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BioWorld - Thursday, December 11, 2025
Home » Newsletters » BioWorld

BioWorld

July 27, 2016

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In the clinic

Clearside Biomedical Inc., of Alpharetta, Ga., reported additional top-line data from its phase II trial called Tanzanite. Read More

Financings

Cardiome Pharma Corp., of Vancouver, British Columbia, priced its previously announced underwritten public offering of 10 million common shares at $3 per common share, for aggregate gross proceeds of $30 million. Read More

Other news to note

Viking Therapeutics Inc., of San Diego, reported top-line results from a proof-of-concept study in a mouse model of X-linked adrenoleukodystrophy (X-ALD), showing that VK0214 rapidly reduced plasma very long chain fatty acid (VLCFA) levels by more than 25 percent in treated animals compared with vehicle controls (p < 0.01). Read More

Regulatory front

An expected increase in the number of generic drug applications submitted to the FDA is lowering the ANDA user fees for fiscal 2017, but that savings will be offset by higher facility fees. Read More

Governments should lead, not follow on prioritizing drug development

A major problem facing people sickened or threatened by neglected diseases is that the for-profit global biopharmaceutical industry sets the agenda for new drug development, and their suffering is not considered worth the investment. Read More

Reverse approach leads to Immunoqure's auto-antibody repertoires

DUBLIN – Immunoqure AG is parlaying an extensive auto-antibody characterization effort involving a cohort of patients with an ultra-rare autoimmune disease into an antibody discovery engine that has uncovered large numbers of highly active antibodies with the potential to address a swath of immunological conditions. Read More

CRISPR heading to the clinic: First gene-editing trial set to start in China

HONG KONG – A team of Chinese scientists from Sichuan University's West China Hospital in the city of Chengdu is one step closer to initiating the world's first human CRISPR clinical trial to test gene-editing technology in a lung cancer treatment. Read More

'Nottingham Dollies' collectively aging well, study reports

Comprehensive health assessment of a group of 13 cloned sheep, including the "Nottingham Dollies," four sheep that were created from the same cell line as Dolly the Sheep, has shown that, as a group, the animals were no more prone to health problems than naturally conceived sheep of the same age. Read More

Alphabet droop? ABC key in Celgene DLBCL PFS hit, OS miss; outlook ROBUST

As Celgene Corp. made ready to unveil second-quarter earnings Thursday, onlookers were disappointed but not hugely surprised by the firm's disclosure that it would not seek approval in diffuse large B-cell lymphoma (DLBCL) with Revlimid (lenalidomide), due to a miss on the key secondary endpoint of overall survival (OS) in interim results from a phase III trial called REMARC. Read More

Tokai terminates pivotal prostate cancer trial; stock plummets

Tokai Pharmaceuticals Inc. called off a pivotal phase III trial comparing its triple-acting prostate cancer drug, galeterone, to Xtandi (enzalutamide, Medivation Inc.) after a data monitoring committee determined the trial was unlikely to meet its primary endpoint. Read More

Street to Gilead: Hurry up already on dealmaking front

Disappointing second-quarter earnings at Gilead Sciences Inc. forced shares (NASDAQ:GILD) down 8.5 percent Tuesday, closing at $81.05 for a loss of $7.50, and led to a chorus of calls for the company to pull the trigger on a big deal. Read More

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