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The 'Dead Cat' Strikes Back: What Does US FDA Do With A Challenging Panel Outcome?

Akcea’s volanesorsen for familial chylomicronemia syndrome barely made it through advisory committee due to a rare but unpredictable and rapidly presenting adverse event that likely can’t be resolved with a REMS. Now what? 
Advisory Committees Drug Safety Rare Diseases

Trump's Drug Pricing Plan – What The Choice Of Words May Mean For India

The Trump Administration’s blueprint on prescription drugs and reducing out-of-pocket costs may still be a work in progress, but there appears to be a careful choice of words, which some experts in developing nations like India believe are pointers on what to expect.

Policy Intellectual Property United States

EMA Clarifies Sponsor's Role In Validating Electronic Systems Used In Clinical Trials

The European Medicines Agency has issued guidance in response to a growing number of queries from sponsors on how they should qualify/validate the electronic systems they use in a clinical trial setting when the systems have already been qualified by a vendor. The issue has already resulted in deviations being issued during good clinical practice inspections.

Clinical Trials Regulation Europe

Pfizer Agrees To Oversight Of Charitable Assistance Programs In DOJ Settlement

Second pharma charity kickback settlement in six months resolves claims Pfizer used charity to pay Medicare patient copays for three drugs.

BioPharmaceutical Regulation Legal Issues
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FDA Performance Tracker

Keeping Track: A Diverse Array Of Approvals, A CRL For Evolus' Botox Competitor, And Coherus Refiles Neulasta Biosimilar

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

UK’s Future Access To EU Trials Portal ‘Outside Our Control,’ Says Govt

The UK will be able to play a full part in the EU’s new clinical trial system if the legislation takes effect during a Brexit transition period. However, if there is no transition period, the extent of its future participation in the new trials portal is far from certain.

Brexit Clinical Trials Regulation

Latest From Regulation

FDA Denies Petition To Pull Teething From OTC Benzocaine Label, Expects Voluntary Changes By Marketers

FDA denies Public Citizen's petition for rulemaking to remove infant teething as an indication for OTC benzocaine and require a contraindication on labels advising against using gel and liquid products for teething pain. The agency has asked marketers for voluntary label changes and says a rulemaking would be too lengthy, but Public Citizen says a rulemaking started when the problem became known would already be completed.

Consumer Safety

UK Biotech Not Impressed By Govt’s Response To MPs’ Brexit Concerns

The UK government has published its response to the concerns raised by a parliamentary health committee about the impact of Brexit on medicines and medical devices. However, the response is lacking in detail, and the biotech industry says it does not provide the information companies need to be able to plan for the future.
Brexit Europe

Brazil Approves First Generic Sovalidi

Brazil’s first generic Sovaldi for hepatitis C is approved.

South America Brazil

Latest From Policy

Impax Defeats FTC Pay-For-Delay Complaint, Helped By Status As Sole Marketer Of Generic Opana ER

FTC Chief Administrative Law Judge finds procompetitive benefit of Endo-Impax patent settlement agreement outweighs unjustified no-authorized generic provision.

Generic Drugs Legal Issues

DTC And The Art Of Selling An Establishment Pricing Plan To A Populist President

The most surprising proposal coming out the Rose Garden drug pricing event was a call for disclosure of prices in DTC ads. As a policy idea, it may be a dud – but that doesn’t mean it isn’t a critical element of the plan.

Advertising, Marketing & Sales Pricing Debate

US Drug Pricing Reform: No More Medicare 'Gravy Train,' Azar Tells Pharma

HHS secretary urges serious proposals from biopharma on enhancing price negotiation in Medicare Parts D and B, promising action from the Administration whether the industry cooperates or not.

Pricing Debate Medicare

Clinical / R&D Explore this Topic

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Latest From Research & Development

Pharmas Join To Build Inflammation Biomarkers In Alzheimer's, Depression

Drug firms exploring link between inflammation and central nervous system disorders are now sharing resources through public/private Biomarkers Consortium project.
Clinical Trials Research & Development

Keytruda, Tecentriq Face Efficacy Questions In Urothelial Cancer

Monotherapy patients with tumors that have low PD-L1 expression experienced decrease survival in two confirmatory trials; however, the immune checkpoint inhibitors’ accelerated approvals are unlikely to be affected pending final results comparing use in combination with chemotherapy to chemo alone.


ImmunoOncology Clinical Trials

Takeda/Shire Merger: Five Things To Worry About

From 'breakthrough' designations to manufacturing hiccups, numerous review and development challenges await the combined entity.

Drug Review Research & Development

Commercial Explore this Topic

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Latest From Commercial

You Work In The Pharmaceutical Industry; Here's Why You Should Care About The Novartis Payments

There's a lot of finger-pointing in the industry when it comes to why pharma has a bad reputation. Maybe it's time everyone who works in pharmaceuticals takes responsibility for it.

Legal Issues Policy

Sarepta Will Challenge Expected No From EMA On Exondys 51

Sarepta is expecting the European Medicines Agency to recommend against EU approval of its Duchenne muscular dystrophy treatment eteplirsen. Persuading the agency to change its mind during the appeal will be an uphill task for the company.

Drug Review Business Strategies

Rebates And Discounts Have A Big Impact On US Drug Prices, IQVIA Report Shows

A new US drug spending report from IQVIA parses out how rebates impact drug spending and explores affordability for patients. The data show drug makers offset about 28% of drug spending and provide some support to industry's arguments on drug pricing. 

Pricing Strategies Pricing Debate

Manufacturing Explore this Topic

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Latest From Manufacturing

Manufacturing Compliance Updates In Brief From US FDA And The EU

FDA issues five more drug GMP warning letters to drug manufacturers and active ingredient manufacturers at sites in India, China, and the US exhorting them to do a better job of testing ingredients and final products and to manage cross-contamination risks better. UK MHRA withdraws the GMP certificate for one Taiwanese API maker for its lack of knowledge of sterile processing. Meanwhile, FDA adds an Indian facility to its drug GMP import alert.
Europe United States

EMA Consults On Two-Step Process For Release And Shipping Of Investigational Products

The European Medicines Agency has issued a draft guideline to support the upcoming Clinical Trials Regulation, explaining how investigational medicinal products should be handled before they are sent to clinical trial sites. 
Europe Clinical Trials

PhRMA, BIO Mum On Trump’s Tariffs

While pressing the US trade representative for stronger IP protection, groups representing the brand biopharma sector remain silent on the Trump administration’s plan to hit China with 25% tariffs.

Manufacturing Trade

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

FDA Denies Petition To Pull Teething From OTC Benzocaine Label, Expects Voluntary Changes By Marketers

FDA denies Public Citizen's petition for rulemaking to remove infant teething as an indication for OTC benzocaine and require a contraindication on labels advising against using gel and liquid products for teething pain. The agency has asked marketers for voluntary label changes and says a rulemaking would be too lengthy, but Public Citizen says a rulemaking started when the problem became known would already be completed.

Consumer Safety

FDA Benzocaine Safety Alert Also Targets Pain From Public Citizen Complaint

FDA is considering forcing off the market OTC benzocaine oral care products for treating infant teething pain, seven years after acknowledging the ingredient's link to a rare but potentially fatal condition, methemoglobinemia, and raising the possibility of requiring label changes.

Consumer Safety

Generics, OTC AND API Groups Object To Proposed US Tariffs On Goods From China

AAM, CHPA, SOCMA and BPTF agree that proposed 25% tariffs on pharmaceuticals and APIs from China is a bad idea, unless perhaps it’s just a negotiating ploy.

Manufacturing Trade
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