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GlaxoSmithKline PLC (GSK.L)

GSK.L on London Stock Exchange

1,838.00GBp
20 Jan 2020
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Latest Key Developments (Source: Significant Developments)

Viiv Healthcare Receives CRL From FDA For Use Of Investigational Cabotegravir, Rilpivirine Long-Acting Regimen In HIV Treatment
Saturday, 21 Dec 2019 

Dec 21 (Reuters) - ViiV Healthcare::RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR USE OF INVESTIGATIONAL CABOTEGRAVIR, RILPIVIRINE LONG-ACTING REGIMEN IN HIV TREATMENT.NO REPORTED SAFETY ISSUES RELATED TO CMC; NO CHANGE TO SAFETY PROFILE OF PRODUCTS USED IN CLINICAL TRIALS TO DATE.REASONS GIVEN IN CRL RELATE TO CHEMISTRY MANUFACTURING AND CONTROLS.  Full Article

UK's MHRA Issues Drug Alert As GlaxoSmithKline Recalls All Unexpired Zantac Stock
Tuesday, 8 Oct 2019 

Oct 8 (Reuters) - Medicines and Healthcare products Regulatory Agency::UK'S MHRA SAYS ISSUED ALERT TO HEATHCARE PROFESSIONALS, AS GLAXOSMITHKLINE IS RECALLING ALL UNEXPIRED STOCK OF FOUR TYPES OF ZANTAC.UK'S MHRA SAYS RECALL IS PRECAUTIONARY MEASURE DUE TO POSSIBLE CONTAMINATION OF ACTIVE SUBSTANCE IN ZANTAC, RANITIDINE, WITH AN IMPURITY CALLED NDMA.  Full Article

Gsk And Lyell Immunopharma To Develop Next Generation Of Cancer Cell Therapies
Tuesday, 8 Oct 2019 

Oct 8 (Reuters) - GlaxoSmithKline PLC ::GSK AND LYELL IMMUNOPHARMA TO DEVELOP NEXT GENERATION OF CANCER CELL THERAPIES.COLLABORATION WILL COMBINE LYELL'S TECHNOLOGIES WITH GSK'S PIPELINE OF CELL THERAPIES AND MANUFACTURING CAPABILITY.ANNOUNCED 5-YEAR COLLABORATION WITH LYELL IMMUNOPHARMA TO DEVELOP NEW TECHNOLOGIES TO IMPROVE CELL THERAPIES FOR CANCER PATIENTS.  Full Article

Vectura Says UK Court Dismissed GSK's Claims Of Passing Off In Respect Of Sandoz's Airflusal Forspiro
Friday, 4 Oct 2019 

Oct 4 (Reuters) - Vectura Group PLC ::VECTURA GROUP PLC - UK COURT RULING IN GSK V SANDOZ PASSING OFF CASE.VECTURA GROUP PLC - ENGLISH HIGH COURT HAS DISMISSED ALL OF GSK'S CLAIMS OF PASSING OFF IN RESPECT OF SANDOZ'S AIRFLUSAL FORSPIRO.  Full Article

GSK Submits Filing To FDA For Trelegy Ellipta Use In Patients With Asthma
Wednesday, 2 Oct 2019 

Oct 2 (Reuters) - GlaxoSmithKline PLC ::GSK SUBMITS FILING TO FDA FOR TRELEGY ELLIPTA USE IN PATIENTS WITH ASTHMA.CO, INNOVIVA FILED SUPPLEMENTAL NDA TO FDA SEEKING EXTRA INDICATION FOR USE OF ONCE-DAILY, SINGLE-INHALER TRIPLE THERAPY, TRELEGY ELLIPTA.  Full Article

FDA Panel Says Benefits Of GlaxoSmithKline's OTC Nicotine Oral Spray Outweigh Risks
Thursday, 19 Sep 2019 

Sept 18 (Reuters) - GlaxoSmithKline PLC ::OVER-THE-COUNTER NICOTINE ORAL SPRAY.OVER-THE-COUNTER NICOTINE ORAL SPRAY.OVER-THE-COUNTER NICOTINE ORAL SPRAY; SAYS BENEFITS OUTWEIGH RISKS.  Full Article

Vectura Says $89.7 Mln Award To Co Related To GSK Litigation Upheld
Friday, 13 Sep 2019 

Sept 13 (Reuters) - Vectura Group PLC ::VECTURA GROUP PLC - VECTURA PROVIDES UPDATE ON GSK LITIGATION.VECTURA GROUP PLC - AWARD OF US$89.7M IN DAMAGES TO VECTURA ON MAY 3, 2019 UPHELD.  Full Article

GlaxoSmithKline - FDA Approved Nucala For Use In Children As Young As 6 Years Old With Severe Eosinophilic Asthma
Friday, 13 Sep 2019 

Sept 12 (Reuters) - GlaxoSmithKline PLC ::NUCALA IS THE FIRST BIOLOGIC APPROVED IN THE US FOR SIX TO 11-YEAR-OLD CHILDREN WITH SEVERE EOSINOPHILIC ASTHMA.GLAXOSMITHKLINE PLC - FDA APPROVED NUCALA (MEPOLIZUMAB) FOR USE IN CHILDREN AS YOUNG AS 6 YEARS OLD WITH SEVERE EOSINOPHILIC ASTHMA.  Full Article

Ionis Licenses Hepatitis B Program To GSK
Tuesday, 27 Aug 2019 

Aug 27 (Reuters) - Ionis Pharmaceuticals Inc ::IONIS LICENSES HEPATITIS B PROGRAM TO GSK.IONIS PHARMACEUTICALS INC - GSK EXERCISES OPTION TO LICENSE PROGRAM FOLLOWING POSITIVE PHASE 2 RESULTS.IONIS PHARMACEUTICALS INC - UNDER AGREEMENT, CO IS ELIGIBLE TO RECEIVE LICENSE FEES, MILESTONE PAYMENTS UP TO $262 MILLION, INCLUDING $25 MILLION LICENSE FEE.IONIS PHARMACEUTICALS INC - ALSO ELIGIBLE TO RECEIVE TIERED ROYALTIES IN LOW DOUBLE DIGITS ON NET SALES AS A PART OF LICENSING AGREEMENT.  Full Article

GSK Long-Acting HIV Injection Meets Goal In Late Stage Study
Thursday, 22 Aug 2019 

Aug 22 (Reuters) - GlaxoSmithKline PLC ::GLAXOSMITHKLINE PLC - VIIV RESULTS POSITIVE FOR EVERY 2 MONTH INJECTION.GSK- PHASE III STUDY RESULTS OF INVESTIGATIONAL, LONG-ACTING, INJECTABLE HIV-TREATMENT TWO MONTHS REGIMEN ATLAS-2M STUDY MET ITS PRIMARY ENDPOINT.GLAXOSMITHKLINE PLC - DETAILED RESULTS FROM ATLAS-2M STUDY WILL BE PRESENTED AT AN UPCOMING SCIENTIFIC MEETING.  Full Article

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Exclusive: Drugmakers from Pfizer to GSK to hike U.S. prices on over 200 drugs

NEW YORK Drugmakers including Pfizer Inc , GlaxoSmithKline PLC and Sanofi SA are planning to hike U.S. list prices on more than 200 drugs in the United States on Wednesday, according to drugmakers and data analyzed by healthcare research firm 3 Axis Advisors.