On October 2, 2020 Zionexa US Corp., a wholly owned subsidiary of Zionexa SAS, specialized in the development and commercialization of in-vivo biomarkers for use in guiding targeted therapies in oncology, reported that the Center for Medicare and Medicaid Services (CMS) has approved transitional pass-through status and reimbursement through a C-code for Cerianna (fluoroestradiol F-18) injection (Press release, Zionexa, OCT 2, 2020, View Source [SID1234567977]).

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Cerianna (fluoroestradiol F-18) injection is a new molecular imaging agent approved by the Food and Drug Administration (FDA) indicated for use in positron emission tomography (PET) imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer (MBC). Cerianna (fluoroestradiol F-18) is the first FDA-approved F-18 PET imaging agent specifically indicated for use in patients with recurrent or metastatic breast cancer. The temporary code, C9060, is effective since October 1, 2020. The permanent code will be expected in January 2021.

"Receiving the pass-through status and the C-code for Cerianna is a very important step in our process to get our new molecule commercialized in the United-States and provide physicians access to a non-invasive and qualitative way to find the optimal treatment for the patient with MBC. MBC is a real health issue with more than 40,000 MBC-related deaths expected in the U.S. in 2019," said Peter Webner, CEO of Zionexa USA. "Our team continues to organize and optimize on our commercial and production strategy and we expect a launch at the end of 2020."

About Metastatic Breast Cancer

Metastatic breast cancer is the most advanced stage of breast cancer. Also called stage IV or advanced breast cancer, MBC means that the cancer has spread beyond the breast to other parts of the body. MBC affects more than 168,000[1] patients in the United-States.

[1] Mariotto et al, 2017

INDICATION

CERIANNA is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.

Limitations of Use
Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).

IMPORTANT SAFETY INFORMATION

Adverse Reactions – Reported adverse reactions include: injection site pain and dysgeusia.

Radiation Risks – Ensure safe drug handling and patient preparation procedures to protect patients and health care providers from unintentional radiation exposure.

Risk of Misdiagnosis – Do not use CERIANNA in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer.

Contraindications – None.

Use in Specific Populations – Lactation: Interrupt breastfeeding.

On October 2, 2020 Shorla Pharma reported that have completed a successful pre-IND meeting with the US Health Authority, the Food and Drug Administration (‘FDA’) on our third oncology drug SH-110 (Press release, Shorla Pharma, OCT 2, 2020, View Source;utm_medium=rss&utm_campaign=sh-110-successful-fda-pre-ind-meeting [SID1234567976]). This proprietary product will have a significant benefit to patients suffering from brain cancer ultimately reducing treatment burden and providing a palatable age appropriate treatment. With this positive outcome we will progress our development programme for this much needed drug.

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On October 2, 2020 PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: PDLI) reported that it has completed the previously announced spin-off of its femtosecond laser system business, LENSAR, Inc. (Nasdaq: LNSR) ("LENSAR") (Press release, PDL BioPharma, OCT 2, 2020, View Source [SID1234567971]).

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PDL stockholders received 0.075879 shares of LENSAR common stock for every one share of PDL common stock outstanding at 5:00 p.m. Eastern Time on September 22, 2020, the record date for the spin-off. Stockholders of PDL who have acquired shares of PDL common stock in the "regular way" market since shortly before the record date and through October 1, 2020 acquired such shares with an entitlement to receive shares of LENSAR common stock in connection with the distribution. Stockholders of PDL who acquired their shares of PDL common stock ex-distribution during that time did so without an entitlement to receive shares of LENSAR common stock in connection with the distribution. LENSAR shares will begin "regular way" trading on the NASDAQ Stock Market on October 2, 2020.

On October 2, 2020 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, neuroscience and biodefense reported that Kineta will be participating in the BIO Investor Forum Digital on October 13-15, 2020 (Press release, Kineta, OCT 2, 2020, View Source;utm_medium=rss&utm_campaign=kineta-to-participate-in-bio-investor-forum-digital [SID1234567970]). Shawn Iadonato, Kineta Chief Executive Officer and Jacques Bouchy, SVP Business Development and Corporate Communications will be meeting with investors and other stakeholders to present an overview of the company with a focus on its novel VISTA immuno-oncology program.

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About BIO Investor Forum Digital
BIO Investor Forum Digital, October 13-15, provides three days of enhanced BIO One-on-One Partnering, interactive educational sessions and Fireside Chats and 160 on-demand company presentations showcasing their drug development programs ready for partnering or venture funding. There is no better virtual event for biotech innovators looking for investors and strategic partners to advance their company to the next stage in their business life cycle. Visit bio.org/investor forum to learn more.

On October 2, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Dr. Roger M. Perlmutter will be retiring as Executive Vice President and President, Merck Research Laboratories (MRL). Dr. Perlmutter will be succeeded by Dr. Dean Y. Li, effective Jan. 1, 2021 (Press release, Merck & Co, OCT 2, 2020, View Source [SID1234567969]). Dr. Perlmutter will remain as a non-executive director, MRL through June 30, 2021 to facilitate a seamless transition.

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"Since rejoining the company seven years ago, Dr. Roger Perlmutter has had a profound impact on Merck and the patients we exist to serve. During his tenure as its President, Merck Research Laboratories have made historic breakthroughs in immuno-oncology and other fields of medicine that have both transformed clinical practice and vastly improved patient outcomes. Roger’s legacy will include a rejuvenated research and development organization, staffed by world class scientists, clinicians and professionals and led by Dr. Dean Li. As a result of Roger’s hands-on and inspirational leadership, MRL is well positioned to bring forward lifesaving medicines and vaccines for many years to come," said Kenneth C. Frazier, chairman and chief executive officer, Merck. "I am enormously grateful for Roger’s decision to return to Merck and for his many meaningful contributions to science, medicine and the health and wellbeing of people around the world."

Since Roger Perlmutter’s appointment as President, Merck Research Laboratories in April 2013, the company has received more than 100 regulatory approvals for its medicines and vaccines globally. This includes more than 15 novel vaccines and therapeutics, including those for multiple cancers, diabetes, and infections caused by Ebola virus, human immunodeficiency virus, hepatitis C virus and cytomegalovirus. Most notably, under Roger’s leadership, Merck has established KEYTRUDA as a foundational immunotherapy for cancer, which continues to transform cancer care throughout the world. Since its first approval, in the U.S., KEYTRUDA has received approval for over 25 indications across 16 tumor types as well as indications for microsatellite instability-high/mismatch repair deficient and tumor mutational burden-high cancers.

"It has been an honor to lead the talented people of Merck Research Laboratories during the last seven years," said Dr. Perlmutter. "I look forward to continuing to work with Dean over the next few months to advance our scientific strategy and continue the strong momentum in our pipeline."

Dean Li is currently Senior Vice President of Discovery Sciences and Translational Medicine, MRL. He joined Merck in 2017 as Vice President and head of Translational Medicine. Prior to joining Merck, Dr. Li held positions of increasing responsibility in translational medical research at the University of Utah. Most recently he served as the H.A. & Edna Benning Professor of Medicine and Cardiology, Chief Scientific Officer, Associate Vice President and Vice Dean at the University of Utah Health System. During his tenure at the University of Utah, he co-founded multiple biotech companies based upon research conducted in his laboratory, including Recursion Pharmaceuticals, Hydra Biosciences and Navigen Pharmaceuticals. Dean received a bachelor’s degree from the University of Chicago and his medical degree, doctorate degree, and training in clinical medicine and cardiology at Washington University School of Medicine in St. Louis. He is a member of the American Society for Clinical Investigation and the Association of American Physicians.

"Since joining us in 2017, Dean has demonstrated strong leadership in building our discovery and translational medicine capabilities, advanced our pipeline and paved the way for Merck Research Laboratories to build on its singular legacy," said Mr. Frazier. "Dean’s strong clinical background and deep scientific and technological expertise make him the right leader to ensure sustained execution of our broad portfolio during this important time."

"Powerful new technologies continue to fuel important progress in enabling the discovery and development of new and better medicines and vaccines," said Dr. Li. "I am very grateful to Roger for his mentorship and the guidance of his leadership team over the past three years and am excited by the opportunity to build upon MRL’s legacy of scientific excellence and innovation."