@FierceMedDev: ICYMI yesterday: FDA clears laser-based comb to combat hair loss. Article | Follow @FierceMedDev
@StacyALawrence: GE-backed InSightec gets $59M for noninvasive surgical tool, adds ex-Mako CEO to board. More | Follow @StacyALawrence
@EmilyWFierce: Power morcellator fallout illustrates major flaw in FDA's device regulation. WSJ story | Follow @EmilyWFierce
> Researchers developed a microphone-equipped earphone, which when connected to a smartphone placed on a bedside table, can be used to monitor sleeping disorders. News
> The FDA granted CVRx a Humanitarian Device Exemption for its Barostim neo legacy device, which electrically triggers the body's own natural blood flow regulation system to treat chronic heart failure and resistant hypertension. The HDE approval pathway is reserved for devices that treat rare conditions. Release
> Brainsway, a med tech company developing treatments for mental disorders, received FDA approval for a multicenter trial of its PTSD treatment. Release
> Nevro, a medical device company focused on reducing chronic pain, completed its first draw down of $20 million before closing fees from its $50 million loan facility with investment firm CRG LP. Release
Biotech News
@FierceBiotech: Cyclacel's cancer drug isn't working in Phase III, but that won't stop the trial. Story | Follow @FierceBiotech
@JohnCFierce: Top Monday story: UPDATED: Onyx vet Tony Coles embarks on a new biotech adventure. More | Follow @JohnCFierce
@DamianFierce: Scathing new ad for tightening regs on private equity. Story | Follow @DamianFierce
> Novartis wins an FDA nod for a long-acting spin on its rare disease drug. Report
> J&J punts a pair of new IBD drugs discovered at Galapagos. News
> Billionaire Soon-Shiong dives into immuno-oncology with $20M Sorrento venture. Article
Pharma News
@FiercePharma: New chief picks team to fuse Actavis with Allergan. Article | Follow @FiercePharma
@EricPFierce: ICYMI: Third round of cuts slated for Novartis US Diovan plant. Total reaches 133 with 394 more gone by 2016. Story | Follow @EricPFierce
@CarlyHFierce: ICYMI yesterday: Baxter backs away from vaccines with Vero tech sale to Nanotherapeutics. More | Follow @CarlyHFierce
> Roche's Lucentis nabs FDA 'breakthrough' tag for diabetic eye disease. More
> FTC plows ahead in pay-for-delay suit over AbbVie's AndroGel. Article
> Fresh off Afinitor failure, Novartis turns tide with Signifor LAR approval. News
Pharma Manufacturing News
> Biocon to build new plant in Vizag, India. Report
> Industry Voices: The future of pharma manufacturing--new disruptive technologies that can impact whole industry structures. More
> Baxter has yet another recall of sodium chloride. News
> Teva continues to whittle down manufacturing network. Story
> Avid Bioservices doubling capacity at its California facility. Article
Biotech Research News
> Scientists look to a pathway in the gut to fix fatty liver disease. Piece
> Repurposed fibroblasts may open the door to new melanoma drugs, screening tech. More
> Investigators hit on a new class of stem cells. Item
> Joslin investigators urge cosmetics groups to get into anti-aging R&D. Article
> NIH's children's health study ends as a $1.2B disaster. Story