A pivotal trial funded by the National Institutes of Health found that an artificial pancreas system from Tandem Diabetes Care (NSDQ:TNDM) was more effective than existing treatments for people with Type 1 diabetes. The Tandem system combines its … [Read More...]
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Are You Prepared for the Upcoming Blanket No Change Certification Reporting Period? Learn more from Reed Tech
Listen to the recording of Reed Tech’s ‘Blanket No Change Certification webinar’ to learn about annual No Change Certification submission requirements for drug product listings and what steps are … [Read More...]
Featured Posts
Ocular Therapeutix dips on Q3 losses
Ocular Therapeutix (NSDQ:OCUL) shares fell today on third-quarter results that narrowly topped the consensus forecast despite a bottom-line dip. The Bedford, Mass.–based ophthalmic insert maker posted losses of -$18,778, or -45¢ per share, on … [Read More...]
InCarda Therapeutics raises $35 million
InCarda Therapeutics — which is developing an inhaled paroxysmal atrial fibrillation drug — filed an SEC Form D confirming the sale of more than $35 million in equity. The Newark, Calif.–based drug-device combo company sold nearly $35.3 million … [Read More...]
Insulet Q3 earnings beat The Street despite bottom-line slide
Insulet (NSDQ:PODD) shares are rising today on third-quarter results that topped the consensus forecast, despite a dip in profits. The Acton, Mass.–based company posted profits of $852,000, or 1¢ per share, on sales of $192.1 million for the three … [Read More...]
Log Pharma Packaging launches smart packaging
Log Pharma Packaging said today that it is launching its ActiveGuard Connect smart packaging solutions. ActiveGuard Connect is designed to address the lack of patient adherence to prescription medicine or supplementation of nutraceuticals. It is … [Read More...]
Surmodics shares drop on Q3 earnings, Sundance DCB wins breakthrough FDA nod
Surmodics (NSDQ:SRDX) shares plummeted today despite third-quarter results that topped Wall Street projections. Eden Prairie, Minn.-based Surmodics posted profits of $3.55 million, or 26¢ per share, on sales of $30.8 million for the three months … [Read More...]
Intersect ENT’s Q3 beats on sales, misses on earnings
Intersect ENT (NSDQ:XENT) this morning posted wider-than-expected losses but topped the consensus sales estimate with its third-quarter results. Menlo Park, Calif.-based Intersect reported losses of -$12.8 million, or -41¢ per share, on sales of … [Read More...]
Regenxbio pulls trigger on option to license Clearside Biomedical’s SCS Microinjector
Clearside Biomedical (NSDQ:CLSD) said yesterday that Regenxbio (NSDQ:RGNX) exercised its option to license Clearside's in-office SCS Microinjector for delivering adeno-associated virus (AAV)-based therapeutics in treating wet age-related macular … [Read More...]
China approves Biotronik’s Orsiro drug-eluting stent
Biotronik said today that China's National Medical Products Administration approved its Orsiro drug-eluting stent. Orsiro is a cobalt-chromium stent that elutes the drug sirolimus via the Berlin-based company's Biolute bioabsorbable polymer … [Read More...]
Pixarbio CEO Reynolds convicted in $13m investor fraud case
Pixarbio founder & CEO Frank Reynolds reportedly faces two decades behind bars after a jury yesterday convicted him of defrauding investors of nearly $13 million. Federal authorities arrested Reynolds, longtime friend and Pixarbio employee Jay … [Read More...]
FDA approves expanded indication for Liletta 6-year IUD
Medicines360 and its partner Allergan (NYSE:AGN) said today that the FDA approved Medicines360's supplemental new drug application to extend the duration use of the Liletta intrauterine device for up to six years. The Liletta … [Read More...]
In case you missed it
- Insulet wins FDA nod for Omnipod with Novo Nordisk’s Fiasp insulin
- DarioHealth beats forecast with Q3 results
- FDA approves Flowonix’s Prometra II programmable pump
- Senseonics touts Humana reimbursement nod for Eversense CGM
- Bryn Pharma raises $18m for nasal epinephrine device
- Clearside Biomedical inks $76m licensing deal with Bausch for Xipere
- Phillips-Medisize wins contract for wearable combination product
- West Pharmaceutical Services launches NovaPure drug-delivery system
- Aptar Pharma’s two-dose nasal spray device to deliver epinephrine
- Clearside Biomedical confirms timeline for Xipere
- Concept Medical wins CE Mark for MagicTouch DCBs
- Novartis unit spikes Pear Therapeutics deal
- NIH study: Tandem Diabetes artificial pancreas bests other treatments
- Gates Foundation backs Credence MedSystem’s drug-delivery device
- Senseonics touts Eversense reimbursement win
Clinical Trials
NIH study: Tandem Diabetes artificial pancreas bests other treatments
A pivotal trial funded by the National Institutes of Health found that an artificial pancreas system from Tandem Diabetes Care (NSDQ:TNDM) was more effective than existing treatments for people with Type 1 diabetes. The Tandem system combines its t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology with a continuous glucose monitor made by DXCM, […]
Frequency Therapeutics launches hearing loss trial, gains the fast track at FDA
Frequency Therapeutics (NSDQ:FREQ) said today that it launched a Phase 2a study and won fast-track designation at the FDA for its regenerative hearing loss drug. The fast-track program aims to speed up the approval of therapies for unmet needs in serious conditions. Woburn, Mass.-based Frequency’s FX-322 candidate is designed to stimulate the regrowth of sensory hair cells […]
Intersect ENT’s Ascend study misses endpoint
Intersect ENT (NSDQ:XENT) shares plunged today after the company said it failed to meet the primary endpoint in a study of its Ascend investigational drug-coated sinus balloon. The 70-person, randomized, double-blind trial was designed to compared treatment with Intersect ENT’s DCB when randomized against an uncoated balloon control. The study missed the primary endpoint, frontal sinus […]
Boehringer Ingelheim touts Spiolto Respimat inhaler data
Boehringer Ingelheim said yesterday that results from a study of its Spiolto Respimat inhaler showed benefits including improving symptoms and lung function in treating chronic obstructive pulmonary disease. The Spiolto Respimat is a soft-mist inhaler designed for the treatment of airflow obstruction in patients with COPD. A pooled analysis exploring COPD treatment with the tiotropium-based […]
Philips touts Stellarex balloon study
Royal Philips (NYSE:PHG) said today that third-party data from worldwide clinical trials for the Stellarex drug-coated balloon showed that there was no difference in mortality between patients treated with the device compared to uncoated percutaneous transluminal angioplasty. The primary analysis consisted of three-year patient-level data from the Illumenate pivotal trial and the Illumenate European randomized controlled […]
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