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Wall Street Beat

Regeneron touts one-year diabetic retinopathy data for Eylea

February 11, 2019 By Sarah Faulkner

Regeneron - updated

Regeneron Pharmaceuticals (NSDQ:REGN) touted one-year results from a Phase III trial of its Eylea aflibercept injection in people with moderately severe to severe non-proliferative diabetic retinopathy. The primary endpoint of the two-year Panorama trial is the proportion of patients who experience a two-step or greater improvement in the ‘diabetic retinopathy severity scale.’ Of the 133 people […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals, Wall Street Beat Tagged With: Regeneron

Pulmatrix announces 1-for-10 reverse split, $1m offering

February 8, 2019 By Fink Densford

Pulmatrix

Pulmatrix (NSDQ:PULM) this week announced both a 1-for-10 reverse split of its stock and the closing of an offering which brought in approximately $905,000. On Tuesday, the Lexington, Mass.-based company said that it initiated a 1-for-10 reverse split of its common stock, putting a single share in the hands of each shareholder for each 10 shares they […]

Filed Under: Business/Financial News, Featured, Wall Street Beat Tagged With: Pulmatrix Inc.

Pulmatrix wins FDA nod for PhII trial of inhaled anti-fungal therapy

February 7, 2019 By Sarah Faulkner

Pulmatrix

Pulmatrix (NSDQ:PULM) said today that the FDA approved a Phase II trial of the company’s inhaled formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis in people with asthma. The Lexington, Mass.-based company plans to kick off the trial in the first half of 2019, with top-line data expected in the second […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Respiratory, Wall Street Beat Tagged With: Pulmatrix Inc.

Reva Medical cuts 44% of workforce

February 5, 2019 By Sarah Faulkner

Reva Medical updated logo

Reva Medical (ASX:RVA) said this week that it plans to cut its workforce by 44%, leaving 22 employees at the San Deigo-based company. In a statement, Reva CEO Reggie Groves cited current market conditions as the primary reason for the staffing reduction. “While we continue to see strong interest in Fantom Encore and are excited about […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular, Wall Street Beat Tagged With: Reva Medical

FDA rejects Alkermes depression drug NDA

February 4, 2019 By Fink Densford

Alkermes

Alkermes (NSDQ:ALKS) said last Friday that the FDA rejected the company’s new drug application for its ALKS 5461 drug intended to treat patients with major depressive disorder. The Dublin, Ireland-based company’s ALKS 5461 once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with MDD for whom standard antidepressant therapies have […]

Filed Under: Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: alkermes

Mylan wins race for generic Advair approval

January 31, 2019 By Nancy Crotti

Mylan logo - updated

FDA has approved the first generic of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug, this one by Mylan (NSDQ:MYL), six months after rejecting Mylan’s application. Canonsburg, PA-based Mylan’s shares jumped 7% to $30.82 at market close after yesterday’s late-afternoon announcement, and were trading at $30.96 mid-morning today. GSK’s stock dipped 2% to$38.70 on the news late yesterday, but had […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Respiratory, Uncategorized, Wall Street Beat Tagged With: FDA, GlaxoSmithKline plc, Mylan, Novartis

Baxter ticks up on Q4, 2018 beats

January 31, 2019 By Brad Perriello

Bax

Baxter (NYSE:BAX) beat Wall Street’s consensus forecast with both its fourth-quarter and full-year results, to tepid reaction from investors, who sent the healthcare giant’s share price up a hair today. Deerfield, Ill.-based Baxter posted a return to black ink for the three months ended Dec. 31, 2018, logging profits of $348 million, or 65¢ per share, […]

Filed Under: Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Baxter

Surmodics posts Street-beating FY2019 Q1 earnings

January 30, 2019 By Fink Densford

SurModics

Surmodics (NSDQ:SRDX) today posted fiscal year 2019 first quarter earnings that beat expectations on Wall Street. The Eden Prairie, Minn.-based company posted profits of $1.3 million, or 9¢ per share, on sales of approximately $22.2 million for the three months ended December 31, seeing a swing from the red on the bottom line while sales grew […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Surmodics

BioCorRx wins $5.6m grant for sustained release naltrexone implant

January 28, 2019 By Sarah Faulkner

BioCorRx updated logo

BioCorRx (OTC:BICX) announced this month that it won a two-year grant from the NIH’s National Institute on Drug Abuse to support the development of its sustained release naltrexone implant for the treatment of opioid use disorder. The grant includes $2.8 million for Feb. 1, 2019 to Jan. 31, 2020, followed by $2.8 million for the second […]

Filed Under: Drug-Device Combinations, Featured, Funding Roundup, Implants, Pharmaceuticals, Wall Street Beat Tagged With: BioCorRx, National Institutes of Health

BTG touts use of radiopaque drug-eluting bead

January 28, 2019 By Sarah Faulkner

BTG's Interventional Oncology Logo

BTG (LON:BTG) said this month that an Australian patient was treated with its radiopaque drug-eluting bead. The DC Bead Lumi product is the first commercial drug-eluting bead that can be loaded with doxorubicin or irinotecan to treat tumors in patients with hepatocellular carcinoma and liver metastases from colorectal cancer, according to BTG. The beads’ radiopacity enable […]

Filed Under: Drug-Device Combinations, Featured, Oncology, Pharmaceuticals, Wall Street Beat Tagged With: BTG

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