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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

Keeping Track: Amgen Parsabiv Is Latest To Receive Complete Response; Pfizer Troxyca ER Finally Approved; Remune Returns

The latest drug development news and highlights from our FDA Performance Tracker.

Keeping Track Performance Tracker 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 & Development Drug Approval Standards Regulation

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

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

Policy & Regulation

Set Alert for Policy & Regulation

PDUFA First: Fees To Support Device Center Staff

To enhance combination product reviews, drug fee revenue will pay for related positions in CDRH.

Combination Products Drug Review BioPharmaceutical

Latest From Regulation

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Regulation

FDA's ANDA Approvals

Generic drug approvals and tentative approvals in mid- to late August.

Regulation Approvals

FDA's NDA And BLA Approvals: Troxyca ER, Palonosetron

Original new drugs and biologics recently approved by FDA.

Approvals Regulation

Latest From 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

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

Clinical / R&D

Set Alert for Clinical / R&D

Latest From Research & Development

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

India Global Trial Hub Dreams Still Distant As Concerns Linger

Indian clinical trial approvals appear to be on the downswing despite government moves to boost the troubled sector, as regulatory uncertainty and negative publicity continue to undermine confidence in the industry.

India Regulation


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

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

EMA Clarifies Compliance With ALCOA Principles Is Key To Meeting Data Integrity Expectations

The EMA's guidance on data integrity expectations focuses on good manufacturing practice requirements and offers advice on minimizing risks at all stages of the data lifecycle in pharmaceutical quality systems.

Regulation Europe

Consumer / OTC Drugs

Set Alert for Consumer / OTC Drugs

Latest From Consumer

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

Differin Gel Enters Changed Marketplace Since Last OTC Acne Drug Approval

Galderma Labs' adapalene gel is pending launch as first OTC acne ingredient approved through an NDA and first new acne ingredient available OTC in 20 years, but company must play in a digitally-oriented marketplace.

Consumer Prescription To Otc Switch