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US FDA Still Waiting For Cures Money, Woodcock Says

When asked about Cures-related hiring, CDER Director says to her knowledge, no funding has been received yet.

FDA Legislation Regulation

Express Scripts-Anthem Split Could Signal Positive Trend For Biopharma

Express Scripts is losing its biggest customer, which could be a sign that plan sponsors are looking for more control over their pharmacy spending -- bad news for the big PBMs but good news for biopharma?

Pharmacy Benefit Management Pricing Debate Policy

UK Election Extends Industry Wait For Accelerated Access Review Response

The UK government’s response to the Accelerated Access Review report is on hold until after the snap general election in June.

Regulation United Kingdom BioPharmaceutical

FDA GMP Warning Letters Review: Rate Soared In 2016 On Sterility And Data Integrity Concerns

Poor data integrity at Asian API firms, poor quality programs at foreign OTC firms and poor sterility assurance at US compounding pharmacies were the main factors leading US FDA to issue 110 drug GMP warning letters in 2016, a huge increase from prior years. Article is first of four-part series in our annual analysis.

Manufacturing Quality Compliance
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Policy & Regulation Explore this Topic

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Paxil's Day In Supreme Court: Is California Playing Fair On Product Liability?

In Bristol case with significant implications for venue shopping, justices question whether courts can preside over suits brought by out-of-state plaintiffs against out-of-state defendants.

Legal Issues Distribution Policy

Latest From Regulation

FDA Patient Feedback Meetings: External Model Ramping Up In 2017

US agency has started transitioning to a new model for Patient-Focused Drug Development meetings, with agency officials attending four externally hosted meetings so far, with at least three more planned for the next few months. So far, the Neurology Products Division has been particularly active with the external meetings.

FDA Rare Diseases

Generics Firms Don’t Infringe Patents Just By Applying For Reimbursement, Australian Court Confirms

Generics companies in Australia that seek a reimbursement listing for versions of originator drugs still under patent will not be infringing the patent provided that they do not offer to supply the products while the patent is still in force, a court has ruled.

Generic Drugs Intellectual Property

Pharma Firms Spend ‘Billions’ On Failing: More Collaboration Needed On Innovation

Speakers at a DIA EuroMeeting session on the challenges and opportunities facing regulators in the years to come discussed several options including more proactive engagement by regulators, more sharing by drug sponsors, and being innovative across the whole of the regulatory landscape.

Innovation Market Access

Latest From Policy

Biosimilars Podcast: What To Expect When Supreme Court Hears Amgen vs. Sandoz

Pink Sheet's Brenda Sandburg talks to Prevision Policy’s Kate Rawson about who has the most at stake in the case, the questions she’ll be listening for during oral arguments, and what might be in store from the newest addition to the Supreme Court: Justice Neil Gorsuch.

Biosimilars Intellectual Property

EpiPen Pricing Got Mylan In Hot Water; Now Sanofi Is Taking Firm To Court

Sanofi claims Mylan blocked its competing Auvi-Q product from the market by offering rebates to payers on the condition they would only reimburse for EpiPen; Sanofi seeks treble damages for lost sales.

BioPharmaceutical Policy

FDA Label Decisions On Paxil Don't Deter Verdict Against GSK In Suicide Case

Chicago jury finds GSK failed to adequately warn about risk of suicidal behavior in patients over age 24 taking paroxetine; GSK argued that FDA had found no increased risk in this population.

Legal Issues FDA

Clinical / R&D Explore this Topic

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Latest From Research & Development

SMA Patient Meeting Showcases FDA Flexibility – And Appreciation From Advocates

US agency's top neurology review officials received warm reception during Patient Focused Drug Development meeting for Spinal Muscular Atrophy. They also delivered a strong message of continued engagement beyond the first drug approval.

Drug Approval Standards Research & Development

Flu Hunters: House Committee Searches For Pandemic Plan

Update to 2005 outline of US response to pandemic influenza was due at the end of 2016, but has yet to be released.

FDA Research & Development

Can Big Data Match Up To The Big Promise?

Big data offers great promise for improving drug development and regulation, but a number of challenges need to be addressed, such as integrating datasets from disparate sources, ensuring the information can be used for the intended purpose, and balancing the interests of individual patients with wider societal benefits.

Innovation Research & Development

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Latest From Commercial

Neurocrine's US Label For Ingrezza Should Provide Edge Over Teva's Austedo In TD

A summertime battle is expected between Neurocrine and Teva once both companies get their tardive dyskinesia drugs on the US market, but Neurocrine's April 11 approval for Ingrezza without an FDA warning label is already giving the biotech an edge.

Approvals Business Strategies

Hawaii's Proposed Oxybenzone Sunscreen Ban Fails Science Test – CHPA

CHPA commits to fighting against onslaught of bills in Hawaii aiming to ban or limit the use of oxybenzone-containing sunscreens, says CEO and President Scott Melville during his address on 2017 priorities during the CHPA Annual Executive Conference in Amelia Island, Fla. March 21.

United States Consumer

Pain Therapeutics Confident It Has US Approval Pathway Set For Remoxy ER

Biotech says it can complete two FDA-mandated studies by year-end and re-file the NDA rejected three times previously by the US agency. Pain Therapeutics also says it will not attempt to commercialize the abuse-deterrent opioid product without a partner.

Drug Approval Standards Complete Response Letters

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA GMP Warning Letters Review: API Supplier Warnings Surge On Data Integrity Concerns

US FDA’s drug GMP warning letters to API suppliers tripled in 2016, driven by data integrity findings in China and India and concerns about facilities and equipment maintenance. Trend could spell trouble for commercial production and launches. While there’s no turning back the clock on supply chain globalization, there’s no turning back the clock on FDA warning letters either.

Manufacturing Quality

FDA’s 2016 Drug GMP Warning Letters

Interactive table describes all 110 drug GMP warning letters that US FDA issued in calendar year 2016.

Compliance Manufacturing

Pharma Industry Still Not At 'Tipping Point' In Adopting Continuous Manufacturing

Regulators and industry officials agree that despite efforts to spur development of continuous manufacturing, uptake has been slow globally. FDA still is on learning curve and acknowledges a knowledge gap around some of the higher order principles associated with continuous manufacturing.

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Consumer Health Weekly Trademark Review April 18, 2017

Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled from the Official Gazette of the U.S. Patent and Trademark Office.

China India

Claritin 'Be An Outsider' Campaign Links Bayer Brand And Public Health

Bayer encourages people to get outside more, noting survey data that all US consumers on average spend 95% of their time indoors; 40% have seasonal allergies that could be helped by OTC antihistamines and allergy drugs such as Claritin. Goodwill-oriented campaign includes social media and philanthrophic donations.

Consumer Advertising, Marketing & Sales

Tylenol Delivers J&J Relief As Global 'Consumer Staples' Sales Slump

J&J says Tylenol outpaced other analgesics in the first quarter as its OTC franchise grew 1.4% on a reported basis to $1.01 bn. CFO Dominic Caruso said new consumer products will add 2 points of incremental growth to the segment in 2017.

United States Consumer
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