Spotlight On... Post-Shkreli KaloBios is still chasing an FDA voucher; AstraZeneca picks up orphan tag in Europe; and more...

KaloBios Pharmaceuticals, which filed for bankruptcy after the arrest of former CEO Martin Shkreli, hasn't given up on its efforts to buy a little-used drug in hopes of winning a coveted coupon for fast FDA review. When Shkreli still ran the company, it signed a deal to acquire a drug for Chagas disease, planning to secure FDA approval and, in the process, win itself a priority-review voucher that can shorten agency reviews from 10 months to 6 months. Those vouchers can be sold to any company at any price, and the most recent deal fetched $350 million. KaloBios ousted Shkreli after his December arrest on charges of securities fraud and filed for bankruptcy shortly afterward, but the company's remaining execs are still pushing to close the Chagas deal and keep the firm afloat, the Wall Street Journal reports. More

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> AstraZeneca ($AZN) picked up the European Medicines Agency's orphan drug designation for acalabrutinib, a cancer drug the company pulled in through its $4 billion acquisition of a majority stake of Acerta Pharma last year. News

> The former CEO of biotech Marrone Bio Innovations has pleaded not guilty to charges that he falsified the company's financial statements, artificially inflating revenue. Story

> French drugmaker OSE Pharma is planning to merge with Effimune, absorbing the company's immunotherapy pipeline as it works through Phase III development with its lead cancer treatment. Item

Medical Device News

@FierceMedDev: Propeller partners with Aptar in hopes of winning race to first integrated 'smart' inhaler. Story | Follow @FierceMedDev

> Boston Scientific's Brazilian operations under investigation, as co-founder to depart. More

> J&J's LifeScan rolls out blood glucose meter with color-based results. News

Pharma News

@FiercePharma: Dana-Farber and MIT team says financial engineering could help pay for big-ticket meds. More | Follow @FiercePharma

> CNBC: Valeant's CEO ready to return from leave, but board isn't sure he's ready. Article

> Bayer's 2016 outlook falls short, but maybe that's a favor to incoming CEO Baumann. Story

CRO News

> A year after its LabCorp buyout, Covance posts steady sales. More

> WuXi's reportedly spinning off its biologics biz in an IPO. Report

> Post-Pfizer Icagen pairs up with Aptuit for drug discovery. Story

> Deal-hungry Icon posts solid final quarter results. Article

Pharma Manufacturing News

> Indian quality moves underway as industry, regulators meet. Report

> Indian pharma snaps up U.S. manufacturing with $1.5B worth of deals in 2015. More

> Japan's Mitsubishi Tanabe expected to have fast-production flu vaccine ready by 2019. Item

> Seqirus adding vax production facility in U.K. Story

> ICIG acquiring Novartis intermediates plant that was set to fold. Article

Pharma Asia News

> Japan's Otsuka announces new plan for delamanid to help curb TB. News

> India kicks off 'red line' guide on antibiotic overprescription. More

> Hong Kong seeks a seat at precision medicine services table. Report

> Indian drug firms bought big in 2015 M&A with U.S. manufacturing focus. Story

> Drug manufacturing quality standards push on in India. Article

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