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…
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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…
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…
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August 21, 2019 Impact: High Amgen announced that the U.S. District court of New Jersey ruled in favor of Amgen regarding the validity of two patents protecting exclusivity of Enbrel from biosimilars. Sandoz immediately announced…
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August 13, 2019 Impact: High Get insight from inThought Research experts on the recent approval of Keytruda Monotherapy for 2L+ Esophageal cancer: Merck has announced that FDA has approved Keytruda (pembrolizumab) as a monotherapy…
July 25, 2019 Impact: High Get insight from inThought Research experts on Novartis results from the phase 3 PARAGON-HF clinical trial evaluating Entresto versus valsartan in HFpEF. Novartis announced topline results from the phase…