December 6th, 2019 Xconomy National — Two clinical trials testing an Ipsen drug in rare connective tissue disorders have been placed on partial hold after safety concerns about chronic dosing of the compound emerged. The partial hold applies to patients under 14 years of age in Phase 2 and Phase 3 tests of the drug,… Continue reading FDA Puts Partial Hold on Tests of Ipsen Drug Acquired in $1B Deal
Author: Xconomy Online News
Bio Roundup: Biogen at CTAD, Sage’s Stumble, Astellas’s $3B Offer & More
December 6th, 2019 Xconomy National — It’s been a roller-coaster year for those hoping for new drugs to treat Alzheimer’s disease, a leading cause of death with rising treatment costs and no clear answer yet as to its cause. Clearing proteins, such as amyloid and tau, was once seen as the top contender for stopping… Continue reading Bio Roundup: Biogen at CTAD, Sage’s Stumble, Astellas’s $3B Offer & More
Biogen Points to Enrollment and Dosing to Explain Alzheimer’s Results
December 5th, 2019 Xconomy San Diego — Biogen revealed detailed results from its Alzheimer’s trial to a jam-packed room of eager conference attendees this week—and while some described it as a major advance in the field, others were less convinced. Samantha Budd Haeberlein, Biogen’s vice president of clinical development, took the stage Thursday morning in… Continue reading Biogen Points to Enrollment and Dosing to Explain Alzheimer’s Results
FDA Rejects Enzyvant’s Regenerative Therapy for Rare Immune Disorder
December 5th, 2019 Xconomy Boston — [Corrected 12:27 p.m. See below.] The FDA has rejected an experimental regenerative therapy that Enzyvant developed to restore immune system function in babies born with a rare disorder. The agency cited manufacturing issues, according to the company. Enzyvant received the notification, formally known as a complete response letter, on… Continue reading FDA Rejects Enzyvant’s Regenerative Therapy for Rare Immune Disorder
Digital Health Survivors & Innovative Incumbents Must Team Up for True Disruption
Xconomy Raleigh-Durham — Editor’s note: This is Part 2 of a two-part post about innovation in digital health, co-authored by Rob Coppedge, CEO of Echo Health Ventures. Read Part 1 here. The Path Forward Between Echo Health Ventures and Blue Cross and Blue Shield of North Carolina, we work deeply on both sides of these partnerships… Continue reading Digital Health Survivors & Innovative Incumbents Must Team Up for True Disruption
Roche Notches FDA Nod in Lung Cancer, Amps Up Competition With Merck
December 4th, 2019 Xconomy San Francisco — A Roche immunotherapy has won an additional FDA approval as a first-line treatment for non-small lung cancer, bolstering the product’s competitive stance versus one from Merck. The FDA approved atezolizumab (Tecentriq) for adults whose non-squamous non-small cell lung cancer (NSCLC) is metastatic, meaning it has spread, and does… Continue reading Roche Notches FDA Nod in Lung Cancer, Amps Up Competition With Merck
GHO Capital Raises Over $1bn, Eyes Biotech Outsourcing Services
December 4th, 2019 Xconomy National — GHO Capital will use the money raised to invest in healthcare, including outsourced service providers, which are seeing demand from smaller biotechs, according to a Jefferies analyst. GHO Capital raised €975 million ($1.1 billion), which exceeded its €800 million target, and is 50% larger than its 2015 maiden fund.… Continue reading GHO Capital Raises Over $1bn, Eyes Biotech Outsourcing Services
Stemonix, Atomwise Team Up on Drug Discovery With MicroOrgans and AI
December 3rd, 2019 Xconomy San Diego — Two venture-backed startups that have developed technologies intended to speed up the drug discovery and development process are combining those tools in a bid to achieve their goals together. San Francisco-based Atomwise has developed deep learning techniques for use in structure-based small molecule drug discovery. Since 2012 it… Continue reading Stemonix, Atomwise Team Up on Drug Discovery With MicroOrgans and AI
Caraway Therapeutics Names Martin Williams as CEO
December 3rd, 2019 Xconomy Boston — Cambridge, MA-based Caraway Therapeutics has named Martin Williams as its CEO. Williams joins the company, which is looking to treat neurodegenerative diseases by preserving neurons, from Yuma Therapeutics where he was the executive chairman. He will remain on Yuma’s board of directors. With more than 30 years of industry… Continue reading Caraway Therapeutics Names Martin Williams as CEO
Astellas Bets On Gene Therapy With $3B Audentes Acquisition Offer
December 3rd, 2019 Xconomy National — Japanese drug giant Astellas Pharma announced late Monday it has agreed to buy Audentes Therapeutics, which is developing gene therapies for rare neuromuscular diseases. It’s an all-cash deal worth $3 billion, with the Astellas offer of $60 per share representing a 110 percent premium to Audentes’ (NASDAQ: BOLD) share price… Continue reading Astellas Bets On Gene Therapy With $3B Audentes Acquisition Offer