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Home » Newsletters » BioWorld

BioWorld

Aug. 31, 2016

View Archived Issues

Third approval flows from U.S. biosimilar pipeline

The FDA approved its third biosimilar Tuesday: Sandoz Inc.'s Erelzi, a biosimilar to Amgen Inc.'s Etanercept. Read More

New kind of guidance needed for emerging technology systems

Recognizing that the future is now, drug and device companies are joining with health care providers and software/IT manufacturers in clamoring for a new kind of FDA guidance to clarify the regulatory path for treatment systems that combine digital health products with drugs. Read More

Ariad completes rolling NDA for brigatinib

Nearly six months after downsizing, in part to focus on gaining regulatory approvals for its anaplastic lymphoma kinase (ALK) inhibitor brigatinib, Ariad Pharmaceuticals Inc. has completed a rolling submission of a new drug application for the candidate. Read More

India's manufacturing quality issues are in the spotlight, again

NEW DELHI – Indian drug manufacturing plants were under the scanner again in August, with the U.S. FDA issuing warning letters to Pfizer Inc. and Frontida Biopharm Inc. for regulatory lapses observed during inspections in plants operating in India. Read More

Two for three in ITP: Rigel's late-stage study echoes earlier work, Wall Street awaits more

As investors look ahead to results later this year from the second phase III trial with Rigel Pharmaceuticals Inc.'s fostamatinib, principal investigator James Bussel said "the fact that, at least so far, the results in this [first] phase III trial mimic and are very similar to the first phase II trial gives all of us on the Rigel team a lot of confidence." Read More

Marathon moves deflazacort toward home stretch in DMD

While Sarepta Therapeutics Inc. waits for the FDA's decision on its DMD candidate, eteplirsen, Marathon Pharmaceuticals LLC is quickening its pace in the race to approval in the field. Read More

Together again: Former Synageva execs return with startup Kiniksa

Last year, Synageva Biopharma Corp. went to Alexion Pharmaceuticals Inc. in one of the year's biggest buyouts – an $8.4 billion cash and stock deal notable for its whopping 140 percent premium. With the ink barely dry on that deal, the former execs of the rare disease firm decided they were ready for another round, regrouping to create new startup Kiniksa Pharmaceuticals. Read More

Other news to note

Bioasis Technologies Inc., of Vancouver, British Columbia, said the results of an in vivo study of the treatment of metastatic HER2+ breast cancer brain tumors in an animal model using BT2111, their trastuzumab-melanotransferrin (Transcend) conjugate, have been published in Pharmaceutical Research. Read More

Appointments & advancements

Retrophin Inc., of San Diego, named Neil McFarlane chief operating officer. Read More

Regulatory front

The California Supreme Court ruled 4-3 Monday that defendants may be sued in the state for claims with no connection to California. Read More

In the clinic

Daiichi Sankyo Co. Ltd., of Tokyo, reported results from the global phase IIIb ENSURE-AF study of 2,199 patients with non-valvular atrial fibrillation (NVAF) undergoing electrical cardioversion, or low-energy shocks to trigger normal heart rhythm). Read More

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