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Home » Newsletters » BioWorld

BioWorld

Aug. 24, 2018

View Archived Issues

Clinical data for Aug. 23, 2018

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Regulatory front

The FDA issued a draft guidance Thursday to tackle some of the practical and ethical challenges of using placebos and blinding in clinical trials testing therapies for hematological malignancies and other cancers. The draft recommends placebo-controlled designs only in selected circumstances, such as when surveillance is the standard of care or when the trial uses an add-on design. Read More

Financings

Obalon Therapeutics Inc., of San Diego, said it entered into an agreement to sell shares of its common stock for aggregate gross proceeds of $10 million in a private placement. The company will sell approximately 5.5 million shares of common stock at $1.82 each. It plans to use the proceeds for commercial operations, working capital and general corporate purposes. Read More

Other news to note

Innovate Biopharmaceuticals Inc., of Raleigh, N.C., said it signed an agreement with Amarex Clinical Research to provide data management and biostatistics for its planned phase III larazotide trial in celiac disease. Larazotide acetate has a mechanism of action that renormalizes the dysfunctional intestinal barrier by decreasing intestinal permeability and reducing antigen trafficking, such as gliadin fragments in celiac disease, and bacterial toxins and immunogenic antigens in nonalcoholic steatohepatitis. Read More

Novartis sees top-line PFS gain in trial of PIK3CA-targeting breast cancer drug

A phase III test combining Novartis AG's phosphoinositide 3-kinase (PI3K) inhibitor, BYL-719 (alpelisib), with fulvestrant to treat a genetically-defined subset of advanced breast cancer patients found that it improved progression-free survival in those individuals, as compared to treatment with fulvestrant alone. The top-line success set the stage for the company to move closer to filing global regulatory applications for the drug, which Novartis oncology chief Samit Hirawat called the first of its kind "to show potential increased benefit and acceptable tolerability for patients." Read More

Head lamp: Rakuten bid with light-activated drug draws $150M in series C

Rakuten Aspyrian Inc.'s $150 million from its series C round will fuel a near-term phase III trial and more with ASP-1929, a light-activated antibody drug conjugate (ADC), CEO Miguel Garcia-Guzman told BioWorld. "Probably by mid-next year, we'll be running ASP-1929 in head and neck cancer plus three additional [oncology] indications," he said, adding that the new capital "will not be able to finance everything toward the market," and the ambitious firm will seek more as needed. Read More

NIH looks to root out bad actors as success breeds growing security risks for research

As it so often is, Thursday's U.S. Senate Health, Education, Labor and Pensions (HELP) Committee hearing on NIH research was a showcase of innovation and the realization of what once seemed the realm of science fiction. But the show-and-tell session wasn't limited to the wonders springing from what NIH Director Francis Collins likes to call the "National Institutes of Hope." Read More

True Gritstone: Potential $1.2B Bluebird deal, IPO filing offer competitive EDGE

Bluebird Bio Inc. and privately held Gritstone Oncology Inc. said they plan to collaborate in a broad cancer cell therapy R&D and commercialization pact involving 10 tumor-specific targets across multiple tumor types and, in certain cases, T-cell receptors (TCRs) directed to those targets. Read More

U.K. pharmas, med techs told to stockpile, import if Brexit flops

LONDON – The U.K. government has told pharma companies to build a six-week stockpile and prepare to import drugs that have a short shelf life by air rather than by road, as part of contingency planning for a no-deal Brexit in March 2019. Read More

Win for Oxervate eye drops from Dompe means non-surgical therapy for rare eye disease

A little over one year after European regulators gave their nod, regulators in the U.S. cleared for marketing Milan-based Dompé farmaceutici SpA's Oxervate (cenegermin) eye drops for neurotrophic keratitis. Read More

Kala eyes early 2019 launch of Inveltys in post-op inflammation and pain

Following its first FDA approval, for Inveltys (loteprednol etabonate ophthalmic suspension 1 percent) to treat inflammation and pain following ocular surgery, developer Kala Pharmaceuticals Inc. said it plans to hire a specialty sales force of about 60 reps to target 80 percent of likely prescribers in preparation to launch the ophthalmic suspension product early next year. Read More

Regulatory actions for Aug. 23, 2018

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