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MERCK

RECARBRIO™ (imipenem, cilastatin, and relebactam)

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)

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Pivotal RESTORE-IMI 2 Phase 3 Study of Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) in Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Met Primary Endpoint

Mon September 30, 2019 6:45 AM|Business Wire|About: MRK

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada,


 https://www.businesswire.com/news/home/20190930005171/en/ 


 https://www.merck.com/product/usa/pi_circulars/r/recarbrio/recarbrio_pi.pdf 

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)

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Final Study Results Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Combination Treatment in Advanced Endometrial Cancer Presented at ESMO 2019 Congress

Sun September 29, 2019 2:30 AM|Business Wire|About: MRK

KENILWORTH, N.J., & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD 

KEYTRUDA® (pembrolizumab)

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)

KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib)

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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

Wed October 2, 2019 6:45 AM|Business Wire|About: MRK

KEYTRUDA is First Anti-PD-1 Therapy Approved as Monotherapy and in Combination with Chemotherapy in First-Line Setting for NSCLC in China

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada


 https://www.businesswire.com/news/home/20191002005162/en/ 

KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib)

Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with pembrolizumab [KEYTRUDA®

KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib)

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

Tue September 17, 2019 5:56 PM|Business Wire|About: MRK

Combination Treatment Approved for Patients with Advanced Endometrial Carcinoma That Is Not Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR), Who Have Disease Progression Following Prior Systemic Therapy and Are Not Candidates for Curative Surgery or Radiation

Under New FDA-Initiated Program, Combination Treatment Is the First to Receive Simultaneous Review Decisions in the U.S., Australia and Canada

KENILWORTH, N.J., & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada, and Eisai 


 https://www.businesswire.com/news/home/20190917006151/en/ 

KEYTRUDA® (pembrolizumab)

Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with pembrolizumab [KEYTRUDA®

Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with pembrolizumab [KEYTRUDA®

image8

 

Pooled Analysis Continues to Show Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Improved Overall Survival Versus Chemotherapy Alone as First-Line Treatment for Patients with Advanced NSCLC Whose Tumors Do Not Express PD-L1

Tue September 10, 2019 6:45 AM|Business Wire|About: MRK

Findings from Pooled Analysis of KEYNOTE-189, KEYNOTE-407 and KEYNOTE-021 (Cohort G) Presented at the IASLC 2019 World Conference on Lung Cancer

KENILWORTH, N.J.--(BUSINESS WIRE)--

Merck (MRK),

Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with pembrolizumab [KEYTRUDA®

Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with pembrolizumab [KEYTRUDA®

Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with pembrolizumab [KEYTRUDA®

image9

 

BriaCell Announces Public Disclosure: Remarkable Responder in Combination Study of Lead Candidate with KEYTRUDA®

Thu September 19, 2019 10:00 AM|GlobeNewswire|About: BCTXF, MRK

Material information is being presented concurrent with this press release at 9:35am Eastern Time at the Next Gen Immuno-Oncology Congress.  Publicly-traded securities of BriaCell Therapeutics Corp. (BCTXF) (TSX-V:BCT) (OTCQB:BCTXF) will remain halted for the duration of CEO Dr. Williams’ presentation.

  • Robust responder experienced a highly remarkable reduction in breast cancer tumors in the adrenal gland and the outer lining of the brain – tumors that had metastasized to areas outside of her breasts.
  • Prior to the Combination Study of Bria-IMT™ with KEYTRUDA®, she had failed prior regimens with 16 agents (13 chemotherapy and 3 hormonal).
  • The patient remains on treatment.
  • Additional patient data sets to be presented at the San Antonio Breast Cancer Symposium on December 10-14, 2019.

BERKELEY, Calif., and VANCOUVER, British Columbia, Sept. 19, 2019 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF)

Lilly

REYVOW™ (lasmiditan)

Selpercatinib (LOXO-292)

Selpercatinib (LOXO-292)

image10

 

Lilly's REYVOW™ (lasmiditan), The First and Only Medicine in a New Class of Acute Treatment for Migraine, Receives FDA Approval

10/11/2019Download PDF- The approval of REYVOW is significant because it represents the first new class of acute migraine treatment approved by the FDA in more than two decades

INDIANAPOLIS, Oct. 11, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) 

Selpercatinib (LOXO-292)

Selpercatinib (LOXO-292)

Selpercatinib (LOXO-292)

image11

 

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

Sun September 29, 2019 10:30 AM|PR Newswire|About: LLY

- 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

PR Newswire

INDIANAPOLIS, Sept. 29, 2019 /PRNewswire/ -- Eli Lilly and Company (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 


 https://www.lillyoncology.com/ 

Verzenio® (abemaciclib)

Selpercatinib (LOXO-292)

Emgality® (galcanezumab-gnlm)

image12


  

Verzenio® (abemaciclib) Significantly Extends Life by a Median of 9.4 Months for Women with HR+, HER2- Advanced Breast Cancer in MONARCH 2 Study

Sun September 29, 2019 10:30 AM|PR Newswire|About: LLY

Overall survival results were consistent across subgroups, including in women with poor prognostic factors - whose cancer quickly returned or spread to their organs, such as liver or lungs

Data presented at the European Society for Medical Oncology (ESMO) 2019 Congress in the Presidential Symposium and simultaneously published in JAMA Oncology

PR Newswire

INDIANAPOLIS, Sept. 29, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY)


 https://www.prnewswire.com/news-releases/verzenio-abemaciclib-significantly-extends-life-by-a-median-of-9-4-months-for-women-with-hr-her2--advanced-breast-cancer-in-monarch-2-study-300927340.html 

Emgality® (galcanezumab-gnlm)

Emgality® (galcanezumab-gnlm)

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 

CYRAMZA® (ramucirumab)

Emgality® (galcanezumab-gnlm)

Jardiance® (empagliflozin)

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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)

Jardiance® (empagliflozin)

Emgality® (galcanezumab-gnlm)

Jardiance® (empagliflozin)

image15

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/ 

Pfizer

investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib,

image16

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

investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib,

image17

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

investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib,

investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib,

investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib,

image18

 

Pfizer Announces Positive Top-Line Results from Second Pivotal Phase 3 Study of Investigational Oral JAK1 Candidate, Abrocitinib, in Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis

Fri September 27, 2019 6:45 AM|Business Wire|About: PFE

–Study achieves all co-primary and key secondary endpoints–

–Safety results show both doses of abrocitinib consistent with prior clinical trial experiences–

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)

LYRICA® (pregabalin)

BAVENCIO® (avelumab) Plus INLYTA® (axitinib)

investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib,

image19

PFIZER ANNOUNCES TOP-LINE RESULTS FROM PHASE 3 TRIAL OF LYRICA® (PREGABALIN) IN PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

Friday, May 24, 2019 - 4:00pmEDT

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE

IBRANCE® (palbociclib)

BAVENCIO® (avelumab) Plus INLYTA® (axitinib)

BAVENCIO® (avelumab) Plus INLYTA® (axitinib)

image20

 

Pfizer Presents New Evidence of IBRANCE® (palbociclib) Effectiveness in HR+, HER2- Metastatic Breast Cancer Patients in Four Real-World Studies at ESMO Congress 2019

Tue September 24, 2019 8:00 AM|Business Wire|About: PFE

First-of-its-kind comparative analysis of real-world data in the CDK 4/6 inhibitor class supports benefits of IBRANCE combination therapy initially shown in clinical trials

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)

Bristol-Myers Squibb

Empliciti (elotuzumab)

Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab)

Empliciti (elotuzumab)

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Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone for Treatment of Patients with Relapsed and Refractory Multiple Myeloma

Fri July 26, 2019 6:59 AM|Business Wire|About: BMY 

Opdivo (nivolumab)

Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab)

Empliciti (elotuzumab)

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

Tue September 10, 2019 5:30 AM|Business Wire|About: BMY

Longest survival follow-up from a pooled analysis of randomized Phase 3 trials of an Immuno-Oncology therapy in this setting demonstrated a greater than five-fold increase in five-year overall survival rates; 13.4% for Opdivo and 2.6% for docetaxel

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

Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab)

Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab)

Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab)

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

Thu September 19, 2019 6:59 AM|Business Wire|About: BMY

Overall survival data from CheckMate -227 Part 1 evaluating Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) in advanced non-small cell lung cancer featured in ESMO Presidential Symposium

Five-year survival data on Opdivo plus Yervoy in advanced melanoma from CheckMate -067, the longest follow-up from a dual Immuno-Oncology Phase 3 trial

New data exploring potential of Opdivo and Opdivo plus Yervoy in esophageal, cervical and prostate cancers

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


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

Opdivo (nivolumab)

Opdivo (nivolumab)

Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab)

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

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

Opdivo demonstrated a 23% reduction in the risk of death and 2.5-month improvement in median overall survival compared to chemotherapy

Results from Phase 3 ATTRACTION-3 trial to be featured in a Presidential Symposium during the European Society for Medical Oncology 2019 Annual Congress

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) (NYSE: BMY) and Ono Pharmaceutical Co., Ltd


 https://www.businesswire.com/news/home/20190930005401/en/ 

Opdivo (nivolumab)

Opdivo (nivolumab)

Opdivo (nivolumab)

image26

 

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...

Tue September 24, 2019 6:59 AM|Business Wire|About: BMY

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 Undergone Complete Resection

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

Opdivo (nivolumab)

Opdivo (nivolumab)

image27

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

Amgen

BiTE® Immuno-Oncology Platform

BiTE® Immuno-Oncology Platform

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)

BiTE® Immuno-Oncology Platform

BiTE® Immuno-Oncology Platform

image29

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

BiTE® Immuno-Oncology Platform

AMG 510, the first KRASG12C inhibitor

image30

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

AMG 510, the first KRASG12C inhibitor

KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab)

AMG 510, the first KRASG12C inhibitor

image31

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


BLINCYTO® (blinatumomab)

KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab)

KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab)

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

Tue September 24, 2019 4:00 PM|PR Newswire|About: AMGNPR Newswire

THOUSAND OAKS, Calif., Sept. 24, 2019 /PRNewswire/ -- Amgen (AMGN)

KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab)

KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab)

KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab)

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Amgen Announces Phase 3 CANDOR Study Combining KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab) Meets Primary Endpoint Of Progression-Free Survival

First Phase 3 Study Combining KYPROLIS and DARZALEX, Two Critical Mechanisms of Action in Treatment of Multiple Myeloma

THOUSAND OAKS, Calif., Sept. 13, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) 

 https://www.darzalex.com/ 

 https://www.kyprolis.com/ 


 https://www.prnewswire.com/news-releases/amgen-announces-phase-3-candor-study-combining-kyprolis-carfilzomib-and-darzalex-daratumumab-meets-primary-endpoint-of-progression-free-survival-300917706.html 

AstraZeneca

Farxiga (dapagliflozin)

trastuzumab deruxtecan (DS-8201)

trastuzumab deruxtecan (DS-8201)

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FDA grants Fast Track designation for Farxiga in heart failure

  PUBLISHED16 September 2019 

 

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death, or the worsening of heart failure, in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).

The FDA’s Fast Track programme is designed to accelerate the development and review of new medicines for the treatment of serious conditions where there is an unmet treatment need.

trastuzumab deruxtecan (DS-8201)

trastuzumab deruxtecan (DS-8201)

trastuzumab deruxtecan (DS-8201)

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

Calquence (acalabrutinib)

trastuzumab deruxtecan (DS-8201)

Calquence (acalabrutinib)

image36

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) 

IMFINZI® (durvalumab)

FASENRA® (benralizumab)

Calquence (acalabrutinib)

image37

  

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

In the Phase III CASPIAN trial IMFINZI at a fixed, convenient dose improved survival with either a cisplatin or carboplatin chemotherapy backbone

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca today presented detailed results from the Phase III CASPIAN trial, showing IMFINZI®(durvalumab) significantly improved overall survival (OS) in patients with previously-untreated extensive-stage small cell lung cancer (SCLC).


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

LYNPARZA® (olaparib)

FASENRA® (benralizumab)

FASENRA® (benralizumab)

image38

 

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

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

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada)


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

FASENRA® (benralizumab)

FASENRA® (benralizumab)

FASENRA® (benralizumab)

image39

  

FASENRA® (benralizumab) Approved in the US for Self-administration in a New Pre-filled Auto-injector, the FASENRA Pen™

Fri October 4, 2019 7:00 AM|Business Wire|About: AZN

FASENRA is now the only respiratory biologic that offers the choice of administration at home or in a doctor’s office with eight-week maintenance dosing

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca


 https://www.businesswire.com/news/home/20191004005089/en/ 

Gilead

image40

 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 

image41

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

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

image42

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

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

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

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

image43

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) 

filgotinib, an investigational, oral, selective JAK1 inhibitor

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

Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF)

image44

  

Gilead and Galapagos Announce Efficacy and Safety Results of Filgotinib Through 52 Weeks in FINCH 1 and FINCH 3 Studies in Rheumatoid Arthritis

Thu October 10, 2019 6:00 PM|Business Wire|About: GILD, GLPG

FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) and Galapagos NV (GLPGF) (Euronext & NASDAQ: GLPG)

Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF)

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

Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF)

image45

 

Gilead Presents New Data From the Company’s HIV Clinical Development Program and Latest Findings on the Impact of HIV Pre-exposure Prophylaxis (PrEP) at IDWeek 2019

Fri October 4, 2019 8:30 AM|Business Wire|About: GILD

- Results from DISCOVER Trial Provide Bone and Renal Safety Profile Data from Participants who Switched from Truvada for PrEP® to Descovy for PrEP™ -

- Analysis Illustrates the Significant and Independent Impact of High PrEP Use on HIV Diagnoses Rate in Major U.S. Cities -

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)


 https://www.businesswire.com/news/home/20191004005097/en/ 

Celgene

image46

 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 

image47

 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

image48

 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 

POMALYST® (pomalidomide)

image49

 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 

POMALYST® (pomalidomide)

POMALYST® (pomalidomide)

image50

 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

POMALYST® (pomalidomide)

POMALYST® (pomalidomide)

POMALYST® (pomalidomide)

image51

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)

abbvie

VENCLEXTA® (venetoclax) in combination with rituximab

image52

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

VENCLEXTA® (venetoclax) in combination with rituximab

image53

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

VENCLEXTA® (venetoclax) in combination with rituximab

VENCLEXTA® (venetoclax) in combination with rituximab

VENCLEXTA® (venetoclax) in combination with rituximab

image54

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 

ABBV-951 and DUODOPA® (levodopa/carbidopa intestinal gel)

VENCLEXTA® (venetoclax) in combination with rituximab

image55

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

MAVYRET® (glecaprevir/pibrentasvir)

ABBV-951 and DUODOPA® (levodopa/carbidopa intestinal gel)

ABBV-951 and DUODOPA® (levodopa/carbidopa intestinal gel)

image56

 

AbbVie Receives FDA Approval of MAVYRET® (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis Across All Genotypes

Thu September 26, 2019 8:00 PM|PR Newswire|About: ABBV, ENTA

- FDA approval is supported by an overall 98 percent cure** rate across this patient population[1]

PR Newswire

NORTH CHICAGO, Ill., Sept. 26, 2019 /PRNewswire/ -- AbbVie (ABBV)

ABBV-951 and DUODOPA® (levodopa/carbidopa intestinal gel)

ABBV-951 and DUODOPA® (levodopa/carbidopa intestinal gel)

ABBV-951 and DUODOPA® (levodopa/carbidopa intestinal gel)

image57

 

AbbVie to Present New and Updated Data From 22 Abstracts, Including Two Late-Breaking Abstracts for ABBV-951 and DUODOPA® (levodopa/carbidopa intestinal gel), at the International Congress of Parkinson's Disease and Movement Disorders®

Mon September 23, 2019 3:01 AM|PR Newswire|About: ABBV

- A second late breaker will showcase interim results from real-world DUOGLOBE study evaluating effect of DUODOPA® (levodopa/carbidopa intestinal gel) on symptoms of advanced Parkinson's disease, quality of life and caregiver burden

- AbbVie will present 20 additional abstracts featuring new and updated data of investigational medicines, and DUODOPA, in Parkinson's disease and other neurodegenerative disorders

PR Newswire

NORTH CHICAGO, Ill., Sept. 23, 2019 /PRNewswire/ -- AbbVie (ABBV)

Johnson & Johnson

INVOKANA® (canagliflozin)

image58

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

INVOKANA® (canagliflozin)

image59

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 

INVOKANA® (canagliflozin)

INVOKANA® (canagliflozin)

INVOKANA® (canagliflozin)

image60

 

Janssen Leverages Wearable Technology to Reimagine Clinical Trial Design


Sat November 16, 2019 9:15 AM|PR Newswire

Company tests innovative trial design with potential to bring medicines to patients faster and more cost-effectively

PR Newswire

TITUSVILLE, N.J., Nov. 16, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson


 https://www.prnewswire.com/news-releases/janssen-leverages-wearable-technology-to-reimagine-clinical-trial-design-300959419.html 


 https://www.janssen.com/janssen-leverages-wearable-technology-reimagine-clinical-trial-design 


 http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVOKANA-pi.pdf 


 https://www.janssen.com/cardiovascular-and-metabolism 


 https://www.jnj.com/johnson-johnson-announces-research-study-with-apple-watch-to-help-improve-afib-outcomes-including-stroke-prevention 




UPTRAVI® (selexipag)

UPTRAVI® (selexipag)

INVOKANA® (canagliflozin)

image61

 

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)

image62

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

UPTRAVI® (selexipag)

image63

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

BeiGene

Tislelizumab and Pamiparib

image64

 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 and Pamiparib

image65

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

Tislelizumab and Pamiparib

Tislelizumab and Pamiparib

Tislelizumab and Pamiparib

image66

 

BeiGene Announces Clinical Data on Tislelizumab and Pamiparib to Be Presented at the European Society for Medical Oncology (ESMO) Congress 2019

Thu September 26, 2019 6:05 PM|GlobeNewswire|About: BGNE

CAMBRIDGE, Mass. and BEIJING, China, Sept. 26, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

Tislelizumab and Pamiparib

image67

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

image68

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

image69

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

Novartis

Kymriah® (tisagenlecleucel)

Lucentis® (ranibizumab 10 mg/ml)

Lucentis® (ranibizumab 10 mg/ml)

image70

 

Novartis completes certification of initial sites in Quebec for first approved Canadian CAR-T therapy, Kymriah® (tisagenlecleucel)(i)

Wed October 9, 2019 8:40 AM|Canada Newswire

  • Kymriah, the first chimeric antigen receptor T cell (CAR-T) therapy approved in Canada is now available at certified sites in Quebec to treat certain patients with relapsed/refractory (r/r) pediatric and young adult B-cell ALL and adult r/r DLBCL
  • Quebec government to reimburse Kymriah therapy for certain patients with life-threatening cancers who are in critical need

DORVAL, QC, Oct. 9, 2019 /CNW/ - Novartis Pharmaceuticals Canada Inc.


 https://www.newswire.ca/fr/news-releases/la-therapie-car-t-cell-maintenant-disponible-au-quebec-821953237.html 

PROMACTA® (eltrombopag)

Lucentis® (ranibizumab 10 mg/ml)

Zolgensma (onasemnogene abeparvovec-xioi)

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

Zolgensma (onasemnogene abeparvovec-xioi)

Zolgensma (onasemnogene abeparvovec-xioi)

Zolgensma (onasemnogene abeparvovec-xioi)

image72

 

Novartis SMA gene therapy shows sustained benefit in late-stage studies

Sep. 19, 2019 7:44 AM ET|About: Novartis AG (NVS)|By: , SA News Editor  

Gilenya® (fingolimod)

Zolgensma (onasemnogene abeparvovec-xioi)

Gilenya® (fingolimod)

image73

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  

Tafinlar® + Mekinist®

Zolgensma (onasemnogene abeparvovec-xioi)

Gilenya® (fingolimod)

image74

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 

Biogen

gene therapy timrepigene emparvovec (BIIB111/AAV2-REP1) for the treatment of choroideremia (CHM)

gene therapy timrepigene emparvovec (BIIB111/AAV2-REP1) for the treatment of choroideremia (CHM)

gene therapy timrepigene emparvovec (BIIB111/AAV2-REP1) for the treatment of choroideremia (CHM)

image75

 

Biogen Announces Enrollment Completion of Global Phase 3 Gene Therapy Study for an Inherited Retinal Disorder

Thu November 21, 2019 7:30 AM|GlobeNewswire|About: BIIBGlobeNewswire

CAMBRIDGE, Mass., Nov. 21, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (BIIB) (Nasdaq: BIIB)


 For more information about the Phase 3 STAR study, visit www.clinicaltrials.gov (NCT03496012). 


 https://www.biogen.com/ 


 https://www.biogen.com/en_us/pipeline.html 

gene therapy timrepigene emparvovec (BIIB111/AAV2-REP1) for the treatment of choroideremia (CHM)

gene therapy timrepigene emparvovec (BIIB111/AAV2-REP1) for the treatment of choroideremia (CHM)

image76

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

SPINRAZA® (nusinersen)

gene therapy timrepigene emparvovec (BIIB111/AAV2-REP1) for the treatment of choroideremia (CHM)

SPINRAZA® (nusinersen)

image77

 

Biogen Advances Spinal Muscular Atrophy (SMA) Clinical Research with New Study Evaluating a Higher Dose of SPINRAZA® (nusinersen) and Additional Data in a Broad Range of Patients

Wed September 18, 2019 7:30 AM|GlobeNewswire|About: BIIB, IONS

  • DEVOTE trial to evaluate safety and even greater efficacy of a higher dose of SPINRAZA in the treatment of SMA; well-established safety profile supports exploration of potential benefits
  • Long-term data from the SHINE study demonstrate improvements in or stabilization of motor function in patients as old as 21 treated with SPINRAZA for up to nearly six years

CAMBRIDGE, Mass., Sept. 18, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (BIIB)

BAN2401

Tecfidera® (dimethyl fumarate)

SPINRAZA® (nusinersen)

image78

 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. 

Tecfidera® (dimethyl fumarate)

Tecfidera® (dimethyl fumarate)

Tecfidera® (dimethyl fumarate)

image80

 

New Data Presented at ECTRIMS Reinforce Long-term Benefits of TECFIDERA® (dimethyl fumarate) Over 10 Years

Wed September 11, 2019 5:00 AM|GlobeNewswire|About: BIIB

  • TECFIDERA consistently maintained low levels of disease activity with no increased risk in adverse events over a decade of treatment
  • Latest interim data from Phase 3 EVOLVE-MS-1 trial show Biogen and Alkermes’ investigational treatment, diroximel fumarate, was generally well tolerated with low rates of treatment discontinuation over 18 months

CAMBRIDGE, Mass., Sept. 11, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (BIIB) (Nasdaq: BIIB)

Roche

Ocrevus® (ocrelizumab)

TECENTRIQ in combination with Abraxane

TECENTRIQ in combination with Abraxane

image81

 

Genentech Presents New Ocrevus (Ocrelizumab) Biomarker Data That Increase Understanding of Disease Progression in Multiple Sclerosis at ECTRIMS

Tue September 10, 2019 1:00 AM|Business Wire|About: RHHBY

– Blood neurofilament light chain (NfL) levels were significantly lowered following Ocrevus treatment in analyses of Phase III studies in RMS and PPMS –

– New data show NfL may be a biomarker for predicting future disability outcomes –

– Separate analyses presented from one of the first studies to demonstrate NfL levels are correlated with active MRI lesions in PPMS –

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


TECENTRIQ in combination with Abraxane

TECENTRIQ in combination with Abraxane

TECENTRIQ in combination with Abraxane

image82

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

Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase,

Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase,

Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase,

image84

 

Genentech’s Fixed Dose Subcutaneous Combination of Perjeta and Herceptin Showed Non-Inferiority When Compared to Intravenous Formulations for People With HER2-Positive Breast Cancer

Fri September 13, 2019 1:00 AM|Business Wire|About: RHHBY

- New fixed-dose combination is administered under the skin in just minutes, significantly reducing the time spent receiving treatment -

- Data will be submitted to health authorities around the world, including the U.S. Food and Drug Administration and European Medicines Agency -

- Results will be presented at an upcoming medical meeting -

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


 https://www.herceptin.com/ 

 https://www.perjeta.com/patient/breast-cancer.html 

 https://www.businesswire.com/news/home/20190912005984/en/ 

Venclexta

Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase,

Gazyva (Obinutuzumab)

image85

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

Gazyva (Obinutuzumab)

Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase,

Gazyva (Obinutuzumab)

image86

 

FDA Grants Breakthrough Therapy Designation for Genentech’s Gazyva (Obinutuzumab) in Lupus Nephritis

Wed September 18, 2019 1:00 AM|Business Wire|About: RHHBY

—There are currently no FDA-approved medicines for lupus nephritis—

—The designation is based on the results of the Phase II NOBILITY study that showed Gazyva, in combination with standard of care, helped more people achieve a complete renal response than standard of care alone—

—Full results from the NOBILITY study will be presented at a medical meeting later this year—

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


 https://www.businesswire.com/news/home/20190917006225/en/ 

Vertex

image87

 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

image88

  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

image89

  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 

image90

 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

image91

 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 

image92

  Jun 18, 2018 

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

Regeneron

EYLEA® (aflibercept) Injection

EYLEA® (aflibercept) Injection

image94

 

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 

EYLEA® (aflibercept) Injection

image95

 June 4, 2018 

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

LIBTAYO® (CEMIPLIMAB)

image96

 May 21, 2018 

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

LIBTAYO® (CEMIPLIMAB)

LIBTAYO® (CEMIPLIMAB)

image98

  March 10, 2018  

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

Biomarin

BMN 307, an investigational AAV5-phenylalanine hydroxylase (PAH) gene therapy

BMN 307, an investigational AAV5-phenylalanine hydroxylase (PAH) gene therapy

image99

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

BMN 307, an investigational AAV5-phenylalanine hydroxylase (PAH) gene therapy

BMN 307, an investigational AAV5-phenylalanine hydroxylase (PAH) gene therapy

BMN 307, an investigational AAV5-phenylalanine hydroxylase (PAH) gene therapy

image100

 

BioMarin, Pioneer in Phenylketonuria (PKU) Therapies, Submits Clinical Trial Application (CTA) in U.K. for Investigational Gene Therapy for PKU

Thu September 26, 2019 8:31 AM|PR Newswire|About: BMRN

2nd Gene Therapy Program in Product Pipeline

PR Newswire

SAN RAFAEL, Calif., Sept. 26, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)b 

BMN 307, an investigational AAV5-phenylalanine hydroxylase (PAH) gene therapy

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

image101

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

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

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

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

image102

 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, adult investigational gene therapy treatment for severe hemophilia A.

Vimizim® (elosulfase alfa)

image103

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

Vimizim® (elosulfase alfa)

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

Vimizim® (elosulfase alfa)

image104

 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)  

Allergan

image105

 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

image107

 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. 

image108

 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 

image109

 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  

Seattle Genetics

Tucatinib in Combination with Ado-trastuzumab Emtansine (T-DM1, Kadcyla®)

Enfortumab vedotin is a novel investigational antibody-drug conjugate (ADC) that targets Nectin-4

Tucatinib in Combination with Ado-trastuzumab Emtansine (T-DM1, Kadcyla®)

image112

  

Seattle Genetics Announces Initiation of Phase 3 Clinical Trial of Tucatinib in Combination with Ado-trastuzumab Emtansine (T-DM1, Kadcyla®) for Patients with Advanced or Metastatic HER2-Positive Breast Cancer

Thu October 10, 2019 8:00 AM|Business Wire|About: SGEN

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


 https://www.businesswire.com/news/home/20191010005257/en/ 


 https://www.seattlegenetics.com/pipeline/tucatinib 

Enfortumab vedotin is a novel investigational antibody-drug conjugate (ADC) that targets Nectin-4

Enfortumab vedotin is a novel investigational antibody-drug conjugate (ADC) that targets Nectin-4

Enfortumab vedotin is a novel investigational antibody-drug conjugate (ADC) that targets Nectin-4

image113

  

Seattle Genetics and Astellas Announce U.S. FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer

Mon September 16, 2019 8:00 AM|PR Newswire|About: ALPMY, SGENPR Newswire

BOTHELL, Wash. and TOKYO, Sept. 16, 2019 /PRNewswire/ -- Seattle Genetics, Inc. (SGEN) (Nasdaq:SGEN) and Astellas Pharma Inc. (ALPMF)


 https://www.prnewswire.com/news-releases/seattle-genetics-and-astellas-announce-us-fda-grants-priority-review-for-enfortumab-vedotin-biologics-license-application-in-locally-advanced-or-metastatic-urothelial-cancer-300918452.html 

ADCETRIS® (Brentuximab Vedotin)

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

Enfortumab vedotin is a novel investigational antibody-drug conjugate (ADC) that targets Nectin-4

image114

 

Seattle Genetics and Takeda Announce Positive Results from Phase 3 ECHELON-2 Clinical Trial Evaluating ADCETRIS® (Brentuximab Vedotin) in Frontline CD30-Expressing Peripheral T-Cell Lymphoma

October 1, 2018 at 6:45 AM EDT

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

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

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

image115

 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)

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

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

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) 

ARRAY AMARIN

BRAFTOVI + MEKTOVI

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

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

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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)

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

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

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)

Array BioPharma (ARRY)

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

Amarin Corporation plc (AMRN)

Array BioPharma (ARRY) Investor Presentation - Slideshow

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

Amarin Corporation plc (AMRN)

Amarin Corporation plc (AMRN)

Amarin Corporation plc (AMRN)

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Amarin Corporation (AMRN) Investor Presentation - Slideshow

Oct. 3, 2019 10:59 AM ET  

Icosapent Ethyl (Vascepa®))

Amarin Corporation plc (AMRN)

Amarin Corporation plc (AMRN)

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New Analysis Shows Icosapent Ethyl (Vascepa®) Is Cost Effective and Offers Rare Finding of Better Outcomes at Lower Healthcare Costs When Used to Treat High-Risk Patients with Cardiovascular Disease or Diabetes and Other Risk Factors

Mon November 11, 2019 1:19 PM|GlobeNewswire|About: AMRN 

 

Projected Lifetime Healthcare Costs of High-Risk Patients on Conventional Medical Therapy, such as Statins, Were Compared with and without the Cardiovascular Risk Reduction Demonstrated with Icosapent Ethyl in the REDUCE IT® Study

Analysis Accounted Patient Treatment Outcomes as Well as U.S. Private Insurance and Medicare Costs

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)


 https://amarincorp.com/ 




Amarin Corporation plc (AMRN)

Amarin Corporation plc (AMRN)

Amarin Corporation plc (AMRN)

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Amarin Corporation (AMRN) Investor Presentation - Slideshow

Sep. 10, 2019 11:56 AM ET  | About: Amarin Corporation plc (AMRN)