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Why Generic EpiPen Is Not The Answer – Until FDA Says It Is

There is no question that the concerns over Mylan’s price increases for EpiPen would deflate as rapidly as the price once an interchangeable generic is approved by FDA, but putting pressure on FDA to get a generic to market may be counterproductive.

Pricing & Regulation Policy United States

GDUFA: Review Costs Continued To Climb Once Formal Review Goals Began

Generic drug reviews during the first year of formal review goals cost 70% more than during GDUFA's inaugural year.

Drug Review Review Pathway Funding

Cempra's Solithromycin On Track To Enter Generic, But Resistant, CABP Market

FDA schedules November advisory committee for Cempra's first-in-class antibiotic for community-acquired bacterial pneumonia.

BioPharmaceutical Regulatory Clinical Development & Trials

EpiPen Outrage In Congress Puts Spotlight On FDA Generic Review

House and Senate letters ask why Mylan's autoinjector doesn't have competition, offering a preview of potential debates on renewal of the generic user fee program.

Legislation Review Pathway Application Process

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

Policy & Regulation

Set Alert for Policy & Regulation

PDUFA VII Already: Could Breakthrough Ideas Apply Outside Program?

Success of enhanced communications in particular made one stakeholder wonder whether FDA could use it with non-breakthrough applications.

Clinical Development & Trials Drug Review Policy

Latest From Regulation

Mylan's EpiPen Nightmare Not Over Yet, But Will Congress Just Write?

Unless Republicans are convinced the market can't fix the problem, Mylan officials may only get congressional letters on the EpiPen price increase.

Application Process Combination Products

EDQM Explains How ICH's Elemental Impurities Guideline Will Apply To CEPs

The European Directorate for the Quality of Medicines & HealthCare has issued guidance explaining the information that should be included in applications for certificates of suitability in the context of the international guideline on elemental impurities, ICH Q3D.

Regulation BioPharmaceutical

Hemispherx 'Redoubling' US Efforts On Ampligen

Chronic fatigue drug received two FDA complete response letters, but company now agrees to additional study, new CEO says. Firm hopes Argentine approval also bodes well.

Research and Development Drug Approval Standards

Latest From Policy

India Mandates Formal Certification Of Personnel In Manufacturing

The Indian drugs regulator has mandated specific formal certification for personnel in the manufacturing space effective 2018, amid an ambitious ongoing initiative to improve skills across functional areas and levels in the life sciences sector. The overall skills improvement plan in the sector hopes to produce a "sustained" stream of more than three million high quality skilled individuals over a 10-year timeframe.

Policy and Regulation Policy

PTAB Knocks Out Two Copaxone 40 mg Patents

Patent Trial and Appeal Board finds claims in '250 and '413 patents covering 40 mg dosage are unpatentable, giving generic manufacturers a chance at early entry once FDA approves ANDAs.

Patent Litigation Legal

The Presidential Transition Teams: A Reunion of “Pfizer Pfriends”?

When Hillary Clinton’s transition team was announced last week, much of the coverage focused (appropriately) on the health care experience of one co-chair, Neera Tanden. But another co-chair, former Michigan Governor Jennifer Granholm, also has an interesting history with the largest US pharma company – and, indirectly, with a member of Donald Trump’s transition team.

Policy BioPharmaceutical

Clinical / R&D

Set Alert for Clinical / R&D

Latest From Research and Development

Hemispherx 'Redoubling' US Efforts On Ampligen

Chronic fatigue drug received two FDA complete response letters, but company now agrees to additional study, new CEO says. Firm hopes Argentine approval also bodes well.

Research and Development Drug Approval Standards

ICER Report Questions Cost-Effectiveness Of PD-1 Drugs In Lung Cancer

ICER report finds EGFR inhibitors are cost-effective in first-line non-small cell lung cancer, but PD-1/L1 inhibitors from Bristol, Merck and Roche may fall short in second-line treatment.

Cancer Clinical Trials

Danish GCP Inspectors Get Full Access To Electronic Patient Data

Changes to the Danish clinical trials legislation will ensure that GCP inspectors, who were earlier denied direct access with their own username and password to electronic health records of trial subjects, now have full access to this information while inspecting studies.

Regulation Clinical Trials


Set Alert for Commercial

Latest From Commercial

Abuse-Deterrent Opioids Effectiveness, Value To Get ICER Review

Pending arrival of several new products prompts evaluation of class, ICER CSO Dan Ollendorf explains; availability of both abuse-deterrent and non-abuse-deterrent drugs among challenging issues.

Cost Effectiveness Pricing Strategies

Pfizer’s $14bn Medivation Buyout Shows How Far Pharma Will Go In Oncology

The competitive bidding process for Medivation shows just how much big pharma is willing to pay for commercial-stage oncology assets. Now that Pfizer has won the biotech, it will have to prove Xtandi is worth the price.

Cancer Business Strategies

People In The News: New Execs At RAPS, CHPA, ACRES

Long-time British Standards Institution official Paul Brooks becomes the Regulatory Affairs Professionals Society's new exec director. Sorrento, Celldex, Retrophin, Arena among companies with executive changes.

People Commercial


Set Alert for Manufacturing

Latest From Manufacturing

Enforcement Log, Dateline 08.25.16: College Pharmacy, Frontida BioPharm, Unimark, Huzhou Aupower, Cape Apothecary, Hospira

Sterility assurance concerns and evidence of microbial contamination predominated in enforcement actions disclosed during the past week, including FDA warning letters, import alerts and EU GMP suspensions. But basic GMP failures were also an issue at some sites.

Manufacturing BioPharmaceutical

Manufacturing Regulatory Updates In Brief: Gelcaps, Co-Crystals And Biosimilars

FDA announces reporting change for hard gel capsules and wants to reclassify co-crystals; IPRF releases biosimilars template.

Manufacturing Biosimilars

49 PIC/S Inspectorates Test-Drive Data Integrity Guidance

Pharmaceutical Inspection Cooperation Scheme member inspectorates are trying out the most comprehensive manufacturing data integrity guidance yet developed. Issued amid a flurry of guidance from various authorities, it could play a key role in harmonizing regulatory approaches.

Manufacturing BioPharmaceutical

Consumer / OTC Drugs

Set Alert for Consumer / OTC Drugs

Latest From Consumer

Weekly Trademark Review Aug. 23, 2016

OTC drug, personal care product and nutritional supplement trademark filings compiled from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

Africa Americas

Naloxone Costs Could Temper Non-Rx Access Even As Distribution Spreads

CVS in 31 states offers naloxone from pharmacists without a prescription and Walgreens offers it in 14, with plans to more than double the program this year. Whether from pharmacists or OTC, "an affordable price is essential if this is to reach the people who need it," says harm reduction advocate Scott Burris.

Consumer Distribution

State AGs Sway Judge Against Homeopathic Firm's False Ad Settlement

A US district court judge says a settlement over false marketing claims by homeopathic maker Similasan would only benefit the two plaintiffs named in the case and their lawyer, and not a class of unnamed consumers who also purchased the firm’s eye, ear, stress and sleep-aid products.

Legal Marketing & Sales