASSOCIATED WITH LOWER DEATH RATE 

PRALUENT® (ALIROCUMAB) INJECTION

Biomarin

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 BioMarin Doses First Participant in Phase 2 Study of Vosoritide for Treatment of Infants and Young Children with Achondroplasia 

Vosoritide
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 BioMarin Receives Milestone Payments from Pfizer for Talazoparib 

Talazoparib
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 BioMarin Receives Standard Approval for Palynziq™ (pegvaliase-pqpz) Injection for Treatment of Adults with Phenylketonuria (PKU), a Rare Genetic Disease 

Palynziq™ (pegvaliase-pqpz) Injection

valoctocogene roxaparvovec, adult investigational gene therapy treatment for severe hemophilia A.

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 BioMarin Provides 3 Years of Clinical Data from Ongoing Phase 1/2 Study of Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A 

 SAN RAFAEL, Calif., May 28, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) 

valoctocogene roxaparvovec
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 BioMarin Announces 20 Poster Presentations at Society for the Study of Inborn Errors of Metabolism (SSIEM) Symposium 2018 

tralesinidase alfa

Vimizim® (elosulfase alfa)

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 BioMarin Announces Approval of Vimizim® (elosulfase alfa) in China for Treatment of Morquio A Syndrome

First and Only Treatment in China Approved for Patients with This Ultra-Rare Genetic Condition

More than 1,300 Patients Treated with Vimizim in Over 50 Countries

Jun 4, 2019

 SAN RAFAEL, Calif., June 4, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN)  

VIMIZIM® (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).

Allergan

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 DUBLIN, Oct. 17, 2018 /PRNewswire/ -- Allergan plc (NYSE: AGN)   

Allergan Announces Completion of Two Positive Safety Studies for Ubrogepant - an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine

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 DUBLIN, Sept. 26, 2018 /PRNewswire/ -

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental New Drug Application (sNDA) for VRAYLAR® (cariprazine), seeking to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults in the current product label. 

VRAYLAR is a once-a-day medication, taken with or without food, for the acute treatment of manic or mixed episodes of bipolar I disorder in adults. In clinical studies, VRAYLAR was proven to help manage manic and mixed episodes of bipolar I disorder.
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 Allergan Presents New Research at the American College of Gastroenterology Annual Scientific Meeting (ACG 2018)

Mon October 8, 2018 8:00 AM|PR Newswire|About: AGN 

VIBERZI is a prescription medicine that helps you proactively manage IBS-D abdominal pain and diarrhea
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 Allergan to file U.S. marketing application for migraine med ubrogepant by next quarter

Oct. 17, 2018 8:22 AM ET|About: Allergan plc (AGN)|By: , SA News Editor  

Advancing the Pipeline Key programs in development that derive from our Open Science pipeline

Seattle Genetics

EA-BCMA is a Novel Empowered Antibody Targeting BCMA for Multiple Myeloma-

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 Seattle Genetics Initiates Phase 1 Clinical Trial of SEA-BCMA for Patients with Relapsed or Refractory Multiple MyelomaNovember 14, 2018 at 8:00 AM EST

-SEA-BCMA is a Novel Empowered Antibody Targeting BCMA for Multiple Myeloma-

-Adds to Seattle Genetics’ Robust Clinical-Stage Development Pipeline across Multiple Hematologic and Solid Tumors-

BOTHELL, Wash.--(BUSINESS WIRE)--Nov. 14, 2018-- Seattle Genetics, Inc. (Nasdaq:SGEN)

We are focused on developing a new generation of targeted, empowered therapies with the goal of advancing the foundation of care. In addition to a comprehensive development program to further expand ADCETRIS® (brentuximab vedotin), our robust pipeline is designed to address significant unmet medical needs.

Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (Nasdaq: SGEN)

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 Genmab and Seattle Genetics Announce Tisotumab Vedotin Data to Be Presented at ESMO 2018 CongressOctober 8, 2018 at 6:50 PM EDT

  • Data presented from updated analysis of full innovaTV 201 expansion cohort in recurrent or metastatic cervical cancer

COPENHAGEN, Denmark & BOTHELL, Wash.--(BUSINESS WIRE)--Oct. 8, 2018-- Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (Nasdaq: SGEN) 

Genmab and Seattle Genetics Announce Tisotumab Vedotin Data to Be Presented at ESMO 2018 Congress Data presented from updated analysis of full innovaTV 201 expansion cohort in recurrent or metastatic cervical cancer October 08, 2018 06:50 PM Eastern Daylight Time COPENHAGEN, Denmark & BOTHELL, Wash.--(BUSINESS WIRE)--Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (Nasdaq: SGEN)

ARRAY

BRAFTOVI + MEKTOVI

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 ARRAY BIOPHARMA ANNOUNCES PRESENTATION OF UPDATED OVERALL SURVIVAL FROM THE PHASE 3 COLUMBUS TRIAL OF BRAFTOVI + MEKTOVI IN ADVANCED BRAF-MUTANT MELANOMA AT 2019 ASCO ANNUAL MEETING- Consistent with prior readouts, BRAFTOVI + MEKTOVI demonstrates 33.6 months median overall survival with longer median follow up over 48 months -
- Landmark analysis estimates 47% and 39% of patients alive at 3 and 4 years, respectively -
- Oral poster presentation June 3, 2019 -

BOULDER, Colo., May 29, 2019 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY)

Array BioPharma Announces Presentation of Updated Overall Survival from the Phase 3 COLUMBUS Trial of BRAFTOVI + MEKTOVI in advanced BRAF-mutant Melanoma at 2019 ASCO Annual Meeting - Consistent with prior readouts, BRAFTOVI + MEKTOVI demonstrates 33.6 months median overall survival with longer median follow up over 48 months - - Landmark analysis estimates 47% and 39% of patients alive at 3 and 4 years, respectively - - Oral poster presentation June 3, 2019 -

BRAFTOVI® (encorafenib), a BRAF inhibitor, MEKTOVI® (binimetinib), a MEK inhibitor, & ERBITUX®

 ARRAY BIOPHARMA ANNOUNCES BRAFTOVI + MEKTOVI + CETUXIMAB MEET PRIMARY ENDPOINTS OF ORR AND OS IN PHASE 3 BEACON CRC TRIAL INTERIM ANALYSIS FOR THE TREATMENT OF BRAF(V600E)-MUTANT METASTATIC COLORECTAL CANCER- BRAFTOVI combinations showed statistically significant improvement in ORR and OS versus control -
- BRAFTOVI + MEKTOVI + cetuximab reduced the risk of death by 48% versus control -
- Potential to be the first chemotherapy-free, targeted regimen for metastatic CRC patients -
- Array intends to submit these data for marketing approval in 2H19 -
- Array will host a conference call today, Tuesday, May 21, 2019, at 9:00 am Eastern Time -

BOULDER, Colo., May 21, 2019 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY)

BRAFTOVI and MEKTOVI are prescription medicines used together to treat people with a type of skin cancer called melanoma: that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene

Array BioPharma (ARRY)

Array BioPharma (ARRY) Investor Presentation - Slideshow

Jun. 11, 2019 3:49 PM ET | About: Array BioPharma Inc. (ARRY) 

PIPELINE
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