Boston-based startup Lyndra said today that it is partnering with pharma giant Allergan (NYSE:AGN) to develop orally administered, once-weekly products for the treatment of Alzheimer’s disease. The collaboration will combine Allergan’s proprietary Alzheimer’s drugs with Lyndra’s sustained-release technology, which is designed to temporarily reside in the stomach for up to one week while delivering a drug. […]
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Japan approves Medtronic’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that its In.Pact Admiral drug-coated balloon won approval from the Japanese Ministry of Health, Labour and Welfare for the treatment of peripheral artery disease in the upper leg. Before the medtech giant can begin commercialization of its drug-device combination product, it must gain reimbursement from the Japanese regulatory body, Medtronic said. “The […]
EpiPen manufacturer is hit with FDA warning letter
Mylan (NSDQ:MYL) today made public a warning letter that the FDA sent to EpiPen manufacturer, Meridian Medical Technologies. In the letter, the regulatory agency summarizes “significant violations of current good manufacturing practice requirements for combination products”, including issues relating to quality control procedures, product complaint resolution and design verification. Among other products, Meridian manufactures Mylan’s EpiPen […]
Aequus touts proof-of-concept trial for anti-nausea patch
Aequus Pharmaceuticals (CVE:AQS) touted data today from an initial proof-of-concept study of its long-acting, transdermal anti-nausea patch, AQS1303. The patch, which combines pyridoxine hydrochloride and doxylamine succinate, is intended to treat nausea and vomiting associated with pregnancy. The oral form of pyridoxine hydrochloride, Diclegis, is dosed up to four times a day. The single-dose comparative bioavailability […]
Vericel CEO: Industry has reached ‘watershed moment’ for cell therapies
Shares in Cambridge-based Vericel Corp (NSDQ:VCEL) surged last year after the FDA approved its bioresorbable scaffold for cartilage repair. The product, Maci, is the first FDA-approved implant to use healthy cartilage tissue from a patient’s own knee to grow cells on the scaffold. Since the product’s approval in December 2016, surgeon uptake has helped to fuel the company’s continued […]
Eli Lilly to cut 8% of workforce in cost-cutting effort
Eli Lilly (NYSE:LLY) said today that it plans to shed 3,500 positions globally as it works to cut costs. The drugmaker estimates that the move will result in yearly savings of about $500 million, starting next year. Lilly said most of the cuts will come from a voluntary early-retirement program that it is offering the U.S., […]
MiMedx wins FDA nod for AmnioFix pivotal trial
MiMedx (NSDQ:MDXG) said today that the FDA has approved its Phase III Achilles tendonitis trial. The 158-patient study is designed to compare the company’s AmnioFix Injectable with a saline placebo injection in the treatment of moderate to severe pain due to Achilles tendonitis. The trial, which is the company’s second late-stage study of AmnioFix, will start […]
Merck leads $11m round for Antidote’s trial-matching tech
Antidote Technologies said today that it inked an $11 million funding round to advance its clinical trial matching technologies. The round was led by Merck’s Global Health Innovation Fund. Existing investors Smedvig Capital and Octopus Ventures participated in the round, which is contingent upon obtaining certain regulatory clearances and is expected to close later this […]
Dexcom partners with Fitbit for glucose-monitoring tech
Dexcom (NSDQ:DXCM) and Fitbit (NYSE:FIT) have partnered to develop and market continuous glucose monitoring technology for people with diabetes, the companies announced today. The companies plan to integrate Dexcom’s CGM data with Fitbit’s new smartwatch, the Fitbit Ionic, so CGM users on Android or iOS devices can see their activity and glucose levels on their […]
Impax settles ‘fax-blasting’ class action suit over EpiPen alternative
Impax Laboratories (NSDQ:IPXL) will pony up $4.8 million to settle claims that it sent blasts of unsolicited faxes to Family Medicine Pharmacy advertising its epinephrine auto-injector, according to a document filed in a Alabama federal court this week. The Alabama-based pharmacy filed the proposed class action suit against Impax in January, alleging that the pharmaceutical company […]