NCCN Announces New Biosimilars Research Projects in Oncology in Collaboration with Pfizer

On March 15, 2021 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP), reported in collaboration with Pfizer Inc., ten projects have been chosen to receive funding to support innovative approaches to improve the processes related to appropriate biosimilar adoption in oncology (Press release, NCCN, MAR 15, 2021, View Source [SID1234576675]).

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The selected organizations and research projects are:

American Society of Clinical Oncology, Inc., ASCO (Free ASCO Whitepaper)’s PracticeNET Learning Network
Analysis of Biosimilar Utilization and Perspectives within ASCO (Free ASCO Whitepaper)’s PracticeNET Learning Network
Baptist Memorial Hospital Tipton
Adoption of Biosimilars in Oncology
Cancer Support Community
Frankly Speaking About Cancer: Biosimilars – Researching Oncology Patient and Caregiver Perceptions
Cedars-Sinai Medical Center
Optimize Systemic Platform to Assure Quality, Value and Evidence-Based Decision Making on Biosimilar Products Use in Oncology Patients
City of Hope Medical Foundation
Challenges to Biosimilar Adoption in Community Oncology Due to Diverse Payer Preferences for Different Biosimilar
Houston Methodist
Impact of Discordant Preferred Drug Status between Hospitals and Payers for Chemotherapeutic Biosimilars
Roswell Park Comprehensive Cancer Center
Identifying Best Practices in Biosimilar Implementation
University of Illinois at Chicago
Developing a Human-Centered Information Packet to Increase Trastuzumab Biosimilars Uptake
The University of Texas at Austin
Biosimilar Optimization in Community Oncology Practice
UT Southwestern Medical Center
Developing a Clinical Decision Support Tool for Biosimilar Use in Oncology
"This research highlights NCCN’s commitment to exploring new avenues for increasing the availability of affordable, effective treatment options in oncology," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "These projects will help us to determine best practices for using biosimilars—when safe and appropriate—and how to educate providers and patients about them."

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology. For more information, visit NCCN.org/ORP.

Oncopeptides announces that the first patients in the United States are being treated with PEPAXTO®

On March 15, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported that PEPAXTO (melphalan flufenamide) is now commercially available across the United States and that the first patients are being treated with the drug (Press release, Oncopeptides, MAR 15, 2021, View Source [SID1234576674]). PEPAXTO, in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

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"I am very pleased that PEPAXTO is now available as an innovative treatment option for patients with multiple myeloma at hospitals and community practices across the United States," says Marty J Duvall, Chief Executive Officer at Oncopeptides AB. "We are committed to working closely with payers and healthcare providers to ensure that all appropriate patients who receive a PEPAXTO prescription have access to the drug".

About melphalan flufenamide

Melphalan flufenamide, also known as melflufen, is the first anticancer peptide-drug conjugate for patients with relapsed or refractory multiple myeloma. Melphalan flufenamide uses innovative technology that links a peptide carrier to a cytotoxic agent, resulting in a lipophilic compound. Due to its high lipophilicity, melphalan flufenamide is distributed into cells. Melphalan flufenamide is designed to leverage aminopeptidases, which are overexpressed in multiple myeloma cells and cause the release of cytotoxic agents. Melphalan flufenamide is administered once monthly, by a thirty-minute infusion.

In the US, PEPAXTO (melphalan flufenamide) is indicated in combination with dexamethasone for the treatment of adult patients with triple class refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-monoclonal directed antibody. PEPAXTO is a registered trademark in the U.S.

CNS Pharmaceuticals to Participate in Inaugural Emerging Growth Virtual Conference

On March 15, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that John Climaco, CEO of CNS Pharmaceuticals will present at the inaugural Emerging Growth Virtual Conference presented by M Vest LLC and Maxim Group LLC (Press release, CNS Pharmaceuticals, MAR 15, 2021, View Source [SID1234576673]). The conference will take place virtually on March 17th and 18th and will feature roundtable discussions with C-suite executives moderated by Maxim Research Analysts, fireside chats with live Q&A, and presentations from hundreds of issuers both domestically and internationally.

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In addition to the presentation, Mr. Climaco will participate in a live glioblastoma panel discussion on Wednesday, March 17th from 9:30-10:30 am ET.

Interested parties are invited to attend the virtual conference and access exclusive content by becoming an M-Vest member and registering HERE. To learn more about the event, please visit the conference website: Emerging Growth Virtual Conference.

Biohaven Announces Proposed Public Offering Of Common Shares

On March 15, 2021 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial-stage biopharmaceutical company with a marketed drug for the acute treatment of migraine and a portfolio of innovative, late–stage product candidates targeting neurological diseases, including rare disorders, reported that it has commenced an underwritten public offering of $200 million of its common shares (Press release, Biohaven Pharmaceutical, MAR 15, 2021, View Source [SID1234576672]). All of the common shares to be sold in the offering will be offered by Biohaven. In addition, Biohaven expects to grant the underwriter a 30-day option to purchase up to an additional $30 million of common shares at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Goldman Sachs & Co. LLC is acting as the book-running manager of the offering.

The offering is being made only by means of a prospectus supplement and the accompanying prospectus, copies of which, when available, may be obtained from the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1–866-471-2526, facsimile: 212-902-9316 or by emailing [email protected].

The shares will be issued pursuant to an effective shelf registration statement on Form S-3. Before investing in the offering, interested parties should read the prospectus and related prospectus supplement for this offering, the documents incorporated by reference therein and the other documents Biohaven has filed with the Securities and Exchange Commission. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of such state or jurisdiction.

Biohaven Announces Pricing Of $200 Million Public Offering Of Common Shares

On March 15, 2021 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial–stage biopharmaceutical company with a marketed drug for the acute treatment of migraine and a portfolio of innovative, late–stage product candidates targeting neurological diseases, including rare disorders, reported the pricing of its underwritten public offering of 2,686,409 of its common shares at a price to the public of $76.00 per share (Press release, Biohaven Pharmaceutical, MAR 15, 2021, View Source [SID1234576671]). In addition, Biohaven has granted the underwriter a 30-day option to purchase up to an additional 402,961 common shares at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering are expected to be approximately $200 million before deducting underwriting discounts and commissions and estimated offering expenses payable by Biohaven. The offering is expected to close on March 17, 2021, subject to satisfaction of customary closing conditions.

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Goldman Sachs & Co. LLC is acting as the book-running manager of the offering.

The offering is being made only by means of a prospectus supplement and the accompanying prospectus, copies of which, when available, may be obtained from the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1–866-471-2526, facsimile: 212-902-9316 or by emailing [email protected].

The shares will be issued pursuant to an effective shelf registration statement on Form S-3. Copies of the registration statement can be accessed through the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of such state or jurisdiction.