Spotlight On... Swiss regulator tracking down fake Harvoni found in EU; FDA weighs expansion of Merck's Keytruda in NSCLC; Scottish cost watchdogs shoot down BMS' Opdivo, Roche's Perjeta; and more...

The Swiss Agency for Therapeutic Products (Swissmedic) said that counterfeit Harvoni that was discovered in Israel had been shipped through an importer in Switzerland. The regulator is now working with other European authorities to figure out if the fake Harvoni packs also went to other countries. Swissmedic said the plastic bottles contained pills which were white coated, instead of the "genuine yellow film-coated tablets." It said it was aware the consumers had been buying the drug abroad because it is so expensive and in limited quantities in Switzerland but warned consumers there is no way to be sure what they are getting online is authentic. More from FiercePharmaManufacturing

@FiercePharma: Valeant sets March 15 release for delayed Q4 results. Item | Follow @FiercePharma

@CarlyHFierce: New rivals, formulary squeeze pose a double threat to Biogen MS sales. Article | Follow @CarlyHFierce

> The FDA is reviewing Merck's ($MRK) application to include new data on its immunotherapy Keytruda that could expand its use within the non-small cell lung cancer (NSCLC) patient population. Report

> The Scottish Medicines Consortium (SMC), Scotland's cost-effectiveness gatekeeper, has rejected Bristol-Myers Squibb's ($BMY) Opdivo as a monotherapy for the treatment of advanced melanoma and Roche's ($RHHBY) Perjeta for treatment of early-stage breast cancer. More

> PCI Pharma Services is exploring a sale that could value it at around $1 billion. Report

> Reducing drug waste could save billions of dollars, according to a new study from researchers at Memorial Sloan Kettering Cancer Center and the University of Chicago. More (sub. req.)

> Fluoroquinolone antibiotics are too risky a treatment for common infections, an FDA panel has said. More

Medical Device News

@FierceMedDev: ICYMI: Next up on Thermo Fisher's to-do list? Some serious M&A: Analyst. More | Follow @FierceMedDev

@EmilyWFierce: Illumina is getting a new CEO. Release | Follow @EmilyWFierce

> Illumina CEO Flatley passes the exec baton on the heels of growth. Article

> NuVasive acquires its Brazilian distributor to perk up sluggish international sales. Report

Biotech News

@FierceBiotech: With $70M in VC cash, Tizona takes a fresh approach to immuno-oncology. Report | Follow @FierceBiotech

@JohnCFierce: Interested in virtual ? Check out Capella: (antibodies). Story | Follow @JohnCFierce

> Amgen heads back to the M&A table with plans to stay 'disciplined.' Story

> Eyeing the U.S. market, TiGenix touts 52-week data from PhIII stem cell trial. More

> Sanofi restructuring claims its JV for vaccines with Merck. Article

Drug Delivery News

> ScPharmaceuticals reports strong PhIII trial of its subcutaneous antibiotic and wearable pump. More

> Spark buys Dublin's Genable for $15M, picking up gene therapy technology for orphan eye disease. Report

> J&J hosts drug delivery implant maker at its new Houston JLABS incubator. Story

> In vitro testing methods needed due to failure of animal models to predict drug delivery in humans. More

> Nanotech delivery system activates natural defense for damaged, diseased skin. Article

Pharma Manufacturing News

> Peregrine's Avid Bioservices unit wraps California biologics expansion. More

> Sagent recalls fluconazole contaminated with antibiotic. News

> Counterfeit Harvoni turns up in Switzerland, Israel. Story

> France's ANSM orders French biotech Theravectys to suspend manufacturing. Item

> Ranbaxy whistleblower pushing Indian regulators to do more. Article

Pharma Asia News

> CSL Behring gets U.S. FDA approval for hemophilia B therapy Idelvion. News

> WuXi AppTec says SynTheAll Changzhou facility out of the gate. Story

> PharmaEngine gets full Taiwan FDA nod to sell Onivyde. Report

> 3SBio gets China FDA IND nod for PEG-irinotecan candidate. Item

> HK-based Chi-Med $100M IPO set for March 14 as interest in China biopharma booms. Article

And Finally... Novartis ($NVS) has partnered with tech behemoth Microsoft ($MSFT), hoping to use its Kinect motion sensor to determine whether its multiple sclerosis treatments are proving effective. More

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