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The Digest

Pharma news roundup and Larvol updates

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Month: May 2019

Weekly Top News – IBD – May 6, 2019

May 6, 2019

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Data from P2 SERENITY trial (NCT02891226) for Crohn’s disease at DDW (May 18- 21, 2019) (Eli Lilly) – Apr 30, 2019 – Q1 2019 Results
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Stelara (ustekinumab) / J&J
GENERAL HEALTH STATUS IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS RECEIVING USTEKINUMAB: RESULTS FROM THE PHASE 3 UNIFI INDUCTION AND MAINTENANCE STUDIES (DDW 2019) – May 2, 2019 – Abstract #Sa1887; Pres time: May 18, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Stelara (ustekinumab) / J&J
EFFECTS OF USTEKINUMAB INDUCTION THERAPY ON ENDOSCOPIC AND HISTOLOGIC HEALING IN THE UNIFI PHASE 3 STUDY IN ULCERATIVE COLITIS (DDW 2019) – May 3, 2019 – Abstract #Tu1735; Pres time: May 21, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Xeljanz (tofacitinib) / Pfizer
ANALYSIS OF HEMATOLOGICAL CHANGES IN TOFACITINIB-TREATED PATIENTS WITH ULCERATIVE COLITIS ACROSS PHASE 3 INDUCTION AND MAINTENANCE STUDIES (DDW 2019) – May 3, 2019 – Abstract #Tu1752; Pres time: May 21, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Xeljanz (tofacitinib) / Pfizer
MEASURING THE MEDIATING EFFECTS OF MAYO SCORE COMPONENTS FOR TOFACITINIB ON DISEASE-SPECIFIC QUALITY OF LIFE IN ULCERATIVE COLITIS: DATA FROM THE OCTAVE PROGRAM (DDW 2019) – May 2, 2019 – Abstract #Sa1873; Pres time: May 18, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Entyvio (vedolizumab) / Takeda
EFFECTS OF INTRAVENOUS VEDOLIZUMAB ON HEALTH-RELATED QUALITY OF LIFE AND WORK PRODUCTIVITY IN PATIENTS WITH CROHN’S DISEASE: RESULTS FROM THE PHASE 3B VERSIFY TRIAL (DDW 2019) – May 2, 2019 – Abstract #Sa1881; Pres time: May 18, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Entyvio (vedolizumab) / Takeda
A PHASE 3 STUDY OF VEDOLIZUMAB FOR INDUCTION AND MAINTENANCE THERAPY IN JAPANESE PATIENTS WITH MODERATE TO SEVERE CROHN’S DISEASE (DDW 2019) – May 3, 2019 – Abstract #Tu1746; Pres time: May 21, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; No abstract available.

 

Alofisel (darvadstrocel) / Takeda
Drugmaker Takeda to introduce value-based pricing in Europe (Nikkei) – Apr 29, 2019 – “Takeda is looking to adopt the pricing mechanism for a stem cell therapy called Alofisel for a complication of Crohn’s disease. Because of the complex production method that involves cell cultivation, the drug is expected to carry a price tag of an estimated 60,000 euros ($67,000)….The drug is expected to go on sale by the end of fiscal 2019 in the U.K. and elsewhere in Europe.”

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Weekly Top News – Psoriasis – May 6, 2019

May 6, 2019

Psoriasis

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
European Commission approves Skyrizi (risankizumab) for the treatment of moderate to severe plaque psoriasis (AbbVie Press Release) – Apr 30, 2019 – “AbbVie…today announced that the European Commission (EC) has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. SKYRIZI (150 mg) is approved to be administered by two subcutaneous injections every 12 weeks…This approval allows for the marketing of SKYRIZI in all member states of the European Union, as well as Iceland, Liechtenstein and Norway….SKYRIZI received EC approval based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance…”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Long-term safety of tildrakizumab in patients with moderate-to-severe psoriasis: incidence of major adverse cardiovascular events through 148 weeks from reSURFACE 1 and reSURFACE 2 phase 3 trials (WCD 2019) – May 3, 2019 – Pres time: Jun 12, 2019; 03:10 PM – 03:20 PM; Location: BROWN 3; No abstract available.

 

Otezla (apremilast) / Celgene
A Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy (clinicaltrials.gov) – Apr 29, 2019 – P3b; N=150; Not yet recruiting; Sponsor: Celgene

 

bimekizumab (UCB4940) / UCB
BE COMPLETE: A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Apr 30, 2019 – P3; N=390; Recruiting; Sponsor: UCB Biopharma S.P.R.L.; Not yet recruiting –> Recruiting

 

pegcantratinib (SNA-120) / Bio3 Research, Sienna
SNA-120, A Novel Topical Non-steroidal Therapy for Psoriasis and Associated Pruritus that Targets the NGF/TrkA Pathway: Results from a Multicenter Phase 2b Study (WCD 2019) – May 3, 2019 – Pres time: Jun 15, 2019; 10:35 AM – 10:45 AM; Location: YELLOW 3; No abstract available.

 

Otezla (apremilast) / Celgene
DISCREET: An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis (clinicaltrials.gov) – May 1, 2019 – P3; N=332; Recruiting; Sponsor: Celgene; Not yet recruiting –> Recruiting

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Risankizumab is Associated With Low and Consistent Infection Rates in Patients With Moderate-to-Severe Psoriasis: Analysis of Short-Term and Long-Term Pooled Clinical Trial Data (WCD 2019) – May 3, 2019 – Pres time: Jun 12, 2019; 02:50 PM – 03:00 PM; Location: BROWN 3; No abstract available.

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi pricing: Wholesales acquisition cost of $59,000/year for maintenance dose and $88,500/year for therapy of new patients (UBS) – May 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67166772; Page no: 1; REPORT TITLE: “AbbVie Inc.- First read: AbbVie “Skyrizi approval is incrementally positive; Clean …”; AUTHOR: Jacob, Navin, et al; DATE: 04/23/2019

 

mirikizumab (LY3074828) / Eli Lilly
Improvement in Psoriasis Scalp Severity Index (PSSI) during Maintenance Treatment with Mirikizumab (WCD 2019) – May 3, 2019 – Pres time: Jun 12, 2019; 03:50 PM – 04:00 PM; Location: BROWN 3; No abstract available.

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