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Concordia Names Six Drugs Targeted By UK Competition Inquiry

Concordia has announced that six more of its medicines are involved in the UK competition inquiry. One law firm says the announcement further underlines the Competition and Markets Authority’s determination to root out anticompetitive practices in the pharma area.

Legal Issues Regulation United Kingdom

China Regulatory Shakeup: Top Regulator Out, Commissioner Reprimanded Amid Vaccine Scandal

Amid aftermath of latest vaccine scandal, top officials including China’s drug reform flagbearer are forced to resign, sending shock waves across the industry.

China Drug Safety Manufacturing

NIH Ends Gene Therapy Trial Reporting Requirements In Reg Streamlining Move

Trial protocols, annual reports, and adverse event reports on gene therapies now only go to US FDA, a signal that the products can be regulated like other drugs and biologics.

Regenerative Medicine Research and Development Strategies Regulation

Paratek And The “Blockbuster” vs. Steady “Stewardship” Approach In Antibiotics

US FDA Antimicrobial Drugs Advisory Committee Chair Baden offers warning about “overuse” to emerging antibiotic sponsor.
Advisory Committees Infectious Diseases Commercial

Teva To Launch First Generic EpiPen In 'Coming Months'; FDA Heralds Approval Of Complex Product

Two-and-a-half years after receiving a complete response letter, Teva's ANDA clears FDA; agency issued three guidances for development of generic epinephrine auto-injectors.

BioPharmaceutical Regulation Approvals
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Global Pharma Guidance Tracker – July 2018

Stay up to date on regulatory guidelines from around the world, with the Pink Sheet's Guidance Tracker.
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Generics In The US 2018

Read this eBook and learn more about the West AccelTRA elastomer components program that was designed to help in this effort. Learn how the AccelTRA component program has been helping generic biopharmaceutical manufacturers by providing a number of key features, for those high-volume products and where manufacturers would like to deal mostly with one high-performing elastomer component.

Read the eBook and discover more

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

FDA Exploring Data-Driven Quality Reviews To Speed Generic Approvals

FDA is seeking input from an advisory committee on the use of a more data-driven model the agency is exploring to standardize quality assessment in generic drug reviews. Agency officials explain that model could help expedite the review of generic drugs to meet review goals under GDUFA II. 

United States Manufacturing Quality

Latest From Regulation

Off-Label Use Of Transmucosal Fentanyl Creates Ethical, Practical Dilemma For US FDA

Advisory committee panelists divided on whether to modify REMS for TIRF products to reduce their wide-ranging off-label use.

Risk Management Neurology

US FDA Advisory Panel Split On Value Of Education In Fentanyl REMS

Some members feel more education has important role in risk management for transmucosal immediate-release fentanyl products, while others think further education will be useless in ensuring the REMS meets its goals. 
Risk Management Neurology

Sponsor-FDA Communications In IND Phase Will Get Outside Review

US FDA seeks White House approval for contacted interviews with 100 to 150 active commercial IND holders.

FDA Research and Development Strategies

Latest From Policy

Medicare Part B Step Therapy Policy May Get Further Guidance From HHS

HHS meeting with stakeholders may lead to adjustments to plan for implementing step therapy in Medicare Advantage for Part B drugs.

Policy Pricing Debate

ICER’s 2019 Agenda Includes CAR-T Therapy, Drugs For Depression, Arthritis, AMD

Proposed list of topics for review in 2019 by the Institute for Clinical and Economic Review includes a total of 15 drugs but that could change as the year goes on.

Policy Cost Effectiveness

Genentech Wins Attorneys' Fees After Phigenix's Aggressive Patent Suit

"Tipping point" occurred when Phigenix changed theory that Genentech's Kadcyla infringed its patent; CEO may be on hook for attorneys' fees.

Legal Issues Intellectual Property

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Fauci: Concerns About Exclusive Licensing Of Government-Developed Products Are Misguided

NIAID director says granting exclusive licenses to drug companies is necessary for late-stage development and production of government-developed products. 
Vaccines Research & Development

Two Neurodegenerative Disease Drugs Secure EMA's Coveted PRIME Designation

What is claimed to be the first therapy targeting the underlying cause of Huntington’s disease and a gene therapy for Lorenzo’s Oil disease have become the latest investigational products to make it onto the European Medicines Agency’s priority medicines scheme.

Europe Innovation

Celtaxsys To Hash Out Phase III Cystic Fibrosis Endpoints With US FDA

Private start-up's acebilustat failed to improve lung function in Phase II, but the anti-inflammatory showed large numerical reductions in pulmonary exacerbations, which can be fatal.

Rare Diseases Clinical Trials

Commercial Explore this Topic

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Latest From Commercial

Stand-Off: Vertex Refuses NICE Data on CF Drug Symkevi, HTA Body Awaits Next Move

Vertex says it will not file data on its cystic fibrosis drug Symkevi (tezacaftor/ivacaftor) until the UK's NICE changes the way it assesses drugs.

Approvals Commercial

Perrigo's OTC Core Could Expand To Include National Brands

Submitting an OTC switch of Nasonex would be a first for Perrigo, as would marketing a national brand OTC if the switch is approved. In tandem with announcing divesture of Perrigo's Rx business, CEO Uwe Rohrhoff says marketing national brands in some OTC categories fits in the company's "value-creation road map."

Prescription To Otc Switch Advertising, Marketing & Sales

Step Therapy For Medicare Part B Drugs Will Lower Costs By 20%, HHS Projects

Beginning in 2019, Medicare Advantage plans may use step therapy in Part B, potentially including “cross management” with Part D drugs, under new guidance from the Centers for Medicare and Medicaid Services.

Pricing Debate Medicare

Manufacturing Explore this Topic

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Latest From Manufacturing

The Quality Lowdown: A Week Of International Intrigue

Or perhaps it's been a week of intriguing international events in global drug quality, as an international group works to ratchet up global standards, regulators aim to ease the coming UK/EU divorce and the US and China play their hands in a tariff poker match. Meanwhile, US FDA looks to avert labeler code crisis, Quebec API firm comes clean about missing identity testing, and US firm recalls drug product based on FDA’s API supplier inspection findings.

Quality Manufacturing

Chinese API Maker Blasted For Failing To Document Equipment Cleaning And Lax Stability Testing Practices

FDA chastised Chinese API maker for inadequate cleaning validation, failing to ensure that products are manufactured in a state of control, and lax stability testing practices. The agency noted that the firm did not learn from observations the agency made of similar mistakes during previous inspections.

United States Manufacturing

Probable Carcinogen Found Haunting More Firms’ Valsartan API

As Zhejiang Huahai works to rid its valsartan API manufacturing process of NDMA impurity, two competitors also have launched recalls after discovering the probable carcinogen in their valsartan API. Meanwhile, US FDA confronts Huahai over handling of impurities that visited chromatograms in the form of ghost peaks.

Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Toxicity Testing For Topical Drugs, Sunscreens Included, On Tap In US FDA Workshop

While FDA does not identify specific product types on the agenda for its public workshop on approaches in skin toxicity testing for topical drug products, advocacy and trade groups anticipate sunscreen ingredient testing could be among the discussion topics. Product expansions have been stifled by regulatory concerns, drawing particular attention from the public health community.

 

Dermatology Consumer

OTC Private Labelers Recall CVS, Walmart Brand Products

Recalls include one lot of CVS Health Sinus Relief manufactured by Product Quest Manufacturing, Walmart's Equate laxative made by Lupin's US office and 12 cough and cold products marketed under Preferred Plus Pharmacy and other private label brands and made by RIJ Pharmaceutical Corp. Chart provides update on recent US OTC recalls.

Consumer Recalls

Bausch Health Boosts Ad Spending For Expanding OTC Eye Care Lineup

"We're investing more to drive growth as we allocate capital to support the launches of new products in the segment like Lumify, for DTC advertising that continue to drive sales growth of other US consumer products like our eye vitamins," says CEO Joseph Papa.

Consumer Ophthalmic
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