Entries by clickgiant

CymaBay Terminates Phase 2B Study of Seladelpar in NASH

December 5, 2019 Impact: High CymaBay Therapeutics has terminated its phase 2b study of PPARδ agonist, seladelpar, in patients with NASH due to atypical histological findings. Planned, blinded histological assessments of liver biopsies from trial participants revealed histology characterized as an interface hepatitis presentation, with or without biliary injury. Notably, the atypical histological findings were […]

Five Tips for Attending Medical & Pharmaceutical Conferences

Networking is critical in almost every industry. In the exceptionally competitive field of healthcare, it is paramount. Medical conferences are an excellent source not only for new clinical data, but also for the latest opinions from physicians. This provides an invaluable look at the future trends for the use of both marketed and pipeline products […]

Pharma Competitive Intelligence Best Practices

Competitive intelligence (CI) is a critical component of market intelligence, including market segmentation, opportunity, penetration, and more. In the pharmaceutical industry and other dynamic, capital intensive industries, staying up to date on relevant competitors and market actions is critical. This paper covers some of inThought’s best practices in pharma competitive intelligence.

Like the Phoenix, Aducanumab Rises

October 31, 2019 Impact: High In March this year, the aducanumab phase 3 Alzheimer’s disease trials were stopped based on futility, meaning that it was statistically almost impossible for the study to meet its endpoint. The operative word was apparently “almost.” Full analysis of the phase 3 results now shows that the high dose arm […]

Keytruda Monotherapy Approved for 1L PD-L1-Positive NSCLC in China

October 11, 2019 Impact: High Merck has announced that the China NMPA (National Medical Products Administration) has approved the use of Keytruda (pembrolizumab) as a frontline monotherapy agent in patients with locally advanced or metastatic NSCLC tumors with PD-L1 expression of at least 1% (TPS ≥1%, determined by an NMPA-approved test), without EGFR or ALK […]

Keytruda/Lenvima Combination Receives Accelerated Approval for 2L+ Endometrial Carcinoma

October 1, 2019 Impact: High Merck and Eisai have announced that FDA has granted an accelerated approval to the combination treatment of Keytruda/Lenvima (pembrolizumab/lenvatinib) for patients with advanced endometrial carcinoma that is not MSI-H (microsatellite instability-high) or dMMR (mismatch repair deficient), who have disease progression following prior systemic therapy and are not candidates for curative […]

FDA Approves Ardelyx Tenapanor (Ibsrela) for IBS-C

September 25, 2019 Impact: High Ardelyx received FDA approval for tenapanor for the treatment of IBS-C in adults. The approval was based on two phase 3 clinical trials, T3MPO 1 and T3MPO2. The brand name for the drug will be Ibsrela. The label contains a black box warning on the risk of serious dehydration in […]

Pivotal DREAMM-2 Study of GSK’s Belantamab Mafodotin is Positive

September 4, 2019 Impact: High GSK has announced that the pivotal phase 2 DREAMM-2 trial (NCT03525678) of belantamab mafodotin has met the primary endpoint of ORR. 196 relapsed multiple myeloma patients who were refractory to an immunomodulatory drug, a PI and an anti-CD38 antibody were enrolled. Safety and tolerability are reportedly consistent with what was observed […]