When Eli Lilly and Co. took over Colucid Pharmaceuticals Inc. for nearly $1 billion in early 2017, it brought then-migraine candidate Reyvow (lasmiditan) back to its founder and now to its FDA approval for the acute treatment of migraine, with or without aura, in adults. Its unusual mechanism puts it outside many other approved migraine treatments, which could hinder its market penetration. Read More
DUBLIN – Shareholders in Allergan plc voted with alacrity to approve Abbvie Inc.'s $63 billion takeover of the Botox maker at an extraordinary general meeting in Dublin Monday. Investors voted 99.64% in favor, with just .36% voting against. Although the outcome was never in any doubt, an unexpected, last-minute €572 million (US$631 million) charge on the transaction, courtesy of the Irish government, is likely to have swayed all but the most hardened holdouts to cast their votes in favor of the deal, lest Abbvie were to get cold feet. Read More
PERTH, Australia – Following stunning interim clinical results for its Celgro nerve regeneration treatment in quadriplegic patients, regenerative medicine company Orthocell Ltd. will focus all its efforts on gaining early FDA approval based on the early results. Read More
HONG KONG – Kobiolabs Inc., a microbiome-based venture from Seoul, South Korea, has secured a ?26.6 billion (US$22.2 million) investment. Founded in 2014, the venture has achieved ?193 billion of enterprise value. Read More
Briefing documents released ahead of Wednesday's meeting of the FDA's Antimicrobial Drugs Advisory Committee, slated to review Shionogi & Co. Ltd.'s cefiderocol for treatment of complicated urinary tract infections (cUTIs), spotlighted a finding of increased mortality among critically ill cefiderocol-treated patients in the company's Credible-CR study. Unclear whether it was "a chance finding or truly reflects a deficit in the activity of cefiderocol," FDA reviewers asked committee members to discuss the point. Read More
LONDON – Mogrify Ltd. raised $16 million in the first close of a series A that it expects to at least double before closing the round in the next 12 months. Read More
Aytu BioScience Inc., of Englewood, Colo., said it entered into definitive agreements with institutional investors Altium Capital and Armistice Capital for the purchase and sale in a private placement of $10 million of series F convertible preferred stock and warrants to purchase common stock. Read More
After proposing an undisclosed alternative price, Clovis Oncology Inc., of Boulder, Colo., got the approval of the U.K.'s National Institute for Health and Care Excellence (NICE) for coverage of its ovarian cancer drug Rubraca (rucaparib) under the Cancer Drugs Fund (CDF) while the company continues to collect long-term overall survival data. Read More
Femtogenix Ltd., of Harpenden, U.K., which is developing the next generation of DNA-interactive antibody drug conjugate (ADC) payloads, said data verifying the favorable toxicity profile and potent efficacy of its pyridinobenzodiazepine (PDD) ADC payload platform in tumor cell models were presented at the World ADC 2019 meeting in San Diego. Read More
A lot of U.S. lawmakers are seeing dollar signs – 345 billion of them, to be exact. That's how much the Congressional Budget Office (CBO) is estimating could be saved in direct federal spending on Medicare Part D prescription drugs from 2023 through 2029 if H.R. 3, the Lower Drug Costs Now Act, was passed. Read More
