Manufacturing and Production

The EMA has launched a review into Genzyme’s multiple sclerosis drug Lemtrada (alemtuzumab) after reports emerged of treatment-related safety issues arising from heart, blood vessel and immune-mediated conditions, some of which were fatal.

While the agency assesses the situation, it announced temporary advice that the drug “should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two disease-modifying therapies or where other disease-modifying therapies cannot be used.

A US jury has awarded a former Genentech employee nearly $250,000 after the black worker was fired from the firm after filing a racial-discrimination complaint against his manager.

Timothy Pruitt, 56, was fired from Genentech in 2017 after working at the company’s Vacaville offices for 21 years.

While Pruitt was fired over allegations that he had falsified timecards and stolen half a sandwich, the IT worker claimed the action came in retaliation after he submitted a discrimination complaint against his manager, Steve Graeff.

Insys Therapeutics has said Andrew Long will take over from Saeed Motahari as the company’s new CEO.

The opioid drugmaker said the decision had come after Motahari agreed to step down from the position of President and CEO.

The firm, who have faced legal issues over the marketing of their fentanyl based spray Subsys, have seen a series of successions in recent years after CEO Michael Babich was arrested in 2016.

Janssen has unveiled promising new Phase 3 for its sodium-glucose transport (SGLT) protein-2 inhibitor Invokana (canagliflozin), showing that the therapy met its primary endpoint in the treatment of chronic kidney disease (CKD) and type 2 diabetes (T2D) when used in addition to standard of care.

In 4,401 participants with T2D or stage 2 or 3 CKD, the therapy reduced in the risk of progression to end-stage kidney disease (ESKD), doubling of serum creatinine, and renal or cardiovascular (CV) death by 30%.

Around half of patients who are prescribed statins do not see their cholesterol drop to desired levels within two years, according to research published in the journal Heart.

Guidelines from Britain’s cost effectiveness body NICE present a target of 40% reduction in low density lipoprotein cholesterol for patients using statins.

However new research shows 51% of patients had a sub-optimal response after 24 months of treatment