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Home » Newsletters » BioWorld

BioWorld

Aug. 21, 2012

View Archived Issues

Clinic Roundup

• Juventas Therapeutics Inc., of Cleveland, treated the first patient in its Phase II STOP-HF trial. The 90-patient, placebo-controlled, randomized, double-blind study is evaluating the safety and efficacy of JVS-100 in late-stage heart failure. Read More

Stock Movers

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Other News To Note

• Imprimis Pharmaceuticals Inc., of Solana Beach, Calif., partnered with DPT Laboratories Ltd., of San Antonio, for a supply of Impracor for Phase III trials for musculoskeletal pain. DPT will also carry out work in formulation analysis, validation of quality assurance processes and procedures, and long-term stability testing. Read More

Affitech's AT001 Enters Clinic, as Delisting Looms

Clinical testing of Affitech A/S' lead antibody, AT001/r84, began this week, just as the company enters its final weeks as a publicly quoted entity and prepares to become a private entity, wholly owned by Russian investors. Read More

'Swim-at-Your-Own-Risk' Days of Social Media to End

Drugmakers that have been splashing in the social media waters may get official pool rules – in another two years. That's how long Congress, under the FDA Safety and Innovation Act (FDASIA), has given the FDA to issue guidance on its policy regarding drug promotion via social media. Read More

Regulus Files for IPO with Buyers Already Lining Up

Hot on the heels of two major partnership deals, Regulus Therapeutics Inc. filed a form S-1 with the SEC for a proposed initial public offering (IPO) for $57.5 million to fund its microRNA pipeline. Read More

Quad PDUFA is Nigh; Approval Likely for Next HIV Blockbuster

A robust second quarter, approval of HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for prophylactic use and competitor setbacks that could add to its lead in the race for an all-oral hepatitis C virus regimen all contributed to an impressive summer for Gilead Sciences Inc. Read More

Pharma: Other News To Note

• Reckitt Benckiser Pharmaceuticals Inc., of Richmond, Va., said the FDA approved the 4-mg and 12-mg doses of Suboxone (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence. Read More

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