Sanofi nabs FDA approval for Menactra booster; AZ's new Bydureon pen rolls out; Par restarts generic Precedex shipments;


@FiercePharma: Top-read on FP Monday: Bristol-Myers socks Merck's brand-new Keytruda with PD-1 patent suit. Article | Follow @FiercePharma

@EricPFierce: ICYMI yesterday: Action against AbbVie, Teva over AndroGel comes as FTC is stalking a $1B settlement this year. Report | Follow @EricPFierce

@CarlyHFierce: ICYMI yesterday: Latest Allergan buzz puts Ireland's Jazz in its dealmaking sights. Story | Follow @CarlyHFierce


Veeva 2020 Unified Clinical Operations Survey

We believe you have the knowledge and expertise to make this year's Veeva 2020 Clinical Operations Report even more robust and insightful than the last. Please take a moment to share your opinion in this 10-minute survey. All qualified respondents will be entered to win a $500 Amazon gift card.

> Sanofi Pasteur won FDA approval for its Menactra vaccine as a booster shot against meningococcal disease in 15- to 55-year-olds. Release

> AstraZeneca ($AZN) said its new Bydureon pen for Type 2 diabetes is now available in the U.S. Report

> Par Pharmaceutical resumed shipping its version of Hospira's ($HSP) sedative Precedex after a U.S. court lifted a restraining order against the launch. Release

> A Washington, DC, federal judge refused to allow the consumer watchdog Public Citizen to access documents related to off-label marketing settlements involving Pfizer ($PFE) and Purdue Pharma. Report (reg. req.)

> Novartis ($NVS) sued two Indian drugmakers for patent infringement, targeting Zydus Pharmaceuticals' plans for a generic version of its Alzheimer's treatment, Exelon Patch, and Dr. Reddy's Laboratories' effort to knock off its cancer drug Gleevec. Report | Report

> U.S. Treasury Secretary Jack Lew called for quick action against tax inversion deals, such as AbbVie's ($ABBV) planned buyout of Shire ($SHPG). Report

> Pfizer Canada donated EpiPen injectors as part of a pilot project aimed at making the anaphylaxis-fighter available at every restaurant and food court in Hamilton, Ontario. Report

Medical Device News

@FierceMedDev: GE Healthcare, FBI allege Chinese engineer stole MRI trade secrets. FierceDiagnostics story | Follow @FierceMedDev

@VarunSaxena2: EU creates €1B fund for research on the use of graphene. Article | Follow @VarunSaxena2

@MichaelGFierce: ICYMI: UO, Berkeley team tailors ultrathin peptoid nanosheets for delivery using oil and water. More from FierceDrugDelivery | Follow @MichaelGFierce

@EmilyWFierce: J&J ordered to fork over $3.27M in vaginal mesh case. Report | Follow @EmilyWFierce

> Israeli startup develops hand-held device for medical marijuana. Report

> Titan Spine offers first spine implant warranty. More

> Stent developer Tryton gets $20M to complete FDA submission, market in EU. Story

Biotech News

@FierceBiotech: Christoph Westphal launches another biotech, with the help of some wealthy friends. Story | Follow @FierceBiotech

@JohnCFierce: Can Novo Nordisk and Orexigen finally open up a blockbuster weight-loss market? More | Follow @JohnCFierce

@DamianFierce:   | Follow @DamianFierce

@EmilyMFierce: Great tool for journalists covering NIH budget: @UMR4NIH launched an interactive map that breaks down state funding. More | Follow @EmilyMFierce

> OrbiMed Advisors banks $325M for a new round of Asian biotech bets. Report

> Boehringer's next-gen COPD treatment hits the mark in Phase III. Article

> PRA lines up a $375M IPO after a string of CRO deals. Story

Biotech Research News

> Compound inhibits both MERS, SARS. Report

> Experimental C. difficile drugs could be more effective than current therapy. Article

> Glaxo's Ebola vaccine effective in monkeys but may require booster shot. More

> 'Disease in a dish' aids Huntington's drug discovery. Item

> Scientists find way to expand blood stem cell production in lab. Story

Pharma Manufacturing News

> ProBioGen will double its Berlin staff to expand cell-based manufacturing. Article

> Germany's Aenova buys North Carolina packaging operation. Item

> Cipla buys two Indian manufacturing facilities for partner Okasa. Story

> Perrigo recalls 367,000 tubes of nicotine lozenges. Report

> FDA, DOJ arrest NECC pharmacist about to leave the country. Article

And Finally... Health officials identified an unusual, serious outbreak of enterovirus in children in the Midwest. Report

Suggested Articles

Only months after a game-changing new approval for Vascepa, Amarin has lost a key fight over its patents—and now it's scrambling to respond.

Move over, Roche. There’s a new small-cell lung cancer therapy on the scene, and it belongs to AstraZeneca.

Fujifilm says it is prepared to ramp up production of Avigan for any country that wants to try it as a potential treatment for COVID-19.