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Latest From Drug Safety

Woodcock: Concerns About US FDA's Biosimilars Suffix Policy Detached From Reality

In an exclusive interview, Center for Drug Evaluation and Research Director Janet Woodcock contends that industry concerns about FDA's new suffix policy aren't reflective of real-world problems.
Biologics Biosimilars

Danish Agency Claims A First In Raw Data Analysis

The Danish Medicines Agency says it is about time that EU regulators developed US FDA-style capabilities to analyze raw data so that they can make better use of the opportunities provided by big data. Agency chief Thomas Senderovitz tells the Pink Sheet how Denmark is setting up a unique data analytics center for drugs and devices without reinventing the wheel.
Denmark Europe

Measles Hearings Offer Counterpoint To Pricing Spotlight: Vaccines Touted As Cost-Effective Solution To Outbreaks

Congressional hearings on the recent outbreaks of measles and other vaccine-preventable diseases offered a positive theme for the industry during the ongoing drug pricing debate.

Legislation Drug Safety

PMDA Chief Defends Japan Spinal Cord Therapy Approval

The head of Japan’s drug and device regulator has defended and supported the country’s recent world-first decision to grant approval to a novel cell-based therapy for spinal cord injuries, saying that patient considerations came first.

Japan Drug Safety

Long-Term Opioid Efficacy Studies Will Take Years, Gottlieb Says

Trials will be mandated as part of new authority granted by SUPPORT Act and are intended to determine whether opioid efficacy decreases with long-term use.
Drug Safety Neurology

FDA Reassures Patients Of Generic Drug Quality Amid Questions In Media Analysis

Commissioner Scott Gottlieb and CDER Director Janet Woodcock say in joint statement that patients can be confident generics are safe and effective and recent media reports misinterpreted inspection and other data when suggesting the contrary.
Drug Safety Generic Drugs

Takeda’s Uloric Gets CV Death Warning And Restricted Indication, But No REMS

Despite advisory committee pressure, US FDA stands firm against imposing REMS targeted at gout drug’s cardiovascular risks; however, Takeda must conduct utilization study to see if labeling changes impact prescribing patterns.

Drug Safety Post Market Regulation & Studies

Latin America Inches Towards Greater Regulatory Harmonization

Regulatory harmonization is gathering pace in Latin America, which is good news for pharmaceutical companies.

South America BioPharmaceutical

Heart Rhythm Concerns Prompt EU-Wide Suspension For Fenspiride Cough Medicines

Fenspiride medicines are being suspended while the European Medicines Agency's pharmacovigilance committee carries out an urgent safety review to address concerns that these drugs can cause sudden serious heart rhythm problems.
Drug Safety Respiratory
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