Moody's, S&P lower ratings on AZ, citing generics; Lundbeck chief says profits on tap for 2016;

@FiercePharma: Luye's schizophrenia drug gets nod to move ahead with NDA approval. FiercePharmaAsia story | Follow @FiercePharma

@CarlyHFierce: $VRX "working hard" to reach out to payers, CEO says. "Historically, I have not spent a lot of time doing that." | Follow @CarlyHFierce

> Moody's and Standard & Poor's both lowered their credit ratings on AstraZeneca ($AZN), citing patent expirations and generic competitors for big-selling products. Report

> Lundbeck CEO Kåre Schultz said he expects the company to return to profitability next year, thanks to deep cost cuts and growing sales of recently launched meds. Report

> Under attack from hostile bidder Horizon Pharmaceuticals ($HZNP), Depomed ($DEPO) hiked its 2015 sales and earnings guidance thanks to strong sales of its Nucynta painkiller. Report

Medical Device News

@FierceMedDev: ICYMI yesterday: Google Life Sciences teams with AHA to target heart disease in $50M research initiative. Article | Follow @FierceMedDev

@VarunSaxena2: JAMA study: Rate of inappropriate stenting is declining. Story | Follow @VarunSaxena2

@EmilyWFierce: Scientists make strides toward full-body PET scanner with $15.5M in tow. Article | Follow @EmilyWFierce

> IBM brings Watson to Boston Children's Hospital for rare pediatric disease diagnosis. News

> FDA cracks down on genetic test makers for direct-to-consumer marketing. Report

Biotech News

@FierceBiotech: ICYMI yesterday: Agios slips on mixed solid tumor data for its Celgene-partnered cancer drug. More | Follow @FierceBiotech

@JohnCFierce: Old ACT was always reliable. Every fresh bit of data was a revolutionary breakthrough. But never got out of early stage R&D. | Follow @JohnCFierce

@DamianFierce: "I can't believe the future is sending feces around the country," said $MCBM's CEO, having never heard of Twitter. More from the NYT | Follow @DamianFierce

> AstraZeneca, GlaxoSmithKline stake rival claims on new lupus therapies. Story

> MiRagen captures a $41M round for a pair of microRNA trials. Article

> Did Sanofi drag its feet on Lemtrada to shortchange Genzyme shareholders? More

Drug Delivery News

> Injectable HIV regimen being developed by J&J and ViiV Healthcare shows promise in trials. Report

> Canadian doctor opens blood-brain barrier using focused ultrasound. Item

> Ebola study will monitor viral entry into cells, with focus on drug delivery. Story

> Injectable HIV regimen being developed by J&J and ViiV Healthcare shows promise in trials. Article

> GSK beats AstraZeneca to finish line, wins FDA approval of first anti-IL-5 injectable for asthma. More

Pharma Manufacturing News

> Court orders Dr. Reddy's to temporarily halt sales of its purple Nexium copy. Story

> Pfizer recalls 21,000 bottles of Xanax that may be too weak. More

> Almac expanding in U.K., investing $24M in Charnwood tech park. Report

> Dr. Reddy's gets slapped with FDA warning letter for three Indian plants. Article

> Sun's U.S. sales crater as plant issues cut deeply. Story

Pharma Asia News

> AstraZeneca shows more solid gains in China on respiratory. More

> Luye's schizophrenia drug gets nod to move ahead with NDA approval. Story

> China to restart mainland IPOs, with pharma ready to roll. Item

> FDA widens review of Dr. Reddy's manufacturing ops. More

> India's Sun Pharmaceutical takes another Ranbaxy-related hit. Article

And Finally... Amgen ($AMGN) rolled out clinical equivalence data on its biosimilar version of Humira at the American College of Rheumatology meeting in San Francisco. Report

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