Induced pluripotent stem cells (iPSCs) are stem cells that have been generated from adult cells through the application of Yamanaka factors, a cocktail of transcription factors named after iPSC pioneer Shinya Yamanaka. Such rejuvenated cells could potentially be a great source of autologous cells for transplantation.

An FDA refuse-to-file (RTF) letter has derailed Acorda Therapeutics Inc.'s new drug application (NDA) for Inbrija, an inhaled levodopa candidate for improving motor function in Parkinson's disease (PD) patients.

John Milligan, president and CEO of Gilead Sciences Inc., pronounced the company’s $11.9 billion acquisition of Kite Pharma Inc. as “a pivot to cellular therapy as our main strategy going forward” but promised that “we’re not going quiet after this deal.”

Virometix AG, of Schlieren, Switzerland, said it raised CHF1.2 million (US$1.3 million) from new shareholders in an extension to its recent series A financing round. The additional funds will be used to further accelerate development of its vaccine candidates for respiratory syncytial virus and cancer immunotherapy.

Boehringer Ingelheim GmbH, of Ingelheim, Germany, presented data from the phase III RE-DUAL PCI trial testing Pradaxa (dabigatran etexilate mesylate) and a single antiplatelet agent to vitamin K antagonist warfarin and two antiplatelets in 2,727 patients with nonvalvular atrial fibrillation who underwent percutaneous coronary intervention (PCI) with stenting.

Calimmune Inc. CEO Louis Breton told BioWorld “a wave is about to crash on the shoreline” for technologies such as those that lured CSL Behring to the table for a buyout deal that included $91 million up front plus milestone payments of as much as $325 million.

DUBLIN – The numbers for the Cantos phase III cardiovascular outcomes trial of Novartis AG’s interleukin-beta1 (IL-beta1) inhibitor, canakinumab, are in.

Atyr Pharma Inc. is raising $45.8 million in equity financing through a private placement expected to help it advance both its pulmonary disease-focused iMod.Fc program and the preclinical Project Orca, an immuno-oncology program from which it plans to identify the project’s first candidate.

The FDA is working under a congressional mandate to adopt a more nimble approach to regulation of regenerative medicine, and the agency has responded with enforcement action against multiple clinics even as FDA Commissioner Scott Gottlieb announced that the agency will “advance a comprehensive policy framework” for regenerative medicine before the end of the calendar year.

A federal grand jury indictment was unsealed, charging two Texas residents in a scheme involving the sale of second-hand prescription drugs via the U.S. drug supply chain.