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Canada Decides Against Suffix-Based Biologics Naming System

Australia Considers Identifying Drugs Filed For Approval

J.P. Morgan Roundtable: The Regulatory Role In Accelerating Complex Therapies
Companies working on cell and gene therapies and novel approaches to neurological diseases participated in a roundtable discussion during the J.P. Morgan Healthcare Conference about how regulators are supporting novel modalities, which in turn improves investor and partner sentiment.

Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts
Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Wait For Benefits Of EudraVigilance Pilot Before Expanding To More EU Products, Says Pharma
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Global Pharma Guidance Tracker – January 2019
Policy & Regulation Explore this Topic
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Deal On European SPC Manufacturing Waiver Is An Acceptable Compromise
A deal on the European supplementary protection certificate manufacturing waiver has been agreed by the European Council, Parliament and the European Commission, providing a concrete path for a regulation to move forward, albeit with compromises on several key provisions. Meanwhile, the European off-patent and brand industries remain at odds over the benefits of the waiver.
Latest From Regulation
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Checkpoint Inhibitors: US FDA Wants Consistent Adverse Event Definitions
US FDA Wins Big In Shutdown-Averting Approps Bill
Latest From Policy
EU Cross-Country Coalition Targets New Products For Joint Pricing Talks
The BeNeLuxAI initiative was among the many topics covered at the DIA Europe 2019 conference in Austria last week. The cross-country coalition has some new drugs in its sights for joint pricing talks and the conference was given an insight into the workings of the collaboration by a Belgian health department advisor close to the initiative.
Pricing Cures For Sickle Cell Disease: Sen. Cassidy Weighs In
Price decisions based on straight calculation of medical costs avoided may overestimate value of a cure, Cassidy warns.
Collaboration And Pay For Performance Deals – The Way To Pay for One-Off Treatments
New payment models, registries and the Cross Border Healthcare Directive could help determine new ways to pay for potentially one-off treatments such as gene therapies in Europe.
Clinical / R&D Explore this Topic
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Latest From Research & Development
Real-World Evidence Takes Courage: A Conversation With IQVIA’s Nancy Dreyer
FDA's Real World Study On Adoption Of PD-1 Dosing Change Aims To Inform Reviewers
Study using US FDA’s Information Exchange and Data Transformation (INFORMED) program will focus on shift from weight-based to flat dosing for Opdivo and Keytruda.
How Much Can Trump’s Childhood Cancer Funding Proposal Boost Drug Approvals?
President Trump’s 2019 State of the Union Address broadly touched on the themes of funding childhood cancer research, drug pricing and eliminating HIV.
Commercial Explore this Topic
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Latest From Commercial
Generic Sensipar: Cipla Challenges Legality of Amgen/Teva Patent Settlement
Cipla, which previously settled with Amgen, alleges Sensipar's formulation patent is currently unenforceable due to ‘patent misuse,’ and brand sponsor’s deal with Teva following a brief generic launch violates federal antitrust law and California state law.
Puma Beats Most Of Stock Drop Suit Over Nerlynx Study Statements
Jury finds one comment in an investor call was false or misleading, limits damages award to $4.50 per share, or $64,000 for the lead plaintiff, a fraction of what was sought. Case suggests that sometimes taking a stock drop case to trial may limit liability.
Poland Kick Starts 2019 With Three Rx-To-OTC Switches
Manufacturing Explore this Topic
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Latest From Manufacturing
FDA Launches Pilot To Gain Practical Experience With 'Established Conditions' In Quality Assessments
FDA is accepting applications from the pharmaceutical industry to pilot the use of established conditions proposed by sponsors in NDAs, ANDAS, BLAs and supplements. The purpose of the pilot is for FDA to gain practical experience in assessing proposed established conditions and to ensure that assessment decisions do not negatively impact user fee time frames.
Immunomedics Dodges Manufacturing Site Specifics In Quest For Cancer Breakthrough Approval
Biotech firm chooses words carefully to wind its way through site inspection findings and CMC review concerns in hopes of winning its first FDA approval for a breakthrough breast cancer treatment.
FDA Proposes To Rely On Industry-Driven Consensus Quality Standards In New Drug Reviews
FDA’s drug center has proposed a new program that would allow pharmaceutical manufacturers to attest that drug products submitted for review conform to certain consensus quality standards. The agency said that such a program would improve drug quality, encourage the development of emerging technology and ensure smoother drug reviews.
Consumer / OTC Drugs Explore this Topic
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Latest From Consumer
Moberg Sells Consumer Health Portfolio To Pay For Rx Research Focus
Pfizer Consumer Health True To Form Pending Move To JV With GSK
Pfizer consumer health sales up 4% to $3.6bn in 2018 as it prepares to move business into JV with GSK anticipated to close in the second half of 2019. Following 2% growth in 2017, a flat year in 2016 and a dip in 2015, Pfizer's view is confirmed of consumer health as a reliable revenue stream but not a strong growth driver.
Biotene OTC Dry Mouth Competitor Remains On Market As GSK Litigates
Former Biotene owner Laclede ordered by US federal judge to stop using brand, now owned by GSK, to promote its competing line of Salivea dry mouth products. But judge rejected GSK’s request that the Salivea dry mouth product marketers are subject to a lifetime non-compete agreement.
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