Industry News

• Medtronicreports IN.PACT global study three-year data  Medtronic data announced continue to reinforce the safety, durability, and consistency of the IN.PACT(TM) Admiral(TM) drug-coated balloon in real-world patients with peripheral arterial disease.
  September 23, 2018  
• Landmark study shows treatment with Abbott's MitraClip® is superior to medical therapy  Abbott announced positive clinical study results from a randomized controlled trial comparing treatment with the MitraClip® device to guideline-directed medical therapy in select patients with secondary mitral regurgitation as a result of advanced heart failure.
  September 23, 2018  
• Boston Scientific Eluvia drug-eluting stent demonstrates superior results  Boston Scientific announced positive 12-month data from the IMPERIAL trial, the first head-to-head drug-eluting stent trial in the superficial femoral artery. In the IMPERIAL trial, the Eluvia stent exhibited superior rates of primary patency.
  September 22, 2018  
• Novartis to file for new Lucentis® (ranibizumab) indication in retinopathy of prematurity  Novartis announced results from a Phase III study of Lucentis® (ranibizumab) versus laser surgery (current standard of care) in premature infants with retinopathy of prematurity. Lucentis pharmacologically targets and reduces the elevated intraocular level of VEGF.
  September 22, 2018  
• Novartis announces positive new phase III brolucizumab (RTH258) data  Novartis announced a new data analysis showing that retinal fluid was detected less often in patients treated with brolucizumab (RTH258) 6 mg versus aflibercept over four visits between weeks 36 to 48. Retinal fluid is a key marker of disease activity in nAMD.
  September 22, 2018  
• GTx announces top-line results from placebo-controlled ASTRID trial of enobosarm  GTx announced that the ASTRID Trial, a Phase 2 double-blind, placebo-controlled clinical trial of orally-administered enobosarm (3 mg or 1 mg) in post-menopausal women with stress urinary incontinence (SUI), did not achieve statistical significance on the primary endpoint.
  September 21, 2018  
• Mylan and Biocon announce positive CHMP opinion for Fulphila®, biosimilar pegfilgrastim  Mylan and Biocon announced that the EMA's Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of Fulphila®, a biosimilar to Amgen's Neulasta® (pegfilgrastim).
  September 21, 2018  
• Seattle Genetics announces ADCETRIS® (Brentuximab Vedotin) approval in Japan  Seattle Genetics announced that its collaborator, Takeda Pharmaceutical, has received approval from the Japanese MHLW for ADCETRIS (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine as a frontline treatment option for CD30-positive Hodgkin lymphoma patients in Japan.
  September 21, 2018  
• Roche announces CHMP recommendation for EU approval of Venclyxto plus MabThera for CLL   Roche announced the EU Committee for Medicinal Products for Human Use has adopted a positive opinion for Venclyxto® (venetoclax) in combination with MabThera® (rituximab) for the treatment of people with chronic lymphocytic leukaemia who have received at least one prior therapy.
  September 21, 2018  
• Mylan launches authorized generic of Ampyra® tablets  Mylan announced the U.S. launch of Dalfampridine ER Tablets, 10 mg, the authorized generic version of Acorda's Ampyra®, which is indicated to improve walking in adult patients with multiple sclerosis. Acorda's U.S. Patent No. 5,540,938, previously upheld by the District Court, expired July 30, 2018.
  September 21, 2018  

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