Vanda Pharmaceuticals’ Hetlioz Shows Promise for Treating Jet Lag
Vanda Pharmaceuticals announced positive results from its JET8 Phase III clinical trial of Hetlioz for jet lag disorder. Source: BioSpace
Prometic Snags Rare Pediatric Disease Designation from the FDA for its Inter-Alpha-Inhibitor-Prot…
Shares of Prometic Life Sciences Inc. jumped this morning after securing the U.S. Food and Drug Administration’s Rare Pediatric Disease Designation. Source: BioSpace
Unum Therapeutics Looks to File IPO, Reveals Patient Deaths in Early Clinical Trial
In its IPO announcement last week Unum revealed early data from its Phase I non-Hodgkin lymphoma therapy that included toxicity concerns at higher dosing levels. Source: BioSpace
Dermira’s Acne Medication Olumacostat Glaseretil Tanks in Two Phase III Trials
Dermira plans to shutter the program and move on to more promising compounds. Source: BioSpace
G1 Therapeutics Unveils Positive Mid-Stage Data for Myelopreservation in SCLC Patients
A mid-stage program aimed at treating myelosuppression in lung cancer patients undergoing chemotherapy is yielding positive results. Source: BioSpace
Korean Drugmaker Draws FDA Warning for Validation, Stability Issues
The FDA served Korean drug manufacturer Nowcos a warning letter after an inspection revealed multiple validation deficiencies and inadequate stability studies. Source: Drug Industry Daily
FDA, DOJ File Complaint Against Arkansas Compounder Following GMP Deviations
Following FDA inspections and a warning letter, the Department of Justice filed a civil complaint against the outsourcing facility Cantrell Drug Company, of Little Rock, Arkansas seeking a preliminary injunction…
Valeant Unit to Pay $58 Million to Settle Allegations of Solodyn Pay-for-Delay Scheme
A Valeant Pharmaceuticals unit agreed to pay $58 million to settle multi-district litigation that accused it of violating antitrust laws to keep generic versions of Solodyn off the market. Source:…
Sessions Tells DEA to Consider Lowering Opioid Production Quotas
Attorney General Jeff Sessions directed the Drug Enforcement Agency to evaluate the possibility of lowering caps on opioid production for drugmakers. Source: Drug Industry Daily
MeiraGTx Earns EMA PRIME Designation for Achromatopsia Gene Therapy Candidate
A new gene therapy to treat a debilitating eye disorder is one step closer to regulatory approval in Europe. Source: BioSpace
- Go to the previous page
- 1
- …
- 152
- 153
- 154
- 155
- 156
- 157
- 158
- …
- 610
- Go to the next page