Strides' Agila plant gets warning letter; Eisai launches Halaven in Russia;

@FiercePharma: GSK's happy: Arzerra won FDA breakthrough status; now, priority review for melanoma combo Tafinlar + Mekinist. Article | Follow @FiercePharma

@EricPFierce: GSK, Genmab get FDA 'breakthrough' designation for Arzerra in first-line use. ICYMI Friday | Follow @EricPFierce

@CarlyHFierce: Check out the new report by @EricPFierce: Top 10 rheumatoid arthritis drugs 2013. Feature | Follow @CarlyHFierce

> Indian drugmaker Strides Arcolab said Monday that it has received an FDA warning letter for one of its plants in its Agila Specialties division, the business which Mylan ($MYL) is buying for $1.6 billion. Story

> Sun Pharmaceutical Industries has gotten FDA approval to make a generic of Takeda's Prevacid, a treatment for active duodenal ulcer. Story

> Zydus has launched in India its patented diabetes drug Lipaglyn. Story

> India's domestic drug market grew just 1.1% in August, the slowest monthly rate recorded. Report

> Israeli drugmaker Protalix BioTherapeutics ($PLX) saw its shares drop about 10% after selling $60 million in convertible notes, a move the markets took as a sign of weakness. Story

> Japanese drugmaker Eisai has launched its breast cancer treatment Halaven in Russia. Story

> A new report says pharmaceuticals sales in Saudi Arabia should grow to more than $7 billion by 2018, from about $4 billion 2012. Story

Medical Device News

@FierceMedDev: Foundation Medicine eyes $92M in IPO. ICYMI Friday | Follow @FierceMedDev

@DamianFierce: Columbia Labs is buying into the CRO biz for $25M, grabbing Molecular Profiles. More from FierceCRO | Follow @DamianFierce

@MarkHFierce: Touch may help prevent hacking of insulin pumps and other wireless, implanted devices. Article via MIT Technology Review. | Follow @MarkHFierce

@MichaelGFierce: Delcath's chemo delivery device suffers FDA rejection. ICYMI from FierceDrugDelivery | Follow @MichaelGFierce

> Quidel scores FDA nods for Life Tech-powered tests. News

> Bard resolves New Jersey vaginal mesh suit. Report

> NeoTract's enlarged prostate implant gains FDA de novo nod. Story

Biotech News

@FierceBiotech: Veeva, provider of sales software to Merck, seeks up to $150M in IPO. Story from FierceBiotech IT | Follow @FierceBiotech

@JohnCFierce: ICYMI: ViroPharma shares soar on report of possible buyout offer. Article | Follow @JohnCFierce

@EmilyMFierce: Cheaper sequencing points cancer drug researchers to 'super responders.' More | Follow @EmilyMFierce

> Biosimilars developer Celltrion defends against allegations of insider trading. Report

> NovaBay shares jump on positive PhII catheter solution study. Item

> Chiesi values Cornerstone Therapeutics at $255M in buyout deal. Story

> FDA lifts hold on Pluristem's stem cell trial after tweaking protocol. News

CRO News

> Harlan ups its European presence. Item

> Theorem teams with Charles River on preclinical work. Report

> Indian CRO TCG teams with Debiopharm for antibiotics. More

> Bayer taps DKSH with eye on Singapore. Story

> Italy's CROS NT reaches into U.S. with Stat-Tech buyout. Article

Biotech IT News

> TranSMART releases new version of research software from Johnson & Johnson. Item

> Qlucore corrals EU funding for hepatitis C software. Report

> AstraZeneca supports iPhone app for helping patients with heart disease. Article

> MIT center grabs $25M grant to build human-like computers. More

> Treato releases latest software: not another social media-listening app for pharma? Story

And Finally... Using big advances in genetic understanding and genetic sequencing technology, researchers are looking at "super responders" for insight into how some existing treatments might be used in certain patient populations. Story