BASEL- Seqirus, part of CSL Limited, said that the US Food and Drug Administration has approved Flucelvax Quadrivalent or Influenza Vaccine, the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older.FLUCELVAX QUADRIVALENT helps protect against the two influenza A viruses and two B virus
Seqirus announced today that the US Food and Drug Administration has approved FLUCELVAX QUADRIVALENT?, the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older. 1,2 FLUCELVAX QUADRIVALENT helps protect against the two influenza A viruses and two B viruses recommended by the World H
By a News Reporter-Staff News Editor at Pharma Business Week Acer Therapeutics Inc., a pharmaceutical company developing therapies for serious rare diseases with significant unmet medical need, announced the company has closed its Series B round with $8.15 million in new investment. Luc Marengere, Managing Partner of TVM Life Science Capital, joi
AAA has recently submitted a New Drug Application to the US Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency for its lead Neuro Endocrine Tumor therapeutic candidate Lutathera. AAA started commercial operations on this site in 2008. It is in Ivrea that Lutathera was developed from a radiochemic
Aeglea BioTherapeutics, Inc., a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat inborn errors of metabolism and cancer, today announced it received Fast Track Designation from the U.S. Food& Drug Administration for its lead investigational molecule, AEB1102, to treat...
Aeolus Pharmaceuticals, Inc., a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection announced today that it will be presenting at the 6 th annual LD Micro Invitational on Tuesday, June 7th at 9:00AM PDT/ 12 Noon EDT at the Luxe Sunset Boulevard Hotel in Los Angeles. Mr. Cavalier will prov
Akari Therapeutics, an emerging growth, clinical-stage biopharmaceutical company, announced today that the European Medicines Agency Committee for Orphan Medicinal Products has issued a positive opinion recommending orphan drug designation for Coversin for the treatment of Guillain Barr Syndrome. "We are pleased to receive this opinion from CO
Akebia Therapeutics, Inc., a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia inducible factor, today presented positive results from a drug-drug interaction study of vadadustat, the Company s oral therapy for the treatment of anemia related to chronic kidney dise
CENTENNIAL, Colo., May 23, 2016/ PRNewswire-USNewswire/ AlloSource , one of the nation's largest providers of cartilage, cellular, bone, skin and soft-tissue allografts for use in surgical procedures and wound care to advance patient healing, today announced the distribution of investigational bioengineered blood vessels for Humacyte's Phase II
By a News Reporter-Staff News Editor at Pharma Business Week Anacor Pharmaceuticals, Inc. announced its financial results for the quarter ended March 31, 2016. In January 2016, we submitted our NDA for crisaborole topical ointment, 2%, to the FDA ahead of schedule. The FDA has accepted the crisaborole NDA for review with a PDUFA goal date of Janu
ANI Pharmaceuticals, Inc. today announced the appointment of Mark Ginski Ph.D as Vice President Corticotropin Product Development, effective May 23, 2016. Mark has held various positions in specialty drug development with Shire Pharmaceuticals, Alba Therapeutics, Cerecor Inc, Questcor Pharmaceuticals and most recently, Mallinckrodt Pharmaceutical
May 23, 2016 DMG Productions announced today the upcoming airing of Innovations with Ed Begley, Jr., scheduled to broadcast on Saturday, May 28, 2016 at 4:00 pET via Fox Business. "These advancements are changing the way we live," said Michele Nehls, Producer for the series. About Innovations& DMG Productions: Innovations, hosted by award winnin
Medivation, Inc. today announced that the talazoparib-containing arm of the I-SPY 2 TRIAL has been activated. "We are delighted that the combination of talazoparib and irinotecan was chosen to be evaluated in this innovative trial design seeking to replace components of standard chemotherapy with more targeted, potentially less toxic agents," said
By a News Reporter-Staff News Editor at Clinical Trials Week Aurinia Pharmaceuticals Inc. announced that after constructive interactions with the Japanese Pharmaceuticals and Medical Devices Agency, the Company will initiate a study of voclosporin in healthy Japanese volunteers. "Japan represents a substantial market opportunity for the Company"
The first quarter of 2016 was highlighted by the completion of patient enrollment in our Phase 2 b clinical trial and obtaining fast track designation from the FDA for voclosporin. In addition to these clinical and regulatory successes, the Company received promising data from the open-label AURION study that further supports our hypothesis on the.
Avid Bioservices, Inc., a wholly owned subsidiary of Peregrine Pharmaceuticals, Inc., today announced the appointment of Pete Gagnon as the company's vice president of process sciences. Prior to joining Avid, Mr. Gagnon spent 25 years as the founder and president of Validated Biosystems, an international consultancy specializing in hands-on develop
By a News Reporter-Staff News Editor at Clinical Trials Week Azevan Pharmaceuticals, Inc., which is developing novel small molecule medicines for disorders of stress, mood, and behavior, announced that enrollment has been completed in a Phase 2 clinical study of the company's lead compound SRX246 in adults with DSM -5 Intermittent Explosive Disor
*Vaccine significantly boosted antibodies and T cells against RSV in the majority of elderly subjects* Vaccine induced a broad immune responses against all RSV subtypes* Conference call and webcast today at 8:30 am EDT COPENHAGEN, Denmark, May 23, 2016- Bavarian Nordic A/S today announced positive top line results from its first-in-man Phase 1 tria
Biocept, Inc., a leading molecular diagnostics company with liquid biopsy technology for cancer profiling and monitoring, announces that it has entered into a master services agreement with a biopharmaceutical company to develop targeted liquid biopsy tests for multiple tumor types and molecular targets. The agreement includes utilizing Biocept's
Biocept, Inc. a leading molecular diagnostics company with liquid biopsy technology for cancer profiling and monitoring, announces that it has entered into a master services agreement with a biopharmaceutical company to develop targeted liquid biopsy tests for multiple tumor types and molecular targets. The agreement includes utilizing Biocept's...
Bracket, a leading clinical trial technology company and specialty services provider, has released a new suite of mobile applications to support pharmaceutical and biotechnology companies running clinical trials. Bracket Patient Diary TM, Bracket RTSM TM, and Bracket Analytics TM are now available for download from iTunes and Google Play.
By a News Reporter-Staff News Editor at Clinical Trials Week CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announces that China's Food and Drug Administration has approved the Company's application to conduct a Phase 2 clinical trial in fibrolamellar..
By a News Reporter-Staff News Editor at Clinical Trials Week Celator Pharmaceuticals, Inc. reported business highlights and financial results for the first quarter ended March 31, 2016. "Our Phase 3 trial of VYXEOS? demonstrated a statistically significant improvement in overall survival, among other benefits, in patients with high-risk acute
Most notably, there are FDA approvals for three vaccines, although two, Gardasil and Cervarix, are preemptive in nature, fighting human papillomavirus that often leads to cancer. Dendreon garnered FDA approval of Provenge in 2010 for metastatic castrate resistant prostate cancer patients who demonstrate minimal or no symptoms. In February 2015, Val
ChemoCentryx, Inc.,, a clinical-stage biopharmaceutical company developing orally-administered therapeutics to treat autoimmune diseases, inflammatory disorders, and cancer, today announced the presentation of positive results from its Phase II CLEAR trial with CCX168 in patients with anti-neutrophil cytoplasmic antibody- associated vasculitis,..