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 […]
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 […]
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.
October 31, 2019 Impact: High China regulators have cleared the IND for the fully human BCMA CAR-T, CT-103A, in development by Nanjing Iaso and Innovent Biologics. In the recent issue of BioWorld (pages 1 & 6), Brian Hall, VP of Business Development at Iaso, stated that a phase 1b/2 trial to confirm the recommended phase […]
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 […]
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 […]
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 […]
October 1, 2019 Impact: High The CHMP adopted a positive opinion recommending a change in the MAA for Remsima to include a new route of administration, new strength, and new pharmaceutical form: Remsima 120 mg solution for subQ injection using prefilled pens or syringes. It is only authorized in the RA indication.
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 […]
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 […]
