Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC Published: Jan 22, 2020 | Tags: Takeda, Alunbrig, (brigatinib), Receives, MHLW, Approval,1L and 2L, Treatment, ALK+ Advanced or Recurrent NSCLC MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the […]Read More
The US FDA has approved 7 NDAs and 2 BLA in Nov 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 105 novel products so far in 2020, including 9 in Dec 2020. Additionally, last year in 2019, the US FDA has approved […]Read More
Shots: The approval is based on P-III EMPOWUR and EMPOWUR long term extension study that involves assessing Gemtesa (75mg, qd) vs PBO in ~4000 patients with OAB for 12wks. The study resulted in reductions in daily UUI, micturitions, and urgency episodes and an increase in the volume voided Gemtesa is a small-molecule β3 adrenergic receptor agonist […]Read More
Merck Collaborates with Siemens for the Digitalization of Production Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test PostEra Collaborates […]Read More
Shots: The P-IIa study involves assessing vibegron (75mg,qd) in 222 women with abdominal pain due to IBS with IBS-D (diarrhea) and IBS-M (mixed IBS) across 35 sites in the US The study did not meet its 1EPs i.e. at least a 30 percent improvement in average worst abdominal pain @12wks. ( 40.9% vs 42.9%), well […]Read More
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