BioBiz: Amgen Inc received approval from The U.S. Food and Drug Administration for Lumakras

0
190

Amgen Inc received approval from the U.S. Food and Drug Administration for its cancer drug, Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy. This is the first approved targeted therapy for tumors with any KRAS mutation, which accounts for approximately 25% of mutations in non-small cell lung cancers. KRAS G12C mutations represent about 13% of mutations in non-small cell lung cancers.

“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “The approval represents a significant step towards a future where more patients will have a personalized treatment approach.”

Lung cancer, the most common cancer type with the highest mortality, can largely be categorized by the genetic mutations that cause it. KRAS is a type of mutation in a group of genes that help regulate cell growth and division.

Bayer today announced that it has entered into an agreement to acquire Noria Therapeutics Inc. (Noria) and PSMA Therapeutics Inc. Through this acquisition, Bayer will obtain exclusive rights to a differentiated alpha radionuclide investigational compound based on actinium-225 and a small molecule directed towards prostate-specific membrane antigen (PSMA). The acquisition broadens Bayer’s existing oncology portfolio of targeted alpha therapies (TATs), which currently includes Xofigo® (radium Ra 223 dichloride), which is approved for metastatic castration resistant prostate cancer (mCRPC) with symptomatic bone metastases and no known visceral metastases, and the proprietary platform of investigational TATs based on thorium-227.

The companies acquired by Bayer, Noria and PSMA Therapeutics, have exclusive world-wide rights to technology licensed from Weill Cornell Medicine (New York, NY, USA) and Johns Hopkins University (Baltimore, MD, USA). Noria was founded by Dr. John Babich, Chief, Radiopharmaceutical Sciences in Radiology at Weill Cornell Medicine.

“Weill Cornell Medicine is committed to bringing our faculty’s innovations to market so that patients can benefit from the latest therapeutics,” said Dr. Lisa Placanica, Senior Managing Director Center for Technology Licensing at Weill Cornell Medicine. “Bayer’s acquisition of Noria and PSMA Therapeutics which have nurtured Dr. Babich’s radiopharmaceutical and diagnostic technology, is an important milestone in drug development, and we look forward to the advances this collaboration can make to enhance prostate cancer therapies.”

LPS Industries a vertically integrated flexible packaging manufacturer, announced the certification of its new Class 100,000 cleanroom.

Madeleine D. Robinson, CEO of LPS Industries, stated, “We’re excited to announce our brand-new Class 100,000 certified cleanroom facility, providing unprinted and custom printed flexible packaging roll stock for the food and medical markets. These customers must meet highly exacting standards, and this cleanroom ensures that we can help them achieve the quality required.”

The advanced state-of-the-art equipment technology gives greater control of the production environment.  The cleanroom has a high exchange HEPA air filtration for superior dust and contamination control as well as HVAC equipment and controllers to ensure consistent temperature and humidity.

Aqualung Therapeutic’s CEO, Joe G.N. Garcia was named invited speaker in the first annual Acute Respiratory Distress Syndrome (ARDS) Drug Development Summit from July 13th-15th. This virtual summit includes several of the world’s top experts on ARDS as faculty presenters including Aqualung’s CEO Joe GN Garcia MD, former Chief of Pulmonary and Critical Medicine at Johns Hopkins University.

The coronavirus pandemic has catapulted ARDS into the limelight and offered a once in a lifetime opportunity to meaningfully study large patient populations with a homogenous disease – revolutionizing the notoriously challenging drug development landscape and widening the window of therapeutic opportunity to treat ARDS for the first time ever.