Cell Therapeutics raises $40M for drug buy, Pixuvri launch; Exelixis launches 'cabo' Phase III

@FierceBiotech: California's CIRM votes to shift stem cell grants toward clinical development side. More | Follow @FierceBiotech

@JohnCFierce: In fresh setback, Alnylam's most advanced drug flunks PhIIb RSV test. (Not what they need right now.) Item | Follow @JohnCFierce

@RyanMFierce: 23andMe's Google ties make today's news of the gene patent less surprising. News | Follow @RyanMFierce

> Seattle-based Cell Therapeutics ($CTIC) is selling $40 million in shares to an institutional investor. The money will be used to complete the acquisition of S*Bio's pacritinib and launch Pixuvri in Europe. Release

> Exelixis ($EXEL) has launched COMET-1, a Phase III pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer. Release

> Federal regulators have rejected Johnson & Johnson's ($JNJ) application for a once-daily version of the HIV drug Prezista. The pharma company, though, says that it does not need to run any additional studies of the drug. Report

> Repros Therapeutics ($RPRX) says it will need to complete a safety analysis of past trials of oral Proellex before regulators allow it to resume studies of a low-dose version of the therapy. Report

> Medivation ($MDVN) and Astellas say that the FDA agreed that the partners may proceed with an Expanded Access Program for enzalutamide (formerly MDV3100) under a treatment protocol in the U.S., while marketing approval is being sought from the FDA. Release

> Trial vets at Flexion claim PhIIb success with lead osteoarthritis drug. Article

> China readies plan to spur its booming biotech sector. Story

> Bristol-Myers pushes latest blockbuster cancer drug prospect into ASCO spotlight. Report

> BMS creates global cancer drug collaboration. More

Pharma News

@FiercePharma: Endo's lobbying yields a provision in House user-fee bill that could protect its Lidoderm patch--NYT. More | Follow @FiercePharma

> Another FDA warning for J&J's McNeil unit. News

> Endo seeks protections in House FDA reauthorization. Item

> Stada must join the generics buyout binge, CEO says. Story

> How does Genentech like it under Roche's wing? Article

Medical Devices News

@FierceMedDev: For Biosensors, stents and an acquisition helped drive a stellar FY2012. Report | Follow @FierceMedDev

@MarkHFierce: Folks, there's still time to submit your nominations for the FierceMedicalDevices Fierce 15 private device developers. Survey | Follow @MarkHFierce

> Foundation Medicine launches innovative cancer diagnostic. Story

> GE opens $80 million research center in China. Article

> FDA cites J&J's McNeil-PPC unit for limp lubricants. News

> U.S. House ramps up for device tax repeal vote next week. More

Drug Delivery News

@DamianFierce: Perhaps you can have too much of a good thing. Penn researchers say too many nanocarriers render treatments ineffective: Story | Follow @DamianFierce

> MIT develops needle-free jet injector. More

> Delivery firm seeks $3M for transdermal platform. Story

> West Pharma looks to cash in on biosimilar delivery. Report

> IntelGenx eyes FDA nod with anti-migraine film results. Item

Biomarkers News

> Biomarkers help select the most fertile donors. News

> Jury is still out on value of genetic biomarkers. Story

> Fitness level may be key to surviving breast cancer. More

> Bile duct biomarker screening for fluke-linked cancer. Article

And Finally… Investigators say that there's anecdotal evidence that bariatric surgery can alter the basic biology that triggers diabetes, suggesting a new approach to curing the ailment. Story

 

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