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Featured Stories

India’s Top Regulator ‘Relieved Of Post’; Temporary Head In Place

India has appointed a temporary head for its Central Drugs Standard Control Organization, after terminating GN Singh’s position.

India Regulation BioPharmaceutical

Pediatric Cancer Studies: US FDA Promises Flexible Approach On Requirements

FDA says it will not be 'held hostage' by its list of molecular targets, but patient advocates worry agency will be deterred from requiring assessments for targets not on the list, while industry worries about being surprised by demands for pediatric data.

Clinical Trials Pediatrics Cancer

How Pfizer Warning Letter Tarnished Sandoz/Momenta's Glatopa Launch

An FDA warning letter to a contract manufacturer, Pfizer, delayed Sandoz/Momenta's Glatopa 40 mg launch, reducing projected revenues and leading Momenta to consider selling assets.
Manufacturing Quality Compliance

Outcomes-Based Contract By Harvard Pilgrim For Testing Could Be Model For Pharma

Prenatal testing services provider IIlumina commits to fund study on whether cost of expanding use of test is offset by reduction in spending on traditional screening practices.

Market Access Pricing Debate Policy

FDA Performance Tracker

Keeping Track: Vitaros Reenters The Wilderness, Remoxy Gives It A Fourth Try, And Two Novel Approvals

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

Drug Review Regulation United States

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

How Middle Eastern Markets Are Transforming Drug Reviews And Driving Competitiveness

The UAE, Jordan, Egypt and Saudi Arabia have all recently announced or implemented new verification/abridged regulatory pathways to improve access to medicines and free up resources.

Middle East and Africa Egypt Saudi Arabia

Latest From Regulation

US FDA Learns 'Lessons Of History,' Takes Opioid Fight To Gabapentinoids

Agency investigating potential misuse and abuse of gabapentinoids, which CDC had recommended as alternative to opioids, in latest twist to epidemic.
Safety Neurology

ANDA Pre-Submission Meetings A 'Challenge' To Integrate Into Development Timelines

US FDA officials appears worried about workload created by product development and pre-submission meetings for complex generics.
Generic Drugs Review Pathway

Recent And Upcoming FDA Advisory Committee Meetings

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

Advisory Committees Drug Review

Latest From Policy

CDC Panel Backs Heplisav-B Use, May Consider Preferential Recommendation

Dynavax's hepatitis B vaccine could end up as preferred choice for certain groups once safety and cost-effectiveness studies are completed.

Infectious Diseases Launches

The Budget Blindside: Did Pharma Fight The Wrong Battle?

The bigger 'Donut Hole' discount is a rare loss for pharma on Capitol Hill – one that may in part be because industry did too good a job fighting off a different drug pricing measure.

Medicare Generic Drugs

Gilead Avoids $2.5bn Jury Verdict As Judge Rules Merck's Hep C Patent Is Invalid

 Merck to appeal decision after district court says Gilead's discovery of sofosbuvir was 'neither routine nor simple.'

Intellectual Property Policy

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

Back To The Future: Mining Previous Trials For Future Drug Development

Researchers and companies will increasingly mine historical clinical data using new technologies to overcome patient scarcity and make sense of huge amounts of disparate data, Medidata says in a new report.

Clinical Trials Digital Health

Disease-Specific Guidances Reflect US FDA's 'Nimble, Collaborative, Patient-Focused' Approach

Patient groups helped with draft guidance on ALS drug development and revision of Alzheimer's draft guidance; agency also issues draft guidance on pediatric seizure, final guidances on DMD and migraine.

Drug Approval Standards Clinical Trials

Alzheimer's Biomarkers Gain Prominence In Drug Development Guidance

US FDA revises draft guidance issued in 2013 to allow research targeting cognition as single endpoint and studies solely evaluating biomarkers; document offers 'potential for multiple advances,' Alzheimer's Association says.

Neurology Drug Approval Standards

Commercial Explore this Topic

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Latest From Commercial

Bristol's Opdivo/Yervoy Bid Will Show Whether Tumor Mutation Burden Is Ready For Prime Time

US FDA officials have supported tumor mutation burden as a biomarker, but analysts question whether a subset analysis of CheckMate 227 will be enough to support approval of Bristol's Opdivo/Yervoy combination in first-line lung cancer.

ImmunoOncology Sales & Earnings

Providers, Payors and Prior Authorization: A Second Front In Pricing Fight

A below-the-radar effort to streamline prior authorization policies could have important implications for easing access to high-priced medicines. A new consensus statement aligns large provider groups with payors on some first principles.

Reimbursement Business Strategies

Just Do It: Lilly CEO Ricks On Rebates At The Pharmacy Counter

Lilly's chief exec came out strongly in favor of passing rebates onto patients at the point of sale, a big issue of debate in the industry. While it's not surprising that Lilly would be in favor of such a move, Ricks was more outspoken than some of his peers have been.

Pricing Debate Medicare

Manufacturing Explore this Topic

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Latest From Manufacturing

US/EU Inspections MRA: Lessons Learned And Challenges Ahead for FDA

Regulators in the US are finding it easier to assess the capability of European inspectorates under the landmark mutual recognition agreement on inspections signed last year, but there are some important implementation challenges that still need to be addressed.  

US States Europe

Pfizer Uses Layered Knowledge Management To Guide Tech Transfers

Pfizer has developed a multilayered knowledge management program that aims to ease the tech transfer process by harnessing institutional knowledge into one place. The program allows employees to ensure that processes remain stable during tech transfer by exploring all available process knowledge available on the product.

Manufacturing Quality

FDA And Industry Officials Tout Benefits Of Performance-Based Established Conditions In ICH Q12

ICH given “two thumbs up" for performance-based established conditions concept in draft Q12 guideline. This approach gives industry much needed flexibility in managing post-approval changes as well as requesting fewer changes from regulators.ICH plans to adopt the guideline as a Step 4 document in 2019.


Manufacturing Quality

Consumer / OTC Drugs Explore this Topic

Set Alert for Consumer OTC Drugs

Latest From Consumer

Abbott Meets UK Claim On OTC Glucose Test Time But Misses On Finger Prick

The firm substantiated the test quickly produces glucose readings for users, but misled consumers by explaining the finger-prick part of the process on an FAQ page accessible with multiple clicks past the brand's website homepage. FreeStyle Libre features a sensor that attaches to skin on the back of the arm and a wireless device that reads information from the sensors.
United States United Kingdom

Reckitt At '2.0' On Consumer Expansion But Question No. 1 Remains, Potential Pfizer Business Bid?

UK firm sees acquisitions of Mead Johnson Nutrition and the Schiff brand as major milestones in its trajectory as a consumer health market competitor, but market analysts say both would be rendered comparatively minor moves if it makes an offer to acquire Pfizer's consumer products business.

Consumer Advertising, Marketing & Sales

OTC Oral Contraceptive Interest Could Be Price Sensitive, Study Suggests

A survey with 2,026 women and 513 teens showed they are willing to pay out-of-pocket for the convenience of OTC access to an oral contraceptive but not to pay as much as they were four years earlier, according to a study led by Daniel Grossman, University of California-San Francisco, and Kate Grindlay, Ibis Reproductive Health.

United States Consumer