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Home » Newsletters » BioWorld

BioWorld

Nov. 2, 2016

View Archived Issues

Pfizer halts its PCSK9 program as industry seeks clarity on class

After advancing its proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, bococizumab, into a global phase III development program that included six lipid-lowering and two cardiovascular (CVD) outcome trials (CVOTs), Pfizer Inc. blinked. Read More

Turnstone’s series B adds $41M to advance trials of oncolytic viral immunotherapy

DUBLIN – Turnstone Biologics Inc. raised $41.1 million in a series B round to accelerate clinical development of its next-generation oncolytic virus and cancer vaccine platform by deploying the technology in different combination settings, cancer indications and with different antigenic payloads. Read More

Upside ‘on steroids’? NASH phase Ib winner for Durect; kidney damage bid up next

Durect Corp. CEO James Brown told BioWorld Today that, although phase Ib results proved encouraging with the endogenous, oral small-molecule DUR-928 in patients with nonalcoholic steatohepatitis (NASH), the phase II trial planned for next year will test the drug in acute kidney damage, an indication where today “the only thing they can do is give you fluids and pray.” Read More

Hypoxia has heartening results after myocardial infarct episode

According to the American Heart Association’s website, “your heart muscle needs oxygen to survive. A heart attack occurs when the blood flow that brings oxygen to the heart muscle is severely reduced or cut off completely.” Read More

Gigagen interrogates cells by the millions seeking therapies that mimic immune system

Gigagen Inc. is a small company seeking to harness the power of genetic material, as its name implies, by the millions. Read More

Post IPO, Noxopharm heading to clinic with lead candidate idronoxil

PERTH, Australia – After completing its IPO in July, Sydney-based Noxopharm Pty Ltd. expects to have the first three clinical trials of its lead compound up and running in the first quarter of 2017. Read More

Regulatory front

The Washington Legal Foundation (WLF) and the National Association of Manufacturers filed an amicus brief asking the U.S. Court of Appeals for the Third Circuit to shut down repeat “bites at the apple” from states that choose not to opt out of federal class-action suits. Read More

Financings

Tonix Pharmaceuticals Holding Corp., of New York, closed its previously announced underwritten public offering of 9.5 million units, consisting of 9.5 million shares of common stock and warrants to purchase 4.75 million shares of common stock, at an offering price of 55 cents per unit. Read More

Appointments and advancements

Codiak BioSciences Inc., of Woburn, Mass., named Benny Sorensen vice president and head of clinical development. Read More

Other news to note

Ampliphi Biosciences Corp., of San Diego, has been granted a small and medium enterprise (SME) designation by the EMA. Read More

In the clinic

Pluristem Therapeutics Inc., of Haifa, Israel, said the U.K.’s regulator cleared the firm’s application for a pivotal phase III trial of PLX-PAD cells in critical limb ischemia for patients unsuitable for revascularization. Read More

Earnings

Shire plc, of Dublin, reported a $387 million net loss for the third quarter and lowered its full-year guidance, citing an increase in integration costs related to its $32 billion buyout of Baxalta Inc., costs related to licensing SHP647 (formerly Pfizer Inc.’s PF-547659) and reorganization costs associated with the planned closure of a facility in its Los Angeles manufacturing site. Read More

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