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Rare Diseases: Growing Understanding Will Unlock Accelerated Approval, FDA Says

US FDA officials say they need knowledge of the disease to have the confidence to use accelerated approval.

Rare Diseases Review Pathway Regulation

New ICH Guide To Eliminate ‘Discordant Advice’ On Juvenile Animal Studies

Experts at the International Council for Harmonisation have nearly completed the first draft of a guideline that explains in which situations nonclinical juvenile animal testing is considered informative and necessary to support pediatric drug development. The guideline is expected to address the "discordant advice" that different regulatory agencies currently offer companies in relation to such studies.

Safety Clinical Trials Pediatrics

Purdue Butrans Pediatric Study Added To Label – Sort Of

US FDA has updated the label for Purdue’s opioid pain therapy Butrans to note the existence of a pediatric study for the buprenorphine formulation. After consulting with its advisory committee, FDA didn’t include any further information.

Advisory Committees Approvals Pediatrics

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

A Big Week For FDA’s Top Eye Drug Reviewer

Ophthalmology supervisory medical officer Wiley Chambers played a key role at three different advisory committee meetings in early October. Only one was a review in his division.

Advisory Committees Drug Review Drug Safety

Latest From Regulation

Biosimilar Firms Fight Against 'Whisper Campaign' On Interchangeability

Industry calls for more education amid concerns that brand sales reps are encouraging providers to use only interchangeable products because they are better than biosimilars.

Biosimilars Advertising, Marketing & Sales

Rx Drug Ads: Number Of Side Effects, Price-Comparison Claims Impact Risk Perception

Commercials citing non-severe side effects dilute message, London study concludes; US FDA finds price comparison claims may cause physicians to think a drug's risks are less severe and that risk info is less prominent on mobile devices.

Advertising, Marketing & Sales Drug Safety

Third Time Lucky For Disabling Skin Disease Biological As EMA Says Yes For PRIME

A biological that is being developed to treat the life-threatening genetic disorder, XLHED, in babies has had its ups and downs, but it has now been accepted on the European Medicines Agency’s PRIME scheme for getting drugs for unmet medical needs to patients faster. Other recipients of PRIME designations this month are Ignyta and, seemingly, GSK.

Europe Drug Review

Latest From Policy

England’s NICE Takes Tough Stance On Opdivo; No Relief from Cancer Drugs Fund

HTA body NICE has rejected in draft guidance the use in the NHS in England of Opdivo (nivolumab) in bladder cancer. Also, the BMS product is unlikely to gain reimbursement from the Cancer Drugs Fund for the indication because further clinical trials in bladder cancer are not ongoing. Similar issues affect the initial rejection by NICE of lenvatinib and sorafenib in advanced metastatic differentiated thyroid cancer patients.

Health Technology Assessment Pricing Strategies

Drug Pricing Legislation Appears Nowhere In Sight Following Senate Hearing

Senators and witnesses rehashed years-old arguments and found little common ground on which elements of drug pricing to address.

Pricing Debate Reimbursement

Antibiotic Incentives: Prize Fund Is Focus Of Presidential Report On Incentives

Upcoming White House report on antibiotic incentives will provide a strong endorsement of one-time payments to reward successful development of new therapeutics. That is a mixed blessing for advocates for legislative action for incentives who are focusing on 'wildcard' patents.

Infectious Diseases Intellectual Property

Clinical / R&D Explore this Topic

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Latest From Research & Development

Chronic Fatigue Syndrome Research Takes Leap Forward With NIH Funding

Research centers are collaborating on projects to find causes of disease; Ampligen, Rituxan and KPAX-002 are only drugs in clinical trials.

Research and Development Strategies Neurology

A Biomarker For Bristol: Mutation Burden Shows Promise In Small Cell Lung Cancer

Phase I/II data from Opdivo/Yervoy combination in SCLC provide more evidence that tumor mutation burden is emerging as a biomarker for immunotherapy, but commercial value is unclear and results don't have implications for the all-important CheckMate 227 non-small cell lung cancer trial, analysts say.

Drug Approval Standards ImmunoOncology

Canada Prepares To Publish Draft Rules On Release Of Clinical Data

Following a public consultation earlier this year, Health Canada has asked for expert advice on its plans to allow the release of clinical data that is currently considered confidential. It expects to publish draft regulations this autumn.

Clinical Trials Canada

Commercial Explore this Topic

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Latest From Commercial

Anthem In-House PBM Will Draw On CVS But Retain Formulary Control

Hybrid approach to pharmacy benefit management expected to save insurer $4bn annually after Anthem ends its relationship with Express Scripts in 2020. Integration of medical and Rx benefit data could lead to more value-based contracting.

Pharmacy Benefit Management Pricing Strategies

Pfizer Takes On International Reference Pricing

Sam Taylor, Pfizer’s head of global pricing, shares his wisdom on the increasingly complex subject of international reference pricing.

Pricing Strategies Pricing Debate

Pfizer Déjà Vu: Is It Time To Sell The Consumer Health Business?

As Pfizer re-examines a potential sale of its consumer business, analysts expect it would attract suitors for its unit, with $15bn to $17bn a likely price, but also say it might be better off continuing to compete in the sector that accounted for around $3.4bn of its 2016 revenues.

Consumer M & A

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA To Name First Eight EU Member State Inspection Partners Under MRA

FDA is on track to name eight EU member country inspectorates as partners capable of conducting GMP surveillance inspections on behalf of the US by a Nov. 1 deadline. Another four are expected to be named by March 2018. The FDA plans to name all 28 EU member countries as partners by mid-2019.

Manufacturing Quality

Manufacturing Compliance Updates In Brief: Dasan, Akorn, Evertogen And 10 Others

Dasan didn't test glycerin for DEG; Akorn didn't see the problem with washed-vial conveyor belt crumbs; Evertogen was undone by a desk audit; six unsanitary compounders were warned; four firms were hit with drug GMP import alerts.

Manufacturing Quality

FDA Outlines How Generic Drug Makers Can Reverse Filing Decisions

ANDA sponsors can file a 'request for reconsideration' disputing regulatory decisions and can appeal some – but not all – of the agency's decisions. If manufacturers are still not happy with outcome, they can go through the formal dispute resolution process.

Generic Drugs Manufacturing

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Fair Trade Is Not FDA's Expertise, Amarin Says In Omega-3 Ingredients Filing

Maker of Rx Vascepa says it's not asking trade panel to interpret the FD&C Act, but to investigate whether some omega-3 ingredient suppliers and marketers are failing to fulfill "certain marketplace expectations about the nature" of their products. ITC is about to decide whether to investigate complaint, which could impact a number of dietary supplement firms.

Consumer Legal Issues

Consumer Health Weekly Trademark Review Oct. 10, 2017

Compiled from the Official Gazette of the US Patent and Trademark Office, Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) marks registered and published for opposition.

Consumer Dietary Supplements

Nicorette, Tylenol Ease J&J's Consumer Pain From Slow Oral Care Sales

J&J’s worldwide OTC drug division sales rose 4.4% to $1bn, driven by the Tylenol and Nicorette brands, the firm reports Oct. 17. Those revenues helped offset softness in the firm’s Listerine and other oral care products due to more competition online from start-ups selling straight to consumers.

Consumer Sales & Earnings