The latest news from the global pharmaceutical industry. Below you will find news and information to keep you up-to-date with what is happening in your industry. Coverage includes regulatory approvals, recall announcements, mergers and acquisitions, personnel news and appointments, new facility and facility expansion updates, collaborations and agreements, and financial updates.
Friday, December 15, 2017
Amgen and LabCentral announced that Kernal Biologics and QurAlis have won the Amgen Golden Ticket at LabCentral.
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Thursday, December 14, 2017
Trovagene announced the filing of its protocol for trial of PCM-075 in combination with abiraterone acetate for mCRPC has been submitted to the FDA.
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Thursday, December 14, 2017
BioSight reports positive final results in a Phase I/II multi-center, open label, dose-escalating study of its lead product BST-236.
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Tuesday, December 12, 2017
The FDA approved Admelog, a short-acting insulin indicated to improve control in blood sugar levels.
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Tuesday, December 12, 2017
Amneal Biosciences received approval for its Triamcinolone Acetonide Injectable Suspension, USP in 40 mg/mL dosage strength.
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Friday, December 08, 2017
Impax Laboratories has received tentative FDA approval on its ANDA for a generic version of Coreg CR extended-release capsules.
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Friday, December 08, 2017
Sirnaomics announced the FDA has granted Orphan-drug designation to STP705 for the treatment of Cholangiocarcinoma.
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Thursday, December 07, 2017
Aptinyx announced Fast Track designation and initiation of Phase 1 development for its candidate to modulate NMDA receptors, NYX-783, in PTSD.
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Wednesday, December 06, 2017
DNAtrix announced the intratumoral delivery of DNX-2401 to the first pediatric patient in a Phase 1 study for diffuse intrinsic pontine glioma.
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Wednesday, December 06, 2017
IM Therapeutics announced the issuance patents for MDOPA and other small molecular entities in immunotherapy for type 1 diabetes and D-MDOPA for T1D ...
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Tuesday, December 05, 2017
AbbVie announced the Phase 3 trial evaluating IMBRUVICA and rituximab in patients with treatment-naïve and previously-treated WM met its primary ...
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Monday, December 04, 2017
Mylan and Aspen announced the U.S. launch of Myleran Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial, a generic version of Busulfex Injection.
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Monday, December 04, 2017
The FDA approved Ogivri as a biosimilar to Herceptin for the treatment of patients with breast or metastatic stomach cancer whose tumors overexpress ...
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Monday, December 04, 2017
Bayer and Loxo Oncology announced updated clinical data from the larotrectinib (LOXO-101) pediatric Phase I SCOUT trial (NCT02637687).
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Friday, December 01, 2017
FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for moderate-to-severe opioid use disorder.
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