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Interactions with Agencies During Drug Development
Pharma

Interactions with Agencies During Drug Development

NDA
April 11, 2019

Welcome to NDA’s free Lunch seminar on Tuesday 30th April 12:00- 14:00 on Interactions with Agencies During Drug Development

AbbVie Presents Positive Phase 3 Data Demonstrating Investigational Elagolix Reduces Heavy Menstrual Bleeding in Women with Uterine Fibroids at 2018 AAGL Global Congress
Pharma

AbbVie Presents Positive Phase 3 Data Demonstrating Investigational Elagolix Reduces Heavy Menstrual Bleeding in Women with Uterine Fibroids at 2018 AAGL Global Congress

AbbVie
November 19, 2018

‍Elagolix, in combination with add-back therapy, achieved statistically significant reduction in heavy menstrual bleeding associated with uterine fibroids compared to placebo

Cardiovascular safety data added to Saxenda® label
Pharma

Cardiovascular safety data added to Saxenda® label

Novo Nordisk Pharmatech A/S
October 25, 2018

Saxenda® is the first and only FDA-approved medicine in a pen indicated to help adults lose weight and keep it off

Positive Phase 2b Data for AbbVie's Upadacitinib Show Significant Induction of Clinical Remission and Response in Patients with Ulcerative Colitis
Pharma

Positive Phase 2b Data for AbbVie's Upadacitinib Show Significant Induction of Clinical Remission and Response in Patients with Ulcerative Colitis

AbbVie
October 23, 2018

‍In U-ACHIEVE, upadacitinib (15/30/45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all ranked secondary endpoints, including endoscopic improvement, clinical remission (per Full Mayo Score) and clinical response, in patients with moderately to severely active ulcerative colitis

InDex Pharmaceuticals publishes post-hoc analysis of the COLLECT study
Pharma

InDex Pharmaceuticals publishes post-hoc analysis of the COLLECT study

InDex Pharmaceuticals
October 19, 2018

InDex Pharmaceuticals Holding AB (publ) today announced the publication of a post-hoc analysis of COLLECT study data. COLLECT was a clinical study of the Toll-like receptor 9 (TLR9) agonist cobitolimod, a first-in-class treatment for patients with moderate to severe ulcerative colitis (UC).

Public Voting is Open for the 2018 AbbVie CF Scholarship Thriving Student Awards, Given to Two Exceptional Students Living with Cystic Fibrosis
Pharma

Public Voting is Open for the 2018 AbbVie CF Scholarship Thriving Student Awards, Given to Two Exceptional Students Living with Cystic Fibrosis

AbbVie
September 11, 2018

‍Earlier this year, 40 AbbVie CF Scholars were awarded $3,000 based on their academic excellence, creativity and community involvement/extracurricular activities

Date
Title
Author
August 28, 2018
InDex Pharmaceuticals Holding AB (publ) interim report January – June 2018
InDex Pharmaceuticals
August 22, 2018
AbbVie Announces Positive Topline Results from Phase 3 Extension Study Evaluating Investigational Elagolix in Women with Uterine Fibroids
AbbVie
August 21, 2018
AbbVie Announces $100 Million Donation to Ronald McDonald House Charities to Support Hospitalized Children and Their Families
AbbVie
August 13, 2018
InDex Pharmaceuticals updates timeline for top line results from the CONDUCT study to first half of 2019
InDex Pharmaceuticals
July 13, 2018
AbbVie Announces Submission of Supplemental New Drug Application to US FDA for Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy
AbbVie
July 13, 2018
AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Blood Cancer Diffuse Large B-Cell Lymphoma (DLBCL) and Ongoing Ibrutinib Clinical Program
AbbVie
June 27, 2018
US patent granted for Tumorad®
Spago Nanomedical
June 27, 2018
AbbVie and Calico Announce Extension of Groundbreaking Collaboration
AbbVie
June 25, 2018
AbbVie and Calibr announce collaboration for next generation T-cell therapies
AbbVie
June 25, 2018
Oral semaglutide demonstrated significant reduction in blood sugar vs placebo in PIONEER 1 trial
Novo Nordisk Pharmatech A/S
June 19, 2018
Novo Nordisk to present 39 abstracts at the 78th Annual American Diabetes Association Scientific Sessions
Novo Nordisk Pharmatech A/S
June 18, 2018
Leading health organizations collaborate with industry on new initiative to combat growing diabetes and cardiovascular disease threat
Novo Nordisk Pharmatech A/S
June 13, 2018
AbbVie Presents Additional Outcomes Data from Three Upadacitinib Phase 3 Studies in Rheumatoid Arthritis at the Annual European Congress of Rheumatology (EULAR 2018)
AbbVie
June 11, 2018
AbbVie Announces U.S. FDA Approval of VENCLEXTA® (venetoclax tablets) in Combination with Rituximab as a Fixed Duration Treatment for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Patients Who Have Received One Prior Therapy
AbbVie
June 5, 2018
AI Speeds Up Pharmaceutical Testing
Oslo Cancer Cluster
June 5, 2018
AbbVie Teams Up with Hidradenitis Suppurativa Patients Around the World to Raise Awareness About the Disease
AbbVie
June 5, 2018
AbbVie Announces Final Results of Tender Offer
AbbVie
May 31, 2018
AbbVie to Present New Data from Several Investigational Studies of Venetoclax as Monotherapy or in Combination for the Management of a Number of Difficult-to-Treat Blood Cancers at 23rd European Hematology Association (EHA) Annual Congress
AbbVie
May 31, 2018
InDex Pharmaceuticals will participate in the Digestive Disease Week (DDW)
InDex Pharmaceuticals
May 31, 2018
AbbVie Announces Updated Preliminary Results of Tender Offer
AbbVie
May 30, 2018
AbbVie Announces Preliminary Results of Tender Offer
AbbVie
May 29, 2018
Governmental fund Investinor invests in Curida
Curida AS
May 25, 2018
Bulletin from Annual General Meeting in InDex Pharmaceuticals Holding AB (publ)
InDex Pharmaceuticals
May 25, 2018
Global Pharma Consulting participates in Swecare Foundation’s 40th anniversary
Global Pharma Consulting
May 25, 2018
IMBRUVICA® (ibrutinib) Plus GAZYVA® (obinutuzumab) Phase 3 iLLUMINATE Trial for First-Line Therapy of Chronic Lymphocytic Leukemia (CLL) Patients Met Primary Endpoint
AbbVie
May 23, 2018
AbbVie to Present at the Jefferies 2018 Global Healthcare Conference
AbbVie
May 23, 2018
AbbVie Donates $100 Million to Strengthen Access to Healthcare, Housing for Hurricane-Ravaged Puerto Rico
AbbVie
May 22, 2018
Head-to-head pharmacokinetic study demonstrated greater factor IX activity with Rebinyn® versus rFIXFc in people with hemophilia B
Novo Nordisk Pharmatech A/S
May 22, 2018
AbbVie to Show Progress and Growth in Oncology Research at the American Society of Clinical Oncology 2018 Annual Meeting
AbbVie
May 22, 2018
InDex Pharmaceuticals Holding AB (publ) interim report January – March 2018
InDex Pharmaceuticals
May 22, 2018
Novo Nordisk increases commitment to stem cell-based therapies
Novo Nordisk Pharmatech A/S
May 9, 2018
AbbVie to Present at the UBS Global Healthcare Conference
AbbVie
May 7, 2018
InDex Pharmaceuticals develops oral formulation of cobitolimod
InDex Pharmaceuticals
May 2, 2018
AbbVie and Rice University establish K.C. Nicolaou Research Accelerator to advance therapies in oncology
AbbVie
May 2, 2018
AbbVie Submits Marketing Authorization Application to the European Medicines Agency for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis
AbbVie
May 2, 2018
AbbVie Presents New Investigational Data for Elagolix at the 2018 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting
AbbVie
April 26, 2018
AbbVie's Upadacitinib Meets Primary and Key Efficacy Endpoints in Phase 2b/3 Rheumatoid Arthritis Study in Japanese Patients
AbbVie
April 26, 2018
AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis
AbbVie
April 26, 2018
Annual General Meeting 2018
InDex Pharmaceuticals
April 26, 2018
Notice of Annual General Meeting in InDex Pharmaceuticals Holding AB (publ)
InDex Pharmaceuticals
April 26, 2018
AbbVie to Present at the Deutsche Bank's 43rd Annual Health Care Conference
AbbVie
April 26, 2018
InDex Pharmaceuticals announces the agenda for its Capital Markets Day in Stockholm on April 25, 2018
InDex Pharmaceuticals
April 12, 2018
AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain
AbbVie
April 9, 2018
AbbVie to Host First-Quarter 2018 Earnings Conference Call
AbbVie
April 5, 2018
AbbVie Announces Global Resolution of HUMIRA® (adalimumab) Patent Disputes with Samsung Bioepis
AbbVie
April 4, 2018
FDA approves inclusion of data from safety outcomes trial in the Tresiba® label
Novo Nordisk Pharmatech A/S
April 4, 2018
InDex Pharmaceuticals gets new patent in Japan
InDex Pharmaceuticals
April 4, 2018
AbbVie is Now Accepting CF Scholarship Applications from Students with Cystic Fibrosis for 2018-2019 Academic School Year
AbbVie
March 21, 2018
AbbVie and the International Myeloma Foundation Announce Partnership to Study the Role of a Genetic Mutation in Outcomes of Patients with Multiple Myeloma
AbbVie
March 21, 2018
Semaglutide injection phase 2 data presented at ENDO demonstrated significant weight loss in adults with obesity
Novo Nordisk Pharmatech A/S
March 16, 2018
Biogen and AbbVie Announce the Voluntary Worldwide Withdrawal of Marketing Authorizations for ZINBRYTA® (daclizumab) for Relapsing Multiple Sclerosis
AbbVie
March 13, 2018
AbbVie Announces Positive Topline Results from Second Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids
AbbVie
March 8, 2018
Julianne Hough Encourages Women to "Speak Up for Endo" during Endometriosis Awareness Month
AbbVie
February 28, 2018
Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of hemophilia A
Novo Nordisk Pharmatech A/S
February 27, 2018
AbbVie to Present at the Cowen and Company 38th Annual Health Care Conference
AbbVie
February 27, 2018
AbbVie Announces Positive Topline Results from Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids
AbbVie
February 27, 2018
AbbVie and Voyager Therapeutics Announce Global Strategic Collaboration to Develop Potential New Treatments for Alzheimer's Disease and Other Tau-Related Neurodegenerative Diseases
AbbVie
February 23, 2018
AbbVie Presents New Positive Late-Breaking Data from Two Phase 3 Psoriasis Trials of Risankizumab at the 2018 American Academy of Dermatology Annual Meeting
AbbVie
February 23, 2018
AbbVie Increases Dividend and Announces New Stock Repurchase Program
AbbVie
February 22, 2018
InDex Pharmaceuticals presents mechanism of action data for cobitolimod at the ECCO congress
InDex Pharmaceuticals
February 22, 2018
Novo Nordisk Launches Rebinyn® in the United States for People with Hemophilia B
Novo Nordisk Pharmatech A/S
February 21, 2018
Novo Nordisk Launches Ozempic® and Fiasp®, Expanding Treatment Options for Adults with Diabetes
Novo Nordisk Pharmatech A/S
February 21, 2018
Novo Nordisk increased reported operating profit by 1% in 2017 to USD 7.4 billion (5% growth in local currencies)
Novo Nordisk Pharmatech A/S
February 15, 2018
New disposal option for California residents using Novo Nordisk medicines and needles
Novo Nordisk Pharmatech A/S
February 14, 2018
AbbVie's Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis
AbbVie
February 8, 2018
AbbVie's Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints
AbbVie
January 16, 2018
AbbVie to Present at the Goldman Sachs 10th Annual Healthcare CEOs Unscripted: A View from the Top
AbbVie
December 13, 2017
AbbVie Announces Phase 3 Study of VENCLEXTA™/ VENCLYXTO™ (venetoclax) in Combination with Rituxan® (rituximab) Meets its Primary Endpoint
AbbVie
December 12, 2017
IMBRUVICA® (ibrutinib) Data Provide Insights Into Its Potential Treatment Benefits for Previously-Treated Chronic Graft-Versus-Host Disease -- A Serious, Possibly Life-Threatening Condition
AbbVie
December 12, 2017
IMBRUVICA® (ibrutinib) Patient-Reported Outcomes Data Detail Long-Term Improvement in Treatment Outcomes and Quality of Life Experience in Chronic Lymphocytic Leukemia (CLL) Patients
AbbVie
December 11, 2017
IMBRUVICA® (ibrutinib) Pooled Analysis Suggests Benefit in Progression-Free Survival (PFS) at 3.5 Years in Patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL)
AbbVie
December 6, 2017
Novo Nordisk Receives FDA Approval of OZEMPIC® (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes
Novo Nordisk Pharmatech A/S
December 5, 2017
IMBRUVICA® (ibrutinib) Plus Rituximab Phase 3 iNNOVATE Trial in Rare Waldenström's Macroglobulinemia Met Primary Endpoint
AbbVie
December 5, 2017
Risankizumab Meets All Primary Endpoints Reporting Positive Results in Fourth Pivotal Phase 3 Psoriasis Study
AbbVie
December 1, 2017
InDex Pharmaceuticals reports new mechanism of action data for cobitolimod
InDex Pharmaceuticals
November 27, 2017
InDex Pharmaceuticals Holding AB (publ) interim report January – September 2017
InDex Pharmaceuticals
November 17, 2017
InDex Pharmaceuticals Holding AB (publ) announces Nomination Committee and financial reporting dates for 2018
InDex Pharmaceuticals
November 17, 2017
Together, the Diabetes and Cardiovascular Communities Recognized World Diabetes Day
Novo Nordisk Pharmatech A/S
November 16, 2017
AbbVie to Present at the Evercore ISI 2017 Biopharma Catalyst/Deep Dive Conference
AbbVie
November 15, 2017
Anthony Anderson, Star of ABC's "black-ish," Partners with Novo Nordisk to Launch "Get Real About Diabetes™"
Novo Nordisk Pharmatech A/S
November 10, 2017
"Diabetes 360" Survey Shows Patients Want More Than Medicine, Need Emotional Support
Novo Nordisk Pharmatech A/S
November 6, 2017
Switching to Tresiba® is Highly Cost-effective and Cost-saving in a Real-world Setting
Novo Nordisk Pharmatech A/S
October 31, 2017
New US study reveals key reasons why millions of people with obesity are not receiving adequate care
Novo Nordisk Pharmatech A/S
October 30, 2017
AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
AbbVie
October 26, 2017
InDex Pharmaceuticals will participate in the United European Gastroenterology Week (UEGW)
InDex Pharmaceuticals
October 26, 2017
Global City Leaders: Cut Obesity By A Quarter To Prevent 100M New Diabetes Cases By 2045
Novo Nordisk Pharmatech A/S
October 24, 2017
AbbVie to Showcase Robust Immunology Portfolio with New and Late-Breaking Data at the 2017 ACR/ARHP Annual Meeting
AbbVie
October 24, 2017
Alector and AbbVie Announce Collaboration to Advance a Novel Class of Immune Therapies for Patients with Alzheimer's Disease
AbbVie
October 23, 2017
Seizing the digital opportunities in pharma
Arthur D. Little AB
October 19, 2017
Novo Nordisk receives positive 16-0 vote from FDA Advisory Committee in favor of approval for semaglutide
Novo Nordisk Pharmatech A/S
October 18, 2017
AbbVie and Harpoon Therapeutics Announce Immuno-Oncology Research Collaboration
AbbVie
October 16, 2017
AbbVie Demonstrates Leadership in HCV with New MAVYRET™ (glecaprevir/pibrentasvir) Data to be Presented at The Liver Meeting® 2017
AbbVie
October 13, 2017
InDex Pharmaceuticals gets new patent in the US
InDex Pharmaceuticals
October 13, 2017
AbbVie and Turnstone Biologics Announce Global Collaboration on Viral Immunotherapies in Oncology
AbbVie
October 2, 2017
Novo Nordisk Receives FDA Approval for Fiasp®, a New Fast-Acting Mealtime Insulin
Novo Nordisk Pharmatech A/S
September 29, 2017
IDF and Novo Nordisk Launch First-ever Global Survey on Cardiovascular Disease Awareness among People with Type 2 Diabetes
Novo Nordisk Pharmatech A/S
September 27, 2017
AbbVie Announces Approval of MAVIRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) in Japan
AbbVie
September 22, 2017
AbbVie and Bristol-Myers Squibb Announce Clinical Research Collaboration to Evaluate a Therapeutic Regimen in Advanced Solid Tumors
AbbVie
September 19, 2017
AbbVie Announces Positive Topline Results from Phase 3 Trial Evaluating VENCLEXTA™/VENCLYXTO™ (Venetoclax) Tablets in Combination with Rituxan® (rituximab) for the Treatment of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia
AbbVie
September 15, 2017
Tresiba® Trial Shows that People with Type 2 Diabetes who Avoid Severe Hypoglycaemia have a Reduced Risk of Death
Novo Nordisk Pharmatech A/S

Nordic Life Science - Insight

NLS Insight's goal is to assist the Nordic regions leading innovators in targeting business collaborations, parnership opportunities and investment potential.

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