On September 1, 2021 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it is scheduled to participate in the following upcoming events (Press release, Arrowhead Pharmaceuticals, SEP 1, 2021, View Source [SID1234587183]):

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Citi’s 16th Annual BioPharma Virtual Conference – September 8-10, 2021
September 9, 2021 – Arrowhead management will host a day of virtual investor meetings

HC Wainwright 23rd Annual Global Investment Conference – September 13-15, 2021
September 13, 2021 – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

Baird’s 2021 Global Healthcare Conference – September 14-15, 2021
September 14, 2021, 4:55 p.m. ET – Vince Anzalone, CFA, Arrowhead’s vice president of investor relations, will participate in a fireside chat presentation

2021 Cantor Virtual Global Healthcare Conference – September 27-30, 2021
September 29, 2021, 9:20 a.m. ET – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

A copy of the presentation materials and/or live webcast links may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

On September 1, 2021 MAX BioPharma reported that it has been awarded an SBIR Direct-to-Phase II grant from the NIH (NIAMS) titled: "Therapeutic Development of Osteogenic Oxysterol, Oxy133, for Spine Fusion" (R44AR079335-01) (Press release, MAX BioPharma, SEP 1, 2021, View Source [SID1234587151]). With limited options on the market, the medical community is excited about the prospect of a safe, efficacious and less-costly product .

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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

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On September 1, 2021 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported its participation in the launch of PERSIST-SEQ, a new international consortium of academic and industrial leaders in the field of cancer research (Press release, Transgene, SEP 1, 2021, View Source [SID1234587142]).

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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

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This collaborative research program aims to provide the cancer research community with a new gold standard workflow for single-cell sequencing by developing and validating best practices as well as generating and analysing high-quality data. The project aims to empower the scientific community to unravel drug resistance and develop smarter therapeutic strategies to better treat cancer and prevent resistance. PERSIST-SEQ is a five-year public-private partnership, funded by the Innovative Medicines Initiative (IMI), and led by the Oncode Institute and AstraZeneca.

Cancer takes 9.6 million lives each year, 90% of which result from untreatable cancer relapse occurring after initially effective treatment. Therapeutic resistance is one of the primary causes of cancer death and is clinically difficult to predict, prevent or treat. Although resistance has been studied extensively in the last decades, there is no comprehensive understanding of its underlying mechanisms, nor how they differ between cancer types or therapies. A better understanding of these mechanisms can contribute to better patient stratification, the development of effective drug strategies targeting the resistance mechanisms as well as improved cancer treatment strategies. Moreover, resistance is a major industrial challenge since it causes failure in the drug discovery and development process. Therapeutic resistance is largely unpredictable and difficult to model. Therefore, better tools are needed to identify or predict resistance mechanisms. These tools would, in turn, decrease the costs and risks associated with cancer drug development significantly.

"Drug resistance in cancer is one of the greatest causes of mortality and despite increasing success with targeted therapies in the clinic, how cancer cells survive drug treatment is still not well understood. We are excited to co-lead this European industry-academic partnership, using state-of-the-art single-cell sequencing to characterise 5 million single cells over 5 years to understand and overcome drug resistance" said Ultan McDermott (AstraZeneca), industrial co-lead of PERSIST-SEQ.

Current experimental approaches fail to study residual disease, the major cause of cancer relapse, and therapeutic resistance in clinically meaningful ways. In the last years novel methods in single-cell sequencing have seen significant advancements. Such techniques combined with advanced cancer modelling approaches can shed light on the intricate processes underlying therapeutic resistance and residual disease. Understanding the mechanisms of cancer resistance is crucial to enable its mitigation and requires a coordinated effort. To address these challenges, PERSIST-SEQ has formed a coalition of field-leading researchers and medical oncologists on cancer resistance who will leverage their ingenious cancer modelling approaches and cutting-edge techniques to perform the sequencing of single tumour cells. PERSIST-SEQ will refine and standardize a broadly applicable workflow for single-cell sequencing in order to improve the understanding of therapeutic resistance in cancer and develop targeted prevention and mitigation techniques.

"I am very excited to be part of this consortium. Not only because of the importance of understanding tumour drug resistance, but also because we will perform this project in close collaboration with industrial partners. I am sure we will learn a lot from each other" commented Prof. Alexander van Oudenaarden (Hubrecht Institute), Principal Investigator of PERSIST-SEQ.

Jean-Marc Balloul, Director Innovation & Partnership at Transgene, added: "We are proud to participate in the PERSIST-SEQ consortium and contribute to the deciphering of immunotherapeutic resistance in cancer cells. Certain tumor cells display pathways that allow them to resist therapeutic approaches based on oncolysis, such as oncolytic viruses. Single-cell sequencing will allow us to better understand these resistance mechanisms and ultimately design immunotherapies that can overcome this hurdle."

About the PERSIST-SEQ consortium
The ultimate goal of the PERSIST-SEQ consortium is to improve the understanding of therapeutic resistance in cancer and create effective strategies to improve cancer treatment and prevent drug resistance. As a result of this effort, the project anticipates a significant step forward for the cancer community and its understanding of tumour plasticity. This can change the way scientists and clinicians view cancer and its related drug developments. In order to achieve this goal, PERSIST-SEQ will develop a standardized approach to single-cell sequencing workflows for the investigation of cells pre-treatment. Uniquely, all experiments and pre-processing of data will be done at Single Cell Discoveries. This will ensure standardization and continuity of both experimental and bioinformatics workflows throughout the project. Importantly, PERSIST-SEQ will employ an open access model to build and sustain its benchmarking procedures and centralized European data infrastructure. This model reduces duplication of effort, thereby promoting collaboration across disciplines and ensuring efficient adoption of state-of-the-art single cell technologies. By presenting an approach which is replicable, the PERSIST-SEQ consortium will facilitate a further investigation of unaddressed tumours and therapies. Therefore, the real impact of the project will stem from the growth of innovation capacity associated with the use of this approach across academic and industrial centres around the world.
PERSIST-SEQ is a public-private partnership funded by the IMI, with representation from academic institutions, small- and medium-sized enterprises, public organizations and pharmaceutical companies. The partners involved in the project are Oncode Institute, Hubrecht Institute, Netherlands Cancer Institute, Single Cell Discoveries, Lygature, Wellcome Sanger Institute, Fondazione del Piemonte per l’Oncologia, Hubrecht Organoid Technology, Institute for Research in Biomedicine (IRB Barcelona), Vall d’Hebron Institute of Oncology, Xenopat, AstraZeneca, Merck KGaA, Darmstadt, Germany, Bayer, Transgene, Charles River.

Acknowledgement of support
PERSIST-SEQ receives funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 101007937. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. See www.imi.europa.eu for more details.

On September 1, 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 that Reddy-Lenalidomide, a generic equivalent to Revlimid (lenalidomide) capsules, is approved by Health Canada and has been launched in the Canadian market (Press release, Dr Reddy’s, SEP 1, 2021, View Source [SID1234587141]). Reddy-Lenalidomide is one of the first generic medications of its kind to launch in Canada.

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"Our launch of Reddy-Lenalidomide represents our firm commitment to providing access to affordable medicines for Canada’s Multiple Myeloma and Myelodysplastic Syndrome (MDS) patient population," says Vinod Ramachandran, Ph.D., Vice President and General Manager, Dr. Reddy’s Laboratories Canada. "Along with this important launch, we are pleased to introduce our Reddy2Assist Platform, which provides convenient one-stop access to assist prescribers and pharmacists with qualification requirements for patients, as well as patient onboarding and registration via web portal, telephone or fax."

Reddy-Lenalidomide capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths, each in blister packs.

Indications & Clinical Use:

Reddy-Lenalidomide is indicated for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Approval for this indication is based on red blood cell transfusion independence response rates. Overall survival benefit has not been demonstrated (see CLINICAL TRIALS, Myelodysplastic Syndromes).

Reddy-Lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who are not eligible for stem cell transplant.

Limitation of Use:

Reddy-Lenalidomide is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials (see WARNINGS AND PRECAUTIONS, Increased Mortality in Patients with CLL).

Contraindications:

Reddy-Lenalidomide is contraindicated in patients who are hypersensitive to it or to thalidomide, pomalidomide or to any ingredient in the formulation or component of the container.
Reddy-Lenalidomide is contraindicated in pregnant women and women at risk of becoming pregnant. If lenalidomide is taken during pregnancy, it may cause severe birth defects or death to the fetus.
Breast feeding women.
Male patients unable to follow or comply with the required contraceptive measures.
Reddy-Lenalidomide treatment should not be started in MDS patients whose platelet levels are less than 50 x 109/L.
Most Serious Warnings and Precautions:

Reddy-Lenalidomide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents and registered with the Reddy-Lenalidomide RMP controlled distribution program.

Pregnancy: Potential for human birth defects, stillbirths and spontaneous abortions. Reddy-Lenalidomide is contraindicated in pregnant women and women at risk of becoming pregnant. Females of Child-Bearing Potential may be treated with Reddy-Lenalidomide provided that adequate contraception, with two simultaneous effective methods of contraception, is used to prevent fetal exposure to the drug. The choice of the two simultaneously effective contraceptive methods will necessitate a risk/benefit discussion between the patient and a qualified physician experienced in the use of contraceptive methods.
Hematologic: Reddy-Lenalidomide is associated with significant neutropenia and thrombocytopenia. Complete blood counts should be monitored. Patients should be advised to promptly report febrile episodes as a dose reduction may be required. In cases of thrombocytopenia, patients and physicians should be observant for signs and symptoms of bleeding, including petechiae and epistaxes.
Venous and Arterial Thromboembolism: The combination of lenalidomide with dexamethasone is associated with an increased risk of venous thromboembolism (predominantly deep vein thrombosis (DVT) and pulmonary embolism (PE), and arterial thromboembolism (predominantly myocardial infarction (MI) and cerebrovascular events) in patients with multiple myeloma. Antithrombotic prophylaxis is recommended.
Hepatic: Hepatotoxicity, including fatal cases, has occurred in patients treated with lenalidomide in combination with dexamethasone: acute hepatic failure, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, and mixed cytolytic/cholestatic hepatitis have been reported. Monitor liver enzymes periodically. Stop Reddy-Lenalidomide upon elevation of liver enzymes.
Anaphylaxis: Reddy-Lenalidomide must be discontinued and should not be resumed.
Reddy-Lenalidomide is only available under a controlled distribution program called Reddy-Lenalidomide RMP.

Other Relevant Warnings and Precautions:

Patients should not donate blood or semen while taking Reddy-Lenalidomide and for 4 weeks after stopping Reddy-Lenalidomide.
In the treatment of previously treated multiple myeloma, consideration should be given to the dose of dexamethasone used in combination with Reddy-Lenalidomide.
Cardiovascular: Increased risk of cardiac disorders. Patients with risk factors for developing atrial fibrillation (e.g. existing heart disease, electrolyte abnormalities, hypertension and infections) should be closely monitored.
Second Primary Malignancies (SPM) has been observed. Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of SPM.
Immune reactions: Angioedema, anaphylaxis and serious dermatologic reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. Drug reaction with eosinophilia and systemic symptoms (DRESS) have also been reported. Patients with a history of severe rash associated with thalidomide treatment should not receive lenalidomide. Graft versus Host Disease and Solid Organ Transplant Rejection have also been reported, some cases fatal.
Infections: Cases of viral reactivation have been reported, including serious cases of herpes zoster or hepatitis B virus (HBV) reactivation. Progressive Multifocal Leukoencephalopathy have been reported, including fatal cases.
Increased mortality in patients with chronic lymphocytic leukemia (CLL). Reddy-Lenalidomide is not indicated and not recommended for use in CLL.
Renal: Dose adjustment should be considered for patients with moderate or severe renal impairment and in patients on dialysis (patients with CrCL < 60 mL/min).
Lenalidomide capsules contain lactose. Patients with rare hereditary problems of glucose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this product.
Thyroid Disorders: Baseline and ongoing monitoring of thyroid function is recommended.
Tumor Lysis Syndrome (TLS) has been observed in patients with CLL, multiple myeloma (MM), and in non-Hodgkin’s Lymphoma [unauthorized indication] treated with lenalidomide. Some cases of TLS were fatal.
Tumor flare reaction has occurred during investigational use of lenalidomide for CLL and mantle cell lymphoma (MCL) [unauthorized indication].
Laboratory tests are required and should be monitored at baseline and throughout treatment.
For More Information:

Consult the Product Monograph at: View Source for important information on contraindications, warnings, precautions, adverse reactions, interactions, dosing and conditions of clinical use. The Product Monograph is also available through our Medical Information Department.

Revlimid is a trademark owned or licensed by Celgene Corporation.

RDY-0921-CAN

On September 1, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that the Company will participate in multiple upcoming investor conferences (Press release, Bausch Health, SEP 1, 2021, View Source [SID1234587140]).

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Sam Eldessouky, executive vice president and chief financial officer; William Woodfield, senior vice president and treasurer; and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the J.P. Morgan European High Yield & Leveraged Finance Conference on Sept. 9, 2021 and the Deutsche Bank 29th Annual Leveraged Finance Conference on Oct. 4, 2021 at 11:00 a.m. ET.

Joseph C. Papa, chairman and chief executive officer; Sam Eldessouky, executive vice president and chief financial officer; and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Morgan Stanley Global Healthcare Conference 2021 on Sept. 13, 2021 at 11:00 a.m. ET.

Live webcasts and audio archives of the September 13 and October 4 events will be available on the Investor Relations page of the Bausch Health Companies Inc. website at: View Source