FDA panel rejects expanded label for Samsca; Japan ponders sanctions for data tampering;

@FierceBiotech: Still trending: FDA OKs 5 blockbusters in slow start to 2013 drug approvals. Report | Follow @FierceBiotech

@JohnCFierce: How can you highlight Irish takeover targets and not mention Shire in the lead? Jazz, Alkermes on top. Bloomberg story | Follow @JohnCFierce

@RyanMFierce: Medicines Co. wraps $240M deal to buy ProFibrix following PhIII success. Story | Follow @RyanMFierce

> A panel of outside experts at the FDA have turned thumbs down on an expanded approval of Otsuka's tolvaptan--Samsca--for autosomal dominant polycystic kidney disease. Story

> Following allegations of data tampering during studies of Novartis' ($NVS) Diovan, a government ministry in Japan is considering new rules that would penalize companies found guilty of falsifying trial results. Story

Medical Device News

@FierceMedDev: Freedom Meditech lands $7M for diabetes device. Story | Follow @FierceMedDev

@DamianFierce: Latest in the BRCA battle: Ambry files antitrust suit against Myriad, claiming monopoly. Article | Follow @DamianFierce

@MichaelGFierce: Ocular Therapeutix nets FDA panel meeting for eye surgery hydrogel. More from FierceDrugDelivery | Follow @MichaelGFierce

> Volcano nudges revenue higher in Q2, but swings to a loss. Item

> Life Tech owes Enzo $48.6M after patent fight. Story

Pharma News

@FiercePharma: From FierceVaccines.com: GSK adding 2-D barcode to 4-in-1 flu vaccine packaging. Story  | Follow @FiercePharma

@CarlyHFierce: Bayer says Eylea meets goal in diabetic macular edema trials. Release | Follow @CarlyHFierce

> Despite India's Herceptin patent moves, biosimilar rival isn't imminent. Report

> U.K. cost watchdogs nix Roche's new breast cancer drug Perjeta. Article

> Study: Pharma payments do sway doctors' prescribing habits. Story

Pharma Manufacturing News

@EricPFierce: Thermo Fisher has opened what it says is the first DPM plant in Singapore to tap growing biologics market. Article | Follow @EricPFierce

> Merck New Jersey plant to close in October. Story

> GSK adding 2-D barcodes to vaccine containers. Report

> Sanofi to make API for Vivus ED drug Stendra. Item

> Manufacturers' policies put hurt on execution drug supplies. Article

Biotech Research News

> Opioid receptor research could help shape drug development for addiction. More

> Plant-based inhibitor could halt HIV infection. Item

> NIH team sees diabetes drug as a possible tool for extending life. Story

> New hep C model could pave way for novel treatments. Article

> La Jolla, Kyowa Hakko Kirin partner on autoimmune disease drug discovery. More

And Finally… Researchers at the Salk Institute for Biological Studies have developed a new tool for protein engineering, offering a new way to add unbreakable bonds between two points in a protein or between two proteins. Release

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