Lawyers suing Johnson & Johnson ($JNJ) and Bayer over alleged injuries from their anticlotting drug Xarelto say that the companies misled editors at The New England Journal of Medicine by failing to speak up about possible discrepancies in patient data from a key trial. The NEJM published a letter, primarily written by Duke University researchers, about the trial, which came under scrutiny last fall because a blood-testing device used in the study had given inaccurate readings. In the letter, the researchers said that readings from the faulty device would not have changed the trial's results. They weren't aware of lab data that might have shed a different light on the device's readings, but the companies were, The New York Times reports. Report
@FiercePharma: Dancing bladders and football-helmeted toenails have FDA questioning cartoons in DTC ads. More from FiercePharmaMarketing | Follow @FiercePharma
@CarlyHFierce: ICYMI: Don't give up on generic Copaxone, despite Teva's aggressive brand defense: Momenta CEO. Article | Follow @CarlyHFierce
> AstraZeneca ($AZN) said the FDA approved a new use for its breast cancer drug Faslodex, alongside Pfizer's ($PFE) popular new treatment Ibrance (palbociclib). Report
> Eli Lilly ($LLY) launched its new once-a-week GLP-1 diabetes drug Trulicity in India. Report
> European regulators backed the latest two-dose human papillomavirus vaccine from Sanofi Pasteur and Merck ($MRK), Gardasil 9. Report
> South Africa's Aspen Pharmacare reported a 14% increase in profits for the half-year ending Dec. 31. Report
Medical Device News
@FierceMedDev: IBM Watson unveils its first Apple ResearchKit effort with massive, patient-designed sleep study. Report | Follow @FierceMedDev
@EmilyWFierce: New York AG launches probe into insurers' coverage of hep C drugs--or lack thereof. More from FiercePharma | Follow @EmilyWFierce
> FDA approves Gore's endoprosthesis for iliac artery aneurysms. Story
> J&J Depuy does a pair of deals, one to treat disc degeneration and another for bundled payments. More
> Medtronic's disappointing earnings highlight challenge posed by currency headwinds. Article
Biotech News
@FierceBiotech: Still licking Duchenne wounds, BioMarin makes an early run at Batten drug OK. More | Follow @FierceBiotech
@JohnCFierce: Syndax braves a market tempest in second IPO try, scores a $53M raise. Article | Follow @JohnCFierce
> Alaska Fund acquires a taste for big biotech startups. Item
> Opexa sheds 30% of its workforce as it awaits make-or-break MS data. Story
> That priority review voucher program? The FDA hates it. More
> Pfizer, Merck KGaA partner PD-L1 drug with Verastem's failed cancer drug. Article
Pharma Manufacturing News
> McKesson extends its Canada supply chain reach with $2.23B deal for Rexall chain. Report
> Another of AmerisourceBergen's Pharmedium facilities cited by FDA. Story
> Bayer spending $2.7B on capacity expansion, outgoing CEO says. Article
> Essentra adding jobs in Wales with pharma packaging facility. More
> CutisPharma adds drug manufacturing to its operations. Item
CRO News
> Infinity taps CRO Pharm-Olam for a Phase II lymphoma study. Report
> PRA eyes double-digit growth in 2016 after a banner revenue year. Story
> Chinese CRO R&G buys into Medidata's trial tech. News
> Medpace signs on to help Actinium get its cancer drug into Phase III. More
> Synexus buys Research Across America, gaining first access to the U.S. Article
Pharma Asia News
> China's Shanghai Fosun Pharmaceutical eyes RMB3B bond issue. Report
> AstraZeneca moves quickly to shed another noncore drug in ProStrakan deal. Item
> HK-based Chi-Med doses first patient in China PhII thyroid cancer trial of sulfatinib. More
> South Korea's Yuhan finds U.S. partner Sorrento for immune checkpoint antibodies JV. Story
> Americas units of Japan's Olympus hit with penalties of $623M in kickback probe. Article
And Finally... A study found that one popular smartphone app that gauges blood pressure is "highly inaccurate." Report