On October 19, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, in 2.5 mg and 20 mg strengths, and tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths, a therapeutic equivalent generic version of REVLIMID (lenalidomide) Capsules, from the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, OCT 19, 2021, View Source [SID1234591521]). With this approval, Dr. Reddy’s is eligible for 180 days of generic drug exclusivity for Lenalidomide Capsules, 2.5 mg and 20 mg.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In September 2020, Dr. Reddy’s announced a settlement agreement of their litigation with Celgene, the maker of REVLIMID (lenalidomide) Capsules and a wholly-owned subsidiary of Bristol Myers Squibb (NYSE: BMY), relating to patents for the branded drug.

In settlement of all outstanding claims in the litigation, Celgene agreed to provide Dr. Reddy’s with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. beginning on a confidential date after March 2022 subject to regulatory approval. The agreed-upon percentages remain confidential. As part of the settlement, Dr. Reddy’s is also licensed to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on January 31, 2026.

"We are pleased with the Agency’s approval of Lenalidomide Capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity," says Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories. "We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients."

On October 19, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported that its third quarter 2021 financial results will be released on Tuesday, November 2, 2021 after the markets close (Press release, Exelixis, OCT 19, 2021, View Source [SID1234591520]). At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update . Access to the event is available via the Internet from the company’s website.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 9563879 to join by phone.

A telephone replay will be available until 8:00 p.m. EDT on November 4, 2021. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 9563879. A webcast replay will also be archived on www.exelixis.com for one year.

On October 19, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported the product launch in Japan for Hiyasta tablets to treat relapsed and/or refractory (R/R) adult T-cell leukemia/lymphoma (ATLL) (Press release, HUYA Bioscience, OCT 19, 2021, View Source [SID1234591519]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Japanese patients with relapsed and/or refractory R/R ATLL have very poor prognosis. The effectiveness of available treatments, such as chemotherapy, diminishes with each relapse. Results from the HBI-8000 study in these patients have demonstrated clinically meaningful tumor response despite the advanced stage of disease. The treatment was safe and side effects could be managed with routine care. "In my opinion, this treatment is expected to address an important unmet medical need," said Dr. Kensei Tobinai, Visiting Scientist of the National Cancer Center Hospital in Japan and medical expert of the HBI-8000 Phase 2 study.

HUYABIO recently announced the approval of Hiyasta by the Japanese Minister of Health, Labor and Welfare based on the results of a clinical trial conducted in Japan in patients with R/R ATLL. Meiji Seika Pharmaceuticals, HUYABIO’s partner, will market the product in Japan. HUYABIO retains worldwide rights to the drug ex-Asia. Development of HBI-8000 is ongoing globally.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This first product launch for our lead oncology drug, HBI-8000, is a major milestone for HUYABIO as we transition into a revenue generating Company. It demonstrates our global reach and ability to develop and commercialize products licensed from China for debilitating diseases and make a major public health contribution."

About HBI-8000
HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATLL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATLL cells more sensitive to immune cytotoxicity targeting.

On October 19, 2021 SHINE Technologies LLC, a nuclear technology company, reported that it has received a $35-million award from the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA) (Press release, Shine Medical Technologies, OCT 19, 2021, View Source [SID1234591518]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The award is part of DOE/NNSA efforts to establish a reliable, U.S.-produced supply of molybdenum-99, or Mo-99, without using highly enriched uranium. Mo-99 is the most commonly used medical isotope, relied on for approximately 40 million patient procedures around the world every year to diagnose conditions such as heart disease and cancer.

"We are really excited to continue and expand our strong partnership with DOE/NNSA," said Greg Piefer, Chairman and CEO of SHINE. "The agency’s support of our Mo-99 project continues to be an accelerant in our efforts to create a large domestic supply of Mo-99, which will both improve the lives of millions of patients and make the world safer through the elimination of highly enriched uranium anywhere in the supply chain."

SHINE-Production-Facility-Construction-10.2021
SHINE plans to use its fusion-based technology to produce medical isotopes at its first-of-a-kind facility in Janesville, Wis.

Construction of SHINE’s medical isotope production facility in Janesville, continues to progress after achieving weathertight status earlier this year. Reaching weathertight status marked the beginning of installation of the plant’s process equipment. Crews most recently began prepping the concrete bays where the neutron generators will be installed. The first two generators are completed and undergoing commissioning. The facility will be the first of its kind and will use SHINE’s patented fusion-based technology to produce Mo-99.

SHINE-Production-Facility-Interior-Construction-10.2021
Progress continues at SHINE’s Moly-99 plant in Janesville, Wis., where equipment is being installed that will produce medical isotopes.

The award was made under a cooperative agreement between DOE/NNSA and SHINE that requires SHINE to provide $35 million to receive the same amount in a matching award from DOE/NNSA.

On October 19, 2021 Amgen (NASDAQ: AMGN) reported that it has successfully completed its previously announced acquisition of Teneobio, Inc. (Teneobio) (Press release, Amgen, OCT 19, 2021, View Source [SID1234591517]). Effective as of Oct. 19, 2021, Amgen has acquired all outstanding equity of Teneobio in exchange for a $900 million upfront cash payment, as well as future contingent milestone payments, to former Teneobio equity holders potentially worth up to an additional $1.6 billion in cash.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Amgen is pioneering the application of T cell engagers and a broad array of bi- and multispecific biologics to treat a range of human diseases across our therapeutic areas of focus," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Teneobio’s expertise and technologies will further expand our repertoire of multispecific architectures and advance our overarching mission to develop transformative innovation to bring to market best-in-class products to serve our patients."

The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which complement Amgen’s existing antibody capabilities and BiTE platform and will enable significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a wide range of important diseases across Amgen’s core therapeutic areas. The acquisition will also add TNB-585, a Phase 1 bispecific T cell engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term Investigational New Drug (IND) filings. TNB-585 complements Amgen’s existing prostate cancer portfolio, which includes acapatamab (formerly AMG 160) and AMG 509, both in Phase 1. Each of these three investigational therapies uses a different approach to treat a highly prevalent disease for which new treatment options are very much needed.

Prior to the consummation of the acquisition, Teneobio distributed to its equity holders all equity held by Teneobio in (i) TeneoTwo, Inc., which develops TNB-486, a bispecific antibody targeting CD19 on tumor cells and CD3 on T-cells, (ii) TeneoFour, Inc., which develops anti-CD38 heavy chain antibodies that block the enzyme functions of CD38, and (iii) TeneoTen, Inc., which develops bispecific antibodies directed against the hepatitis B surface antigen (HBsAg) and CD3.