Search Results for “FDA” – Page 171 – media

Fresenius dumps its $4.3B Akorn buyout, and a ‘legal battle royale’ could come next

Akorn has filed a complaint in Delaware Chancery Court asking Fresenius to follow through on the pair's buyout agreement. A year after inking its $4.3 billion Akorn buyout agreement, Fresenius intends to scrap the deal. Akorn, though, isn’t having it, and analysts say a “legal battle royale” could be on the horizon.
- Source: fiercepharma
- 629
- April 26, 2018
acquisition Series
Steth IO launches digital stethoscope housed within smartphone case

On Tuesday, Bothell, Washington-based Steth IO announced the launch of its smartphone-based digital stethoscope.
- Source: MobiHealthNews
- 842
- April 26, 2018
FDA medtech mHealth New Approvals
Urotronic gets OK for advanced trial to treat narrowed urethras

Plymouth-based medical device maker Urotronic is ramping up clinical research on its Optilume drug-coated balloon to treat men with narrowed urethras, accelerating the data-gathering process for its novel device.
- Source: StarTribune
- 1,917
- April 26, 2018
FDA medical device medtech Researches
Next year’s flu shot will shield only 20% against dominant strain

Recent doubts about traditional egg-based flu shots could mean more business for vaccines manufactured in cells. Protection against the dominant H3N2 flu strain offered by the coming season’s flu vaccine will still be far from optimal—putting it mildly. And that's thanks to the widely used manufacturing process based on eggs, a new study predicts.
- Source: fiercepharma
- 667
- April 24, 2018
H3N2 flu strain Researches vaccine
NEJM editorial slams design of GSK’s pivotal trial of 3-in-1 COPD drug Trelegy

GSK is shifting resources towards key therapeutic classes, including respiratory disease.
- Source: fiercepharma.
- 600
- April 24, 2018
Company Insight GSK respiratory disease Trelegy Ellipta
Amid tough respiratory competition, AstraZeneca inks Symbicort outcomes-based deals

It's no secret that respiratory drugs make up a crowded field, and forthcoming generics will make the competition tougher still. AstraZeneca's Symbicort is no stranger to the fallout, either, what with payers pressing prices and new rivals grabbing share.
- Source: fiercepharma
- 635
- April 20, 2018
AstraZeneca Company Insights Symbicor
Amgen Presents First-Of-Its-Kind Data At AAN Annual Meeting Reinforcing Robust And Consistent Efficacy Of Aimovig™ (erenumab) For Migraine Patients With Multiple Treatment Failures

The LIBERTY Trial was Conducted in Patients who Have Tried Two to Four Therapies Without Success -- a Uniquely Difficult-to-Treat Population Often Excluded From Migraine Prevention Trials Patients Taking Aimovig had Nearly Three-Fold Higher Odds of Having Their Migraine Days cut by Half or More Compared to Placebo Safety and Tolerability Were Consistent With Results Seen in the Pivotal Clinical Program; Over 97 Percent of Those Taking Aimovig Completed the Double-Blind Treatment Phase Data Selected by the American Academy of Neurology Science Committee as one of the Most Noteworthy Presentations at 2018 Annual Meeting
- Source: prnewswire
- 640
- April 20, 2018
Amgen migraine
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combination as First-Line Treatment

Bristol-Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).
- Source: news.bms
- 902
- April 17, 2018
New Approvals Opdivo RCC Yervoy
Updated Overall Survival Data for LYNPARZA® (olaparib) in gBRCA-Mutated HER2-Negative Metastatic Breast Cancer Presented at AACR

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today presented data from the Phase III OlympiAD trial, showing the final overall survival (OS) results for LYNPARZA®(olaparib) in metastatic breast cancer at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, April 14-18, 2018.
- Source: businesswire
- 876
- April 17, 2018
AstraZeneca breast cancer Clinical Trials Merk
Shire Announces Sale of Oncology Business to Servier for $2.4 Billion

Sale of Oncology business unlocks embedded value within Shire`s portfolio and sharpens focus on core areas reinforcing our leadership in rare diseases
- Source: finance.yahoo
- 657
- April 17, 2018
Company Insights oncology rare diseases

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