Regeneron shares slide on FDA delay; Pfizer partners with Qiagen on cancer drug diagnostic; Clavis touts positive cancer data;

@FierceBiotech: PhRMA demands an overhaul of FDA's regs on drug names. Report | Follow @FierceBiotech

@JohnCFierce: WSJ on FDA's early vemurafenib approval. It's cheering to see regulators move well ahead of a deadline. Report | Follow @JohnCFierce

@RyanMFierce: A source in small-medium U.S. biopharma has told me taking the trip to meet offshore investigators for trials is well worth the time & money. | Follow @RyanMFierce

@MaureenFierce: Only half of MDs surveyed were aware Brilinta was approved. Survey Most won't switch patients from Plavix. | Follow @MaureenFierce

> The FDA has pushed back its review of Regeneron's Eylea for blindness by three months, a move that triggered a sharp 13% drop in its share price. The new PDUFA date is November 18. Story

> Pfizer has partnered with Qiagen on the development of a new diagnostic for its experimental drug dacomitinib, now in Phase III for lung cancer. Story

> Norway's Clavis says it has snagged positive interim Phase II data for its lead cancer drug elacytarabine in combination with idarubicin in patients with acute myeloid lymphoma. Clavis has another cancer drug program partnered with Clovis. Elacytarabine is now in a Phase III leukemia study. Release

> Shares of Protalix were buoyed by the news that the FDA has accepted its resubmission for its Gaucher's drug. Story

> Xcelience, a Florida company that assists developers with early-stage research work, says it will add 45 new jobs in an expansion planned in Tampa. Report

> The British government is designating Pfizer's old research complex in Sandwich as a new enterprise zone in the hope that a group of smaller drug companies can fill the void being left by the pharma giant's departure. Report

Pharma News

@FiercePharma: Antipsychotics beat mood stabilizers for manic episodes, with generic Haldol in first place. Zyprexa, Risperdal next. Story | Follow @FiercePharma

> Merck shifts China strategy away from hiring reps. Article

Drug Delivery News

> "Nanolids" keep meds bottled up until ready for release into tumors. Report

> Microscale gelatin mold can cook up drug-delivering particles. More

> Drug-eluting sinus implant gets FDA premarket approval. Article

> Molecular "Fed-Ex truck" knocks down mutant proteins, delivers genes. Details

> Osmotica's Georgia expansion shows there are jobs in drug delivery. News

> June deals a snapshot of drug-delivery trends. Story

Medical Device News

> AngioDynamics taps DeVivo as CEO. More

> QIAGEN, Pfizer team up on companion diagnostic. Report

> EO2 Concepts looks for a better way to treat wounds. Story

> Ex-Competitive Technologies CEO gets his money. News

> Revolutions Medical gets win against Globe. Details

> Abbott's BVS used in first patient in Japan. Article

And Finally... Scientists say they've been able to fit bats with the world's smallest GPS devices. Release

Suggested Articles

Novartis unveiled more data showing how its asthma combo QMF149 fared against the standard of care: a combination of the same types of drugs.

Johns Hopkins researchers developed a biodegradable polymer to transport large therapies into cells—including genes and even CRISPR.

UCB’s bispecific antibody recently beat Johnson & Johnson’s Stelara at clearing psoriasis symptoms, and now it has bested AbbVie’s Humira, too.