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Latest Pharma Insights


Innovation In OTC Switches Takes Multimedia Approach In US FDA Draft Guidance
Sponsors can point consumers to video displays, website information and mobile apps to help them choose products that have been...
Scrip - July 17, 2018
Lilly CEO Breaks From PhRMA, Innovators With Support For CREATES Act
Legislation that would prevent REMS from blocking generics appears to be gaining momentum.
Scrip - July 17, 2018
US FDA’s Biologics Transition Plan Will Consider Therapeutic Equivalence Ratings
While industry awaits formal guidance ahead of March 2020 transition deadline for certain protein products, FDA's Christl says plan will...
Scrip - July 17, 2018
MassMEDIC Taps Device News Publisher As New Prez
The Massachusetts-focused device industry trade group has appointed journalist Brian Johnson as its new president, replacing long-time leader Tom Sommer.
Scrip - July 17, 2018
With First IND, Recursion Readies Its AI, Experimental Biology Approach For The Clinic
Emerging Company Profile: With an early focus on rare, monogenic diseases, Recursion believes its platform combining artificial intelligence and experimental...
Scrip - July 17, 2018
As J&J Sees Continued Drug Price Declines, CEO Urges Slow Policy Change Via Trump's Blueprint
J&J told investors to anticipate negative net drug pricing of 4%-6% across its portfolio in 2018, following a 4.6% negative...
Scrip - July 17, 2018
FDA Denies WVE Petition For Feminine Wash Colorant Guidance
FDA doesn’t see a need for the guidance requested by Women’s Voices for the Earth, but that doesn’t mean the...
Scrip - July 17, 2018
Who Is Responsible? Congressional Cybersecurity Inquiry Reveals Manufacturer, Provider Rift
Hospitals and clinicians are pushing back against any assertion that they share equal responsibility with product manufacturers for cybersecurity of...
Scrip - July 17, 2018
US FDA May Approve Biosimilars With EU-Licensed Reference Products To Boost US Market
Commissioner Scott Gottlieb says move could allow biosimilar sponsors to avoid anti-competitive efforts by brand sponsors in US.
Scrip - July 17, 2018
ReCor Deal Underscores RDN Revival – But Also Reason For Backing Medtech?
Certain VCs are becoming reluctant to invest in medtech, citing difficulties such as a shrinking pool of buyers and increasing...
Scrip - July 17, 2018
J&J's Invokana Slows CKD Progression In Diabetes
Positive top-line efficacy data from the CREDENCE study suggest the SGLT2 inhibitor slows the progress of chronic kidney disease in...
Scrip - July 17, 2018
European Parliament To Commission: How Will New Regulations Be Ready On Time?
Little has been forthcoming from the European Commission about actions it is taking to get the new European regulatory framework...
Scrip - July 17, 2018
EMA 'Completely Reworks' Parts Of Gene Therapy Products Guideline
The European Medicines Agency has revised several sections of its 2001 guidance on the development and evaluation of gene therapy...
The Pink Sheet - July 17, 2018
New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
Scrip - July 17, 2018
UK Regulator Considers Jail For Non-Compliance With Coming EU Safety Features
The Medicines and Healthcare products Regulatory Agency has issued for consultation proposals on how it will ensure the UK meets...
Scrip - July 17, 2018
Warning Letter Roundup & Recap – July 17, 2018
No device-related warning letters were released by US FDA the week of July 17.
Scrip - July 17, 2018
Roche Steps Closer To Flu Market Domination With Phase III Baloxavir Results
Not even a month after the FDA granted the antiviral Priority Review, baloxavir marboxil has shown superior efficacy in its...
Scrip - July 17, 2018
Eight Pivotal Trial Read-Outs Expected In Q3
A number of pivotal studies are expected to report top-line data in the third quarter. Here, with the help of...
Scrip - July 17, 2018
Medtech Suppliers Still Out Of Pocket As Turkish Hospital Debt Trundles On
Even though the Turkish government has settled some of the sizeable debt owed by hospitals to medical device and pharmaceutical...
Scrip - July 17, 2018
Novartis And Cohen: A View Into Pharma's Policy Concerns As Trump Took Office
As then-Novartis CEO Joe Jimenez worked with former Trump lawyer Michael Cohen on drug pricing issues, the pharma industry was...
Scrip - July 17, 2018
QUOTED. July 17, 2018. David Brunel.
Biodesix Inc. is acquiring Integrated Diagnostics Inc. for both its flagship XL2 lung-cancer test and to upgrade its ability to...
Scrip - July 17, 2018

Innovation In OTC Switches Takes Multimedia Approach In US FDA Draft Guidance
Sponsors can point consumers to video displays, website information and mobile apps to help them choose products that have been...
Scrip - July 17, 2018
Lilly CEO Breaks From PhRMA, Innovators With Support For CREATES Act
Legislation that would prevent REMS from blocking generics appears to be gaining momentum.
Scrip - July 17, 2018
US FDA’s Biologics Transition Plan Will Consider Therapeutic Equivalence Ratings
While industry awaits formal guidance ahead of March 2020 transition deadline for certain protein products, FDA's Christl says plan will...
Scrip - July 17, 2018
MassMEDIC Taps Device News Publisher As New Prez
The Massachusetts-focused device industry trade group has appointed journalist Brian Johnson as its new president, replacing long-time leader Tom Sommer.
Scrip - July 17, 2018
With First IND, Recursion Readies Its AI, Experimental Biology Approach For The Clinic
Emerging Company Profile: With an early focus on rare, monogenic diseases, Recursion believes its platform combining artificial intelligence and experimental...
Scrip - July 17, 2018
As J&J Sees Continued Drug Price Declines, CEO Urges Slow Policy Change Via Trump's Blueprint
J&J told investors to anticipate negative net drug pricing of 4%-6% across its portfolio in 2018, following a 4.6% negative...
Scrip - July 17, 2018
FDA Denies WVE Petition For Feminine Wash Colorant Guidance
FDA doesn’t see a need for the guidance requested by Women’s Voices for the Earth, but that doesn’t mean the...
Scrip - July 17, 2018
Who Is Responsible? Congressional Cybersecurity Inquiry Reveals Manufacturer, Provider Rift
Hospitals and clinicians are pushing back against any assertion that they share equal responsibility with product manufacturers for cybersecurity of...
Scrip - July 17, 2018
US FDA May Approve Biosimilars With EU-Licensed Reference Products To Boost US Market
Commissioner Scott Gottlieb says move could allow biosimilar sponsors to avoid anti-competitive efforts by brand sponsors in US.
Scrip - July 17, 2018
ReCor Deal Underscores RDN Revival – But Also Reason For Backing Medtech?
Certain VCs are becoming reluctant to invest in medtech, citing difficulties such as a shrinking pool of buyers and increasing...
Scrip - July 17, 2018
J&J's Invokana Slows CKD Progression In Diabetes
Positive top-line efficacy data from the CREDENCE study suggest the SGLT2 inhibitor slows the progress of chronic kidney disease in...
Scrip - July 17, 2018
European Parliament To Commission: How Will New Regulations Be Ready On Time?
Little has been forthcoming from the European Commission about actions it is taking to get the new European regulatory framework...
Scrip - July 17, 2018
New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
Scrip - July 17, 2018
UK Regulator Considers Jail For Non-Compliance With Coming EU Safety Features
The Medicines and Healthcare products Regulatory Agency has issued for consultation proposals on how it will ensure the UK meets...
Scrip - July 17, 2018
Warning Letter Roundup & Recap – July 17, 2018
No device-related warning letters were released by US FDA the week of July 17.
Scrip - July 17, 2018
Roche Steps Closer To Flu Market Domination With Phase III Baloxavir Results
Not even a month after the FDA granted the antiviral Priority Review, baloxavir marboxil has shown superior efficacy in its...
Scrip - July 17, 2018
Eight Pivotal Trial Read-Outs Expected In Q3
A number of pivotal studies are expected to report top-line data in the third quarter. Here, with the help of...
Scrip - July 17, 2018
Medtech Suppliers Still Out Of Pocket As Turkish Hospital Debt Trundles On
Even though the Turkish government has settled some of the sizeable debt owed by hospitals to medical device and pharmaceutical...
Scrip - July 17, 2018
Novartis And Cohen: A View Into Pharma's Policy Concerns As Trump Took Office
As then-Novartis CEO Joe Jimenez worked with former Trump lawyer Michael Cohen on drug pricing issues, the pharma industry was...
Scrip - July 17, 2018
QUOTED. July 17, 2018. David Brunel.
Biodesix Inc. is acquiring Integrated Diagnostics Inc. for both its flagship XL2 lung-cancer test and to upgrade its ability to...
Scrip - July 17, 2018

EMA 'Completely Reworks' Parts Of Gene Therapy Products Guideline
The European Medicines Agency has revised several sections of its 2001 guidance on the development and evaluation of gene therapy...
The Pink Sheet - July 17, 2018

Record Breaking First Half For Start-Ups Raising Cash In Europe
The first half of 2018 appeared promising for the European biopharma sector, with multiple large investment funds promising cash to...
IN VIVO - July 16, 2018

EU's New MDR/IVDR Governance Group: What's At The Top Of Its Agenda?
Precious few details are available on the readiness of necessary structures and documents to support the EU's new Medical Device...
Medtech Insight - July 16, 2018
Global Device Approvals, Weekly Snapshot: July 9-15, 2018
A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This...
Medtech Insight - July 16, 2018
Compliance Corner: Follow These 4 Tips From FDA's Maisel For A Better Pre-Market Experience
Bill Maisel – the director of the Office of Device Evaluation within US FDA's Center for Devices and Radiological Health...
Medtech Insight - July 16, 2018
DATA: Open Payments: Zimmer, Medtronic Top List Of Spenders
Major medical device companies paid almost $1bn in consulting fees, royalties, research costs and other expenses to physicians in 2017...
Medtech Insight - July 16, 2018
CHART/TABLE: Starts & Stops: July 9-15, 2018
Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial...
Medtech Insight - July 16, 2018
Do What You Can, And Do It Now: MDR/IVDR Experts Advise Industry To Move Quickly
There are hurdles to compliance with the EU Medical Device and IVD Regulations –  but companies must jump them now...
Medtech Insight - July 16, 2018
CHART/TABLE: Medtech Money Flow: Weekly M&A And VC Deals, July 9-15, 2018
In this weekly feature, Medtech Insight presents a roundup of the previous week's M&A deals and venture financing rounds recorded in...
Medtech Insight - July 16, 2018
QUOTED. July 16, 2018. Seema Verma.
Proposals for the 2019 Medicare physician fee schedule and clinical laboratory fee schedule (CLFS) released July 12 include reforms designed...
Medtech Insight - July 16, 2018

New Chapter Founders' Vision Limited, Voice Stifled Under Parent Firm P&G
New Chapter founders Paul and Barbi Schulick leave and sever ties with parent firm Procter & Gamble six years after...
The Rose Sheet - July 16, 2018
California Baby Will Transition Products To New 100% Plant-Based Preservative
The Los Angeles-based natural product trailblazer says it will be positioned to use 100% bio-based claims – and USDA’s corresponding...
The Rose Sheet - July 16, 2018

Harvard Bioscience sells Denville Scientific to Thomas Scientific for $20mm
Harvard Bioscience Inc. sold Denville Scientific Inc. to Thomas Scientific LLC for $17mm up front and a $3mm earn-out.
Strategic Transactions - May 26, 2018
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