Exelixis buoyed after FDA cancels 'cabo' panel; Bayer adds new app for blockbuster hopeful regorafenib;

Conversations on Twitter :

  • Analysts and experts dissect Exelexis chances after announcement that FDA's advisory panel no longer plans to discuss its thyroid cancer drug cabozantinib at November meeting here, here and here.

 @FierceBiotech: XBiotech hatches big plans for Austin campus. Item | Follow @FierceBiotech

 @JohnCFierce: At long last, Ironwood gets its OK, shifts to commercialization alongside development. News | Follow @JohnCFierce

> Shares of Exelixis ($EXEL) surged after the company alerted investors that the FDA was canceling a planned panel review for cabozantinib as a new therapy for thyroid cancer. Analysts interpreted the move as an indication of the FDA's confidence in the drug, indicating a better potential for approval. Story

> Bayer has filed for approval of its blockbuster contender regorafenib as a treatment for gastrointestinal cancer. The drug has already been filed for metastatic colorectal cancer. Story

> The preclinical CRO Charles River has bought out Accugenix for $17 million, adding its testing technology used in drug and device development. Report

Pharma News

 @FiercePharma: Two drugmakers hit the Forbes "Fab 50" in Asia: Australia's CSL and India's Sun Pharma. Item | Follow @FiercePharma

> Novartis begs vets for loyalty through animal drug shortages. Article

> Avastin tops list of most-requested cancer meds in U.K. Report

> FDA flags cataract risk in kids using Vertex's Kalydeco. Story

Medical Device News

 @FierceMedDev: Bacterin International, a maker of bone graft material and antimicrobial coatings, won $25M in financing from OrbiMed. Release | Follow @FierceMedDev

 @MarkHFierce: BSX is slashing more jobs and splitting its cardio business in two--undoing changes enacted by the old CEO. More | Follow @MarkHFierce

 @DamianFierce: Baxter is recalling four Automix devices over a deadly malfunction risk. The FDA has labeled it a Class I. News | Follow @DamianFierce

> Zynex gets 510(k) for urinary incontinence device. News

> MDxHealth's revenues soar, losses deepen in H1. Item

Pharma Manufacturing News

 @EricPFierce: Hospira goes back to Orchid, picks up API plant, R&D center for $200 million. Good news tainted a bit by FDA warning. Story | Follow @EricPFierce

> Closed plants lead Novartis to plead for vet loyalty. Story

> Claris squares off against former partners in U.S. injectables market. Article

> Scots reject GSK wind turbines; tidal turbines up next. Story

Vaccines News

 @AlisonBFierce: What does AstraZeneca's new CEO mean to vaccinemaker MedImmune? More | Follow @AlisonBFierce

> S. Korea, Sweden partner up to find Alzheimer's vaccine. Item

> West Nile virus breaks out in the South. News

> CSL nets closeout letter after FDA violations. More

> Flu adjuvant adds promise to vaccine. Report

And Finally... Investigators at the Karolinska Institute have produced fresh evidence to demonstrate that chocolate can guard against the risk of a stroke. Article

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