On October 12, 2021 Agilent Technologies Inc. (NYSE: A) reported its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as an aid in identifying patients with early breast cancer (EBC) at high risk of disease recurrence, for whom adjuvant treatment with Verzenio (abemaciclib) in combination with endocrine therapy is being considered (Press release, Agilent, OCT 12, 2021, View Source [SID1234591195]). This is the first IHC assay measuring Ki-67 expression to receive FDA approval in the context of treatment with Verzenio and was developed in collaboration with Eli Lilly and Company.

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"Agilent’s Ki-67 IHC MIB-1 pharmDx (Dako Omnis) companion diagnostic assay for the Dako Omnis advanced staining platform has been designed and tested to aid in evaluating risk of recurrence in early breast cancer (EBC)"

Understanding the risk of recurrence in EBC is vital for informing disease management, as identifying patients at high risk can provide clarity for patients as well as facilitate treatment decisions to potentially improve outcomes. Conventional methods for evaluating the risk of recurrence in EBC are based on staging and are performed according to standard clinical and pathological features of the disease. However, these standard features may not capture the full risk of recurrence for individuals with EBC.

The American Joint Committee on Cancer has identified the Ki-67 biomarker as Level of Evidence III in diagnosing EBC due to its association with cellular proliferation. Ki-67 is thus an important component of comprehensive risk assessment, but it has been inconsistently applied in the past.1

"Agilent’s Ki-67 IHC MIB-1 pharmDx (Dako Omnis) companion diagnostic assay for the Dako Omnis advanced staining platform has been designed and tested to aid in evaluating risk of recurrence in early breast cancer (EBC)," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "Its approval establishes a clinically relevant standard for recurrence risk assessment in EBC so that more high-risk patients who may experience clinical benefit from treatment with Verzenio are identified."

This approval builds on Agilent’s previous successes in expanding the clinical applicability of therapeutic biomarker analysis, further cementing the company’s position as a provider of diagnostic assays that deliver high quality and ease of implementation.

On October 12, 2021 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, reported preliminary financial results for its third quarter ended September 30, 2021 (Press release, Sarepta Therapeutics, OCT 12, 2021, View Source [SID1234591185]).

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Sarepta expects its net product revenues for the quarter to be approximately $166.9 million, compared to net product revenues of $121.4 million for the same period of 2020.
The Company had approximately $1.6 billion in cash, cash equivalents and investments as of September 30, 2021, compared to $1.9 billion as of December 31, 2020.
These preliminary financial results are the responsibility of management and have been prepared on a consistent basis with prior periods. The Company has not completed its financial closing procedures for the quarter ended September 30, 2021 and its actual results could be materially different from these preliminary financial results. In addition, the Company’s independent registered public accounting firm has not reviewed, compiled, or performed any procedures with respect to these preliminary financial results.

On October 12, 2021 Sarepta Therapeutics, Inc. (Nasdaq:SRPT), the leader in precision genetic medicine for rare diseases, reported that it is offering to sell, subject to market and other conditions, $500,000,000 in shares of its common stock in an underwritten public offering (Press release, Sarepta Therapeutics, OCT 12, 2021, View Source [SID1234591184]). Sarepta also intends to grant the underwriters a 30-day option to purchase up to an additional $75,000,000 in shares of its common stock.

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Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC and Credit Suisse Securities (USA) LLC are acting as the underwriters of the proposed offering.

Sarepta intends to use the net proceeds from the offering principally for the continuation of, and initiation of further, clinical trials, commercialization, manufacturing, business development activities, including the potential licensing or acquisition of complementary products, technologies and entities, and other general corporate purposes.

The shares are being offered by Sarepta pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). The offering is being made only by means of a written prospectus and prospectus supplement. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement relating to these securities may also be obtained from the offices of Goldman Sachs & Co. LLC, at Prospectus Department, 200 West Street, New York, New York 10282, by telephone at 866-471-2526, by facsimile at 212-902-9316 or by e-mail at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204, or by emailing [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; or Credit Suisse Securities (USA) LLC, Attn: Prospectus Department, 6933 Louis Stephens Drive, Raleigh, North Carolina 27560, Telephone: 1-800-221-1037, or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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

On October 12, 2021 Upsher-Smith Laboratories, LLC (Upsher-Smith) reported that Ira Katz, RPh, owner of Little Five Points Pharmacy in Atlanta, Georgia, is the winner of the 2021 National Community Pharmacists Association (NCPA) Willard B. Simmons Independent Pharmacist of the Year award (Press release, Upsher-Smith Laboratories, OCT 12, 2021, View Source [SID1234591170]). Katz received the award on Monday, October 11 at NCPA’s 123rd Annual Convention in Charlotte, North Carolina.

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The annual award is given to a pharmacist who exhibits exemplary professional leadership, service to community and commitment to independent pharmacy. This year marks Upsher-Smith’s 13th year of sponsoring the prestigious award in conjunction with NCPA. The award is named in honor of Willard B. Simmons, a former executive secretary of NCPA (then known as the National Association of Retail Druggists) and a longtime trustee of the NCPA Foundation.

Katz opened the Little Five Points Pharmacy 40 years ago and has been recognized over the years for the contributions he’s made to his profession and community. As a pharmacist committed to reducing the number of lives lost due to opioid overdoses, Katz understands the importance of community education when it comes to opioid safety. Through his pharmacy, he provides naloxone (Narcan) administration education and has made the product available, free of charge, to those in the community, including local businesses and restaurants. Katz is a proud independent pharmacist and is frequently interviewed by local media outlets, sharing his knowledge and expertise with the community.

In addition to his service to the patient community, Katz is active within the professional community. He has been an NCPA member for more than 20 years. He is Chairman of the Board of the Georgia Academy of Independent Pharmacy (AIP) where he has been a board member for more than 25 years and also serves on the AIP Alternative Income Committee. He is also a member of the Georgia Pharmacy Association (GPhA), serving on its Governmental Affairs team.

"Ira Katz has played an invaluable role as a community pharmacist, and we couldn’t be more pleased to help NCPA recognize his achievements," said Rusty Field, President and CEO, Upsher-Smith. "Ira is a proven leader who has demonstrated that a pharmacist’s role goes far beyond dispensing medications. His efforts to educate and marshal resources to help those in need have single handedly made a difference in people’s lives."

"Ira’s leadership, dedication, and commitment to community make him a deserving recipient of this year’s Willard B. Simmons Independent Pharmacist of the Year Award," said NCPA CEO B. Douglas Hoey, pharmacist, MBA. "Ira’s service to his community has saved lives and is unwavering. He is a prime example of the importance of community pharmacies to people in cities and towns across America. We are grateful to Upsher-Smith for its support in recognizing exemplary pharmacists like Ira Katz."

On October 12, 2021 NanoImaging Services, Inc., the premier industry provider of cryoEM services, microscope access and training, and Viva Biotech Holdings, a leading open-access and innovation-driven technology platform company, reported a partnership agreement to develop a streamlined, cryoEM enabled gene-to-structure workflow, to ultimately accelerate medicinal chemistry analysis (Press release, Lifescience Newswire, OCT 12, 2021, View Source [SID1234591166]).

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This strategic partnership will bring together NanoImaging Services’ industry-leading expertise and innovation in high-resolution structural enablement by cryoEM and Viva Biotech’s world leading drug discovery platform to enable the management of projects from construct design through to final maps and subsequent protein supply, and analyses for medicinal chemistry cycles. This seamlessly integrated workflow will facilitate target and structure validation for companies with challenging targets in an efficient and cost-effective manner, streamlining drug discovery pipelines and ultimately reducing the time to clinic.

Giovanna Scapin, Ph.D., Chief Scientific Officer at NanoImaging Services said, "One of the strongest predictors of success in structural enablement of drug discovery targets is the purity, homogeneity, and in-depth biochemical and biophysical characterization of the reagents involved. This agreement utilizes our industry-leading expertise and innovation in high-resolution structural enablement by cryoEM, partnered with a worldwide leader in protein production and characterization. Together we aim to successfully target the most complex and challenging projects in drug discovery for our shared clients in a cost- and time- effective manner."

"We are very excited to build the strategic cooperation with NanoImaging Services," said Dr. Ren Delin, Executive Director and President of Viva. "NanoImaging Services, the world’s top cryoEM service provider, has considerable advantages in technology and equipment. As the world’s leading drug discovery platform, Viva has efficient protein purification and production capabilities, along with the advanced membrane protein expression and screening technology. Our cooperation is expected to further enhance the ability of target discovery, to empower the clients to develop new drugs as soon as possible, and benefit more patients." said Dr. Ren Delin, Executive Director and President of Viva Biotech.

By combining forces and aligning these already successful and proven workflows, target enablement and medicinal chemistry timelines can be shortened significantly. This, along with the increased success rates, can contribute to bringing down the overall investment costs and creating a more efficient workflow.

To find out more about NanoImaging Services cryoEM solutions for protein structure determination, please visit our website here => View Source