This week, the European Medicines Agency recommended the suspension of more than 300 generic drug approvals and applications, after they uncovered “unreliable” tests conducted by Micro Therapeutic Research Labs. The India-based contract research firm is part of the country’s drug-testing industry, which has faced problems with international regulators in recent years. European officials have reportedly […]
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Organogenesis launches PuraPly antimicrobial clinical program
Organogenesis said today that it launched its PuraPly Antimicrobial clinical research program, which will evaluate patients treated with PuraPly AM for up to 12 weeks. The 1st studies have started enrolling patients, according to Organogenesis. The Canton, Mass.-based company’s PuraPly AM is a 510(k)-cleared device indicated for the management of acute and chronic wounds. The […]
Cardiologist Dr. Kereiakes: the Synergy bioabsorbable stent boasts flexibility & safety
Dr. Dean Kereiakes knows a thing or 2 about coronary stents – he’s been a principal investigator in a number of clinical trials evaluating coronary stents over the past 20 years. So it counts when Kereiakes names the Synergy stent made by Boston Scientific‘s (NYSE:BSX) “the safest stent yet.” An interventional cardiologist at the Christ Hospital, he was also a […]
CMS updates on criteria for Dexcom G5 coverage
Shares in DexCom Inc. (NSDQ:DXCM) jumped 9% today after the Centers for Medicare & Medicaid Services updated the criteria for coverage of the company’s G5 Mobile continuous glucose monitor. The device is the only therapeutic CGM classified as durable medical equipment under Medicare Part B. Patients covered by Medicare who have Type I or II diabetes and […]
Lilly details plans for $850m investment in U.S. operations
Eli Lilly (NYSE:LLY) said today that it plans to invest $850 million in its U.S. operations in 2017. The company presented details of its plans at the Lilly Technology Center in Indianapolis, joined by federal, state and local government officials. Lilly said it will invest in an $85 million expansion of its Trulicity device assembly […]
Abbott divests 60% of its stake in Mylan
Abbott (NYSE:ABT) divested 60% of its remaining stake in Mylan (NSDQ:MYL) this week, according to regulatory filings, disposing of 44 million shares at $41.60 apiece. The trade was valued at $1.7 billion. In 2014, Mylan bought Abbott’s generics business outside the U.S. in a deal that rang in at nearly $5.3 billion. The deal allowed Canonsburg, Penn.-based Mylan […]
Gamida Cell wins additional EMA orphan drug designation for NiCord
Gamida Cell said today that the European Medicines Agency granted its NiCord cell graft an additional orphan drug designation as a treatment for hematopoietic stem cell transplantation, or bone marrow transplantation. The treatment is a graft derived from umbilical cord blood which has been expanded and enriched with stem and progenitor cells, according to the […]
BioClin Therapeutics raises $30m to advance antibody-drug combo therapy
BioClin Therapeutics said yesterday that it closed a $30 million Series B round led by new investors Sofinnova Ventures and Ysios Capital. Existing investors HealthCap, Life Sciences Partners and Tekla Capital Management also invested. The company plans to use the newly-acquired funds to advance its lead candidate, B-701, as a treatment for metastatic bladder cancer in […]
Intact Vascular finishes patient enrollment for angioplasty clinical trial
Intact Vascular said today that it finished enrollment for the Toba II clinical trial evaluating its Tack Endovascular System in combination with standard or drug coated balloon angioplasty in arteries above the knee. The company’s trial enrolled 210 patients and will focus on the superficial femoral artery and the proximal segment of the popliteal artery, […]
Tandem Diabetes Care prices $22.5m public offering
Tandem Diabetes Care (NSDQ:TNDM) today announced the pricing details of a $22.5 million underwritten public offering. The company priced 18 million shares of its common stock at $1.25 apiece. Tandem also gave underwriters a 30-day option to buy up to an additional 2.7 million shares of common stock at the public offering price. The offering is expected […]
