China relents to having FDA in country; Shire has rare stumble with eye drug;

@FiercePharma: Whooping cough is making a comeback--and the FDA thinks it might know why. Story from FierceVaccines | Follow @FiercePharma

@EricPFierce: Mylan intends to launch 800 injectable products in next 5 years, 150 in US, now that it own Agila. Yesterday's story | Follow @EricPFierce

@CarlyHFierce: NICE smiles on Sanofi's Aubagio the day after snubbing Lemtrada. Story | Follow @CarlyHFierce

> China has finally agreed to allow the FDA to station 10 FDA inspectors in that country. Report

> An FDA panel next week will discuss tablets from Merck ($MRK) and Stallergenes for treating grass pollen allergies. Story (sub. req.)

> Shire ($SHPG), which has been doing really well, has stumbled with its recently acquired eye drug. Story

> Lupin has launched in the U.S. its generic version of AbbVie's ($ABBV) Trilipix delayed-release capsules for reducing cholesterol. Item

> Teva Pharmaceutical Industries ($TEVA) has launched in the U.S. a generic version of Medicis Pharmaceutical's Aldara for treating warts and skin lesions. Report

> A Cleveland, OH, cardiologist, speaking at a seminar by the American Enterprise Institute, has questioned the effectiveness of some of the drugs made by Ranbaxy Laboratories. Story

Medical Device News

@FierceMedDev: Biocartis and VIB join forces to develop unique diagnostic cancer test. Release | Follow @FierceMedDev

@MarkHFierce: An Xconomy contributor offers another point-of-vew on the 23andMe issue - a clash of cultures and business models. More | Follow @MarkHFierce

@MichaelGFierce: ICYMI: 'Worm-shaped' nanoparticles best at infiltrating breast cancer. Story from FierceDrugDelivery | Follow @MichaelGFierce

@GalenMoore: China finally allows the FDA to add inspectors to bolster oversight. More | Follow @GalenMoore

> Jarvik Heart's Japan regulatory win gives Thoratec a new heart pump challenge. Story

> Thermo's 'ever-increasing appetite for debt' raises analysts' eyebrows. Article

> 23andMe capitulates, yanking all health-related gene tests pending FDA review. Report

> Medtronic's spinal division generates a shot of good news. More

> Sorin collects EU approval for its Intensia family of cardiac devices. Item

Biotech News

@FierceBiotech: Chutes & Ladders this week: GoBalto gets new CEO as founder Chung steps down & more. Feature | Follow @FierceBiotech

@JohnCFierce: Mixed outcome for lifitegrast PhIII, 1 of Fleming Ornskov's 1st deals for Shire-$160M SARcode buyout - hit 1 missed. Release | Follow @JohnCFierce

@DamianFierce: So Geron is soaring on these imetelstat results "embargoed" for Monday. More | Follow @DamianFierce

@EmilyMFierce: With drug-resistant malaria strains on the rise, a new report says basic research for malaria needs a boost. Story | Follow @EmilyMFierce

> Biotech vet joins R&D troika to take compounds from campus to clinic. Story

> Shire's new CEO sees one of his first-round biotech deals sour in PhIII. Article

> Novartis hits PhIII paydirt with promising myeloma drug. Report

> Geron soars as marrow cancer drug shines in preliminary results. Story

And Finally... A survey conducted for Medical Marketing & Media found that some doctors will hold off before moving patients to sofosbuvir, the new hepatitis C treatment from Gilead Sciences ($GILD) expected to be approved any day now by the FDA. Story

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