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Biosimilar Substitution: US State Laws Require Physician Communication And, In Some Cases, Lower Prices

Bills allowing pharmacies to substitute biosimilars for reference biologics have been enacted in all but eight states. Interactive map notes state-by-state provisions.

Biosimilars State News Legislation

Argentina Considers Creating National HTA Body

Argentina could be on the way to creating a national health technology appraisal organization.

South America Argentina Comparative Effectiveness

Roche’s External Control Arms Show What Real-World Evidence Can Look Like In Practice

With Flatiron, Roche is at the forefront of the emerging field of RWE. Roche Pharma President O’Day described how the company is using such data in the real world of regulation and reimbursement.

Clinical Trials Digital Health Drug Review

EMA Alerts Stakeholders To Next Steps For EU Drug Safety Monitoring System

The European Medicines Agency has outlined key steps it plans to take over the next couple of years to improve the EudraVigilance drug safety monitoring system, including easier access for organizations and users, better communications with stakeholders, and the introduction of new reporting formats. Predictably, there's a Brexit sting in the tail.
Drug Safety Europe Standards

FDA Performance Tracker

Keeping Track: Keytruda Adds Two New Uses, Furoscix ‘Patch Pump’ Gets A CRL, And Nightstar Nabs An RMAT

The latest drug development news and highlights from our US FDA Performance Tracker.
Drug Review Regulation United States

Clinical and Research Excellence Awards 2018 eBook

The Clinical and Research Excellence (CARE) Awards provides an opportunity for the pharma industry to celebrate all its achievements, and pay tribute to the people and teams behind these feats. 2017 was a successful year for the industry, which was evident by the volume and quality of the entries received for this year’s CARE Awards.

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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.

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Policy & Regulation Explore this Topic

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Posting Preapproval Access Policies Could Help Prevent ‘Blame And Shame’ Under Right To Try

Many biopharmas have not publicly posted their policies for evaluating and responding to expanded access requests as required under the 21st Century Cures Act. Putting this information out will help set patient community expectations, but will not viewed by US FDA as off-label promotion, experts say at BIO annual meeting.

Legislation Clinical Trials Policy

Latest From Regulation

Mylan's Fulphila Approval: Lack Of US FDA AdComm May Be A Positive For Biosimilar Industry

The advisory committee route for approving a first biosimilar to a reference product is no longer necessarily the norm, going by FDA's recent approval of Mylan/Biocon's pegfilgrastim-jmdb, which references Amgen’s Neulasta; agency’s view that a meeting was not needed should encourage other biosimilar aspirants.

Biosimilars Advisory Committees

Moxidectin Sponsors Credit PRV Program For Enabling River Blindness Approval

Medicines Development for Global Health is the first nonprofit to earn a priority review voucher for bringing a neglected tropical disease therapy to US approval. Project carried on research from the Wyeth era.

Approvals Rare Diseases

EMA's Revised Pediatric Class Waiver List Comes Into Effect July 28

Marketing authorization applications for medicines that are no longer subject to a class waiver as per the revised list will need a pediatric investigation plan.
Europe Clinical Trials

Latest From Policy

Takeda Gives UK’s NICE Economic Model Review Service Thumbs Up

A new service provided by UK HTA body NICE for evaluating economic models that will be reviewed by health technology appraisal bodies has been a success, according to Takeda.

Europe United Kingdom

The Trump Effect On Drug Pricing: Uncertainty Is The Only Constant

Those “massive” price cuts US President Trump said would be announced this week? Never mind.
Reimbursement Pricing Debate

US FDA’s Plan On Right To Try: Big On Congressional Engagement, Short On Policy Details

Internal group headed by Principal Deputy Commissioner Rachel Sherman will develop implementation recommendations, which could include new guidance, regulations, a Q&A document or ‘nothing at all,’ Commissioner Gottlieb tells BIO annual meeting; he promises consultation with the law’s supporters and critics on Capitol Hill ‘to fully understand what the intent was with different provisions.’

Legislation FDA

Clinical / R&D Explore this Topic

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Latest From Research & Development

Kite’s CAR-T Therapy Makes It Back Onto EMA’s PRIME, Along With Three New Products

The four latest products to be accepted onto the European Medicines Agency’s popular priority medicines scheme target mantle cell lymphoma, chikungunya, hematopoietic stem cell transplant patients, and the rare monogenic disease, X-linked myotubular myopathy.

Regulation Market Access

Toxicology Initiative From US FDA Aims To Replace Animal Safety Models, But Slowly

Predictive Toxicology Roadmap will help make drug development more efficient by promoting new technologies for safety testing, Commissioner Gottlieb says.

Clinical Trials Research & Development

Biodefense Bill Moving In Senate; Still Debate Over Best Approach For Flu

US Pandemic and All Hazards Preparedness Act appears on track for on-time reauthorization – but there may still be debate over whether and how to dedicate funding specifically for pandemic flu preparedness and stockpiling.
Infectious Diseases Legislation

Commercial Explore this Topic

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Latest From Commercial

Branded Advair Breathes Another Day; Mylan Says A CRL Is On The Way For A Generic

FDA alerted Mylan to expect a complete response letter related to its ANDA for generic Advair. The company said it still could receive an approval prior to the standard 90-day time period after responding to the letter, because the application has a priority designation.

Generic Drugs Respiratory

Why The Right-To-Try Law Is Not Right For Some Biotech Companies

Two CEOs explain why their rare disease companies will not grant preapproval access to investigational drugs under new federal law; Alnylam sees no need for framework beyond FDA’s expanded access pathway, while Sarepta is focused on the ‘grand goal’ of getting drugs studied and approved for the patient community.

Rare Diseases Clinical Trials

BIO Notebook Day 4: Gottlieb Seeks Early Engagement On Gene Therapy; Ireland’s Brexit Opportunities; AMAG’s Bremelanotide Strategy; Alzheimer’s ‘Learnings’

US FDA to head off cell/gene therapy manufacturing issues with pre-IND meetings; Republic of Ireland will “chase any opportunities” for business partners stemming from Brexit, even while hoping UK reconsiders EU departure; AMAG won’t follow the flibanserin PR approach with newly submitted female sexual dysfunction drug bremelanotide; United Neuroscience CMO Ajay Verma says Alzheimer’s trial setbacks are “learnings,” with progress toward novel therapies moving faster than it has for cancer and HIV.

Regenerative Medicine Neurology

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA Lauds St. Gallen's Findings On 10 Metrics For Ensuring Drug Quality

US FDA touts new evidence that high performance of pharmaceutical manufacturing sites on 10 quality maturity metrics correlates with robust pharmaceutical quality systems, operational excellence and good business. An FDA-funded study by St. Gallen also finds that low performance, on the other hand, correlates with manufacturing problems.

United States Manufacturing

ANDA Amendments Cannot Get Mid-Review Communications Like Full Applications - FDA

Generic industry officials ask that information requests and discipline review letters be issued during ANDA amendment assessments, but the US agency says they are not allowed in GDUFA II.

FDA Generic Drugs

How Manufacturers Need To Shore Up Fragile Supply Chains To Prevent Antibiotics Shortages

The potential of an impending “apocalypse” of antibiotic drug shortages means that the pharmaceutical industry should pay careful attention to managing fragile supply chains for these drugs. A report details how manufacturers can manage these supply chains to avert potential shortages.

Manufacturing Infectious Diseases

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

US House Committee Requests Proof Of FDA Progress Seizing Opioids In International Mail

Energy & Commerce's Republican and Democrat leadership ask FDA Commissioner Scott Gottlieb about work by the agency's Office of Criminal Investigations focused on opioid drugs, the office's staffing and its priorities. They note FDA's FY2018 appropriation included $94m for its work in international mail facilities.

Policy & Regulation Safety

Rulemaking For OTC Switch Process Changes Pushed To 2019

Target date moved from August 2018 to February 2019 for publishing an NPRM for allowing currently Rx drug ingredients to be available nonprescription under conditions of safe use. US HHS annual spring update on regulatory priorities for FDA and its other agencies also pushes back target dates for other OTC drug NPRMs, including FDA's long-delayed finalization of several monographs including sunscreen ingredients.

Consumer Drug Approval Standards

US FDA Crossing Off More Foreign OTC Firms On Globalization Checklist

FDA issued 39 warning letters to OTC drug facilities, most of them outside the US, in 2017, a number significantly boosted by an initiative to inspect a total of 1,000 foreign drug manufacturers from January 2017 through September 2019 , says CDER compliance director Donald Ashley. Many GMP violations behind FDA's warning letters concerned “rudimentary" requirements.

Consumer Manufacturing