Novartis' Odomzo nabs EU approval in basal cell skin cancer; Hospira's Remicade biosim gets Australian nod;

@FiercePharma: Horizon puts forth its slate of new Depomed directors. Story | Follow @FiercePharma

@EricPFierce: FDA warning letter castigates three Mylan sterile drug plants in India. FiercePharmaManufacturing story | Follow @EricPFierce

@CarlyHFierce: In case you missed my foray into Google Forms, we're doing a survey on the next M&A move from $AGN. More | Follow @CarlyHFierce

> Novartis ($NVS) won European approval for Odomzo, its new treatment for basal cell carcinoma, the most common form of skin cancer. Release

> Hospira's ($HSP) biosimilar copy of the Merck & Co. ($MRK) anti-inflammatory blockbuster Remicade, dubbed Inflectra, won approval in Australia for a range of uses, including Crohn's disease, ulcerative colitis, psoriatic arthritis and plaque psoriasis. Release

> Canadian regulators approved Bristol-Myers Squibb's ($BMY) hepatitis C treatment Daklinza; the drug is awaiting clearance from the FDA. Report

> GlaxoSmithKline ($GSK) took out a building permit in Memphis, TN, for $2 million worth of improvements at a facility there. Report

> AstraZeneca ($AZN) affiliate Definiens, which sells tissue analytics software, is opening up a new office in Cambridge, MA. Report

Medical Device News

@FierceMedDev: BioDelivery snags new FDA approval for Onsolis after ditching Meda partnership. FierceDrugDelivery story | Follow @FierceMedDev

@VarunSaxena2: Edge files for up to $115M IPO to support locally delivered med for brain aneurysms. ICYMI from FierceDrugDelivery | Follow @VarunSaxena2

@EmilyWFierce: $ILMN CEO Flatley opens up about Helix and "app store" for human genomes. MIT Technology Review article | Follow @EmilyWFierce

> LDR raises $86.5M to back ongoing launch of cervical disc replacement device. More

> Boston Sci earns FDA approval of Innova stent to treat peripheral artery disease. Article

Biotech News

@FierceBiotech: Reborn Akari grabs $75M in financing for another Soliris rival. Article | Follow @FierceBiotech

@JohnCFierce: I'm sure the FDA feels ever so much better now that Addyi is in Valeant's hands. Oh yeah. | Follow @JohnCFierce

@DamianFierce: Turing has a new Form D reflecting that $90M claim but now including warrants and a loan. SEC filing | Follow @DamianFierce

> Samsung, Biogen lining up a $1B IPO for biosimilar joint venture: WSJ. Report

> Drugs just don't get rejected much anymore, report says. Item

> In a setback, Macrocure says PhIII regenerative med study is a flop. More

> Controversial Valeant Pharma swoops in with a $1B Addyi buyout. Article

> Lundbeck to advance schizophrenia drug solo after taking an ax to early-stage pipeline. Story

Vaccines News

> Pfenex enters anthrax vaccines realm with $143.5M BARDA contract. News

> NIAID funds Soligenix with $2.7M in ricin vaccine effort. Report

> Team outlines potential target for aggressive breast cancer vaccine. Item

> WHO: Vaccine hesitancy is a mounting challenge for immunization programs. More

> Inovio's MERS vaccine shows 100% protection in mice, camels, monkeys. Article

CRO News

> Evotec's hybrid R&D model keeps revenue rolling. More

> U.K. CRO conglomerate bags another testing outfit with eyes on toxicology. Story

> Actelion taps DKSH to break into Asia. Item

> WuXi watches profits slip on its way to going private. Article

Pharma Manufacturing News

> Aurobindo lays out plans for 3 new plants. Item

> Mylan expands recalls from plants spanked in FDA warning letter. Article

> Merck recalls 276,000 bottles of cancer med that could pose risk to children. News

> Indonesia's Kimia to build $71M plant to make herbal meds. Story

> Union posts email exchange with Merck CEO over plant dangers from job cuts. Article

Pharma Asia News

> SK Chemicals ready to sell home-grown influenza vaccine as season gets underway. Report

> Mylan sees three Indian plants under FDA scanner on quality. Story

> Australia's Benitec prices Nasdaq IPO at $9.21 a share. Article

> Singapore's Asian American Medical eyes oncology expansion in southern China. More

> Australia's TGA registers Hospira's Inflectra. Item

And Finally... With rare diseases, recruiting in clinical trials can be a challenge. Report

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