LMC Healthcare

Business Insights

Ascletis Pharma Inc. | February 14, 2022

Ascletis Pharma Inc.announces that it has submitted marketing authorization applications for ritonavir in Germany, France, Ireland and United Kingdom through its agent in Europe. It is expected that more marketing authorization applications for ritonavir in certain other countries, including the ones in Europe, North America and Asian Pacific will soon be submitted. Ascletis has been in discussion with both domestic and international companies, including major multi-national...

Pharma Tech

Wavegate Corporation | January 14, 2022

Wavegate Corporation announced that the U.S. Food and Drug Administration has granted Breakthrough Device designation for its StimuLux™ optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation. The FDA's Breakthrough Device designation is designed to expedite the development and regulatory review of medical devices that are intended to treat serious or life-threatening diseases. To qualify for this designation, preliminary evidence must demonstrate a ...

Fiercepharma | June 09, 2020

Consumers are on edge as the COVID-19 pandemic casts doubts on the quality of drugs reaching shelves around the world. On U.S. shores, experts say those issues are warranted—and a wave of Pfizer recalls for menopause drug Duavee won't help build confidence. Pfizer voluntarily recalled two batches of Duavee––marketed as Duavive abroad––from U.K. shelves after identifying faulty packaging that may have reduced the drug's efficacy, the U.K.'s Medicines and ...

Pharmacy Market

Globenewswire | August 23, 2023

Vincerx Pharma, Inc. a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported that it has received clearance for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for VIP943. Vincerx expects to enroll the first patient in the study early in the fourth quarter of 2023. "The IND clearance by the FDA is...