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Aquestive Therapeutics’ treatment approved by FDA for neurological disorder amyotrophic lateral sclerosis (ALS)

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Aquestive Therapeutics’ treatment approved by FDA for neurological disorder amyotrophic lateral sclerosis (ALS)

Nov 22, 2019: The U.S. Food and Drug Administration approved Aquestive Therapeutics’ treatment for neurological disorder amyotrophic lateral sclerosis (ALS).

According to the ALS Association, ALS is an ultra-rare neurodegenerative disorder that causes the death of neurons that controls the  voluntary muscles, in United States more than 6,000 people diagnosed with this disease.

Company’s Shares, which developed riluzole oral film (ROF) and will market the film with the brand name Exservan, rose 4% at $6.76 after the bell. https://kfgo.com/news/articles/2019/nov/22/fda-approves-aquestives-als-treatment/960323/

AbbVie to present Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) , in American Society of Hematology (ASH) Annual Meeting for the treatment of Leukemias, Lymphomas and Other Blood Cancers

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AbbVie to present Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) , in American Society of Hematology (ASH) Annual Meeting for the treatment of Leukemias, Lymphomas and Other Blood Cancers

Nov 21, 2019 : AbbVie, a research-based global biopharmaceutical company announced that between Dec 7- 10  in American Society of Hematology (ASH) Annual Meeting & Exposition,  in Orlando more than 40 abstracts, including 18 oral presentations will be presented that include presentations on Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/VENCLYXTO®) , which helps improving  the lives of people living with various difficult-to-treat blood cancers.

IMBRUVICA (ibrutinib)  blocks a protein called Bruton’s tyrosine kinase (BTK). It is an oral, once-daily medicine that works in a different way than chemotherapy.

VENCLEXTA®/VENCLYXTO® (venetoclax) selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. VENCLEXTA/VENCLYXTO targets the BCL-2 protein and helps to restore the apoptosis process. https://news.abbvie.com/news/press-releases/abbvie-to-present-latest-clinical-research-in-treatment-leukemias-lymphomas-and-other-blood-cancers-at-2019-ash-annual-meeting.htm

Harpoon Therapeutics and AbbVie Announce an elite worldwide option and license transaction for HPN217 and Expand Existing Discovery Collaboration

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Harpoon Therapeutics and AbbVie Announce an elite worldwide option and license transaction for HPN217 and Expand Existing Discovery Collaboration

Nov 21, 2019: Harpoon Therapeutics, Inc. a clinical-stage immunotherapy company developing a novel class of T cell engagers, and AbbVie Inc, a global biopharmaceutical company, announced an elite worldwide option and license transaction for HPN217, Harpoon’s B cell maturation antigen (BCMA)-targeting Tri-specific T cell Activating Construct (TriTAC®), and an expansion of their existing discovery collaboration for up to six additional targets established by the two companies in October 2017.

The TriTAC platform produces novel T cell engagers targeting both solid tumors and hematologic malignancie.“Harpoon has built a unique and unshared  biologics platform that utilizes the patient’s own immune system to attack cancer. HPN217, targeting BCMA, is poised to proceed to clinical development for the treatment of multiple myeloma”,

Harpoon’s BCMA TriTAC combined with AbbVie’s development expertise, has the potential to generate innovative new medicines for patients with cancer. Under the terms of the license and option agreement, Harpoon granted to AbbVie an option to license worldwide exclusive rights to HPN217 through Phase 1/2 clinical trials. https://news.abbvie.com/news/press-releases/harpoon-therapeutics-and-abbvie-announce-licensing-and-option-collaboration-to-advance-hpn217-harpoons-bcma-targeting-tritac-and-expand-existing-discovery-collaboration.htm

XCOPRI (cenobamate tablets) approved by FDA for the treatment partial-onset seizures in adults

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XCOPRI (cenobamate tablets) approved by FDA for the treatment partial-onset seizures in adults

Nov 21, 2019: SK Life Science new option to treat adults with partial-onset seizures, XCOPRI (cenobamate tablets) approved by FDA which has an often difficult-to-control condition that can have a significant impact on patient quality of life.

Seizures occur when group of nerve cells (neurons) in the brain undergo uncontrolled activation generally for short period of abnormal electrical activity in the brain also uncontrolled movements, abnormal thinking or behavior, and abnormal sensations are reported,Movements can be violent, and changes in consciousness can occur.

XCOPRI causses Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity also patients with hypersensitivity to cenobamate should avoid XCOPRI. https://fda.einnews.com/pr_news/502878004/fda-approves-new-treatment-for-adults-with-partial-onset-seizures

US Food and Drug Administration (FDA) approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

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US Food and Drug Administration (FDA) approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

Nov 21,2019: AstraZeneca announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

This approval is based on positive reports from the interim analyses of two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL.

Calquence in combination with obinutuzumab or as a monotherapy significantly reduced the relative risk of disease development or death versus the comparator arms in both 1st-line and relapsed or refractory CLL.

Results from both trials shows that safety and tolerability of Calquence were consistent with its established profile.

This approval of Calquence provides new hope for patients with one of the most common types of adult leukaemia, offering incomparable efficacy and a constructive tolerability profile.

In the Calquence combination arm, risk of disease progression or death was reduced by 90%and in the monotherapy arm it was reduced by 80%. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/calquence-approved-in-the-us-for-adult-patients-with-chronic-lymphocytic-leukaemia-21112019.html

U.S. FDA approved IN.PACT AV paclitaxel-coated balloon for the treatment of Arteriovenous Fistula Lesions

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U.S. FDA approved IN.PACT AV paclitaxel-coated balloon for the treatment of Arteriovenous Fistula Lesions

Nov. 21, 2019: Medtronic  announced U.S. Food and Drug Administration (FDA) approval of the IN.PACT™ AV drug (paclitaxel)-coated balloon for the treatment of failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis. vessel restenosis limits the ability to use AV fistulae effectively.

Patients often undergo one to three maintenance procedures per year which can result in significant disruptions to critical hemodialysis care and increased costs to the healthcare system,so in order to minimize the the cost and maximizing a patient’s uninterrupted access to lifesaving dialysis care, Pivotal randomized trial results from the IN.PACT AV Access trial have shown IN.PACT AV DCB can extend the time between reinterventions by maintaining AV access site patency.

IN.PACT AV DCB, holds the technology from Medtronic’s IN.PACT™ Admiral™ platform, increases blood flow and reduces thickening of the vessel wall by delivering the proven anti-proliferative drug paclitaxel (penetrates deep into the vessel wall to prevent restenosis and  extend time between reinterventions). http://newsroom.medtronic.com/news-releases/news-release-details/medtronic-drug-coated-balloon-receives-us-fda-approval-treat

Zydus receives final approvals from the USFDA for Isosorbide Dinitrate Tablets for the treatment of Angina and Desonide Cream for skin diseases

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Zydus receives final approvals from the USFDA for Isosorbide Dinitrate Tablets for the treatment of Angina and Desonide Cream for skin diseases

Nov. 21, 2019: Zydus Cadila has received the final approval from the USFDA for marketing Isosorbide Dinitrate Tablets USP ( 5 mg, 10 mg, 20 mg, 30 mg and 40 mg)  to prevent attacks of Angina (chest pain).

These tablets dilate blood vessels, increases blood flow through to the heart. These will be manufactured at the group’s formulations manufacturing facility at Baddi. The group also received the final approval for Desonide Cream (US RLD – Desonide Cream), 0.05%.

The drug is a mild corticosteroid, used to treat a multiplicity of skin conditions (e.g., eczema, allergies, dermatitis, rash)in order to reduce swelling, itching and redness. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. https://zyduscadila.com/public/pdf/pressrelease/Zydus_receives_final_approvals_from_the_USFDA_for_Isosorbide_Dinitrate_Tablets_and_Desonide_Cream.pdf

Astellas and Welldoc together develop and commercialize BlueStar® a digital health solution cleared by the U.S. Food and Drug Administration (FDA) for the treatment of type 1 or type 2 diabetes

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Astellas and Welldoc together develop and commercialize BlueStar® a digital health solution cleared by the U.S. Food and Drug Administration (FDA) for the treatment of type 1 or type 2 diabetes

Nov 20, 2019  – Astellas Pharma Inc. and Welldoc, Inc. announced that the companies have entered into a collaboration and license agreement directed toward the development and commercialization of digital health solutions, BlueStar® in Japan and certain other Asian markets for patients with diabetes.

U.S. Food and Drug Administration (FDA)- in the United States cleared the use of BlueStar  by healthcare providers and their patients aged 18 years and older who have type 1 or  type 2 diabetes. It not only assists patients in managing their disease by capturing ,transmitting blood glucose data and tracking medication, activity, diet and exercise, but also useful for  individual patient treatment data and machine learning to provide customized motivational, behavioral, and educational training messages to aid in diabetes self-management. https://www.astellas.com/en/news/15441

Officials:Blackberries sold in Fresh Thyme grocery stores cause hepatitis A

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Officials:Blackberries sold in Fresh Thyme grocery stores cause hepatitis A

Nov 21,2019: Consumers of 11 states are warned by Nebraska and federal health officials as hepatitis A outbreak that includes Nebraska, Indiana and Wisconsin has been traced to blackberries sold in Fresh Thyme grocery store

https://www.washingtonpost.com/business/officials-multistate-hepatitis-a-cases-traced-to-berries/2019/11/20/fecb0be4-0bf3-11ea-8054-289aef6e38a3_story.html

NGFA–KSU Food Safety Modernization Act Feed Industry Training course to set regulations for safe animal feed

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NGFA–KSU Food Safety Modernization Act Feed Industry Training course to set regulations for safe animal feed

Nov. 20, 2019: FDA has issued final regulations under the Food Safety Modernization Act that require feed facilities to comply with new current good manufacturing practices and to implement a written animal food safety plan that is developed and overseen by a preventive controls qualified individual.

This training was held on November 5–7, 2019 and allowed participants to learn about the fundamentals and manufacturing principles of food safety and how to create an effective food safety plan.

This three day course focuses on improving overall food safety where people from the industry come to learn about new regulations.

There are certificates training from the Food Safety Preventive Controls Alliance (FSPCA) for the  Participants, as well as an additional Hazard Analysis and Critical Control Point (HACCP) training to recieive the certificate, participants must  demonstrate the requirements by Preventative Controls Qualified Individual (PCQI) per the FDA’s regulations.
https://fda.einnews.com/article__detail/502768398-k-state-university-igp-institute-holds-ngfa-ksu-food-safety-modernization-act-training-course?vcode=XIbw

USFDA Approved GIVLAARI(givosiran) for the Treatment of Adults with Acute Hepatic Porphyria

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USFDA Approved GIVLAARI(givosiran) for the Treatment of Adults with Acute Hepatic Porphyria

Nov. 20, 2019: Alnylam Pharmaceuticals, the leading RNAi therapeutics company, announced  the USFDA approved GIVLAARI™ (givosiran) injection (subcutaneous) for the treatment of adults with acute hepatic porphyria (AHP).

AHP is an exceptional, genetic diseases characterized by devitalizing, potentially life-threatening attacks and, for some patients, chronic manifestations that depressingly impact daily performance and quality of life.

Long-standing complications of AHP are chronic neuropathic pain, chronic kidney disease, hypertension and liver disease. GIVLAARI reduces the rate of porphyria attacks that required hospitalizations, urgent healthcare visits or IV hemin administration at home. http://investors.alnylam.com/news-releases/news-release-details/alnylam-announces-approval-givlaaritm-givosiran-us-food-and-drug

Merck’s anti-PD-1 therapy KEYTRUDA(pembrolizumab) for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

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Merck’s anti-PD-1 therapy KEYTRUDA(pembrolizumab) for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

Nov 20,2019: For the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score [CPS] ≥1),Merk announced that the European Commission has approved KEYTRUDA(pembrolizumab) as Merck’s anti-PD-1 therapy, a monotherapy or in combination with platinum and 5-fluorouracil (5-FU).

This approval  based on reports from the pivotal Phase 3 KEYNOTE-048 trial, in which KEYTRUDA, compared with standard treatment (cetuximab with carboplatin or cisplatin plus 5-FU), demonstrated a significant enhancement in overall survival (OS) as monotherapy and in combination with chemotherapy in patients whose tumors expressed PD-L1 (CPS ≥1).

From this disease  patient’s appearance and their daily functions, such as eating and speaking get affected.

KEYTRUDA monotherapy and combination regimen cover the market of all 28 EU member states plus including Iceland, Lichtenstein and Norway.KEYTRUDA 200 mg injection (IV) for every three weeks. https://www.mrknewsroom.com/news-release/oncology/european-commission-approves-two-new-regimens-mercks-keytruda-pembrolizumab-fi

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