On September 23, 2020 BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, reported that it has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the use of the ThinPrep Pap Test PreservCyt Solution vial as an approved sample type for its BD Onclarity HPV Assay (Press release, BD Pharmaceutical Systems, SEP 23, 2020, View Source [SID1234565541]).

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The BD Onclarity Assay PMA supplement was submitted to the FDA to expand sample claims and platform usage. Pictured BD Onclarity HPV Assay reagent plates.
The BD Onclarity Assay PMA supplement was submitted to the FDA to expand sample claims and platform usage. Pictured BD Onclarity HPV Assay reagent plates.
The PMA supplement would expand the sample claims that can be used in addition to the BD SurePath vial for the detection of human papillomavirus (HPV) using the BD Onclarity HPV Assay. The submission includes performance data for the BD Viper LT and the BD COR Systems. An additional supplement was submitted in January 2020 to seek approval for the BD Onclarity HPV assay on the BD COR System and the BD SurePath Liquid Based Cytology vial.

BD recently announced the FDA approval of a PMA supplement that included the expansion for genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66 making the BD Onclarity HPV Assay the only FDA-approved assay to individually identify and report these genotype results.

"This PMA supplement to the FDA signifies BD’s commitment to expanding the availability of the BD Onclarity HPV Assay in the U.S. to support better patient management by providing clinicians more data to inform treatment decisions across multiple collection devices," said Dave Hickey, president of Integrated Diagnostic Solutions for BD. "BD is dedicated to providing comprehensive screening solutions that are accessible globally in the fight to eliminate cervical cancer."

About BD Onclarity HPV Assay
The BD Onclarity HPV Assay detects and identifies 14 high-risk human papillomavirus (HPV) types in a single analysis and provides genotyping information from specimens collected for cervical cancer screening purposes in the BD SurePath Collection Vial and in the Hologic PreservCyt Solution (not approved in the United States). The assay is for use in accordance with clinical guidelines and within the scope of local regulatory authorizations as part of a comprehensive approach to cervical cancer screening. The BD Onclarity HPV Assay has FDA approval for clinical use in cytology-based screening with ASC-US triage, in co-testing paradigm, and in primary HPV screening. BD Onclarity HPV Assay has FDA approval for use in vaccinated women. As the previously vaccinated subpopulation ages, the screening population will progressively include women with reduced prevalence of HPV 16 and 18, increasing the value of extended genotype reporting in a mixed population of vaccinated and unvaccinated women.7

On September 23, 2020 Patient group ALK Positive and LUNGevity Foundation reported the three 2020 recipients of the ALK-positive Lung Cancer Research Awards (Press release, LUNGevity Foundation, SEP 23, 2020, View Source [SID1234565540]). This award, driven by ALK Positive—a group that has grown to 2,000+ ALK-positive lung cancer patients and their caregivers in 50+ countries—supports high-impact research that seeks to quickly improve outcomes for the approximately 5% of non-small cell lung cancer patients who have tested positive for a mutation in the anaplastic lymphoma kinase (ALK) gene and that has the potential to transform ALK-positive lung cancer from an inevitably fatal condition into a chronic, or even curable, condition.

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The 2020 ALK-Positive Lung Cancer Research Award Program represents the second collaboration between LUNGevity Foundation, the premier private funder of lung cancer research in the U.S., and ALK Positive. The two organizations are working together to change outcomes for people diagnosed with ALK-positive lung cancer. ALK Positive is the foremost group of ALK-positive patients and is directly influencing the direction of research that will, one day, save their lives. These awards total $1,600,000 with monies raised by ALK Positive.

The three awards selected are:

Phase 1 first-in-human clinical trial with a therapeutic ALK vaccine in patients with ALK+ NSCLC: Mark Awad, MD, PhD, Dana-Farber Cancer Institute
Overcoming bypass signaling to enhance clinical responses in ALK-positive lung cancer: Ibiayi Dagogo-Jack, MD, Massachusetts General Hospital
Overcoming ALK resistance with covalent cysteine-reactive inhibitors: A. John Iafrate, MD, PhD, Massachusetts General Hospital
Two of the selected projects are clinical trials. The first is to test a therapeutic ALK vaccine and builds on Dr. Mark Awad’s 2018 grant aimed at understanding the antibody response against the ALK protein and to determine which parts of the ALK protein trigger an immune response. If successful, this would be the first vaccine for ALK-positive patients. The second clinical trial is to determine how to improve clinical response in ALK-positive patients by using combination therapies to combat acquired resistance to ALK tyrosine kinase inhibitors. The third translational research project is to determine a way to overcome resistance to ALK medications using a novel approach that targets the ALK protein for degradation.

"We are thrilled to be driving the grant selection and award process, and to fund such cutting-edge research that we hope will lead to new treatment options that can help fulfill the mission of ALK Positive to improve the life expectancy and quality of life of patients with ALK-positive cancer worldwide. These three projects, including the first-ever lung cancer clinical trials funded by a patient-driven organization, represent the direction in which we want to go. Our ALK Positive ‘family’ raised the $1.6M to fund this research that will impact the lives of patients worldwide," explains Colin Barton, Chair of the ALK Positive Medical Committee. "LUNGevity has an exceptional reputation and is a major private funder of lung cancer research in the U.S. We are excited to partner with them on these important projects."

"LUNGevity is proud to be partnering with ALK Positive to identify and drive research projects that have the potential to quickly improve outcomes for ALK-positive patients," says Upal Basu Roy, Vice President of Research at LUNGevity Foundation. "We’re excited that these projects combine the patient voice with the scientific rigor demanded of such critical research, and we are hopeful that they will lead to saved lives."

On September 23, 2020 Centene Corporation (NYSE: CNC) ("Centene" or the "Company") reported that it has commenced an underwritten public offering to sell $2,200,000,000 of senior notes due 2030 (the "Notes"), subject to market and other conditions (Press release, Centene , SEP 23, 2020, View Source [SID1234565539]).

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Centene intends to use the net proceeds from the offering of the Notes, together with cash on hand, to redeem of all of its outstanding 4.75% Senior Notes due 2022 (the "2022 Notes Redemption"), all of its outstanding 5.25% Senior Notes due 2025 and all of WellCare Health Plans, Inc.’s, a Delaware corporation and a wholly-owned subsidiary of the Company, outstanding 5.25% Senior Notes due 2025 (together, the "2025 Notes Redemptions"), including all premiums, accrued interest and costs and expenses related to the 2022 Notes Redemption and the 2025 Notes Redemptions. Pending the application of the net proceeds of the offering for the foregoing purposes, net proceeds may be temporarily used for general corporate purposes. The foregoing does not constitute a notice of redemption or an obligation to issue a notice of redemption for the outstanding notes of any series.

BofA Securities, Barclays, J.P. Morgan, Truist Securities and Wells Fargo Securities are acting as joint book-running managers for the offering of the Notes.

This offering is being made pursuant to an effective shelf registration statement and prospectus and a related preliminary prospectus supplement filed by the Company with the Securities and Exchange Commission (the "SEC"). Before you invest, you should read the prospectus and the related preliminary prospectus supplement, the registration statement and other documents that Centene has filed with the SEC for more complete information about Centene and this offering.

Copies of the prospectus supplement and related prospectuses for this offering can be obtained from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department or by email at [email protected]; from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected], or by calling (888) 603-5847; from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by calling +1 (866) 803-9204; from Truist Securities by email at [email protected]; and from Wells Fargo Securities, LLC, 550 S. Tryon Street, 5th Floor, Charlotte, North Carolina 28202, Attention: Leveraged Syndicate.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities described herein in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On September 23, 2020 The National Comprehensive Cancer Network (NCCN) reported the publication of the organization’s first patient and caregiver resource focused on a childhood cancer type (Press release, NCCN, SEP 23, 2020, View Source [SID1234565538]). The brand new NCCN Guidelines for Patients: Pediatric Acute Lymphoblastic Leukemia (ALL) shares the latest expert advice for treating infants, children, and adolescents with the most common pediatric malignancy. This guidance is intended to enable patients, their parents or guardians, and other caregivers to advocate for the best evidence-based care available. This new source of information is available for free at NCCN.org/patients thanks to support from the NCCN Foundation. The book is endorsed by Alex’s Lemonade Stand Foundation, National Marrow Donor Program (NMDP)/Be The Match, CancerFree Kids, The Pediatric Cancer Foundation of the Lehigh Valley, and The Leukemia & Lymphoma Society (LLS).

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NCCN Guidelines for Patients: Pediatric Acute Lymphoblastic Leukemia
"My heart aches for every child, parent, and guardian who experiences an earth-shattering event like a cancer diagnosis," said Patrick Brown, MD, Associate Professor of Oncology and Pediatrics, Director, Pediatric Leukemia Program, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Chair, NCCN Guidelines Panels for Adult and Pediatric ALL. "Thankfully, advances in treating pediatric ALL represent one of the most profound successes in medical history. Nearly 90% of the kids who are diagnosed with this type of leukemia can be cured with inexpensive and widely-available therapies, as explained in these guidelines. Our aim in sharing this information is to prepare people for what they’re facing while also giving them reason to feel hopeful."

NCCN Guidelines for Patients are directly based on the clinical practice versions that inform doctors all over the world of the best way to manage cancer patients. NCCN Guidelines are considered the gold standard for clinical direction and policy in cancer management and are the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. The evidence-based recommendations are formulated by top experts from across the 30 leading cancer centers that are part of NCCN.

The patient guidelines contain the same treatment information, but are written with easy-to-understand wording. They include charts and images, a glossary of medical terms, and suggested questions to ask during appointments. An independent study found them to be among the most trustworthy resources for people seeking online information about cancer.

"We know firsthand how important it is for families to have accurate and trusted information about their child’s treatment plan," said Liz Scott, Executive Director, Alex’s Lemonade Stand Foundation. "We are honored to endorse the NCCN Guidelines for Patients: Pediatric ALL. There is so much power and hope in information!"

"We want every child around the world to receive the best-possible cancer care," said Marcie Reeder, MPH, Executive Director, NCCN Foundation. "That’s why it’s important for patients and caregivers to know what their doctors know. Nearly 1 million people visited our patient information website in 2019. I hope they came away with the knowledge and comfort to feel empowered against whatever they might be facing."

The library of NCCN Guidelines for Patients currently contains nearly 50 different books, including recommendations for breast, colon, lung, and prostate cancers. There are also books on supportive care topics like managing cancer-related distress, nausea and vomiting, side-effects from immune checkpoint inhibitors (ICIs) and chimeric antigen receptor (CAR) T-cell therapy, and special considerations for adolescents and young adults across all cancer types. The books are available for free digital download online or via the NCCN Patient Guides for Cancer App. Printed versions are available for a nominal fee at Amazon.com.

On September 23, 2020 Metabolon, Inc., the global leader in metabolomics solutions advancing drug development and precision medicine, reported the close on $72 million in combined debt and equity financing (Press release, Metabolon, SEP 23, 2020, View Source [SID1234565537]). This round of financing included Perceptive Advisors as a new participant. EW Healthcare Partners and other existing investors also participated in the financing.

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"We are thrilled by this strong show of support from Perceptive Advisors and our current investors," said Rohan (Ro) Hastie, President and CEO, Metabolon. "I am also extremely excited that some of the company’s earliest investors participated in this round of investment as well. The incremental funding will help accelerate our growth and expand our client base, in addition to helping further our R&D programs in machine learning to enable novel biomarker discovery and expand our precision medicine platform."

Metabolomics, the large-scale study of all small molecules in a biological system, is the only ‘omics technology that provides a current-state functional readout of a biological system. By leveraging the world’s largest proprietary metabolite database, Metabolon can decipher thousands of discrete chemical signals from genetic and non-genetic factors to reveal biological pathways. Metabolon’s technology makes connections where other ‘omics cannot and provides the definitive representation of the phenotype.

The company today also announced the appointment of Robert A. Cascella, Chief Business Leader, Precision Diagnostics, and Executive Vice President of Phillips, as one of three independent members of the Metabolon Board of Directors.

"Rob’s 30-year career in the healthcare industry comprises an impressive track record of value creation and delivering integrated solutions," said Hastie, "We are honored to have his expertise on the board to help lead Metabolon to our next stage of growth."

Cascella joins Todd Schermerhorn, retired senior vice president and chief financial officer of C. R. Bard, Inc, and Jan Lundberg, formerly President of Lilly Labs and head of R&D, as independent board members.