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CMO Selkirk blueprints $90M factory to help bring injectable drug manufacturing stateside
Even as the pandemic winds down in the U.S., the push to bring drug manufacturing stateside persists. Privately held contract manufacturer Selkirk Pharma is teeing up a flagship facility in Washington state to do just that
Engineering | 10/06/2021 | By Darshana | 260
Zydus Cadila receives US FDA approval for fluphenazine HCl tablets
Zydus Cadila has received final approval from US FDA to market fluphenazine hydrochloride tablets in the strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg (Prolixin tablets). This medication is used to treat symptoms of a certain type of mental/mood condition (schizophrenia)
Engineering | 31/05/2021 | By Darshana | 200
Bharat Biotech signs MoU with GCVC for drug substance for Covaxin
Bharat Biotech International Limited has signed an MoU with Gujarat Covid Vaccine Consortium (GCVC) towards contract manufacturing for the drug substance for Covaxin
Engineering | 28/05/2021 | By Darshana | 179
Moderna announced that the phase 2/3 study of its Covid-19 vaccine (mRNA-1273) in adolescents has met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. In the study, no cases of Covid-19 were observed in participants
Engineering | 27/05/2021 | By Darshana | 182
Zydus Cadila launches Ujvira for breast cancer treatment
Zydus Cadila, a global innovation driven healthcare company, launched trastuzumab emtansine, the first antibody drug conjugate (ADC) biosimilar and a highly effective drug for treating both early and advanced HER2 positive breast cancer, under the brand name 'Ujvira'. HER2 positive breast cancer is considered an aggressive form and constitutes 20 to 25%
Engineering | 25/05/2021 | By Darshana | 584
Ambu to launch US FDA approved sterile, single-use duodenoscope, aScope Duodeno
The Ambu, a company develop, produce and market diagnostic and life-supporting devices for hospitals and rescue services, announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for aScope Duodeno on 17 July 2020 and is now ready for commercial launch as planned
Engineering | 20/07/2020 | By Darshana | 581
Wipro 3D collaborates with SCTIMST launches emergency breathing assist system, AirBridge
Wipro 3D, a business of Wipro Infrastructure Engineering, in technical collaboration with Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thrivuvananthapuram, has launched AirBridge, the Wipro Chitra Emergency Breathing Assist System (EBAS)
Engineering | 08/07/2020 | By Darshana | 409
FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer
Today, the U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer
Engineering | 01/07/2020 | By Darshana | 394
FDA Approves New Therapy for Dravet Syndrome
The U.S. Food and Drug Administration today approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older. Dravet syndrome is a life-threatening, rare and chronic form of epilepsy. It is often characterized by severe and unrelenting seizures
Engineering | 29/06/2020 | By Darshana | 436
today announced the CE-IVD launch of its automated digital pathology algorithm, the uPath PD-L1 (SP263) image analysis for non-small cell lung cancer (NSCLC). The algorithm provides pathologists with automated assessments of scanned slide images that are objective and reproducible and have the potential to aid diagnosis
Engineering | 26/06/2020 | By Darshana | 324
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