Matinas BioPharma Holdings, Inc., a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective therapeutics for the treatment of serious and life-threatening infections, announced that on December 31, 2015, the Company filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its lead antibacterial development candidate, MAT2501.
Vericel Corporation, a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, announced that it has submitted a
Torn notebook recording deficiencies, lack of batch manufacturing records, use of unofficial notebooks, lack of audit trails on operation of computer systems, product mix-ups due to manufacturing deficiencies are some of the violations found by USFDA at Cadila Healthcare Ltd's two plants.
BioQ Pharma and Cipla the signed of a strategic distribution, supply and development agreement for the registration and commercialization of BioQ Pharma's Ropivacaine infusion pharmaceutical in India.
BioQ Pharma Incorporated, a specialty pharmaceutical company focused on the development and commercialization of single-use, large-volume ready-to-use infusible pharmaceuticals, and Cipla Limited, “Cipla,” a global pharmaceutical company that uses cutting edge technology and innovation to meet the everyday needs of all patients, announced the signing of a strategic distribution, supply and development agreement for the registration and commercialization of BioQ Pharma's Ropivacaine infusion pharmaceutical in India.
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF)
Pharma Major Lupin Limited (Lupin) announced that its US subsidiary Lupin Pharmaceutical Inc. has launched its Tri-Lo-Marzia™ Tablets (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg) having received approval from the United States Food and Drug Administration (FDA) to market a generic equivalent of Janssen Pharmaceuticals Inc. (Janssen) Ortho Tri-Cyclen® Lo Tablets, (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg).
Novartis announced today a collaboration with Qualcomm Incorporated through its subsidiary, Qualcomm Life, Inc., in digital innovation with the Breezhaler(TM) inhaler device to treat COPD. Under this collaboration, Qualcomm Life will provide the technology solution for the connectivity of the next generation of the Breezhaler(TM) inhaler, a device used for Novartis' portfolio of COPD treatments of Onbrez(TM) Breezhaler Seebri(TM) Breezhaler, and Ultibro(TM) Breezhaler, the leading LABA/LAMA treatment.
Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, and Symphogen, a private biopharmaceutical company developing recombinant antibodies and antibody mixtures, announced a broad strategic immuno-oncology collaboration.
The U.S. Food and Drug Administration issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
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