Signs are pointing toward the possibility of a grand overhaul of federal regulation of the device (and drug) industry by the end of the Obama administration after all. Progress on a bill had been slow out of the gate in the Senate following last year's overwhelming passage of the 21st Century Cures Act in the House of Representatives. But several Democratic and Republican senators and representatives just met with Vice President Joe Biden at the White House to discuss their efforts. It appears that the idea of combining Republican-led regulatory easing with Democratic desires like "moonshot" cancer research and the Precision Medicine Initiative is gaining stream, according to the House Energy and Commerce Committee. The meeting with Vice President Biden comes on the heels of an unexpected agreement in a key Senate committee, which led to the advancement of three bills to simplify regulation of med tech. Meanwhile, AdvaMed just touted a bill, introduced by reps. Todd Young (R-IN) and Scott Peters (D-CA), to encourage federal reimbursement of investigational medical devices. The trade association proposed the initiative at a press conference last year, but it was not included in the House's 21st Century Cures Act. More from the House Energy and Commerce Committee | More from AdvaMed
@FierceMedDev: Med tech, healthcare services venture firm HealthQuest raises oversubscribed $225M fund. Story | Follow @FierceMedDev
@VarunSaxena2: The chart is just so darn startling/horrible. (Have mentioned it in stories about opioid abuse-deterrent tech.) More from the NYT | Follow @VarunSaxena2
@EmilyWFierce: 10X Genomics locks down $55M for long-read sequencing tech. News | Follow @EmilyWFierce
> Athletic performance company Exos has partnered with Intel to create fitness based wearable technology. More
> Bloomberg conducted an analysis of compensation for Masimo ($MASI) CEO Joe Kiani that shows a giant golden parachute for the exec of $112 million--suggesting the patient monitoring company is aiming to be acquired. More
> Vestagen, whose garments are being reviewed by the FDA for claims that they reduce acquisition and retention of dangerous contaminants, has nabbed a licensing and distribution deal with major U.S. uniform distributor Dove Professional Apparel for nursing school uniforms. More
> Implantable CGM startup Senseonics ($SENH), which previously went public via a reverse merger and is backed by VC giant NEA, plans to sell 15.8 shares at $2.85 per share, thereby raising about $45 million--its first significant sum since being publicly listed. More
Biotech News
@FierceBiotech: ICYMI from FierceBiotechResearch: HIV drug increases therapeutic window for skin cancer by slowing drug resistance. Story | Follow @FierceBiotech
@JohnCFierce: As in everything, GSK moves SOOOOO slowly. CEO Witty will leave March, 2017. No rush. | Follow @JohnCFierce
> J&J takes to Europe with its latest biotech incubator. Story
> Bayer wins FDA approval for a long-acting hemophilia drug. News
> GSK adds Miltenyi Biotec to its oncology shopping CAR-T as Witty checks out. Article
Pharma News
@FiercePharma: India's Lupin hauled up by U.S. FDA for lapses at Goa plant. More from FiercePharmaAsia | Follow @FiercePharma
@CarlyHFierce: Takeda dumps weight loss med Contrave, leaving Orexigen in the lurch. More from FiercePharmaMarketing | Follow @CarlyHFierce
> Chicago psychiatrist slapped with prison time in Teva kickbacks case. More
> GlaxoSmithKline CEO packs his bags for March 2017 exit. Article
CRO News
> INC snags a Quintiles vet as its new science leader. More
> Covance launches mobile health suite for clinical trials. Report
> PDS Life Sciences launches new FDA data compliance service. Story
> Quotient Clinical expands into Japan after PE buyout. Article
Pharma Manufacturing News
> Contract manufacturer PCT will handle TxCell production in U.S. Item
> European drug regulators find lots of plant issues in first quarter. Story
> China's FDA urged to get track-and-trace system in place. Item
> FDA castigates India's Emcure for routinely faking data. Report
> P&G joins Pfizer and Abbott in fighting India's cough med ban. Article
Pharma Asia News
> Chi-Med raises $101.25M in IPO, joining China's BeiGene on Nasdaq. News
> Abbott India unit, others, get court stay on fixed-dose drug bans. Item
> U.S. biotech Quark's siRNA trials include China, India legs. Report
> Nasdaq exec says biotechs prime Asian unicorns for listings. Story
> India's Lupin hauled up by U.S. FDA for lapses at Goa plant. Article