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IN THE NEWS


Tufts Study Says Drug Development Costs $2.6 Billion

Development costs spiked 145 percent over the past decade.

Impact of Republican Senate Takeover on FDA Remains Uncertain

The Republican landslide in the midterm election will put GOP lawmakers in the driver’s seat on the generics labeling rule, user-fee negotiations and agency funding, but experts say the political shift’s impact remains uncertain.

FDA Finalizes Guidance on Vaginal Microbicides for HIV Prevention

Companies developing vaginal microbicide gels to prevent HIV infections should have a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue in human studies evaluating the safety and tolerability of the products, says a new final guidance.

Tufts: Drug Development Costs $2.6 Billion

Pharmaceutical companies today spend an average of $2.6 billion to get their products to market, according to a new report that finds R&D costs have increased 145 percent over the past decade.

Merck’s Hepatitis C Combo Falls Short in Study

An experimental four-week, triple-therapy regimen proved largely ineffective.

AZ & Amgen: Brodalumab Superior to Stelara for Plaque Psoriasis

Amgen and AstraZeneca said their experimental psoriasis compound brodalumab demonstrated better outcomes than Janssen’s therapy Stelara in a Phase III trial, a development that moves the drug one step closer to market in the competitive therapeutic area.

Three Ebola Drugs to Undergo Clinical Trials in West Africa in December

Clinical trials of three experimental Ebola therapies are set to begin in West Africa next month with results due as soon as February, according to Doctors Without Borders.

FDA Advisors Reject Novartis’ Multiple Myeloma Drug

The oncology-drug advisory committee said safety concerns overwhelmed benefits.

EMA Tries to Allay More Concerns About Data Redaction

European regulators yesterday told the European Union ombudsman that they adhered to the law when allowing manufacturer AbbVie to redact information from its clinical study reports, marking the latest twist in the debate over European trial data transparency.

Biomarkers for Drug-Induced Kidney Injury Receive Boost From EMA, FDA

The European Medicines Agency has lent its support to an initiative to qualify biomarkers that can provide an early warning on an investigational compound’s risks of causing drug-induced kidney injuries, an endorsement that researchers say is necessary to move to the next phase of development.

Merck’s Hepatitis C Combo Falls Short

Merck’s effort to expand its footprint in the lucrative hepatitis C market stumbled, with an experimental four-week, triple-therapy regimen proving largely ineffective.

SCRS: Sites Need to Put More Effort Into Good Clinical Practice Training

Clinical trial sites need to brush up on their good clinical practice training specs and shouldn’t expect sponsors to compensate them for doing so, says Christine Pierre, president of the Society for Clinical Research Sites.

FDA: How to Use Galactomannan As Aspergillosis Biomarker

Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development.

Panel: Sponsors Need to Record More Patient-Centered Data

Drug sponsors need to find more thoughtful, comprehensive ways of recording and integrating patient outcomes data into their efficacy analyses, but long questionnaires may not be the solution, a top FDA official says.

New Framework Would Standardize Site Practices

A new Society for Clinical Research Sites white paper outlines a set of best practices that members of industry group TransCelerate hope will eventually help clinical trial sites improve their compliance.

FDA Outlines Design Expectations for Acute Migraine Treatment Trials

Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age, as more women than men suffer from migraines, according to FDA draft guidance on trial design expectations for the pain drugs.

FDA Advisors Reject Novartis’ Multiple Myeloma Drug

The FDA oncology-drug advisory committee turned down Novartis’ investigational multiple myeloma drug Farydak by a 5-2 vote, citing safety concerns that largely overwhelmed benefits.

India’s New Guideline on Patent Applications Should Spur R&D in Country

India’s final guideline on drug patent applications drops a proposed clause that would have required manufacturers to list names of similar generic products in their filings.

FDA Solicits Feedback on Clinical Investigation Requirements

The FDA is seeking industry feedback on burdens related to its regulations of clinical investigations on the safety and effectiveness of unapproved new drugs and biologics.

Report: Sales Growth of Orphan Drugs Will Far Outpace Other Products

Sales of orphan drugs are expected to grow more than twice as fast as non-orphan drugs in the U.S., Europe and Japan in the coming years, as drugmakers take advantage of lower costs for clinical trials and higher prices when products launch, a new report shows.

Nymox’s Prostate Drug Fails in Phase III

Nymox Pharmaceutical’s investigational treatment for enlarged prostate failed to meet primary endpoints in two Phase III tests, after posting stronger results in previous trials.

Anticipated Rival to Sovaldi Is Expected to Upend Hepatitis C Market

Gilead Sciences could soon lose its dominance of the hepatitis C market, as payers hint they may abandon the company’s blockbuster Sovaldi in favor of lower-cost alternatives that are expected to launch in the coming months.

FDA Seeks to Improve Communication With IND Sponsors

The FDA wants to improve the way it communicates with sponsors of investigational new drug applications and is seeking industry and academia’s advice on how to accomplish that goal.

J&J's Ebola Vaccine Set to Enter Human Testing

A collaboration with GSK could be a possibility.

Sponsors Seeking Treatments for Invasive Aspergillosis May Use Galactomannan Biomarker

Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development.

Another Ebola Vaccine Is Set to Enter Human Testing

Johnson & Johnson has spent $200 million on production of an Ebola vaccine that is set to begin human testing in the U.S., Europe and Africa in January, but talk of potential collaboration with GlaxoSmithKline remains only theoretical at this point.

FDA Explains Trial Design Expectations for Acute Migraine Treatments

Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age early in the drug development process, as more women than men have the condition, according to a new FDA draft guidance.

Sponsors’ GCP Framework Seeks to Improve Clinical Trial Site Performance

A coalition of drugmakers wants to boost performance at clinical trial sites by establishing common standards for good clinical practices and skill requirements for investigators.

Celegene’s Multiple Myeloma Drug Imnovid Rejected by NICE

Imnovid did not show superiority over either Revlimid or Velcade.