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Drug Pricing: Could Expedited Review Of Competing Brands Create The Desired Pressure?

Payer groups suggest during FDA's Hatch-Waxman meeting that agency prioritize NDAs moving into the same class to push prices lower.

Pricing Debate Generic Drugs Regulation

Brand 'Evergreening' Piques FDA Interest, But Solutions Remain Elusive

Agency eager to hear suggestions on the subject, also known as product hopping, but even reform advocates were cautious of stifling meaningful reformulations of products.

Generic Drugs Life Cycle Management Pricing Debate

FDA Announces Plans To Develop Supply Chain Security Pilot Program

FDA has announced its intent to establish a supply chain pilot program with the input of the pharmaceutical industry and is holding three upcoming meetings on supply chain security.

Manufacturing Quality United States

EU CHMP Decides On New Oncology Drugs & New Treatments for Mastocytosis, Atopic Dermatitis

The European Medicines Agency’s key scientific committee, the CHMP, is deciding this week whether a dozen or so new medicines that are in the final stages of the evaluation process should be approved for marketing across the EU. The committee will discuss 13 initial marketing authorization applications.

Approvals Regulation Europe

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

FDA's Kopcha Presses Ahead On Quality Metrics Despite Industry Pushback

The head of US FDA's drug quality office, Michael Kopcha, rebukes industry pushback that got White House's ear and demands more constructive feedback on quality metrics. Industry workshop participants come up with creative ideas, but FDA finds them problematic. Asked whether industry should dive in or wait and see on voluntary phase of metrics initiative that begins in January, another FDA official says, "That's a tough one."

Manufacturing Quality Compliance

Latest From Regulation

Children To Get A Voice In EMA Scientific Discussions

Patients under the age of 18 will be allowed to take part on a case-by case basis in EMA discussions on the development and assessment of medicines for children and adolescents.

Pediatrics Drug Review

You Say Goodbye, I Say Hello – MHRA Moves In, EMA Moves Out

The UK Medicines and Healthcare products Regulatory Agency is relocating to the very area in east London the European Medicines Agency is being forced to abandon.

Europe United Kingdom

EMA Can Do More With Its Guidance On Multiplicity Issues In Clinical Trials, Says EFPIA

EU research-based industry association EFPIA has made several suggestions to improve the European Medicines Agency’s draft guideline on addressing multiplicity issues in clinical trials. Multiplicity can have a substantial influence on the rate of false-positive conclusions, which may affect approval and labeling of an investigational drug.

Clinical Trials Regulation

Latest From Policy

FDA's New Chief Of Staff Is Former CDRH Policy Head Silvis

US FDA Commissioner Scott Gottlieb has appointed Lauren Silvis as his chief of staff. Silvis has been acting in the role for a few months, following a two-year stint as deputy director of the device center.

FDA Leadership

US FDA Gets A New Lawyer: Rebecca Wood Named Chief Counsel

Former Sidley Austin partner brings a wealth of experience in drug product liability litigation and federal preemption. She replaces agency veteran Elizabeth Dickinson, who will stay on as senior deputy to the chief counsel.

FDA Leadership

India Mulls Contentious Move To All ‘Vegetarian’ Pharma Capsules

India, one of the largest generic drug producers globally, is considering banning animal-origin gelatin capsules to respect the “religious sentiments” of the large number of Indians who are vegetarian, but groups are raising objections.

India Manufacturing

Clinical / R&D Explore this Topic

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Latest From Research & Development

Keeping Track: Tremfya Clears FDA; Dextenza Amendment Is Too Late; Emicizumab, Abemaciclib Filed

The latest drug development news and highlights from our US FDA Performance Tracker.

Performance Tracker Regulation

Master Protocols Are Both Welcome And Inevitable – US FDA's Woodcock

Center for Drug Evaluation and Research Director Janet Woodcock continues to promote innovation in clinical trial design with a review of master protocols in the New England Journal of Medicine.

Clinical Trials Personalized Medicine

Master Protocols In Practice

Basket trials are building a path for tissue-agnostic drug development in oncology, and plans are proceeding for more master protocols in pediatric cancers, acute myeloid leukemia and pancreatic cancer.

Clinical Trials Research & Development

Commercial Explore this Topic

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Latest From Commercial

Commercial Capsules: Soriot, IPOs, Deals And Hemophilia Data

IPOs are up, hemophilia is driving company pipelines, speculation over Pascal Soriot's career plans drive billions from AstraZeneca's market capitalization, Sanofi signs a $650m vaccine deal, private equity bidders up their offer for Stada and earnings season kicks off. Commercial capsule rounds up recent business news and trends reported by sister publication Scrip.

Commercial Business Strategies

340B Squeeze Begins: New HRSA Head Doesn’t Tip His Hand

HRSA Administrator George Sigounas made his public debut during the annual 340B coalition summer conference in Washington, DC. The setting was significant giving the prominence of the drug discount program on the Trump Administration agenda, but Sigounas didn’t offer much insight into the potential changes to come.

Healthcare Systems Reimbursement

Does Astellas ABPI Suspension Show Pharma Self-Policing Works In UK?

UK self-regulation is baring its teeth by keeping Astellas in the dog house – but is its methods effective? The ABPI thinks so.

Regulation Compliance

Manufacturing Explore this Topic

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Latest From Manufacturing

India Mulls Contentious Move To All ‘Vegetarian’ Pharma Capsules

India, one of the largest generic drug producers globally, is considering banning animal-origin gelatin capsules to respect the “religious sentiments” of the large number of Indians who are vegetarian, but groups are raising objections.

India Manufacturing

CAR-T Therapies: Failure To Meet Release Specifications May Not Bar Patient Use

Some patients in Novartis' pediatric leukemia pivotal trial for tisagenlecleucel (CTL019) received out-of-spec product following the sponsor's consultation with US FDA, and the same thing might occur in the commercial setting.

Advisory Committees Drug Review

EU Officials Note Similarities In Post-Approval Changes For Biosimilars, Reference Drugs

EU pharmaceutical and industry officials note some common trends and similarities in post-approval changes for biosimilars and reference products. One vexing problem in instituting post-approval changes is whether to use the reference drug or the approved biosimilar and regulatory guidance in this area is lacking.

Biosimilars Manufacturing

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

International Headwinds Counter J&J's Consumer Growth Confidence

"Some much weaker markets and some macroeconomic conditions, particularly in China and India" prompt J&J to adjusts its overall and consumer business expectations, CFO Dominic Caruso says. Its consumer product revenues climbed 1.7% to $3.5bn in is latest quarter.

Consumer Advertising, Marketing & Sales

C&D Oral Care Marketing Flows To Professionals Through WaterPik

Church & Dwight acquires Water Pik Inc. for $1bn in a deal that will give the Arm & Hammer marketer access to the dental professional market, expand its oral care device business and stretch international distribution of water flosser products which already have 90% US market share.

Consumer M & A

Consumer Health Weekly Trademark Review July 11, 2017

Compiled from the Official Gazette of the U.S. Patent and Trademark Office] for [Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) registered and published for opposition.

Consumer Trademarks