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Situation Far From Ideal But EU Network Will Survive Brexit

Brexit undoubtedly will cause some short-term disruption to the EU medicines regulatory network but the network will survive without the UK. That’s according to former European Medicines Agency head Thomas Lönngren. Meanwhile, the timetable for relocating the EMA is likely to be finalized in a few days’ time – as are the criteria for hosting the agency when it moves from London.

Brexit Regulation Europe

Gottlieb Advances, But FDA's Future Seems Increasingly Partisan

Senate committee votes to send the FDA Commissioner nominee to the Senate floor, but with only two Democratic votes.

FDA Leadership Regulation

Oncology Combo Drugs Face UK Market Access Disappointment

New oncology drugs forming new treatment combinations will face a tough ride through England’s influential health technology appraisal body, NICE.

BioPharmaceutical Policy Market Access

RoxyBond Clears US FDA With Abuse-Deterrent Properties, But No REMS Yet

Inspirion's oxycodone is first immediate-release opioid approved with abuse-deterrent language in labeling.

Approvals Risk Management Regulation

FDA Performance Tracker
For more on the FDA Performance Tracker, click here.

Policy & Regulation Explore this Topic

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FDA GMP Warning Letters Review: Foreign Drug Product Firms Hit Hard On GMP Basics

Many of the 30 drug product firms that received FDA warning letters in 2016 were foreign cosmetics and hygiene manufacturers that appeared to need education on US GMP requirements. Another major focus in letters to drug product firms last year was sterility assurance in the US and abroad.

Manufacturing Quality Compliance

Latest From Regulation

Rydapt And Alunbrig Approvals Headline Good Week For Targeted Oncologics At US FDA

After almost 20 years, targeted therapy for oncology is still producing breakthroughs. This week saw two breakthrough-designated novel kinase inhibitor approvals, Novartis' Rydapt (midostaurin) and Takeda's Alunbrig (brigatinib), and breakthrough status for Pfizer's next-generation candidate lorlatinib.

Approvals Cancer

Canada Introduces World First 48-Hour Reporting Requirement

New regulations in Canada could mean companies are required to notify the regulator more quickly about foreign risk communications and conduct new post-marketing safety tests.

Drug Safety BioPharmaceutical

EMA And Brexit: Rental Liabilities Could Add €350m To Relocation Costs

The EMA could be landed with a hefty rental bill on top of the actual costs of relocating to another European city, raising questions as to who will bear the financial burden. Meanwhile, the EMA has met with EU regulators to discuss future allocation of work, and Barcelona, Spain’s second city, has officially joined the race to host the agency.

Brexit Regulation

Latest From Policy

Rhetoric Meets Reality: A Timeline Of Trump's First 100 Days

President Trump is empty-handed on health care victories so far, as initial health reform repeal efforts collapsed and the shock value of drug pricing tweets wore off. But some actions may evolve into biopharma impact further down the road.

Policy FDA

ANDA Case Filings Drop 32%, But Still High Compared To Last Decade

Lex Machina reports that 316 ANDA cases were filed in 2016 compared to 468 in 2015; number of inter partes review petitions filed on Orange Book patents has declined since 2015.

BioPharmaceutical Policy

Part D Reforms: Concerns With Specialty Cost Sharing, Merging Part B Coverage Raised

BIO comments respond to the Centers for Medicare and Medicaid Services' call for input on ways to improve the Medicare Part D program.

Policy Medicare

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

Commercial Explore this Topic

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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: Compounding Pharmacies Drew The Most Letters In 2016

More than half of last year’s 110 drug GMP warning letters went to compounding pharmacies as US FDA’s crackdown on poor aseptic practices in sterile compounding continued. The complexity surrounding GMP applicability continued to complicate the enforcement landscape in 2016 despite FDASIA distinction between traditional and outsourcing compounders, final article in our four-part series reports.

Manufacturing Quality

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 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

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

'Slow-Growth' Global Trend Shakes Up P&G Product Strategy Start To Finish

P&G’s health care segment advanced 4% in the third quarter to $1.84bn, but sales declined for its other business units, a trend the firm sees worldwide across consumer industries. CFO Jon Moeller unveils the firm’s “irresistible superiority” product development strategy to counter slower global consumer spending.

United States Consumer

Consumer Business Reliable And Right At Home At GlaxoSmithKline

CEO Walmsley's familiarity with Glaxo's consumer health business was clear in her response to analysts' questions about the firm's future as a three-unit operation. The business marketing brands including Flonase and Excedrin is a more reliable revenue driver than the pharma business, she said.

Consumer 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