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IN THE NEWS


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age early in the drug development process, as more women than men have the condition, according to a new FDA draft guidance.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.

Millennium’s Cancer Drug Velcade Scores Another New Indication

It can now be used to treat patients with mantle cell lymphoma.

Gilead’s New Hep C Treatment Gets FDA Approval

The approval boosts the company’s already robust hepatitis C portfolio.

Chimerix’s Ebola Drug to See Clinical Trials

The FDA last week approved the company’s emergency investigational NDA.

Q&A Guidance Clarifies Criteria for EMA Adaptive Licensing Pilot

A question-and-answer document released by the European Medicines Agency in September clarifies terms of engagement and expected outcomes for applicants to the agency’s adaptive licensing pilot program.

BMS Pulls NDA for Hepatitis C Combo Drug

The company cited concerns of an insufficient target population.

Panel: Drug Sponsors Need to Record More Patient-Centered Data

Drug sponsors should find a more comprehensive way of recording and integrating patient outcomes data into their efficacy analyses, says a top FDA official who notes the lack of such data often presents a roadblock to making regulatory decisions.

Another Ebola Drug to See Clinical Trials

Drugmaker Chimerix said it may soon start testing its broad-spectrum antiviral drug brincidofovir against the Ebola virus, after the FDA this week approved the company’s emergency investigational new drug application.

EMA Streamlines Pediatric Development Plans for Childhood Vaccine Combo

Companies developing pediatric vaccines for diphtheria, tetanus and pertussis, or DTaP, can streamline the process by using a single dosing schedule in clinical trials, new guidance from the European Medicines Agency says.

EMA Publishes Updated Guideline on Pediatric Investigation Plans

Sponsors submitting plans to test drug products in children in Europe need to provide the European Medicines Agency with information on all formulations being developed, according to final guidance published Sept. 27.

CDSCO Clarifies Requirements for Clinical Trial Applications

Indian authorities are reminding clinical investigators that trial applications must include information on the unmet medical need and risk-benefit assessments of the proposed drug, as well as comparisons of the innovator product and existing options.

BMS Pulls NDA for Hepatitis C Combination Drug

Bristol-Myers Squibb has withdrawn its NDA for a hepatitis C combination drug of Daclinza and asunaprevir, citing concerns of an insufficient target population.

FDA Publishes List of Patient-Focused Disease Research Areas

The FDA has issued a preliminary list of 20 disease targets under an initiative to spur drugmakers to include patient perspectives earlier in the drug development process.

Lilly Scraps Lupus Drug Candidate

Researchers determined efficacy data from Phase III trials weren’t strong enough to support a regulatory submission.

FDA Finalizes Guidance on Accelerated Approval of Early Breast Cancer Trials

Drugmakers seeking accelerated approval of a presurgical treatment for high-risk, early-stage breast cancer may consider conducting multiple trials rather than a traditional single trial, according to a new FDA guidance that aims to give sponsors an earlier indication as to the success of a drug candidate.

Expert Details Benefits of Social Media Use for Drug Development

The FDA has issued guidance on using social media for approved products, but the agency has been markedly silent on how drugmakers can use Facebook, Twitter and other platforms for drug development, an expert said.

EMA Adopts Trial Transparency Policy

Manufacturers that sell drugs in the European Union will soon have to make publicly available clinical trial data supporting approval of those products, under a landmark transparency policy adopted yesterday by the European Medicines Agency.

Lilly Scraps Lupus Drug Candidate Following Insufficient Efficacy Data

Eli Lilly has given up on its lupus drug candidate tabalumab after researchers determined the efficacy data from two Phase III studies were not strong enough to support a regulatory submission.

EMA Finalizes Pediatric Investigation Plan Guideline

Drug sponsors submitting plans to test products in children in Europe need to provide the European Medicines Agency with information on all formulations they are developing, according to a finalized pediatric investigation plan that took effect this week.

EMA Releases New Pediatric Development Plan for DTaP Vaccines

Pharmaceutical companies developing new pediatric vaccines for diphtheria, tetanus and pertussis (DTaP) should conduct clinical trials using a single dosing schedule as a means to streamline the process, according to a new guidance from the European Medicines Agency.

Tekmira's Ebola Drug May Soon Be in West Africa

Canada's Tekmira Pharmaceuticals received FDA clearance to provide its TKM-Ebola RNA interference therapeutic to patients with suspected or confirmed cases of the deadly disease.

Executive Order Aims to Combat Antibiotic-Resistant Bacteria, Stoke Pipeline

A federal effort to spur the development of new drugs to treat antibiotic-resistant infections comes as the industry warns the antibiotics pipeline is running dangerously low and more financial incentives will be required to encourage development in this area.

Merck Halts Development of Lung Cancer Treatment

The therapy had failed a previous Phase III trial last fall.

EMA Q&A Guidance Provides Clarity on Adaptive Licensing Pilot Program

The European Medicines Agency wants to help manufacturers take advantage of its adaptive licensing pilot program, which aims to speed patient access to new treatments via a process that authorizes products for use by targeted populations in stages.