Drugs

Since Our Last Issue ...

Evotec has entered into a definitive agreement with Aptuit under which Evotec will acquire all operational business of Aptuit for $ 300 million that will expand Evotec’s role as a leading player in integrated outsourced drug discovery and development solutions.

LabCorp has agreed to purchase private contract research organization (CRO) Chiltern for $1.2 billion. Chiltern has a presence in 47 countries, employing more than 4,500 people, and provides comprehensive clinical development, medical and scientific affairs, data and analysis, pharmacovigilance and strategic regulatory services for clinical trial support.

Avalign Technologies has announced that is has acquired Thortex and Millennium Surgical for undisclosed terms. Thortex provides precision manufacturing, porous coatings and metal injection solutions to the medical device market. It has porous coating solutions for titanium and cobalt-chrome orthopedic implants and manufacturing and engineering technologies for medical device OEMs. Millennium Surgical offers specialty surgical instruments in a variety of clinical areas like neurosurgery, ophthalmics and orthopedics.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome