Register for our free email digests:
Featured Stories
Industry Warns Of ‘Conflicting’ Clinical Requirements For Drug-Device Combinations In EU
EU regulators are being urged to get their skates on and publish guidance on new clinical requirements that will kick in soon for integral drug-device combination products.
GAO Report On Part D May Dampen Congressional Enthusiasm For POS Rebates
Legislation redirecting manufacturer rebates on prescription drugs to the point of sale could face an uphill battle following report’s description of the way rebates lower costs in Medicare Part D.
Pfizer’s Ibrance And The Realities Of 'Real-World' Evidence
US FDA approved expanded label for male breast cancer based on a supplement that included only non-traditional data sets. But agency is making clear that the “substantial” evidence for efficacy still came from the traditional pivotal trials – in women.
Spotlight On Biosimilars
Genentech Was Too Slow In Trying To Halt Amgen's Herceptin Biosimilar Launch
Genentech's delay in requesting an injunction, as well as its licensing deals with Mylan, Celltrion and Pfizer, show it won't suffer irreparable harm from sales of Amgen's biosimilar, judge says.
Global Pharma Guidance Tracker – July 2019
European Performance Tracker
Policy & Regulation Explore this Topic
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Regulation
Keeping Track: A Quintet Of Novel Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.
Pink Sheet Podcast: Zolgensma Saga Continues, ICER Reviews DMD Drugs, FDA Issues Another LPAD Approval
Pink Sheet reporters review Novartis' latest response to Zolgensma data manipulation, discuss ICER reviews of Sarepta's Duchenne muscular dystrophy treatments, and recap the FDA's latest antibiotic approval.
NHS England Tackles Barriers To Use Of Cannabis-Based Medicines in UK
A review of barriers to the prescribing of cannabis-based medicines for children with epilepsy in England suggests that much needs to be done to generate the necessary evidence to assuage prescribers’ concerns.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Frontiers In Real-World Evidence: US FDA Partners With Syapse To Explore Sources Beyond Electronic Records
Oncology Center of Excellence will collaborate with the health data company to explore RWE sources for precision medicine.
Pretomanid Approval For Resistant TB: With Regulatory Flexibility Comes Usage Restrictions
US FDA's approval of the TB Alliance's pretomanid regimen for highly treatment-resistant tuberculosis comes with an LPAD designation and advisory committee-requested language to limit use.
Latest From Policy
Korea’s Clinical Trial Road Map Eyes Faster Development, Patient Safety, Rare Diseases
Amid fierce jostling among Asian countries to attract clinical research, South Korea unveils a five-year road map to accelerate trial activities and improve global competitiveness, focusing on expansion of opportunities for rare and intractable diseases, protection of subjects' rights and enhancement of new drug development capabilities.
Canada Overhauls Drug Pricing, But Devil Will Be In The Detail
Long awaited changes to Canada’s Patented Medicines Regulations have been announced, but companies will have to wait for new guidelines from the pricing watchdog to better understand how they will be implemented.
Outcomes-Based Pricing: Can It Facilitate The Study Of Precision Dosing?
Roche's Richard Peck says adoption of outcomes-based pricing in the US could be powerful incentive to study precision dosing, although he also calls on drugmakers to put out scientific examples.
Clinical / R&D Explore this Topic
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Research & Development
NHS England Tackles Barriers To Use Of Cannabis-Based Medicines in UK
A review of barriers to the prescribing of cannabis-based medicines for children with epilepsy in England suggests that much needs to be done to generate the necessary evidence to assuage prescribers’ concerns.
Outcomes-Based Pricing: Can It Facilitate The Study Of Precision Dosing?
Roche's Richard Peck says adoption of outcomes-based pricing in the US could be powerful incentive to study precision dosing, although he also calls on drugmakers to put out scientific examples.
Temple Wants US FDA To Consider Including PK/PD In Labels To Inform Dosing
CDER's Robert Temple said the US FDA has generally been nervous about using PK/PD analyses to support labeling changes, but that it might be time to rethink the subject.
Commercial Explore this Topic
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Commercial
Novartis’ “Living Drugs”: Kymriah, Zolgensma – And Diovan?
Novartis is pioneering the new “living drugs” model. But its present financial performance benefits from regulatory problems that have beset generic competitors to a franchise written off for dead: the antihypertensive brand Diovan (valsartan).
Sunset Begins For Roche's Herceptin As Amgen/Allergan Biosimilar Launches
Amgen and Allergan launched the first US biosimilar for Roche's Herceptin – and the Swiss pharma's Avastin – at a 15% discount to the brand-name products' list prices. Infographic reviews Herceptin's past and its future competitors.
When It Comes To FTC M&A Review, The Times May Be A Changin'
Spark signaled in an SEC filing that its merger with Roche could be delayed into 2020, fueling more speculation that FTC is increasing scrutiny over biopharma mergers.
Manufacturing Explore this Topic
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Manufacturing
US FDA Warning Letter Draws Indian Solvent Recycler Into Valsartan Crisis
Lantech’s solvent recovery operations expected to meet US drug GMP requirements due to risk of carcinogens in blood pressure medications.
NHS England Tackles Barriers To Use Of Cannabis-Based Medicines in UK
A review of barriers to the prescribing of cannabis-based medicines for children with epilepsy in England suggests that much needs to be done to generate the necessary evidence to assuage prescribers’ concerns.
Do Not Be So Quick To Blame Microbes On The Lab, The US FDA Warns Emcure
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.