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Medtronic touts therapy delivered via SynchroMed pump in patients with...
Medtronic (NYSE:MDT) touted data today showing that intrathecal baclofen therapy delivered via the company’s SychroMed II infusion pump performed better than the conventional treatment for patients...
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Endo Pharmaceuticals hit with subpoena over opioid products
Endo Pharmaceuticals (NSDQ:ENDP) was hit by a grand jury subpoena yesterday from the U.S. Attorney’s Office for the Southern District of Florida over its oxymorphone products. The subpoena requests an...
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FDA revises label on opioid cold meds to limit pediatric use
The FDA this week announced that it’s mandating labeling changes to cut the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in kids under 18 years of age. The...
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Tandem Diabetes registers $40m offering
Tandem Diabetes Care (NSDQ:TNDM) has registered for a $40 million offering of its common stock, according to an SEC filing posted today. Shareholders for the San Deigo, Calif.-based company approved a...
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FDA kicks the can on off-label marketing
The FDA has placed an indefinite hold on implementing new regulations relating to how the agency determines a medical product’s intended use. The decision to press pause on the new rules drew cheers...
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Voluntis, WellDoc partner to offer digital diabetes management system
Voluntis has inked a commercial deal to combine its insulin titration tech with WellDoc‘s coaching platform to create a digital management solution for people with Type II diabetes. Cambridge,...
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Aprinoia raises $11m for Alzheimer’s imaging, therapy programs
Aprinoia Therapeutics said today that it has raised $11.1 million in a Series B round, led by KTB Network and DCI Partners. The Taiwan-based biotech plans to use its new funds to advance the...
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WaveForm touts clinical trial data for continuous glucose monitor
WaveForm Technologies said today that it has finished four clinical trials of its continuous glucose monitoring system and that it expects to win CE Mark clearance for the device this year. The...
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FDA’s Gottlieb updates on IV bag shortages after Hurricane Maria
[Image courtesy of NOAA]FDA commissioner Dr. Scott Gottlieb expects that the shortage of IV fluids caused by Hurricane Maria in Puerto Rico will improve in the coming weeks and months, according to a...
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BioAdvance drops $3.2m on device, drug bets
Early-stage life science fund BioAdvance announced that it has added an array of new companies to its portfolio, investing nearly $3.2 million into companies from the mid-Atlantic region of the U.S....
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Valeritas launches V-Go wearable insulin delivery device in Puerto Rico
Valeritas (NSDQ:VLRX) said today that its V-Go wearable insulin delivery system is available in Puerto Rico. The Bridgewater, N.J.-based company has partnered with Fusion Consulting group to promote...
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Rebelling against high prices, hospitals form nonprofit generic drug company
A consortium made up of 300 hospitals – and counting – are taking a bold step to address high drug prices and shortages of essential medicines: they’re cutting out the pharma middleman and starting...
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Senate panel approves HHS nominee Azar
The Senate finance committee has approved president Donald Trump’s nominee for chief of the Dept. of Health and Human Services, Alex Azar. The former drug company executive is expected to be confirmed...
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Smiths updates recall for Medfusion syringe pumps
Smiths Medical has amended an urgent medical device recall that it first issued in August for its Medfusion syringe pump model series 3500 and 4000. After acknowledging that a defect in certain models...
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EpiPen shortage in Canada to last until March
Pfizer Canada (NYSE:PFE) has warned Health Canada that there is a shortage of 0.3 mg EpiPen auto-injectors due to a manufacturing disruption. The company, which licenses the emergency allergy treatment...
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Braeburn dealt setback over monthly, weekly opioid abuse therapy
The FDA has issued a complete response letter to Braeburn Pharmaceuticals, denying its application for an investigational weekly and monthly buprenorphine depot injection designed to treat adults with...
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SFC Fluidics inks deal with JDRF to develop automated insulin delivery system
SFC Fluidics has inked a two-year deal with JDRF to develop an automated insulin delivery system that combines a continuous glucose monitor and an insulin delivery algorithm into a single disposable...
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Pulmatrix wins EU nod for inhaled dry-powder anti-fungal trial
The UK Medicines and Healthcare Products Regulatory Agency has given Pulmatrix (NSDQ:PULM) the go-ahead to launch its first-in-human study for an inhaled formulation of the anti-fungal drug,...
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Lenis inks distribution deal for needle-free injection system
Lenis Medical and Premier Distributing have inked an exclusive distribution deal for the U.S. sales of its needle-free injection system. Lenis’ high-velocity, spring-loaded device injects medication...
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Glytec touts patient outcomes for diabetes management system
Four new studies were published in this month’s issue of the Journal of Diabetes Science and Technology touting patient outcomes linked to Glytec‘s eGlycemic diabetes management system, the company...
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