Covidien gets CE mark; FDA launches data-sharing initiative;

@FierceMedDev: Merck will work with Sysmex to develop a colon cancer Dx that guides treatment for the drug Erbitux. Release | Follow @FierceMedDev

@VarunSaxena2: RT @AdvaMedUpdate: AdvaMed Opens China Office: official recognition will enhance AdvaMed's ability to partner w/Chinese authorities. Release | Follow @VarunSaxena2

@MichaelGFierce: 'Quadrapeutics' works in preclinical study of hard-to-treat tumors. Story | Follow @MichaelGFierce

@EmilyWFierce: Devicemakers celebrate early regulatory wins despite 2013 setbacks. Report | Follow @EmilyWFierce

> Covidien ($COV) received a CE mark for its Nellcor Respiration Rate System enabling monitoring of respiration rate via a finger sensor. Release

> The FDA launched its openFDA initiative today in an effort to make its publicly available data easier to find and analyze. Release

> Private equity firms Astorg Partners and Montagu Private Equity are in discussions to buy French diagnostic equipment maker Sebia from another private equity company. Story

Biotech News

@FierceBiotech: Join @FierceBiotech's @JohnCFierce and a panel of experts at our Exec Breakfast in San Diego June 18th. More | Follow @FierceBiotech

@JohnCFierce: Love seeing $TEVA and $AZN provide huge peak sales projections on experimental drugs. Keep it coming. I will never forget. | Follow @JohnCFierce

@DamianFierce: "Marijn" rhymes with "Bahrain," not "Carmine," right? Release | Follow @DamianFierce

@EmilyMFierce: ICYMI yesterday: Omeros wins FDA blessing for eye treatment. Report | Follow @EmilyMFierce

> Prosensa gets an FDA green light for its once-failed DMD drug. News

> Teva buys into a blockbuster migraine drug rivalry with $825M Labrys buyout. More

> NPS throws ice water on $4B Shire rumor, but Wall Street keeps the faith. Article

> ASCO spotlight burns Puma shares. Item

> Sanofi CEO Viehbacher now calls beloved Boston biotech hub his home. Report

Pharma News

@FiercePharma: Top-read special report Monday: The top 10 pharma companies by 2013 revenue. Report | Follow @FiercePharma

@TracyStaton: ICYMI yesterday: AstraZeneca chief bristles at tying exec pay to Pfizer's spurned £55-per-share bid. Story | Follow @TracyStaton

@EricPFierce: FDA catches Wockhardt U.S. plant up to same tricks as banned Indian plants. Story | Follow @EricPFierce

@CarlyHFierce: ICYMI yesterday: Valeant's Allergan bid gets hostile as Ackman makes a play for board control. Report | Follow @CarlyHFierce

@JustinHFierce: Norway's Vaccibody and Jersey's Phibro ink agreement for developing novel poultry vaccines to corner $1B market. Release | Follow @JustinHFierce

> Pfizer adds another $325M to Neurontin settlement tally. Total? $945M. Article

> Bayer CEO's long goodbye: Dekkers to depart at end of 2016. News

> Study: Subbing Avastin for Lucentis could save U.S. $3B on eye treatment. More

> Chicago sues J&J, Purdue, Endo, Actavis, Teva over opioid marketing. Story

> In management reorg, Teva taps Actavis alum to helm new global generics unit. Report

Biotech Research News

> Genetically engineered malaria parasite could expedite vaccine development. Article

> Alzheimer's compound gradually lowers amyloid in mice brains. Story

> Sangamo's gene editing tech fixes immune flaw in stem cell study. Article

> Biogen, Array strike preclinical autoimmune disease pact. Item

> Nektar cancer drug shrinks tumor growth in preclinical study. More

Pharma Manufacturing News

> FDA's OK for Boehringer Ingelheim plant gives it and Lilly hope on diabetes drug. Report

> Zydus recall flags another costly bottle mixup. Story

> Iran plant starts production of vet drugs but sets sights on human meds. More

> FDA catches Wockhardt U.S. plant using same spurious testing procedures as Indian plants. Article

> Alexion recalls Soliris for third time for particulate. Story

And Finally... "The sources of potential bias leading to inaccurate reporting of original rhBMP-2 efficacy and safety profile include flawed study design, methodological technique, data reporting and analysis, and significant financial conflict of interest," concludes an academic study of the overoptimistic Infuse Bone Graft clinical trial. Abstract

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