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Home » Newsletters » BioWorld

BioWorld

April 18, 2018

View Archived Issues

TLR9 agonists hit and IDO candidate misses when combining drugs with immuno-oncology

CHICAGO – With blocking the PD-1 pathway working so well in so many tumor types, a seemingly never-ending number of companies are taking an "if you can't beat 'em, join 'em" approach, adding their therapies to anti-PD-1/PD-L1 drugs.  Read More

Ultragenyx, Kyowa Hakko Kirin land first FDA-approved XLH therapy

Ultragenyx Pharmaceutical Inc. and partner Kyowa Hakko Kirin Co. Ltd. (KHK) have won FDA approval for Crysvita (burosumab), making it the first U.S.-approved treatment for X-linked hypophosphatemia (XLH), a rare, inherited form of rickets. The chronic progressive musculoskeletal disorder is estimated to affect about 3,000 children and 9,000 adults in the U.S. Read More

GW's fate not 'doobie-ous' as CBD adcom approaches

GW Pharmaceuticals plc CEO Justin Gover said solid science and years of cooperating with not only the FDA but also with the Drug Enforcement Administration (DEA) allowed his firm to reach the brink of an FDA panel meeting on its cannabidiol (CBD) oral solution for types of epilepsy, potentially followed by approval in June. Read More

FDA will have to make the case for its 'bold' 2019 budget request

"The Trump administration's FY 2019 budget request for FDA is likely to be the boldest and largest funding request in recent memory, and maybe ever," Rep. Robert Aderholt (R-Ala.) said in opening the first congressional hearing on the agency's fiscal 2019 budget. Read More

Denovo kicks off phase III biomarker-driven trial in DLBCL

SHANGHAI – Denovo Biopharma LLC, a cross-border biotech with offices in San Diego and Shanghai, has dosed the first patient in a phase III trial of DB-102 (enzastaurin) to treat diffuse large B-cell lymphoma (DLBCL). DB-102 is a serine/threonine kinase inhibitor of the PKC beta and AKT pathways. Read More

'20 years to overnight success': Panel offers advice navigating between academia and industry

CAMBRIDGE, U.K. – They are currently relishing the challenges of academic research, but 100 early career scientists gathering in Cambridge this week need new skills if they are to fulfill their aspirations to be biotech entrepreneurs and industry leaders of tomorrow. Read More

Luye's Parkinson's disease drug enters phase III in China

HONG KONG – China' Luye Pharma Group Ltd. said its investigational drug with billion-dollar potential, rotigotine extended-release microspheres for injection (LY-03003), was granted the regulatory approval to enter phase III trials in China. Read More

New approach breaches 'firewall' between GWAS, effectors

Researchers have identified infection with Epstein-Barr virus (EBV), best known for causing mononucleosis, as a risk factor for seven autoimmune diseases. Read More

Unauthorized FDCs in cross-hairs of India's CDSCO

NEW DELHI – India's drug quality administration is cracking down on companies that manufacture and sell unauthorized and untested fixed-dose combination (FDC) drugs, following recent inspections that brought that issue into the spotlight. Read More

Financings

Mateon Therapeutics Inc., of South San Francisco, said it completed a private placement transaction with accredited investors for the sale of 14.625 million shares of unregistered Mateon common stock at 20 cents per share.  Read More

Appointments & advancements

AIT Therapeutics Inc., of New York, appointed Stephen J. DiPalma chief financial officer. Read More

Other news to note

Orphazyme A/S, of Copenhagen, Denmark, disclosed the creation of a U.S. subsidiary, based in Newton, Mass., called Orphazyme U.S. Inc., which will directly support the U.S. market and work to establish closer relationships with the medical, patient and financial communities. Read More

Regulatory front

The U.S. Court of Appeals for the Fourth Circuit struck down a Maryland law that went into effect in October to stop generic drug price gouging. The court, in a split decision, overturned a lower court by ruling that the law is unconstitutional because it directly regulates transactions that occur outside the state.  Read More

Clinical data for April 17, 2018

Read More

Regulatory actions for April 17, 2018

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Conference data: American Association for Cancer Research (Chicago)

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