On October 2, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has received notification from the U.S. Food and Drug Administration (FDA) that the company’s submitted Investigational New Drug application (IND) has been placed on hold. The notification gave no details as to the reason(s) for the FDA’s decision (Press release, PharmaCyte Biotech, OCT 2, 2020, View Source [SID1234567981]).

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The FDA will issue an official hold letter within the next 30 days with written details identifying the reason(s) that FDA examiners issued the hold. Once PharmaCyte has the official letter it can address all of the identified reasons for the hold. Then, PharmaCyte will file a response to the official letter from the FDA. The FDA will have another 30 days to review the material submitted by PharmaCyte and decide whether to lift the hold.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "The decision by the FDA to place our IND application on hold was a deep disappointment to all of us at PharmaCyte; however, we are grateful that the FDA didn’t reject our IND application and we will have an opportunity to address their concerns. I know our many colleagues, who have worked so hard over the years to try to get our treatment ready for clinical use in patients with locally advanced inoperable pancreatic cancer in the hope that we can fulfill an unmet clinical need for such patients, are also disappointed, but we all welcome the opportunity to continue to engage with the FDA to further our treatment.

"The disappoint also applies equally to our loyal and patient shareholders. We do not plan to give up in getting the hold lifted – we will do everything within our power to do so."

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.