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Latest Pharma Insights


Appointments: Impax, Mylan, Eisai, Cipher, Hutchison and Arena Pharmaceuticals, Bridge Medicines and ProMIS
This week's round up of recent appointments includes new CEOs at Impax Laboratories, Cipher Pharmaceuticals and Bridge Medicines, and other...
Scrip - March 30, 2017
Data Add To Strengthening Efficacy Case For Takeda Dengue Vaccine
Newly published details of interim clinical data for Takeda's candidate vaccine for dengue show activity across all serotypes that seems...
Scrip - March 30, 2017
Genentech's Early Cancer Technology Scout On Partnering, Roche Setup & BD Challenges
There is still much more to be learnt about cancer immunology, particularly what drives cancer cell growth, proliferation and resistance...
Scrip - March 30, 2017
NPA On The Hill, Recalls: Health And Wellness New Products Roundup
Natural Products Day marks 20 years; Plandai helm stays in Duffield family; diaper rash cream, high-lead supplements recalled; and more...
The Rose Sheet - March 30, 2017

Appointments: Impax, Mylan, Eisai, Cipher, Hutchison and Arena Pharmaceuticals, Bridge Medicines and ProMIS
This week's round up of recent appointments includes new CEOs at Impax Laboratories, Cipher Pharmaceuticals and Bridge Medicines, and other...
Scrip - March 30, 2017
Data Add To Strengthening Efficacy Case For Takeda Dengue Vaccine
Newly published details of interim clinical data for Takeda's candidate vaccine for dengue show activity across all serotypes that seems...
Scrip - March 30, 2017
Genentech's Early Cancer Technology Scout On Partnering, Roche Setup & BD Challenges
There is still much more to be learnt about cancer immunology, particularly what drives cancer cell growth, proliferation and resistance...
Scrip - March 30, 2017

Cost Sharing Fight: PhRMA Says Insurance Design Is Real Pricing Culprit
New report finds increase in use of deductibles and coinsurance charging members list prices.
The Pink Sheet - March 29, 2017
User Fee Bill Could Become Ensnared In US Abortion Politics
Amendment defunding Planned Parenthood is one ACA repeal refugee that could hitch a ride with user fee bill, which would...
The Pink Sheet - March 29, 2017
Pfizer Ex-Marketing Director Agrees To Injunction, Ending Trade Secret Suit
Former Pfizer employee has joined Sun Pharma as it launches ophthalmic drug and expands its specialty portfolio, which includes Phase...
The Pink Sheet - March 29, 2017
Mylan’s Generic Advair Delay Gives Leverage To Rivals
Mylan received a “complete response” letter from FDA on its application for a generic version of GSK’s blockbuster Advair, offering...
The Pink Sheet - March 29, 2017
Ocrevus Launching Quickly Even After Manufacturing Worries Delayed US Approval
Genentech’s ocrelizumab, a CD20-directed antibody, becomes first US-approved treatment for primary progressive multiple sclerosis and is also indicated for relapsing...
The Pink Sheet - March 29, 2017
Genentech's Subcutaneous Rituximab Breezes Through US FDA Advisory Committee
Lack of concerns about reformulation of product among either Oncologic Drugs Advisory Committee members or FDA reviewers and the decades-long...
The Pink Sheet - March 29, 2017
US FDA And OMB Should ‘Pause’ Billion-Dollar Quality Metrics Program, Industry Groups Say
High projected cost and low perceived benefit merits further dialogue on US FDA's quality metrics initiative, industry coalition says. One...
The Pink Sheet - March 29, 2017
India’s E-Plan To Map Drug Sales – Turning Point For Better Traceability?
A government plan aimed at putting in place an e-platform to regulate the sale of medicines in India, is expected...
The Pink Sheet - March 29, 2017
EMA Expanding Use Of Early Background Summaries To Support Initial Drug Evaluations
The European Medicines Agency is expanding an initiative in which its product team summarizes critical background information about new drugs...
The Pink Sheet - March 29, 2017
Antibiotic Development: Limited Population Pathway In US Removes Barrier
Allergan's Avycaz could be indicator of how FDA will use the 21st Century Cure's new approval mechanism; experts maintain the...
The Pink Sheet - March 29, 2017
CHMP’s March Recommendations Include Dinutuximab, Nonacog Beta Pegol And Trumenba
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) meets monthly to review applications for centralized EU...
The Pink Sheet - March 29, 2017

Cardio-Neuro Innovator LivaNova Prepares For Challenges Ahead
LivaNova was formed from the merger of cardiovascular disease therapy company Sorin Group and neuromodulation innovator Cyberonics. The role and...
IN VIVO - March 29, 2017
To Get Pricing Right, Pharma Must Understand Payer Behavior, Trump Or No Trump
When it comes to drug pricing, one size certainly doesn’t fit all. Biopharma firms need to devise and design appropriate...
IN VIVO - March 29, 2017

AUDIO: AdvaMed-Chair Exit Interview: Vince Forlenza On Medtech Policy Priorities
BD CEO Vince Forlenza just finished his two-year term as board chairman of AdvaMed. For the most part, his successor...
Medtech Insight - March 29, 2017
Number To Know…57
There were 57 quality-related warning letters sent by US FDA to device-makers in 2016. That's the fewest since 2002.
Medtech Insight - March 29, 2017
Will EU's Delegated And Implementing Acts Replace Guidance?
The new EU regulations for devices and IVDs are close to adoption, but much of the upcoming EU requirements are...
Medtech Insight - March 29, 2017
US FDA's 'Program Alignment' Inspection Scheme Coming Mid-May; Details Still Murky
The agency's new inspectional approach – which will be structured along commodity-specific product lines – will be ready for primetime...
Medtech Insight - March 29, 2017

NPA On The Hill, Recalls: Health And Wellness New Products Roundup
Natural Products Day marks 20 years; Plandai helm stays in Duffield family; diaper rash cream, high-lead supplements recalled; and more...
The Rose Sheet - March 30, 2017