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Home » Newsletters » BioWorld

BioWorld

March 20, 2019

View Archived Issues

Some eye Urovant aslant, weigh Myrbetriq metrics; 'misplaced' ideas in OAB?

Urovant Sciences Ltd.'s favorable top-line data from the phase III study called Empowur with vibegron in adults with overactive bladder (OAB) did not bring the stock-boosting effect that some might have expected, as doubters fretted that the once-daily beta-3 adrenergic receptor agonist did not perform well enough relative to generic tolterodine, even though – as J.P. Morgan analyst Eric Joseph pointed out – the latter was not meant for a head-to-head comparison. Read More

Regen med, biosimilars can drive more Asian innovation

SINGAPORE – For David Lane, chief scientist at the Agency for Science, Technology and Research (A*STAR), it is clear what is required for driving innovation in Asia. "You need to sustain basic science," Lane said in his opening keynote speech at the Phar-East Pharma and Biotech Festival on Tuesday. "People want instant results, but sustaining basic science is the key to innovation." Read More

Oncimmune scoops up Protagen, gains platform for identifying autoantibodies

LONDON – Oncimmune Holdings plc is extending its reach in autoantibody-based testing, acquiring Protagen Diagnostics in an all-share deal that values the German company at up to £4.11 million (US$5.45 million). Read More

New approach makes immune cells kiss and tell

Long before any currently available detection method can find a tumor, the future patient's immune cells have found that tumor and are working on eliminating it. Now, researchers from Stanford University have developed a method to use such immune cells as sentinels, enabling earlier detection of tumors. Read More

Use of CROs continues to grow, but companies remain skeptical

The use of contract research organizations (CROs) by drug developers has continued to grow at an 8 percent clip annually since 2010, reaching an estimated $86 billion in 2018, according to a new report from the Tufts Center for the Study of Drug Development (CSDD). Read More

Regulatory front

A federal district judge has given the FDA through April 28 to reconsider its demand that Vanda Pharmaceuticals Inc., of Washington, conduct additional chronic toxicity studies of its NK1 antagonist, tradipitant, in animals.  Read More

Earnings

Akebia Therapeutics Inc., of Cambridge, Mass., reported pro forma unaudited 2018 sales of $96 million for the hyperphosphatemia and iron deficiency anemia drug Auryxia (ferric citrate), representing 72 percent growth over 2017 sales.  Read More

Financings

Evolus Inc., of Newport Beach, Calif., said it closed a $100 million senior debt facility with Oxford Finance LLC to help fund the launch of Jeuveau (prabotulinumtoxinA-xvfs), approved last month by the FDA to treat severe glabellar (frown) lines in adults.  Read More

Other news to note

Marizyme Inc., of Fort Collins, Colo., signed a letter of intent to evaluate the licensing or acquisition of certain undisclosed non-opiate pain relief and rare disease assets from Chromocell Corp., of North Brunswick, N.J. Read More

Clinical data for March 19, 2019

Read More

Regulatory actions for March 19, 2019

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