@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