BioSpace News Archive

Pharm Country

Elite Pharmaceuticals Reports Positive Topline Results from Pivotal Bioequivalence Studies for an Extended-Release Generic

The topline results indicate that the generic product is bioequivalent to the branded product.

January 10, 2018
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4 min read
Policy

China Food and Drug Administration (CFDA) Approves Biomerica Colorectal Screening Test to Help Identify the Early Warning Signs of Colorectal Cancer

The EZ Detect colorectal screening test is the simplest at home test to detect fecal occult (hidden) blood, an early warning sign of colorectal cancer.

January 10, 2018
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3 min read
Business

PositiveID Announces 2017 Highlights and Projects Continued 30% Growth

Company expects year-over-year growth of over 30% for the 2017 fourth quarter and 2018 first quarter.

January 10, 2018
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7 min read
Drug Development

Delcath Announces Special Protocol Agreement Modification With FDA

The modification agreement revises the FOCUS trial’s eligibility criteria.

January 10, 2018
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4 min read
Drug Development

Atara Biotherapeutics Announces FDA Clearance to Proceed With Enrollment at U.S. Sites for Ongoing Global Phase I Clinical Study to Evaluate ATA188 in Patients With Progressive or Relapsing-Remitting Multiple Sclerosis

The primary objective of Atara’s ongoing Phase 1 clinical study is to assess the safety of ATA188 in patients followed for at least one year after the first dose.

January 10, 2018
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7 min read
Libella Gene Therapeutics’ New Clinical Study May be the World’s First Cure for Alzheimer’s Disease

Libella Gene Therapeutics will conduct an outside the United States clinical trial in Cartagena, Colombia, using gene therapy to reverse age-related diseases, starting with Alzheimer’s.

January 10, 2018
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3 min read
Business

Accelerate Diagnostics Achieves CE-IVD Milestone for Severe Bacterial Pneumonia Assay, Doubles Revenue for 2017 in Q4

Revenue for the fourth quarter of 2017 of $2.1 million, a 52 times increase over the fourth quarter of 2016.

January 10, 2018
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3 min read
SurgaColl Holdings Ltd Announces Series A Funding, Opens HQ in Alderley Park

Surgacoll today announced the completion of its Series A funding, led by the GM&C Life Sciences Fund, and including investment from Julz Co, a US-based healthcare fund.

January 10, 2018
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2 min read
Drug Development

Avadel Pharmaceuticals Receives Orphan Drug Designation From FDA for FT 218 for the Treatment of Narcolepsy

The designation has been granted on the plausible hypothesis that FT 218 may be clinically superior to the same drug already approved for the same indication.

January 10, 2018
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5 min read
Evogene Announces Positive 2nd Year Field Trial Results in Corn Bio-Stimulant Ag-Biologicals Program

Results demonstrated significant yield improvement; selected microbial strains to be tested as part of the collaboration with DuPont-Pioneer.

January 10, 2018
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4 min read