At the 2018 National Rx Drug Abuse and Heroin Summit today, National Institutes of Health director Dr. Francis Collins announced that the agency is launching the ‘Helping to End Addiction Long-term’ initiative. The NIH expects to spend nearly $1.1 billion in 2018 on research dedicated to expanding treatment options for people who are addicted to […]
Eli Lilly inks $63m deal with Sigilon to develop encapsulated cell therapies for diabetes
Eli Lilly (NYSE:LLY) plans to put $473 million on the table to fund a collaboration with Cambridge, Mass.-based startup Sigilon Therapeutics, the insulin-maker reported today. The goal of the newly-established partnership is to develop encapsulated cell therapies to treat Type I diabetes. In patients who suffer from Type I diabetes, pancreatic beta cells are killed off […]
Fagron combines with Humco and its drug-delivery tech in $70m deal
Pharmaceutical compounding company Fagron (EBR:FAGR) plans to combine with Humco and its portfolio of drug-delivery technology in a deal valued up to $70 million, the companies announced today. According to the agreement, Humco chairman & CEO Gregory Pulido will become executive chairman while Andrew Pulido, Humco’s president of global pharmaceuticals, will assume the role of president. “I […]
Sunovion launches inhaled COPD therapy in U.S.
Sunovion Pharmaceuticals launched its Lonhala Magnair drug in the U.S. for the long-term maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease, the company reported today. Sunovion touts its drug as the first nebulized long-acting muscarinic antagonist approved to treat COPD in the U.S. The product is delivered using the Magnair nebulizer […]
AstraZeneca’s once-weekly diabetes drug wins expanded FDA approval
AstraZeneca (NYSE:AZN) said today that the FDA approved its extended-release formulation of exenatide, Bydureon, for use as an add-on therapy to basal insulin in adults with Type II diabetes. The company’s once-weekly GLP-1 injectable was first approved in the U.S. in 2012. Bydureon’s expanded use is based on data from AstraZeneca’s 28-week Duration-7 trial, the company […]
FDA clears Adherium’s inhaler sensor for OTC sales
The FDA gave Adherium (ASK:ADR) the go-ahead to launch over-the-counter sales of its Smartinhaler sensor for AstraZeneca‘s (NYSE:AZN) Symbicort asthma inhaler, the company touted last week. Adherium’s product installs directly onto a patient’s inhaler to monitor and boost medication adherence. The device records the time and date that a patient uses their inhaler and transmits […]
Report: FDA guidance ‘fraught with potential complications’ for drug-device products
The FDA issued revised guidance documents earlier this year clarifying the agency’s ‘Refuse to Accept’ policy for 510(k)s and PMAs. The updated policy raises questions for companies developing and submitting combination products for regulatory approval, according to lawyers Allyson Mullen and Rachael Hunt. The associate partners detailed changes to the components that companies must include […]
Reva inks distro deal for bioresorbable scaffolds in Turkey
Reva Medical (ASX:RVA) inked a distribution deal with Kardionet Healthcare & Foreign Trading to launch commercial operations in Turkey for its bioresorbable scaffold tech, the company reported today. According to the terms of the deal, Kardionet will be responsible for sales, marketing, customer training and support for Reva’s Fantom and Fantom Encore bioresorbable devices in Turkey. […]
Report: Pharma companies ask Supremes to take eye-dropper case
A group of pharmaceutical companies, including Allergan (NYSE:AGN) and Merck (NYSE:MRK), have asked the Supreme Court to review a case between the industry players and patients regarding the design of the companies’ eye-droppers, according to a report from the AP. In the on-going legal debate, patient groups have claimed that the companies’ devices dispense large drops of medication […]
Intersect ENT launches Sinuva steroid-releasing sinus implant
Intersect ENT (NSDQ:XENT) launched its steroid-releasing sinus implant, Sinuva, in the U.S. today. The company’s drug-eluting device is designed to treat nasal polyp disease in patients who have undergone previous sinus surgery. Sinuva is placed during a routine doctor’s office visit and releases an anti-inflammatory steroid, mometasone furoate, directly to the patient’s nasal polyps for up to […]
