Judge chastises FDA for keeping silent on Seroquel petition; Bayer's pharma unit 'very stable,' CFO says;

 @FiercePharma: Judge chastises for silence on AstraZeneca petition against generic Seroquel. Forced us into 'fire drill,' he says. Item | Follow @FiercePharma

> A U.S. judge scolded the FDA for dragging its feet on a peititon from AstraZeneca ($AZN) against generic versions of its Seroquel antipsychotic. Report

> Bayer is reaping benefits from the weak euro, the German company's CFO told Finanz und Wirtschaft, adding that its pharma division is "very stable," if threatened by future government spending cuts. Report

> Vaccination with the H1N1 flu shot in 2009 was linked to a "small but significant risk" of Guilain-Barré syndrome, according to a study in the Journal of the American Medical Association. Item

> A U.S. judge nixed a lawsuit that attempted to hold Hospira ($HSP) accountable for one woman's inability to obtain necessary treatment amid a shortage. Report

> Japan's Shionogi opened a new office in London as a beachhead for expansion into the rest of Europe. News

> Pernix Therapeutics launched its Omeclamox-Pak, a combination therapy to treat Helicobacter pylori infection and duodenal ulcer disease. Report

Biotech News

 @FierceBiotech: Eli Lilly aims to up game. Item | Follow @FierceBiotech

@JohnCFierce: In latest R&D setback, Lilly's schizophrenia drug flunks a PhIII (and yes, it is a big deal). More | Follow @JohnCFierce

@RyanMFierce: Interesting to see ‪genomics‬ firm 23andMe build ‪social web‬ presence with CureTogether buyout. More | Follow @RyanMFierce

> Edmond de Rothschild scores $152M for its fourth biotech fund. Story

> GSK, Shionogi HIV treatment wows analysts, beats Atripla in head-to-head. Item

> Biotech fundraising sours in a bleak first half. More

Medical Device News

@FierceMedDev: Mako's declining sales estimates for its surgical robot devices caused investors to drive the stock down 43%. Ouch. More | Follow @FierceMedDev

@MarkHFierce: We have extended the nomination deadline for the 15 fiercest medical device developers to July 13. Spread the word. Survey | Follow @MarkHFierce

@DamianFierce: As Obama signs the FDA reauthorization bill, device groups remain optimistic for a more efficient future. More | Follow @DamianFierce

> Neuravi reels in $6.5M Series A for stroke treatment device. Article

> Terumo completes enrollment in stent study for FDA, Japanese regulators. Story

> Drug-eluting stents deployed too much, researchers conclude. News

> Bloomberg: 3i Group looking to unload Dx firm Labco. Item

Biomarkers News

> Counting eosinophils signpost survival in coronary artery disease. Item

> Colorectal cancer marker tags poor outcomes. Article

> Pronota biomarker test recognizes preeclampsia. Story

> Immune cells counted to predict survival after angioplasty. News

Drug Delivery News

> SRI gets Defense grant to develop oral-delivered MS drug. News

> QLT seeks options for eye drug delivery tech in major shakeup. Article

> Harvard docs use nanoparticles to get drugs to clotted arteries. Story

> Biotech builds IPO case on cancer drug delivery platform. Item

And Finally... In an interview, EMA chief Guido Rasi pledged to open up its raw data to researchers to improve drug development and patient care. Report

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.