Bayer (ETR:BAYN) reported last week that its antibiotic drug-device combination product failed in a phase III trial. In the 725-patient Inhale trial, Bayer’s Amikacin Inhale did not out-perform a placebo as a treatment for Gram-negative pneumonia in patients on ventilators. Bayer licensed the rights to Nektar Therapeutics‘ (NSDQ:NKTR) antibiotic-delivery product for $175 million in 2007, according […]
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Wearable CGM biosensor dev BioLinq raises $10m
Biosensor developer Biolinq said today it closed a $10 million Series A financing round to support its wirelessly-enabled biosensor patch designed for continuous monitoring of biomarkers, with an initial focus on monitoring glucose in diabetes patients. The round was led by M Ventures in collaboration with Hikma Ventures and joined by Grey Sky Venture Partners, […]
How Enable Injections plans to bring value to pharma with its drug-delivery device
Mike Hooven is no stranger to the medical device industry – he has spent the last 30 years launching companies and developing technologies for a variety of clinical applications. So when he ventured into drug delivery, he knew that he needed to find out what people in the pharmaceutical industry needed. A number of executives […]
GSK, Innoviva seek expanded label for triple inhaler
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data from the landmark Impact trial to the FDA in the hopes of landing an expanded label for the Trelegy Ellipta triple inhaler. The two companies are hoping that their therapy could be used to treat airflow obstruction and to reduce exacerbations in people with chronic obstructive pulmonary disease. Trelegy Ellipta, […]
FDA approves first two-drug HIV regimen in a single pill
The FDA yesterday approved the first two-drug regimen available in a single pill for the maintenance treatment of HIV. The drug, Juluca, combines ViiV Healthcare‘s integrase strand transfer inhibitor and Janssen Therapeutics‘ non-nucleoside reverse transcriptase inhibitor. The treatment is indicated for adults with HIV who are virologically suppressed on a stable anti-retroviral regimen for at […]
Governor passes law to keep birth control free in Massachusetts
Massachusetts governor Charlie Baker signed a law on Monday requiring health insurers to cover at least one kind of every type of FDA-approved birth control. The new law protects health care services and rights for women across the state, “irrespective of what goes on in Washington,” the Republican governor said at the bill’s signing, according […]
FDA wants to improve access to generic abuse-deterrent opioids: here’s how
The FDA commissioner, Dr. Scott Gottlieb, has made the opioid crisis a priority in his time at the agency. Yesterday, the regulatory body issued guidance to help promote the development of generic opioids designed to prevent abuse. To date, the FDA has approved 10 of these products, called abuse-deterrent opioids. But, as Gottlieb noted in […]
Facing pressure in diabetes, Novo Nordisk plans next big push – obesity
The world’s largest diabetes drug-maker, Novo Nordisk (NYSE:NVO), is reportedly looking to boost its efforts to treat obesity as the company’s well-established diabetes drugs face competition. At Novo Nordisk’s capital markets day yesterday, CEO Lars Fruergaard Jorgensen told investors that the company wants to rival surgery with their drugs as a solution for obesity. The drug-maker’s […]
Using digital pills, researchers find patients consume fewer opioids than expected
Clinicians at Brigham and Women’s Hospital published a paper in the December issue of Anesthesia & Analgesia showing that digital pills successfully monitored patients taking opioids following an injury. To track the participants’ opioid use, researchers used etectRx‘s ID-Cap system, which includes a capsule embedded with an ingestible sensor. “As an investigational tool, the digital pill provides a […]
Restasis buyers level antitrust lawsuit against Allergan
A proposed class of Restasis buyers filed an antitrust suit last week in a Texas federal court against Allergan (NYSE:AGN), according to reports from Law360. The suit accuses Allergan of blocking generics to its dry-eye drug using tactics like sham infringement suits and a controversial deal with a Native American tribe. In September, Allergan struck a deal […]