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.)

Suggested Articles

Amid Amgen's pricing war with Sanofi and Regeneron's Praluent, PCSK9 cholesterol fighter Repatha has shown a clinical benefit for HIV patients.

A month after the FDA approved it, Esperion's Nexletol showed it can lower cholesterol regardless of statin and ezitimibe treatment.

AstraZeneca's Farxiga can help prevent worsening or death in heart failure patients regardless of other therapies received, according to new data.