Pharmaceuticals

Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance
Pharmaceuticals

Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance

MORGANTOWN, W.Va., Oct. 25, 2019 /PRNewswire/ -- Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot (see table below) of Alprazolam Tablets, USP C-IV 0.5 mg, to the consumer/user level. This lot is being recalled due to the potential presence of foreign substance. Clinical impact from the foreign material, if present, is expected to be rare, but the remote risk...

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Pharmaceuticals

Lilly Presents Positive Results for Taltz® (ixekizumab) in Pediatric Patients with Moderate to Severe Plaque Psoriasis at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress

Taltz is the first and only IL-17A inhibitor with published clinical trial results in pediatric patients with moderate to severe plaque psoriasis Indianapolis, Oct. 12, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that Taltz met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque...

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Pharmaceuticals

Southern California Biotech Company Sets New Quality Paradigm in Bio-available Innovation

Global biotech solutions company, Herbalmax Inc., announces the release of its redesigned product range for the home health nutraceutical market Irvine, Calif., April 26, 2019 /PRNewswire/ -- Herbalmax Inc. is pleased to announce the upcoming release of its refortified line of bio-available nutraceuticals led by its leading NMN (nicotinamide mononucleotide) product, Reinvigorator. In addition...

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Spero Therapeutics Announces FDA Acceptance of IND Application for SPR994
Pharmaceuticals

Spero Therapeutics Announces FDA Acceptance of IND Application for SPR994

Cambridge, Mass., Feb. 04, 2019 (Globe Newswire) -- Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections, today announced the acceptance by the U.S. Food and Drug Administration (FDA) of its Investigational...

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AbbVie Presents New Data from Phase 3 MURANO Trial of VENCLEXTA®/VENCLYXTO® (Venetoclax) in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia Who Completed the Fixed Treatment Course
Pharmaceuticals

AbbVie Presents New Data from Phase 3 MURANO Trial of VENCLEXTA®/VENCLYXTO® (Venetoclax) in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia Who Completed the Fixed Treatment Course

- The data demonstrated that VENCLEXTA®/VENCLYXTO® in combination with rituximab (VenR) reduced the risk of disease progression or death compared to a standard of care, bendamustine plus rituximab (BR), after a median three-year follow-up[1] - Of the 130 patients who completed rituximab plus the 24-month fixed duration of venetoclax and remained off therapy for a median of 9.9 months, the...

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Aravive Presents Detailed Results of Phase 1 Clinical Trial of AVB-S6-500 at the 2018 EORTC-NCI-AACR Symposium
Pharmaceuticals

Aravive Presents Detailed Results of Phase 1 Clinical Trial of AVB-S6-500 at the 2018 EORTC-NCI-AACR Symposium

HOUSTON, Nov. 13, 2018 (GLOBE NEWSWIRE) -- Aravive, Inc. (Nasdaq: ARAV), a clinical-stage biopharmaceutical company, today announced detailed results of its first-in-human Phase 1 clinical trial of AVB-S6-500 in healthy volunteers. As previously announced, the trial met the safety and tolerability endpoints for the trial and demonstrated clinical proof-of-mechanism for AVB-S6-500 in neutralizing...

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Pharmaceuticals

AbbVie Receives Health Canada Approval of ORILISSA™ (elagolix) for the Treatment of Moderate to Severe Pain Associated with Endometriosis

Endometriosis affects up to one in 10 women of reproductive age in Canada. 7 out of 10 women being managed for endometriosis have unresolved pain throughout the month. The approval of ORILISSA is supported by data from two replicate Phase 3 studies, which evaluated nearly 1,700 women. In clinical trials, ORILISSA™demonstrated sustained relief over 12 months across the two most common types...

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Pharmaceuticals

Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA

NKTR-181 is a First-in-Class Investigational Opioid to Treat Chronic Low Back Pain in Adult Patients New to Opioid Therapy SAN FRANCISCO, July 30, 2018 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that the U.S. Food and Drug Administration (FDA) has filed and accepted for review the company's New Drug Application (NDA) for NKTR-181 for the treatment of chronic low...

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