LONDON – In the thick of Brexit uncertainty over the future of medicines regulation, the ability to recruit staff from Europe and involvement in EU research programs, a U.K. life sciences strategy published Wednesday sets out future plans for the sector. Read More

Biogen Inc., of Cambridge, Mass., reported results from a recently conducted analysis of the long-term extension (LTE) of its ongoing phase Ib study of aducanumab, its treatment for early Alzheimer's disease, including data from the placebo-controlled period and LTE for patients treated with aducanumab up to 24 months in the titration cohort and up to 36 months in the fixed-dose cohorts. Read More

Inventiva SA, of Daix, France, said the EMA awarded orphan status to odiparcil (formerly IVA-336) for the treatment of mucopolysaccharidosis type VI. Read More

Immix Biopharma Inc., of Los Angeles, said it closed its series A financing to support its lead investigational product, Imx-110, through the completion of a phase Ib trial. Read More

The FDA released a draft revised guidance to provide product-specific recommendations on the design of bioequivalence studies to support ANDAs for digoxin tablets. Read More

HONG KONG – In the wake of the Indian patent office granting U.S. pharmaceutical giant Pfizer Inc. a patent for its pneumococcal conjugate vaccine (PCV), hopes have been dashed for better access to an affordable vaccine against pneumonia in the developing country of more than 1.3 billion people. Read More

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. Read More

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. Read More

Immunogen Inc. has enough cash – almost – to reach the phase III readout with antibody-drug conjugate (ADC) mirvetuximab soravtansine (mirv) in ovarian cancer, thanks to the option deal for earlier-stage ADCs with Jazz Pharmaceuticals plc, which paid $75 million up front. Read More

DUBLIN – Astrazeneca could garner as much as $400 million from a deal with Takeda Pharmaceutical Co. Ltd. to co-develop its preclinical alpha-synuclein-targeting antibody, MEDI-1341, which is slated to enter clinical development in Parkinson's disease before year-end. Read More