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BioWorld - Thursday, April 30, 2026
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Clinic Roundup

Nov. 12, 2013
• Galena Biopharma Inc., of Portland, Ore., presented a poster at the Society for Immunotherapy of Cancer Conference in National Harbor, Md., detailing results of the Phase I portion of its trial for the folate-binding protein vaccine, a cancer immunotherapy product in development for patients with HLA A2-positive cancers.
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Pharma: Other News To Note

Nov. 12, 2013
• Sunovion Pharmaceuticals Inc., of Marlborough, Mass., said the FDA approved Aptiom (eslicarbazepine acetate), an antiepileptic drug, for use as adjunctive treatment of partial-onset seizures.
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Shire Offers $4.2B for Viropharma to Boost Rare Disease Portfolio

Nov. 12, 2013
By Nuala Moran
LONDON – Shire plc is paying $4.2 billion to acquire Viropharma Inc, giving it a stranglehold on the market for hereditary angioedema (HAE) treatments, with the leading products for prophylaxis and for treating acute attacks both residing in the same portfolio.
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One Down; One to Go: Zalicus Bust Leaves Pain Bid Standing

Nov. 12, 2013
By Randy Osborne
Something of a mystery surrounds the Phase II dashed hopes with Zalicus Inc.’s oral calcium channel blocker Z160, which missed its primary endpoints in two pain indications, testing patients with lumbosacral radiculopathy and postherpetic neuralgia.
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FDA: Generic Industry Mature Enough for Full Responsibility

Nov. 12, 2013
By Mari Serebrov
Now that generic drugs are a fully grown industry in the U.S., the FDA said it’s time for generic drugmakers to take responsibility for the labeling of their products and face the same liability as the makers of brand drugs and biologics.
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FDA Fast Tracks Alnylam RNAi Drug; Firm Launches Phase III

Nov. 12, 2013
By Catherine Shaffer
Alnylam Pharmaceuticals Inc. received coveted fast-track designation for its RNAi therapeutic, patisiran, to accelerate its development for treatment of transthyretin (TTR)-familial amyloid polyneuropathy (FAP). The company recently reported positive Phase II results for the product, and has begun a Phase III program.
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Santarus Clause: Patent Expiry Not a Hitch in $2.6B Salix Deal

Nov. 11, 2013
By Randy Osborne
Salix Pharmaceuticals Ltd.’s $2.6 billion buyout of Santarus Inc. for $32 per share in cash provides entry into the primary care physician space, while bringing aboard more products – albeit a couple that are facing patent expirations fairly soon.
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Change a Constant in Burgeoning Chinese Market

Nov. 11, 2013
By Marie Powers
Although 2013 is the third year for the BIO Convention in China – BIO China, as it’s more commonly known – it’s back to the basics this year as the Biotechnology Industry Organization (BIO) and the China Center for Pharmaceutical International Exchange seek to strengthen ties between their members and to connect Western biopharmas with players in the emerging Chinese biotech market.
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Lemtrada’s sBLA Submission for MS Faces Major Issues

Nov. 11, 2013
By Peter Winter
The FDA released its briefing documents in advance of the Peripheral and Central Nervous System Drugs Advisory Committee meeting Nov. 13. The committee will discuss the supplemental biologics license application (sBLA) for Lemtrada (alemtuzumab) injection, submitted by Genzyme Corp., a Sanofi SA company, for use in multiple sclerosis (MS).
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Arena Builds Pharma Muscle in Expanded Belviq Deal with Eisai

Nov. 11, 2013
By Jennifer Boggs
Shares of Arena Pharmaceuticals Inc. jumped 17.4 percent Friday on news of an expanded alliance with Eisai Inc. for obesity drug Belviq (lorcaserin), a deal that brings $60 million up front and aims to advance the drug into new commercial markets and possibly new indications.
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