Survey Shows Drug Makers Don't Expect To Begin Serializing All Packages By November Deadline
Concerns that the US pharmaceutical industry will not have the necessary serialization systems in place to fully comply with DSCSA...
Scrip - October 19, 2018

Pharma Q3 Results Preview: Biogen, Gilead, Celgene
Ozanimod re-filing is a big near-term catalyst for Celgene. Biogen investors will be looking for more information about the development...
Scrip - October 19, 2018

Deal Watch, Licensing & Alliances: Amgen Places $66m Bet On Genetic Sequencing
Already partnered with Oxford Nanopore through its acquisition of deCODE Genetics, Amgen invests in the UK biotech to enhance its...
Scrip - October 19, 2018

Deal Watch, M&A: Warp Drive And Its Partnerships Acquired By Revolution
Once expected to be absorbed by Sanofi, US biotech Warp Drive Bio now will become part of California’s Revolution Medicines...
Scrip - October 19, 2018

Only Health-Care Case At US Supreme Court This Fall Looks At Preemption
The Supreme Court will hear arguments this fall in a lawsuit concerning whether FDA decisions can protect drug manufacturers from...
Scrip - October 19, 2018

Medtronic Vet Christopher Barry Takes Helm At Nuvasive
About three years after becoming CEO of NuVasive, Gregory Lucier is ceding the role to Barry, who has led Medtronic's...
Scrip - October 19, 2018

With TheraFlu PowerPods, GSK Brews Market For OTCs From Coffee Makers
GSK takes Theraflu brand from medicine cabinet to kitchen with launch of PowerPods of OTC ingredients delivered through single-serve coffee...
Scrip - October 19, 2018

Hong Kong Medtech Regulators Face Need For System Update
Speed and efficiency are apparently on the minds of Hong Kong's regulators, who have proposed to shorten approval times for...
Scrip - October 19, 2018

Q&A: Ireland's Success In Attracting Medtech Companies
Medtech Insight talked to Rachel Shelly, the Head of Medical Technologies for IDA Ireland, about the Irish government's continuing efforts...
Scrip - October 19, 2018

Controversial Dengue Drug Among Six Products To Get EMA Thumbs Up
Dengvaxia, the dengue vaccine from Sanofi that was suspended in the Philippines last year, is among six new products to...
Scrip - October 19, 2018

Every Little Helps: Shire Product Advances Fortify Takeda's Bid
A positive opinion in the EU for Shire's Takhzyro and a favorable US advisory committee vote for prucalopride are incremental...
Scrip - October 19, 2018

Voters Likely To Pick And Choose Among Device Industry Favorites In Close Races
Among the very tight Republican and Democrat contests anticipated in this November’s US midterm elections are more than a few...
Scrip - October 19, 2018

DATA: Results Recap: Neovasc's Tiara TMVR Succeeds In 12 Patients
Results Recap is Medtech Insight's exclusive summary of clinical trial results that have been announced or published in the past...
Scrip - October 19, 2018

Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Scrip - October 19, 2018

EU Launches Joint Assessment Of Pediatric & Orphan Drugs Legislation
A new European Commission consultation marks the launch of an evaluation exercise to assess the joint impact of the EU...
Scrip - October 19, 2018

QUOTED. Oct. 19, 2018. David Skibinski.
SnapMD CEO David Skibinski is very bullish about the central role telehealth will play in cardiology and health care more...
Scrip - October 19, 2018

Survey Shows Drug Makers Don't Expect To Begin Serializing All Packages By November Deadline
Concerns that the US pharmaceutical industry will not have the necessary serialization systems in place to fully comply with DSCSA...
Scrip - October 19, 2018

Pharma Q3 Results Preview: Biogen, Gilead, Celgene
Ozanimod re-filing is a big near-term catalyst for Celgene. Biogen investors will be looking for more information about the development...
Scrip - October 19, 2018

Deal Watch, Licensing & Alliances: Amgen Places $66m Bet On Genetic Sequencing
Already partnered with Oxford Nanopore through its acquisition of deCODE Genetics, Amgen invests in the UK biotech to enhance its...
Scrip - October 19, 2018

Deal Watch, M&A: Warp Drive And Its Partnerships Acquired By Revolution
Once expected to be absorbed by Sanofi, US biotech Warp Drive Bio now will become part of California’s Revolution Medicines...
Scrip - October 19, 2018

Only Health-Care Case At US Supreme Court This Fall Looks At Preemption
The Supreme Court will hear arguments this fall in a lawsuit concerning whether FDA decisions can protect drug manufacturers from...
Scrip - October 19, 2018

Medtronic Vet Christopher Barry Takes Helm At Nuvasive
About three years after becoming CEO of NuVasive, Gregory Lucier is ceding the role to Barry, who has led Medtronic's...
Scrip - October 19, 2018

With TheraFlu PowerPods, GSK Brews Market For OTCs From Coffee Makers
GSK takes Theraflu brand from medicine cabinet to kitchen with launch of PowerPods of OTC ingredients delivered through single-serve coffee...
Scrip - October 19, 2018

Hong Kong Medtech Regulators Face Need For System Update
Speed and efficiency are apparently on the minds of Hong Kong's regulators, who have proposed to shorten approval times for...
Scrip - October 19, 2018

Q&A: Ireland's Success In Attracting Medtech Companies
Medtech Insight talked to Rachel Shelly, the Head of Medical Technologies for IDA Ireland, about the Irish government's continuing efforts...
Scrip - October 19, 2018

Controversial Dengue Drug Among Six Products To Get EMA Thumbs Up
Dengvaxia, the dengue vaccine from Sanofi that was suspended in the Philippines last year, is among six new products to...
Scrip - October 19, 2018

Every Little Helps: Shire Product Advances Fortify Takeda's Bid
A positive opinion in the EU for Shire's Takhzyro and a favorable US advisory committee vote for prucalopride are incremental...
Scrip - October 19, 2018

Voters Likely To Pick And Choose Among Device Industry Favorites In Close Races
Among the very tight Republican and Democrat contests anticipated in this November’s US midterm elections are more than a few...
Scrip - October 19, 2018

DATA: Results Recap: Neovasc's Tiara TMVR Succeeds In 12 Patients
Results Recap is Medtech Insight's exclusive summary of clinical trial results that have been announced or published in the past...
Scrip - October 19, 2018

Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Scrip - October 19, 2018

EU Launches Joint Assessment Of Pediatric & Orphan Drugs Legislation
A new European Commission consultation marks the launch of an evaluation exercise to assess the joint impact of the EU...
Scrip - October 19, 2018

QUOTED. Oct. 19, 2018. David Skibinski.
SnapMD CEO David Skibinski is very bullish about the central role telehealth will play in cardiology and health care more...
Scrip - October 19, 2018

Public Citizen: FDA Deliberately Excluded Risk Committee From Dsuvia Panel To Get Positive Vote
Public Citizen's letter also features commentary from Analgesic Drug Products Advisory Committee Chairman Raeford Brown, who voiced his displeasure with...
The Pink Sheet - October 18, 2018

Shire’s Motegrity: US FDA Panel Nod On CV Safety Comes With Concern About Neuropsych Events
In unanimously endorsing prucalopride for chronic idiopathic constipation, advisory committee seems reassured by extensive data on 5-HT4 agonist’s cardiovascular safety...
The Pink Sheet - October 18, 2018

US FDA's Ostroff, Twice An Acting Commissioner, Retiring Next Year
A former Walmart executive will replace the deputy commissioner for foods and veterinary medicine, who spent nearly 15 months total...
The Pink Sheet - October 18, 2018

Drug Pricing Reform In Medicare And Medicaid: Upcoming Regulatory Action
Two highly anticipated proposed rules in Medicare Part D are scheduled for near-term release.
The Pink Sheet - October 18, 2018

Drug Pricing Reform In Medicare And Medicaid: Upcoming Regulatory Actions
Two highly anticipated proposed rules in Medicare Part D are scheduled for near-term release.
The Pink Sheet - October 18, 2018

Acne Claims For Cosmetics Leave Blemish On UK Advertising Regs
Advertising Standards Authority issued decisions Oct. 17 on complaints against three cosmetics brands and an online beauty retailer for statements...
The Pink Sheet - October 18, 2018

Seqirus Completes Long Journey To Restore Afluria's Pediatric Indication
The key to pediatric approval for a flu vaccine: a manufacturing root cause investigation and subsequent process improvements.  
The Pink Sheet - October 18, 2018

How Brazilian Patients Might Access Sickle Cell Disease Drug Faster
Masters Speciality Pharma is in the process of registering sickle cell disease drug Siklos in Brazil. The company revealed how it...
The Pink Sheet - October 18, 2018

New EU Approvals
Six new products, including Eli Lilly's breast cancer drug Verzenios, have been added to the Pink Sheet’s 2018 list of EU centralized approvals of...
The Pink Sheet - October 18, 2018

VistaGen Stocks Neuropsychiatry Pipeline And Takes Aim At Depression Market
Shawn Singh, CEO of VistaGen, a growing Silicon Valley-based biotech focused on psychiatry and neurological drug development, outlines the company’s strategy...
IN VIVO - October 17, 2018

Deals In Depth: August 2018
In a partnership worth up to $5 billion, Affimed and Genentech will discovery innate immune cell immunotherapies for solid and...
IN VIVO - October 17, 2018

Device-Makers Need Open Up More On Cybersecurity In Pre-Market, Draft Guidance Says
A new update to the pre-market cybersecurity guidance issued four years ago reflects how US FDA's thinking on the issue...
Medtech Insight - October 18, 2018

SnapMD Brings Virtual Cardiologist To Patients
Telehealth is a growing trend in cardiology and SnapMD says it's on the forefront.
Medtech Insight - October 18, 2018

Market Intel: Digital Tech At The Heart Of Cardiology Innovation
Digital health technologies from smartphone applications, wearables, digital weight scales and telehealth are rapidly changing the landscape of cardiac care...
Medtech Insight - October 18, 2018

AUDIO: Device Week, Oct. 18, 2018 – Digital Health Market Intelligence; New Blood Therapies Harvested From The Ocean
In this edition of Device Week, Medtech Insight's Marion Webb gives an overview of her new Market Intelligence article on...
Medtech Insight - October 18, 2018

European Commission Sheds Light On MDR/IVDR Progress In Vital Update
A new "rolling plan" provides deadlines for implementing actions, and other efforts, that are necessary to get the new EU...
Medtech Insight - October 18, 2018

QUOTED. Oct. 18, 2018. Charlie Dent.
Many are awaiting the outcome of the upcoming US midterm congressional elections. But its unlikely the newly elected Congress will...
Medtech Insight - October 18, 2018

FDA Ban On Flavoring Ingredients Should Prompt Removal From Fragrances – WVE
The battle between hazard and risk ideologies goes on as NGO Women’s Voices for the Earth calls for the removal...
The Rose Sheet - October 18, 2018

Sparq's Vitamin Vapor Inhalation Product Could Spark Regulatory Interest
Vitamin Air is so novel, it could get FDA's attention for misbranding as a supplement and being an unapproved new...
The Rose Sheet - October 18, 2018

Essential Oil Sleep Claims In Hot Water With UK Advertising Regulator
UK Advertising Standards Authority advised Puressentiel not to make ad claims reserved for licensed medicinal products. Puressentiel argued its products...
The Rose Sheet - October 18, 2018

Gauss Surgical raises $12mm in Series A round
Gauss Surgical Inc. raised $12mm through its Series A round from Promus Ventures (led and takes a board seat), Summation Health Ventures, and LifeForce Ventures. The company markets its Triton digital imaging and artificial intelligence-driven device as a blood loss monitor during surgical procedures and childbirth.
Strategic Transactions - October 18, 2018

Series B round brings $12.6mm to Gauss Surgical
Gauss Surgical Inc. (markets the Triton system for real-time blood loss monitoring during surgery and childbirth) raised $12.6mm in its Series B round from Providence Ventures (lead), Jump Capital, Promus Ventures, LifeForce Ventures, Summation Health Ventures and the Stanford-StartX Fund.
Strategic Transactions - October 18, 2018

Gauss Surgical completes $20mm Series C round
Gauss Surgical Inc. (digital imaging and artificial intelligence) raised $20mm through its Series C round. Northwell Health, SoftBank Ventures Korea, and LS Polaris Innovation participated, along with venture arms of health care systems including UNC/REX Healthcare, OSF Healthcare, Providence Healthcare, Orland Health, Spectrum Health, Mount Sinai Health System, and the Memorial Hermann Health System.
Strategic Transactions - October 18, 2018

SI-Bone goes public netting $100.4mm
Medical device firm SI-Bone Inc. netted $100.4mm in its oversubscribed initial public offering on the Nasdaq. The company sold 7.2mm shares priced at $15, the high end of its anticipated range. It originally planned to sell 6mm shares.
Strategic Transactions - October 18, 2018