Month: September 2023

Clinical Trials, Pharmaceuticals

Amivantamab-lazertinib Combo Shows Promise in Lung Cancer Treatment: Study

The Janssen Pharmaceutical Companies of Johnson and Johnson have released encouraging topline results from a study involving amivantamab-vmjw (trade name Rybrevant) used in combination with lazertinib for the treatment of non-small cell lung cancer (NSCLC). The study demonstrated a statistically significant and clinically meaningful improvement in progression-free survival when administered as a first-line treatment for patients with locally advanced or metastatic NSCLC characterized by epidermal growth factor receptor (EGFR) mutations. Continue reading Amivantamab-lazertinib Combo Shows Promise in Lung Cancer Treatment: Study

Ann Poorboy
Pharmaceuticals

Eli Lilly Resolves Whistleblower Lawsuit Amid Manufacturing Concern

In a recent development, pharmaceutical giant Eli Lilly and a former employee, Amrit Mula, have reached a settlement in a lawsuit stemming from Mula’s claims of manufacturing irregularities and data falsification related to the company’s blockbuster diabetes drug, Trulicity. The case had gained attention due to Mula’s allegations that she was wrongfully terminated after flagging these issues within the organization. Continue reading Eli Lilly Resolves Whistleblower Lawsuit Amid Manufacturing Concern

Ann Poorboy
Research

Madrigal Pharmaceuticals Sets Sights on $500 Million in Public Offering to Propel NASH Therapy

Published September 30, 2023 Madrigal Pharmaceuticals, headquartered in Pennsylvania, has revealed its ambition to raise approximately $500 million in gross proceeds through a forthcoming public offering. These funds are earmarked to bolster the company’s clinical and commercial endeavors as it progresses towards the potential launch of its nonalcoholic steatohepatitis (NASH) therapy, resmetirom. Scheduled to conclude on October 3, 2023, this strategic offering will be facilitated … Continue reading Madrigal Pharmaceuticals Sets Sights on $500 Million in Public Offering to Propel NASH Therapy

Ann Poorboy
Diagnostics, FDA, Medical Device

FDA Proposes Stricter Regulations for In Vitro Diagnostics: A Paradigm Shift in Medical Testing Oversight

Published September 30, 2023 In a move that could reshape the landscape of medical diagnostics, the FDA has unveiled a proposed rule that explicitly designates in vitro diagnostics (IVDs) as medical devices under the Federal Food, Drug, and Cosmetic Act. This designation applies even when the manufacturer of the IVD is a laboratory, marking a significant departure from decades of more lenient regulation. The FDA’s … Continue reading FDA Proposes Stricter Regulations for In Vitro Diagnostics: A Paradigm Shift in Medical Testing Oversight

Ann Poorboy
Rare Diseases, Research

A Breakthrough in Treating Complex Neurological Disorders: The Promise of Granulocyte Colony-Stimulating Factor (G-CSF)

As we delve deeper into the intricate mechanisms of the immune system and neurological disorders, cases like this provide a glimmer of hope for patients facing daunting medical challenges. The potential of G-CSF as an immunomodulatory therapy offers new possibilities for those living with complex conditions that were once considered difficult to treat. Continue reading A Breakthrough in Treating Complex Neurological Disorders: The Promise of Granulocyte Colony-Stimulating Factor (G-CSF)

Ann Poorboy
Rare Diseases, Research

Breakthrough Study Shows Promising Alternative for Sickle Cell Disease Treatment

Study offers a ray of hope for SCD patients, highlighting the potential for alternative treatment options in the absence of a matched donor. The remarkable success of the reduced toxicity protocols employed in this study may pave the way for improved transplant strategies, ultimately enhancing the quality of life for those suffering from this debilitating disease. Continue reading Breakthrough Study Shows Promising Alternative for Sickle Cell Disease Treatment

Ann Poorboy
Pharmaceuticals

FDA Clears Amicus Therapeutics’ Pompe Disease Treatment

Amicus Therapeutics has received official FDA approval for its groundbreaking treatment, Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat), aimed at providing hope and relief to adults suffering from late-onset Pompe disease (LOPD). This approval is especially significant for patients who have not experienced improvement with their current enzyme replacement therapy (ERT). Continue reading FDA Clears Amicus Therapeutics’ Pompe Disease Treatment

Ann Poorboy
Pharmaceuticals

Bluebird Bio Enhances Manufacturing Capacity for Gene Therapies Zynteglo and Skysona in Collaboration with Lonza

Published September 29, 2023 Bluebird Bio is gearing up to boost its manufacturing capacity in partnership with Swiss contract development and manufacturing organization (CDMO) Lonza as its gene therapies, Zynteglo and Skysona, continue to gain momentum. The collaboration between Bluebird Bio and Lonza, initially forged in June 2016, has recently been amended for the second time since its inception. As part of this updated agreement, … Continue reading Bluebird Bio Enhances Manufacturing Capacity for Gene Therapies Zynteglo and Skysona in Collaboration with Lonza

Ann Poorboy
Clinical Trials, Investors

Vaccinex Marks Success with $9.6 Million Public Offering and Reveals Phase 1b/2 Pepinemab Study Update

Published September 29, 2023 Vaccinex, Inc. (Nasdaq: VCNX), a pioneering clinical-stage biotechnology company specializing in innovative approaches to treating neurodegenerative diseases and cancer, has unveiled its recent milestone. On September 28, 2023, the company announced the successful pricing of a public offering of 9,600,000 shares of its common stock (or common stock equivalents) and accompanying warrants. This achievement is part of Vaccinex’s ongoing efforts to … Continue reading Vaccinex Marks Success with $9.6 Million Public Offering and Reveals Phase 1b/2 Pepinemab Study Update

Ann Poorboy
Pharmaceuticals

FDA Approves Bosutinib (Bosulif) for Pediatric Patients with Chronic Myelogenous Leukemia

This FDA approval signifies a significant advancement in the treatment of pediatric patients with CP Ph-positive CML, offering them new hope and improved treatment options. For patients who may have difficulty swallowing capsules, the contents of the capsules can be mixed with applesauce or yogurt, providing a more accessible means of administration. Continue reading FDA Approves Bosutinib (Bosulif) for Pediatric Patients with Chronic Myelogenous Leukemia

Ann Poorboy