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Celera Group

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Biohaven Relaunches As Biohaven Ltd. After Pfizer Buyout Closes

As signaled when Pfizer acquired Biohaven’s Nurtec and CGRP assets, Biohaven will continue under a modified name, with a focus on epilepsy, obsessive compulsive disorder and spinal muscular atrophy.

Business Strategies Companies

The Quality Lowdown: No Longer Stoppered By Pandemic, US FDA Finds Serious Problems

Some filling lines and API plants fared poorly in post-pandemic inspections, with shortfalls identified in sterility assurance and impurity control. Zhejiang Tianyu and System Kosmetik got warning letters. Alvotech, Cipla and Aurobindo got Form 483 reports posted on the FDA website.

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Clene Sees Path Forward For ALS Candidate Despite Late-Stage Trial Failure

The US firm’s nanoparticle candidate has disappointed in a late-stage ALS trial but experts say secondary survival data could prove a silver lining given an increasingly flexible US regulatory environment.

Clinical Trials Neurology

AstraZeneca’s LogicBio Buyout Will Give Other Troubled Gene Therapy Companies Hope

Many gene therapies companies have faced R&D and financial problems this year but the longer term potential of the field and low prices might tempt big pharma into deals.

Gene Therapy FDA
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