Category Regulatory

Pfizer Reports Encouraging Overall Survival Results in Phase 3 Study of ADCETRIS® Treatment for Relapsed/Refractory Diffuse Large B-cell Lymphoma

Pfizer Inc. (NYSE: PFE) has disclosed promising findings from a Phase 3 clinical trial investigating the efficacy of the antibody-drug conjugate ADCETRIS® (brentuximab vedotin) in conjunction with lenalidomide and rituximab for treating patients afflicted with relapsed/refractory diffuse large B-cell lymphoma…

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Neurological Conditions Impact Over 1 in 3 Individuals, Ranking as the Primary Cause of Global Illness and Disability

A recent comprehensive study, published in The Lancet Neurology, has revealed staggering figures regarding neurological conditions worldwide. In 2021, over 3 billion individuals were found to be living with such conditions, marking them as the foremost cause of global illness…

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The Chemical Quality Control Laboratory: Guardian of Standards in the Pharmaceutical Plant

The Role of Quality Control at Orion Pharmaceuticals Maija Blomquist, the Quality Control Manager for Materials, Gels & Ointments, underscores the pivotal role of quality control in maintaining Orion’s product standards. Acting as sentinels throughout the production cycle, her team…

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Wegovy® Approved in US to Lower Cardiovascular Risk in Overweight or Obese Individuals with Existing Heart Conditions

Novo Nordisk has announced today that the US Food and Drug Administration (FDA) has granted approval for an expanded label for Wegovy®. This approval, based on a supplemental New Drug Application (sNDA), extends the indication of Wegovy® to include the…

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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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