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11/20/2017

A group of 27 European states will decide today on where the new location of the European Medicines Agency will be after Brexit. They will select from 19 candidates.

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European Medicines Agency
11/20/2017

Amsterdam was chosen as the new site of the European Medicines Agency after three rounds of voting and a tiebreaking coin toss. More than 65% of EMA staff said they would be willing to relocate to that city or to Milan, which tied with Amsterdam in the final round of voting, according to the agency, which warned of permanent damage to the regulatory system if it did not have to sufficient staff to perform assessment and safety monitoring functions.

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Endpoints News
11/20/2017

The US FDA, European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency are working on a way to allow drugmakers to conduct a single development plan for antibiotics that will be accepted by all three agencies. Regulators from the three agencies had their third meeting in October and also agreed on the importance of studying antibiotics in pediatric patients.

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Regulatory Focus
11/20/2017

The FDA granted approval to Zydus Cadila's ethacrynate sodium for injection USP in 50 mg/vial, which is intended to reduce the swelling caused by congestive heart failure, cancer, liver and kidney disease and other disease conditions. The drug will be manufactured at the company's facility in Moraiya, Ahmedabad.

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PharmaBiz (India)
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FDA, Zydus Cadila
11/20/2017

Bayer's Cipro, or ciprofloxacin inhalation powder, was not recommended by an FDA panel for use in adult patients to reduce exacerbations caused by bacterial respiratory pathogens and noncystic fibrosis bronchiectasis. The drug did not achieve the primary endpoint of improving median time to first pulmonary exacerbation versus placebo use in 14- and 28-day on/off regimens of Cipro in a late-stage study.

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BioCentury
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Bayer, FDA
11/20/2017

The FDA changed the action date to May 8, 2018, for Lipocine's Tlando testosterone undecanoate to allow more time for the analysis of additional data filed with the amendment to the new-drug application for the hypogonadism treatment. The advisory committee meeting date of Jan. 10, 2018, remains unchanged.

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BioCentury
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FDA, Lipocine
11/20/2017

A recall was issued by Green Cuisine for 36,854 pounds of Trader Joe's brand chicken salad and turkey salad because of the presence of glass fragments and hard silica. Affected in the recall were White Meat Chicken Salad, Turkey Cranberry Apple Salad and Curried White Chicken Deli Salad, all of which have use-by dates of Nov. 10 through Nov. 21 and were sold in 12 states.

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Trader Joe
11/20/2017

AdvaMed expressed uncertainty about whether the Indian government will address the medical device industry's concerns on stent pricing caps in a hearing that will be held by the National Pharmaceutical Pricing Authority next year, said Abby Pratt, vice president of global strategy and analysis at AdvaMed. "We're seeing reports directly from hospitals and others that the so-called benefits of the price control -- the cost savings from the price controls -- are not being passed along to patients," Pratt said, adding that research shows that distributors and local hospitals are responsible for high costs.

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Abby Pratt, Indian government
11/20/2017

The first-in-human validation of Implandata Ophthalmic Products' next-generation Eyemate microsensor implant was performed at the University Eye Hospital in Germany. The device, which comes with the implantable microsensor and a hand-held device for implant powering and data readout, allows for continuous remote monitoring of intraocular pressure and reduces the size of incision for implantation from 4 mm to 2.7 mm.

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MassDevice (Boston)
11/20/2017

An initial public offering brought in $89.6 million for scPharmaceuticals. The FDA is reviewing the firm's Furoscix, or scFurosemide, as a treatment for decompensated heart failure outside of the inpatient setting, with an action date of June 23, 2018.

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BioCentury
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FDA