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Home » Newsletters » BioWorld

BioWorld

March 14, 2019

View Archived Issues

Akari skyrockets as FDA clears pivotal trial for dual-action Coversin in pediatric TMA

LONDON – Shares in Akari Therapeutics plc (NASDAQ:AKTX) shot up 224 percent to close at $5.90 per share Wednesday, with shares changing hands at nearly 3,000 times the average volume, after the company announced it has FDA approval for a pivotal trial of Coversin in pediatric thrombotic microangiopathy (TMA), a frequently fatal complication of bone marrow transplants. Read More

Aerie wins FDA nod for IOP-lowering product Rocklatan

A little less than a year after launching Rhopressa (netarsudil), its first drug for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, Aerie Pharmaceuticals Inc. has won FDA approval for Rocklatan, a once-daily eye drop that adds the widely prescribed prostaglandin analogue (PGA) latanoprost to the mix.  Read More

Beware of consequences, Sub Health told as it considers bills to speed generic entry

"We're actually on the threshold of doing something," Rep. Peter Welch (D-Vt.) said Wednesday as the House Energy and Commerce Subcommittee on Health took up seven bills aimed at increasing generic and biosimilar competition in the U.S. in a bid to reduce prescription drug prices. Read More

Advancing new medicines in the pipeline to treat sickle cell disease

More than 100,000 Americans are currently living with sickle cell disease (SCD), which occurs in approximately one out of every 500 African-American births and one out of every 36,000 Hispanic-American births, according to estimates by the CDC. In 2017 and 2018, two new medicines to treat SCD were approved by the FDA – the first therapies to be marketed in almost two decades. Read More

Scientists grow kidney tubules derived from ASCs in microfluidic chips

LONDON – The researchers who developed the first adult stem cell (ASC)-derived organoid of the intestine, the "mini-gut," have now applied the same technique to grow kidney tubules from human kidney ASCs in microfluidic chips. Read More

New Zealand's CuroNZ tests neural regeneration peptides for epilepsy, Lennox-Gastaut

PERTH, Australia – Auckland, New Zealand-based CuroNZ has begun a small proof-of-concept study in epilepsy for a cell-penetrating peptide that crosses the blood-brain barrier. Read More

Appointments and advancements

Bioasis Technologies Inc., of Guilford, Conn., appointed Deborah A. Rathjen president and CEO. Read More

Financings

Trovagene Inc., of San Diego, said it received approximately $3 million in proceeds from holders exercising common stock purchase warrants at $6.60 each. The warrants were issued as part of units sold in the company's $18 million public offering, which closed in June last year. Read More

Other news to note

Hoth Therapeutics Inc., of New York, entered a commercial evaluation sublicense and option agreement with the University of Maryland, Baltimore and Isoprene Pharmaceuticals Inc., of Baltimore, for retinoic acid metabolism-blocking agents as treatments for dermatological conditions. Terms of the deal weren't disclosed. Read More

Regulatory front

The FDA approved a new generic of angiotensin II receptor blocker Diovan (valsartan) for blood pressure and heart failure, after prioritizing review of the application in the wake of recent shortages following multiple valsartan recalls due to nitrosamine impurities.  Read More

Clinical data for March 13, 2019

Read More

Regulatory actions for March 13, 2019

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