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Latest Pharma Insights



France Invites Advanced Therapy Makers To Use Fast-Track Trial Approval Pathway
Updated guidance on France’s experimental fast-track procedure for approving clinical trials shows that the pathway has entered a new phase.
The Pink Sheet - February 19, 2019
Canadian Decision On Biological Names Leaves US As The Outlier
Health Canada’s decision to not add a suffix to non-proprietary names for biologics, including biosimilars, has left the US as...
Scrip - February 19, 2019
Money Too Tight To Mention At Motif After Iclaprim 'No' From FDA
Hit with a complete response letter from the US FDA for its antibiotic to treat ABSSSI, Motif needs to raise...
Scrip - February 19, 2019
EU ‘Big Data’ Report: Big Opportunities – And Big Challenges
EU regulators have produced the first fruits of their ambitious “big data” project aimed at ensuring that the EU drug...
The Pink Sheet - February 19, 2019
How Are Low-Risk Devices And IVDs Impacted By A No-Deal Brexit – In The UK And EU27?
Most low-risk medical devices and IVDs do not need notified body involvement in the EU. This means that, in the...
Medtech Insight - February 19, 2019
DATA: Medtech Money Flow: M&A And VC Deals, Feb. 11-17, 2019
This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, from Feb...
Medtech Insight - February 19, 2019
DATA: Medtech Money Flow: M&A And VC Deals, Feb. 11 - 17, 2019
This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, from Feb...
Medtech Insight - February 19, 2019
Glenmark Plans To Spin Out A US-Based ‘Innovation’ Business – And May Pull The Plug On Advair
Having amassed a significant pipeline of innovative assets, India’s Glenmark has made the choice to spin them off into a...
Scrip - February 19, 2019
FDA Guides On Pathway For Competitive Generic Therapies
Draft guidance on the approval pathway for competitive generic therapies (CGTs) has been published by the FDA in the agency’s...
Scrip - February 19, 2019
Bayer Launches Clarinaze Allergy Control Following Successful Rx-to-OTC Switch In UK
Having received the green light for its prescription-to-OTC switch, Bayer is launching in UK pharmacies Clarinaze Allergy Control backed by...
The Rose Sheet - February 19, 2019
‘No Pain, No Gain’ in Germany’s OTC Market: Pain-Relief Launches From GSK and Fysioline, Aspirin Complex Returns
GSK adds medicine-free heat patch to Voltaren range, Fysioline launches Arthro Cream based on its trademarked ‘Ice Power’ menthol combination, and pharmacists restock Bayer's blockbuster drug...
The Rose Sheet - February 19, 2019
EU Offers Efficiency Tips For When Manufacturers Transfer Notified Bodies
What do incoming EU notified bodies need to do, and what shortcuts might they be able to take, when manufacturers...
Medtech Insight - February 19, 2019
Another World-First As Japan OKs Spinal Injury Cell Therapy Trial
In another globally pioneering move, Japan approves a trial with its flagship iPS cell technology in spinal cord injury, following...
Scrip - February 19, 2019
CNS-focused Arvelle spins off from Axovant with planned $100mm initial round
Axovant Sciences Ltd. spun off its small-molecule platform assets into a new company, Arvelle Therapeutics GMBH, which received commitments for an initial capital raise of over $100mm (assumed to be its Series A round) from a syndicate of investors, including NovaQuest Capital Management, Life Science Partners, BRV Capital Management, Andera Partners, and HIG BioHealth Partners.
Strategic Transactions - February 19, 2019
QUOTED. Feb. 19, 2019. Walton Taylor.
The American Society of Breast Surgeons published new guidelines, recommending that genetic testing should be offered to all patients with...
Medtech Insight - February 19, 2019

Canadian Decision On Biological Names Leaves US As The Outlier
Health Canada’s decision to not add a suffix to non-proprietary names for biologics, including biosimilars, has left the US as...
Scrip - February 19, 2019
Money Too Tight To Mention At Motif After Iclaprim 'No' From FDA
Hit with a complete response letter from the US FDA for its antibiotic to treat ABSSSI, Motif needs to raise...
Scrip - February 19, 2019
Glenmark Plans To Spin Out A US-Based ‘Innovation’ Business – And May Pull The Plug On Advair
Having amassed a significant pipeline of innovative assets, India’s Glenmark has made the choice to spin them off into a...
Scrip - February 19, 2019
FDA Guides On Pathway For Competitive Generic Therapies
Draft guidance on the approval pathway for competitive generic therapies (CGTs) has been published by the FDA in the agency’s...
Scrip - February 19, 2019
Another World-First As Japan OKs Spinal Injury Cell Therapy Trial
In another globally pioneering move, Japan approves a trial with its flagship iPS cell technology in spinal cord injury, following...
Scrip - February 19, 2019

France Invites Advanced Therapy Makers To Use Fast-Track Trial Approval Pathway
Updated guidance on France’s experimental fast-track procedure for approving clinical trials shows that the pathway has entered a new phase.
The Pink Sheet - February 19, 2019
EU ‘Big Data’ Report: Big Opportunities – And Big Challenges
EU regulators have produced the first fruits of their ambitious “big data” project aimed at ensuring that the EU drug...
The Pink Sheet - February 19, 2019

Execs On The Move, Feb 2019
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
IN VIVO - February 18, 2019
Science Matters: Merck Joins Crowded NASH Race As Several Data Readouts Loom
No NASH treatments are on the market yet, but Phase III data readouts are emerging, mid-stage drugs are demonstrating their...
IN VIVO - February 18, 2019
Hitting Refresh: Aduro CEO On Company Cuts, Pipeline Programs And Alliances
Aduro Biotech announced a “strategic reset” in January 2019 that will see the Californian company center around two core pipeline...
IN VIVO - February 18, 2019

How Are Low-Risk Devices And IVDs Impacted By A No-Deal Brexit – In The UK And EU27?
Most low-risk medical devices and IVDs do not need notified body involvement in the EU. This means that, in the...
Medtech Insight - February 19, 2019
DATA: Medtech Money Flow: M&A And VC Deals, Feb. 11-17, 2019
This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, from Feb...
Medtech Insight - February 19, 2019
DATA: Medtech Money Flow: M&A And VC Deals, Feb. 11 - 17, 2019
This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, from Feb...
Medtech Insight - February 19, 2019
EU Offers Efficiency Tips For When Manufacturers Transfer Notified Bodies
What do incoming EU notified bodies need to do, and what shortcuts might they be able to take, when manufacturers...
Medtech Insight - February 19, 2019
QUOTED. Feb. 19, 2019. Walton Taylor.
The American Society of Breast Surgeons published new guidelines, recommending that genetic testing should be offered to all patients with...
Medtech Insight - February 19, 2019

Bayer Launches Clarinaze Allergy Control Following Successful Rx-to-OTC Switch In UK
Having received the green light for its prescription-to-OTC switch, Bayer is launching in UK pharmacies Clarinaze Allergy Control backed by...
The Rose Sheet - February 19, 2019
‘No Pain, No Gain’ in Germany’s OTC Market: Pain-Relief Launches From GSK and Fysioline, Aspirin Complex Returns
GSK adds medicine-free heat patch to Voltaren range, Fysioline launches Arthro Cream based on its trademarked ‘Ice Power’ menthol combination, and pharmacists restock Bayer's blockbuster drug...
The Rose Sheet - February 19, 2019

CNS-focused Arvelle spins off from Axovant with planned $100mm initial round
Axovant Sciences Ltd. spun off its small-molecule platform assets into a new company, Arvelle Therapeutics GMBH, which received commitments for an initial capital raise of over $100mm (assumed to be its Series A round) from a syndicate of investors, including NovaQuest Capital Management, Life Science Partners, BRV Capital Management, Andera Partners, and HIG BioHealth Partners.
Strategic Transactions - February 19, 2019
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