FDA warns of heart risks with Astellas imaging drugs; Vertex unloads Incivo royalties to J&J for $152M;

@FiercePharma: Best-read new news Tuesday: Can Teva find a partner to save it from itself? Story | Follow @FiercePharma

@EricPFierce: GSK continues to lead with continuous processing. Will use technology at $136.5 million plant in India. More | Follow @EricPFierce

@CarlyHFierce: Roche's Kadcyla approved in the EU for advanced HER2-positive breast cancer. Release | Follow @CarlyHFierce

> The FDA warned that Astellas Pharma's diagnostic agents Lexiscan and Adenoscan carry a rare but serious risk of heart attack and death and shouldn't be used in patients with signs of cardiovascular instability. Report

> Vertex Pharmaceuticals ($VRTX) sold its Incivo royalty rights to partner Johnson & Johnson ($JNJ), which markets the hepatitis C treatment outside the U.S.; Vertex markets the same drug under the Incivek brand name in the U.S. Release | Report

> U.S.-based generics maker Mylan ($MYL) said it will offer $2 billion in bonds to help finance its purchase of the Indian injectables maker Agila Specialties. Report

> Perrigo ($PRGO) shareholders approved the Allegan, MI-based company's move to Ireland as it buys the Dublin-based drug developer Elan ($ELN). Report

> Health Canada approved Medivir's new hepatitis C treatment simeprevir, which recently won the FDA nod as well. Report

> The Swiss drugmaker Actelion ($ATLN) launched its lymphoma treatment Valchlor (mechlorethamine), a gel applied topically twice a day, in the U.S. Report

> Jordan's Hikma Pharmaceuticals signed a long-term prefilled-syringe supply deal with Unilife ($UNIS). Report

Medical Device News

@FierceMedDev: ResMed wins German court injunction against two respiratory device patent rivals. More | Follow @FierceMedDev

@MarkHFierce: J&J's $2.5B settlement addresses thousands of lawsuits over faulty metal hip implants but many will remain in play. Story | Follow @MarkHFierce

> Qiagen TB test gains Chinese regulatory approval. Article

> GenomeDx Biosciences seals multiple insurance deals for prostate cancer Dx. News

> Next Bard vaginal mesh trial set for December; settlement rumors remain. Report

Biotech News

@FierceBiotech: Clovis bets up to $420M on targeted cancer drug. News | Follow @FierceBiotech

@JohnCFierce: Great talk with Missouri Bio and KansasBio today. About half read Fierce on their cell phones. New day and new media. | Follow @JohnCFierce

@DamianFierce: Meet Rebecca Friend, publisher of the FierceBiotech family of publications. More | Follow @DamianFierce

@EmilyMFierce: News about Art Levinson's Calico breaks on... Google+? Story | Follow @EmilyMFierce

>  Argos rakes in $17.5M more to wrap up PhIII for cancer drug. More

>  Moderna nails $110M to get mRNA tech into the clinic. Article

>  BioMarin skates through FDA panel for rare disease drug. News

>  Google's Calico poaches Roche guru Barron to steer R&D. Article

Drug Delivery News

@MichaelGFierce: Delivery guru Robert Langer discusses nanomeds, up-and-coming ventures, new frontiers. Editor's corner | Follow @MichaelGFierce

> Unilife signs $80M deal to supply Hikma with prefilled syringes. Story

> FDA allows pivotal trial of Actinium's armed-antibody isotope delivery. Article

> Svelte begins pivotal trial for drug-eluting stent. Report

> Study: Genes delivered directly to heart stymie heart failure. More

> Dual-wave approach clears path for cancer drug delivery. Story

> Oramed wins European patent for insulin pill tech. Item

Diagnostics News

> GenapSys nails down $37M to advance next-generation gene sequencing tech. Article

> Trovagene pledges results, in part, from cancer urine test launch. Report

> Houston Methodist-led team shows potential of early breast cancer blood Dx. More

> Atossa makes headway in getting breast cancer test back to market. Article

> FDA OKs 4 Illumina next-generation sequencing devices. Report

> Johns Hopkins approach shows promise in early dementia diagnosis. Item

And Finally... What does cancer smell like? Scientists are using an electronic "nose" to find out. Report (sub. req.)

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