Pulmatrix prices $15m underwritten public offering
Pulmatrix (NSDQ:PULM) today priced an underwritten public offering of 23,500,000 units, including one share of common stock, one Series A warrant to buy one share of common stock and one Series B...
View ArticleFoundation Medicine launches genomic profiling test for solid tumors
Foundation Medicine (NSDQ:FMI) today launched the first FDA-approved comprehensive genomic profiling assay for all solid tumors in the U.S. The test, FoundationOne CDx, is designed to detect specific...
View ArticleSunovion seeks FDA nod for sublingual film to treat Parkinson’s disease
Sunovion Pharmaceuticals submitted a new drug application to the FDA this week for its apomorphine sublingual film designed to treat motor fluctuations experienced by people with Parkinson’s disease....
View ArticleDexcom CEO on ‘treading new ground’ with G6 glucose monitor
Kevin Sayer sold his first glucose sensor in 1994. More than twenty years later, the chief executive of Dexcom (NSDQ:DXCM) still believes that glucose-monitoring technology can transform the way...
View ArticleMyriad’s breast cancer diagnostic wins approval in Japan
Myriad Genetics (NSDQ:MYGN) subsidiary Myriad Genetics Laboratories said today that the Japanese Ministry of Health, Labor & Welfare approved its Bracanalysis Diagnostic System to be used with...
View ArticleIntersect 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...
View ArticleReport: 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...
View ArticleReva 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...
View ArticleReport: FDA guidance ‘fraught with potential complications’ for drug-device...
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...
View ArticleFDA 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...
View ArticleAstraZeneca’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...
View ArticleSunovion 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...
View ArticleFagron 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....
View ArticleEli Lilly inks $63m deal with Sigilon to develop encapsulated cell therapies...
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...
View ArticleNIH launches $1.1B initiative to accelerate treatment options for opioid...
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’...
View Article‘Nightmare bacteria’ swarming the country, CDC reports
Last year, the Centers for Disease Control and Prevention identified more than 200 cases of bacteria that could resist nearly all antibiotics, the agency reported today. The CDC said that these...
View ArticlePavmed reports prelim results of warrant exchange offer
Pavmed Inc. (NSDQ:PAVM) today reported the preliminary results of its offer to exchange two Series W warrants for a single Z warrant. Approximately 10,151,682 Series W warrants were tendered and not...
View ArticleFerring Pharma acquires Rebiotix and its microbiome therapy platform
Ferring Pharmaceuticals inked a deal to acquire Rebiotix and its platform of living drugs for an undisclosed amount, the companies announced today. The Roseville, Minn.-based company is developing a...
View ArticleSurgeon general issues rare advisory urging public to carry overdose reversal...
For the first time in 13 years, the U.S. surgeon general has issued a public health advisory. The last notice, composed in 2005, centered around the risks of drinking during pregnancy. The one issued...
View ArticleCardinal Health donates 80,000 Narcan doses to first responders in Appalachia
Cardinal Health today began its donation of more than 80,000 doses of Narcan, a nasal spray designed to reverse opioid overdoses, to community organizations in Ohio, Kentucky, Tennessee and West...
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