FDA launches review of Sanofi diabetes drug lixisenatide; Agency review planned for GSK/Theravance COPD therapy;

 @FierceBiotech: Pfizer axes CovX research unit and 100 jobs in San Diego. More | Follow @FierceBiotech

@JohnCFierce: Coronavirus, which killed 5 of the 12 people known to have been infected by it, is suited to spread easily in humans. Report | Follow @JohnCFierce

> The FDA has formally launched its review of Sanofi's ($SNY) lixisenatide, a closely watched diabetes treatment. The European Commission approved the treatment at the beginning of February. Story

> The FDA also accepted an application on UMEC/VI for COPD from GlaxoSmithKline ($GSK) and Theravance ($THRX). Release

> Ann Powell Judge has left Shire ($SHPGY) to take on the new role of senior vice president, human resources, for Bristol-Myers Squibb ($BMY). Report

> Australia's PolyActiva raised AUD$9.2 million in a Series B financing round from a consortium of investors including the Medical Research Commercialization Fund, Brandon Biosciences Fund 1, Yuuwa Capital and angel investors. Release (PDF)

Pharma News

@FiercePharma: Novartis nixes $78M non-compete with Chairman Vasella amid frenzy of criticism from Swiss. Report | Follow @FiercePharma

@EricPFierce: Gilead recall raises question about Vistide stocks. Company tells providers to look to generic suppliers. Story | Follow @EricPFierce

@AlisonBFierce: Court: Sanofi is not liable to pay local capital gains tax for its 30B rupee acquisition of Indian vax maker Shantha. More | Follow @AlisonBFierce

> GSK, Roche teaming with anti-doping agency. Report

> Novartis nabs another FDA-approved indication for everolimus. More

> Takeda preps for first Actos trial now opening in LA. News

Medical Device News

 @FierceMedDev: PolyActiva pulls in $9.5M for intraocular implant work. Story | Follow @FierceMedDev

 @MarkHFierce: AutoGenomics aborted its second IPO attempt in a few years. The company promises #3, but we'll see. More | Follow @MarkHFierce

 @DamianFierce: In case you missed it over the weekend, Quintiles is finally kicking off the process of going public. News | Follow @DamianFierce

> Medtronic rides emerging markets growth to strong quarter. Story

> NeuroMetrix eyes sales rep expansion for pain device rollout. Article

Biotech Research News

> Antidepressant could reverse sickle cell disease. More

> Nicotinamide slows breast tumor growth in mice. Story

> Human stem cell trial set to begin in Japan. Item

> Compound could restore learning, memory in Angelman syndrome. Article

CRO News

> QPS swings into North Carolina with Hamner partnership. Story

> Charles River predicts strong 2013 despite Q4 slump. More

> With revenue rolling, AMRI looks to CDMO boom in 2013. Article

> Quintiles files IPO worth $600 million--or much more. News

Biotech IT News

> Genomics? There could be an app for that. Item

> Boehringer Ingelheim goes to Hungary for R&D software. More

> EU enters expensive race to map out brain secrets with computers. Article

> CLC bio capitalizes on surge in DNA sequencing. Story

Pharma Manufacturing News

> AMRI 'money pit' now money maker. Item

> GSK commits to continuous processing. More

> Gilead recalls some Vistide; supplies may be an issue. Article

> FDA lambastes Jamaican manufacturer over sterility, quality. Story

And Finally… A new coronavirus--or NCoV--which has killed 5 of the 12 people known to have been infected by it appears readily suited to spread easily in humans, according to a group of scientists. But immune-boosting drugs also appear to fight the virus effectively. Story

 

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