FDA approves first 3-D printed therapy; Galleon names new CEO;

@FierceBiotech: ICYMI: Sorrento buys into biosimilars with a Chinese antibody deal. Story | Follow @FierceBiotech

@JohnCFierce: How to lose a billion dollars -- $AXON cap down to $1.28B, down about a billion from its IPO. | Follow @JohnCFierce

@DamianFierce: $SHPG first proposed a merger on July 10, meaning $BXLT lasted nine whole days before someone tried to buy it. | Follow @DamianFierce

> The FDA has approved Aprecia's new epilepsy drug, which it says is the world's first 3-D printed therapy. Story

> Horsham, PA-based Galleon Pharmaceuticals named ex-Chelsea CEO Joseph Oliveto as its new chief executive officer today. Oliveto replaces James C. Mannion, who will retire as CEO and continue to serve as a strategic advisor to the company. Release

Medical Device News

@FierceMedDev: OraSure gets FDA nod for emergency use of rapid Ebola test. FierceDiagnostics story | Follow @FierceMedDev

@VarunSaxena2: Intuitive awards grants to support training of its da Vinci robot using virtual reality. Article | Follow @VarunSaxena2

@EmilyWFierce: The FDA just approved the first 3-D printed drug. More from MedScape | Follow @EmilyWFierce

> Philips on the hunt for more deals amid HealthTech refocus. Report

> MacuLogix raises $5M to back FDA-cleared early AMD diagnostic. Article

> Stanford scientists develop brain-controlled sensor geared toward ALS patients. More

Pharma News

@FiercePharma: Sales of diabetes drugs in Japan are a key H2 performance gauge, Sanofi CEO says. FiercePharmaAsia story | Follow @FiercePharma

@CarlyHFierce: Realizing that a proposed Shire deal with a pharma spinoff in the Chicago suburbs is exactly what this summer was missing. $SHPG $BXLT $ABBV | Follow @CarlyHFierce

> Lilly faces first trial over claims of Cymbalta withdrawal symptoms. Report

> Deal-minded Shire offers $30B for new spinoff Baxalta in public bid. News

Drug Delivery News

> Recommended chemotherapy administration method found underutilized. Report

> Emergent BioSolutions launches autoinjector to protect against chemical weapons attacks. Item

> NanoSmart's targeted cancer killer gains another orphan designation for Ewing's sarcoma. More

> Dauntless gets $12M in Series A to develop cancer med using intranasal platform. Story

> Northwestern bags $17.5M from NIH to develop implant for delivery of drugs that prevent HIV. Article

Pharma Manufacturing News

> GSK beefing up in U.S. drug and inhaler plant. Article

> FDA looks at Baxter Mexico plant for more saline supply. Report

> Wockhardt retrieves millions and millions of drugs in effort to win back FDA approval. Story

> FDA approves seizure drug made with 3-D technology. Item

> Generics maker Amneal revamping former J&J plant in Ireland. Article

Pharma Asia News

> Takeda submits post-marketing Actos study that shows no link to bladder cancer. News

> Merck eyes opportunity for omarigliptin filing with Japan's PMDA. Report

> Bayer sees Q2 bright spots in China pharma, but consumer health is more complicated. Story

> Sales of diabetes drugs in Japan are a key H2 performance gauge, Sanofi CEO says. More

> Amgen says Vectibix sales in Japan got Q2 boost on shipments to Takeda. Article

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