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Quidel Corporation ($QDEL) stock showed strong movement as the company announced receiving the FDA’s 501(k) clearance and Clinical Laboratory Improvements Amendments waiver for its Sofia Influenza A+B Fluorescent Immunoassay  to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid, differential detection of Influenza types A and B. The waiver will help the drug in accessing bigger market.
Quidel stock is up 17 percent this year so far. It has gained 53 percent in the past 12 months. The company said that Sofia 2 is the next-generation version of Sofia instrumented system and it uses original Sofia’s fluorescent chemistry design while improving upon the graphical user interface and optics system.

Intuitive Surgical ($ISRG) announced that the FDA has granted 510 (K) clearance to its da Vinci X Surgical System. The system has already received CE mark, which was granted last month. The system is designed to provide surgeons and hospitals with access to some of the most advanced robotic-assisted surgery technology at a lower cost.  Using this system, the medical professionals can access Intuitive’s  portfolio of advanced, innovative robotic-assisted surgical technologies.
Intuitive stock has gained 44 percent in this year so far while its 12 months gain stands at 43 percent. The stock created its new 52 weeks high in its previous trading session.

 

Zimmer Biomet ($ZBH) suffered a setback as the FDA issued a Class 1 recall covering its SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulators. The decision has been taken on account of  higher-than-allowed levels of certain chemicals that may be toxic to tissues and organs. Class 1 recall is the most serious category of recall. The decision applies to 33 devices in the field that were distributed between March 28 and April 6.

MannKind ($MNKD) announced promoting its Chief Commercial Officer Michael Castagna, Pharm.D.,  to CEO effective May 25. The departing CEO Matthew Pfeffer will continue as advisor through July.

Bayer ($BAYRY) announced receiving the FDA approval for its supplemental Biologics License Application (sBLA) for its myBETAapp and BETACONNECT Navigator for MS drug BETASERON (interferon beta-1b). The myBETAapp is expected to be available for free download at the Apple app store, Google Play or Betaseron.com in mid-July.

Pfizer ($PFE) announced receiving the European Commission approval TRUMENBA (meningococcal group B vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in people at least 10 years old. The drug was awarded accelerated approval by the FDA in October, 2014.

 

AstraZeneca ($AZN) announced inking a multiyear outcomes-based contracts with  Harvard Pilgrim. The agreement is concerned with Brilinta and BYDUREON. Under the BRILINTA deal, Harvard Pilgrim will be assessing if the drug reduces the number of hospitalizations for patients with acute coronary symptoms after their first discharge, among other things. Under the BYDUREON deal, Harvard will track how well the product helps diabetics reach their HbA1c goals.
Guided Therapeutics ($GTHP) announced that it has received an order for 10 LuViva Advanced Cervical Scans in Indonesia. The company has already sold 14 units in the country. Guided Therapeutics claimed that cervical cancer is the second most-common cancer in Indonesian women with more than 93M at risk. 

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Stifel Nicolaus
Reiterates
Abbott Laboratories (ABT)
Buy
$49.00 -> $51.00
Low
Chardan Capital
Upgrades
Akari Therapeutics PLC (AKTX)
Sell -> Neutral
$6.50 -> $6.00
Low
Cantor Fitzgerald
Reiterates
Ardelyx (ARDX)
Buy
$12.00
Low
Stifel Nicolaus
Reiterates
Baxter International (BAX)
Hold
$58.00 -> $61.00
Low
Mizuho
Reiterates
Biogen (BIIB)
Neutral
$290.00 -> $274.00
Low
Benchmark
Raises Target
EXACT Sciences (EXAS)
Buy -> Buy
$34.00 -> $50.00
Low
JPMorgan Chase & Co.
Reiterates
GlaxoSmithKline plc (GSK)
Neutral

Medium
SunTrust Banks
Upgrades
INC Research Holdings (INCR)
Hold -> Buy
$48.00 -> $67.00
Low
Mizuho
Lowers Target
Jazz Pharmaceuticals plc - (JAZZ)
Neutral -> Neutral
$150.00 -> $144.00
Low

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