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First generics of Gilenya approved by FDA for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients

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First generics of Gilenya approved by FDA for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients

Dec 05, 2019: The U.S. Food and Drug Administration approved three applications for the first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body more frequently in women than men.

Fingolimod risks include slowing of the heart rate, especially after the first dose, may also increase the risk of serious infections. Patient taking this drug are reported with a rare brain infection that usually leads to death or severe disability, called progressive multifocal leukoencephalopathy (PML) has been reported. https://fda.einnews.com/pr_news/504090689/fda-approves-first-generics-of-gilenya

U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Alecto’s investigational therapeutic AL001, for the treatment of patients with frontotemporal dementia

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U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Alecto’s investigational therapeutic AL001, for the treatment of patients with frontotemporal dementia

Dec. 05, 2019: U.S. Food and Drug Administration (FDA) has granted Fast Track designation for  Alecto’s investigational therapeutic, AL001, for the treatment of patients with frontotemporal dementia (FTD) carrying specific genetic mutations in the granulin gene (FTD-GRN).

It is currently evaluated in a Phase 2 trial for the treatment of FTD-GRN and FTD-C9orf72. Fast Track designation is intended to facilitate the development and accelerate the review of therapies for serious conditions and fill an unmet medical need.

Programs with Fast Track designation possibly will benefit from the early and frequent communications with the FDA, potential priority review, and additionally a rolling submission of the marketing application.

AL001 is a monoclonal antibody designed to modulate progranulin, a regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, including FTD, Alzheimer’s disease, and Parkinson’s disease.

It increases the level of progranulin in humans by inhibiting a progranulin degradation mechanism, AL001 discovered and engineered in collaboration of Alector and Adimab, LLC. https://fda.einnews.com/pr_news/504092810/alector-announces-fda-fast-track-designation-granted-to-al001-for-the-treatment-of-patients-with-frontotemporal-dementia

U.S. FDA approved BMS Breakthrough Therapy Designation for ORENCIA® (abatacept) just to help in Preventing Acute Graft-Versus-Host Disease, a Potentially Life-Threatening Complication After Stem Cell Transplant

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U.S. FDA approved BMS Breakthrough Therapy Designation for ORENCIA® (abatacept) just to help in Preventing Acute Graft-Versus-Host Disease, a Potentially Life-Threatening Complication After Stem Cell Transplant

DEC 04, 2019: Bristol-Myers Squibb Company  announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA® (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors.

GvHD after a hematopoietic stem cell transplant occurs when transplanted donor T-cells recognize antigenic differences between donor and recipient and attacks the recipient’s healthy tissue and organs.

Stem cell transplant infusions include donor T-cells, a type of white blood cell that recognizes and destroys foreign invaders in the recipient’s body including cancer cells.

GvHD occurs when the donor T-cells also recognize the patient’s healthy cells as foreign and start attacking healthy tissues and organs. 

T-cell activation requires a signaling process called co-stimulation. ORENCIA, a therapy currently approved to treat various arthritic conditions, binds to and inhibits protein targets involved in co-stimulation, thus inhibiting T-cell activation.

ORENCIA® is an immunomodulator that disrupts the continuous cycle of T–cell activation that characterizes Rheumatoid Arthritis. https://news.bms.com/press-release/rd-news/bristol-myers-squibb-announces-us-fda-breakthrough-therapy-designation-orencia

U.S. Food and Drug Administration (FDA) approved Investigational New Drug (IND) application for Dominant Negative PD-1 “Armored” Next Generation CAR-T Cell Therapy

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U.S. Food and Drug Administration (FDA) approved Investigational New Drug (IND) application for Dominant Negative PD-1 “Armored” Next Generation CAR-T Cell Therapy

Dec. 04, 2019: Innovative Cellular Therapeutics (ICT) announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ICTCAR014 (next generation CD19-targeting CAR-T cell therapy) that expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells.

Data presented in November at the Society for Immunotherapy of Cancer (SITC) represents objective response rate of over 92%, the ICTCAR014 program highlights our accelerated and de-risked approach for developing novel immunotherapies. https://fda.einnews.com/pr_news/503959110/innovative-cellular-therapeutics-announces-fda-clearance-of-ind-for-its-dominant-negative-pd-1-armored-next-generation-car-t-cell-therapy

Ardelyx’s kidney disease drug succeeded in regulating elevated blood phosphate levels in patients with chronic kidney disease (CKD)

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Ardelyx’s kidney disease drug succeeded in regulating elevated blood phosphate levels in patients with chronic kidney disease (CKD)

Dec 04, 2019, Ardelyx lnc said about its experimental drug succeeded in regulating elevated blood phosphate levels in patients with chronic kidney disease (CKD) in a late-stage study.

As per reports, tenapanor showed a greater difference in serum phosphorus levels compared to placebo.

Approx 70% of CKD patients on dialysis continue to experience elevated phosphorus levels, also called hyperphosphatemia , at any point in time, the company said despite treatment with phosphate binders.

Iin September Ardelyx said that in another late-stage study patients treated with tenapanor and phosphate binders, the only approved therapy for hyperphosphatemia, showed a significant reduction in serum phosphorus levels compared to phosphate binders alone.

Tenapanor if approved will be the only non-binder treatment for high serum phosphorus levels in patients with chronic kidney disease on dialysis.
https://ardelyx.com/what-we-do/

United States Food and Drug Administration (USFDA) approved Bortezomib for Injection (IV) 3.5 mg/vial for the treatment of cancers in adult patients

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United States Food and Drug Administration (USFDA) approved Bortezomib for Injection (IV) 3.5 mg/vial for the treatment of cancers in adult patients

December 04, 2019: Dr Reddy’s Laboratories  launched Bortezomib for Injection (IV) 3.5 mg/vial for the treatment of certain types of cancers in adult patients, in the US market approved by the United States Food and Drug Administration (USFDA).

This product is for intravenous use only for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma who already  received at least one prior therapy.

Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester) that After reconstitution, 1 ml of solution for intravenous injection contains 1 mg  bortezomib. https://www.drugs.com/uk/bortezomib-dr-reddys-3-5-mg-powder-for-solution-for-injection-leaflet.html

U.S. Food and Drug Administration (FDA) approved Regenerative Medicine Advanced Therapy (RMAT) designation from the for ADP-A2M4 for the treatment of synovial sarcoma

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U.S. Food and Drug Administration (FDA) approved Regenerative Medicine Advanced Therapy (RMAT) designation from the for ADP-A2M4 for the treatment of synovial sarcoma

Dec. 03, 2019: U.S. Food and Drug Administration (FDA) approved Adaptimmune Therapeutic’s  Regenerative Medicine Advanced Therapy (RMAT) designation for ADP-A2M4 for the treatment of synovial sarcoma.

If product have  regenerative medicine therapy, such as a T-cell therapy, and is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition then that is eligible for RMAT designation.

Data from patients with synovial sarcoma treated in the expansion phase of Adaptimmune’s Phase 1 trial with ADP-A2M4 were recently presented at CTOS. There was an overall response rate of 50%, and a disease control rate of 93%. https://ir.adaptimmune.com/news-releases/news-release-details/regenerative-medicine-advanced-therapy-designation-granted-fda

Immunomedics Resubmits Biologics License Application to FDA for the treatment of metastatic triple-negative breast cancer (mTNBC)

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Immunomedics Resubmits Biologics License Application to FDA for the treatment of metastatic triple-negative breast cancer (mTNBC)

Dec. 03, 2019: Immunomedics,a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC) announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in quest of accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC).

If sacituzumab govitecan approved, it could become an important new treatment option for patients with late-stage mTNBC. https://fda.einnews.com/pr_news/503880625/immunomedics-resubmits-biologics-license-application-to-the-fda-for-sacituzumab-govitecan

The U.S. Food and Drug Administration (FDA) has cleared the Atreca’s Investigational New Drug (IND) application for first-in-human Phase 1b clinical trial of ATRC-101 in patients with solid tumors

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The U.S. Food and Drug Administration (FDA) has cleared the Atreca’s Investigational New Drug (IND) application for first-in-human Phase 1b clinical trial of ATRC-101 in patients with solid tumors

Dec. 03, 2019:The U.S. Food and Drug Administration (FDA) has cleared the Atreca’s Investigational New Drug (IND) application for first-in-human Phase 1b clinical trial of ATRC-101 (monoclonal antibody) in patients with solid tumors in early 2020.

The Phase 1b trial will be an open-label, dose escalation, monotherapy trial with an adaptive 3+3 design and will register patients with a wide variety of solid tumor cancers (ovarian, non-small cell lung, colorectal, breast and acral melanoma).

The antigenic target of ATRC-101 (ribonucleoprotein complex) is expressed on over 50% of patient samples for each tumor types. https://fda.einnews.com/pr_news/503880628/atreca-announces-fda-clearance-of-investigational-new-drug-application-for-atrc-101

OSE Immunotherapeutics Announces Positive Results from first-in-human dose-escalation, randomized, double-blind, placebo-controlled Phase 1 trial of Anti-IL-7 Receptor Antagonist OSE-127

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OSE Immunotherapeutics Announces Positive Results from first-in-human dose-escalation, randomized, double-blind, placebo-controlled Phase 1 trial of Anti-IL-7 Receptor Antagonist OSE-127

Dec 02, 2019: OSE Immunotherapeutics  announced completion and positive results from the Phase 1 study of OSE-127, a humanized monoclonal antibody with a differentiated mechanism of action and full-antagonist of CD127 receptor, alpha chain of the interleukin-7 receptor (IL-7R).

The Phase 1 study results illustrate a good safety and tolerability profile for OSE-127, that help to determine the dosing and administration schedule for the two planned Phase 2 trials in ulcerative colitis and Sjögren’s syndrome.

This study was a first-in-human dose-escalation, randomized, double-blind, placebo-controlled Phase 1 trial which aimed in order to evaluate the safety and tolerability of single- and multiple-ascending intravenous and subcutaneous doses of OSE-127 in 63 healthy volunteers.

Up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases, OSE-127 is developed in partnership with Servier 1 under an option agreement and also  Servier plans to develop OSE127 in Sjögren’s syndrome. https://ose-immuno.com/wp-content/uploads/2019/12/EN_191202_OSE-127-Ph-1.pdf

AstraZeneca divests rights Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in the US and Canada to Cheplapharm Arzneimittel GmbH (Cheplapharm)

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AstraZeneca divests rights Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in the US and Canada to Cheplapharm Arzneimittel GmbH (Cheplapharm)

Dec. 03, 2019: AstraZeneca has agreed to put up for sale the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in the US and Canada to Cheplapharm Arzneimittel GmbH (Cheplapharm). 

Seroquel and Seroquel XR are used mainly to treat schizophrenia and bipolar disorder, have lost their compound patent protection in the US and Canada.This divestment reduces the number of mature medicines to enable reinvestment in main therapy areas.

Cheplapharm recently decided to acquire the commercial rights to Seroquel and Seroquel XR in most of the  European markets and Russia from AstraZeneca.

Cheplapharm will make an candid payment of $35m to AstraZeneca and may also make future sales-contingent payments of up to $6m.
https://www.astrazeneca.com/media-centre/press-releases/2019/astrazeneca-divests-rights-to-seroquel-and-seroquel-xr-in-the-us-and-canada-03122019.html

Co-Diagnostics Gets “Indian FDA” Approval for Infectious Disease Testing (in vitro diagnostic assays)in One of the World’s Biggest Markets

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Co-Diagnostics Gets “Indian FDA” Approval for Infectious Disease Testing (in vitro diagnostic assays)in One of the World’s Biggest Markets

Dec. 03, 2019: Co-Diagnostics  Inc. announced that Indian regulators have approved five in vitro diagnostic assays to be manufactured and sold by CoSara Diagnostics Pvt Ltd., the company’s joint venture for manufacturing in India.

The approved tests are used for tuberculosis, malaria, hepatitis B, hepatitis C, and human papillomavirus.

The Indian Central Drug Standard Control Organization (or “CDSCO”) is the regulatory body that is responsible for the approval of pharmaceuticals and medical devices for their use in the Indian healthcare market, serving the corresponding function as the Food and Drug Administration in the United States, making CDSCO approval in India analogous to FDA approval in the United States. inauguration of the JV manufacturing plant earlier this year as  announced by Co-Diagnostics.

https://fda.einnews.com/pr_news/503886489/co-diagnostics-nasdaq-codx-gets-indian-fda-approval-for-infectious-disease-testing-in-one-of-the-world-s-biggest-markets

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