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Home » Newsletters » BioWorld

BioWorld

April 11, 2016

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Bench Press: BioWorld looks at translational medicine

A team at the German University of Bonn has shown that cyclodextrin, a compound that is used as a pharmaceutical solubilizing agent, appears to have the potential to be an active drug itself, as it dissolved cholesterol crystals in both mice and human blood vessels taken from atherosclerotic patients. Read More

In the clinic

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said data published in The Lancet Respiratory Medicine showed that levels of eosinophils can help identify patients with chronic obstructive pulmonary disease who may or may not benefit from the addition of an inhaled corticosteroid (ICS) to the treatment regimen. Read More

Other news to note

Sanofi Pasteur MSD, of Lyon, France, part of Sanofi SA, said the European Commission has approved a two-dose schedule for adolescent girls and boys aged 9 to 14 for Gardasil9, its 9-valent human papillomavirus vaccine. This new schedule brings the label for Gardasil9 in line with recommendations in several European countries that opted for two-dose schedules in routine vaccination of adolescents in this age group. Read More

Regulatory front

The Pharmaceutical Research and Manufacturers of America (PhRMA) issued the following statement on recommendations voted on at the April meeting of the Medicare Payment Advisory Commission (MedPAC): “PhRMA strongly opposes the sweeping new Medicare Part D recommendations approved by MedPAC earlier today. Read More

Juno brings CAR T to China, pairs up with Wuxi Apptec

SHANGHAI – Juno Therapeutics inc., of Seattle, has decided to make its mark in China by partnering with Shanghai-based Wuxi Apptec, a contract research service platform, to build a new company from the ground up, dubbed JW Biotechnology (Shanghai) Ltd. Read More

Clinical development: Overengineered, underengineered – or just right?

HAMBURG – The blame game is a favored industry pastime, and drug regulators were set up to get it in the neck on the final day of the DIA Europe meeting, in an Oxford-style debate on the motion: This house believes that overengineered clinical development has inhibited innovation. Read More

Missing linc leads to celiac disease

Researchers have tied low levels of a long noncoding RNA (lncRNA or lincRNA) to an increased susceptibility for celiac disease, an immune response to the wheat protein gluten that damages the small intestine. Read More

Durect examination: FDA wants under way phase III to add new active control

Durect Corp. said Friday it was still “working through the logistics” of changes wanted by the FDA in the already-started phase III trial called Persist with Posimir, an extended-release form of bupivacaine delivered via depot for pain after surgery, and Wall Street nicked the shares only slightly as the focus remains on Remoxy (oxycodone), for which the new drug application (NDA) was resubmitted last month. Read More

FDA questions safety, efficacy of Clovis Oncology’s rociletinib in NSCLC subset

Executives of Clovis Oncology Inc. look to have an uphill battle convincing members of the Oncology Drugs Advisory Committee (ODAC) Tuesday of the clinical benefit of rociletinib in a subset of NSCLC patients, based on briefing docs released Friday raising questions as to both the drug’s safety and efficacy. Read More

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