Category Regulatory

Oragenics, Inc. Readies Phase II Clinical Trials for Concussion Treatment Drug

Oragenics, Inc. (NYSE American: OGEN), a company dedicated to developing innovative intranasal pharmaceuticals for neurological disorders, has revealed its readiness to embark on the final stages of GMP manufacturing and formulation for its drug candidate, ahead of the anticipated Phase…

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PDA India Chapter Annual Meeting: Ensuring Quality & Compliance in Pharma Manufacturing and Regulatory Standards – March 11-15, Hyderabad, India

PQE Group eagerly anticipates participating in the 2024 PDA India Chapter Annual Meeting in Hyderabad from March 11-15, focusing on critical issues in the pharmaceutical and medical device sectors. The conference will delve into topics such as environmental monitoring, aseptic…

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Vivani Medical Announces Pricing of $15.0 Million Registered Direct Offering of Common Stock and Warrants

Vivani Medical, Inc. (Nasdaq: VANI), a pioneering biopharmaceutical company in the preclinical stage, has recently announced a significant move towards advancing its innovative long-term drug implants. In a registered direct offering, the company has entered into a securities purchase agreement…

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Celltrion Reveals New Two-Year Results of Subcutaneous Infliximab (CT-P13 SC) for Treating Inflammatory Bowel Disease (IBD) at 19th ECCO Congress

Celltrion presented encouraging findings from the extensive LIBERTY studies, including LIBERTY-CD 1 and LIBERTY-UC 2, focusing on patients with Alzheimer’s disease, Crohn’s disease (CD), or moderately to severely active ulcerative colitis (UC). Additionally, the company shared endoscopic results from a…

Read MoreCelltrion Reveals New Two-Year Results of Subcutaneous Infliximab (CT-P13 SC) for Treating Inflammatory Bowel Disease (IBD) at 19th ECCO Congress

Ironwood Pharmaceuticals to Showcase Four Abstracts at ASPEN’s 2024 Nutrition Science & Practice Conference

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a company specializing in gastrointestinal healthcare, has revealed plans to present findings from four studies examining apraglutide in adults diagnosed with short bowel syndrome with intestinal failure (SBS-IF), a condition where individuals rely on parenteral…

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Health Canada Grants Approval for Remsima™ SC in Treating Inflammatory Bowel Disease (IBD)

Celltrion Healthcare Canada Limited has announced today that Health Canada has granted approval for Remsima™ SC as maintenance therapy for adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). Remsima™ SC, a subcutaneous form of infliximab,…

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Initiative by WHO to Enhance Global Health Resilience through Biomanufacturing Workforce Training

The COVID-19 pandemic has brought to light the vulnerabilities inherent in global supply chains, especially affecting the access of low- and middle-income countries (LMICs) to crucial medical supplies. The disproportionate concentration of manufacturing capacity in a handful of nations and…

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Sarepta Therapeutics Receives U.S. FDA Acceptance for Efficacy Supplement Enabling Expansion of ELEVIDYS Indication

Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a pioneer in precision genetic medicine for rare diseases, has announced today that the U.S. Food and Drug Administration (FDA) has accepted and filed the Company’s efficacy supplement to the Biologics License Application (BLA) for…

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Positive Results for Mosunetuzumab in Japanese Phase I Study: Meeting Primary Endpoint for Relapsed and Refractory Follicular Lymphoma Expansion Cohort

Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) has revealed that the anti-CD20/CD3 bispecific antibody mosunetuzumab has successfully met the primary endpoint of achieving a complete response rate (CRR) in an expansion cohort within the Japanese Phase I study. This study aimed…

Read MorePositive Results for Mosunetuzumab in Japanese Phase I Study: Meeting Primary Endpoint for Relapsed and Refractory Follicular Lymphoma Expansion Cohort