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Hookipa and Gilead in Collaboration

Under the terms of the agreement, Gilead will provide an upfront payment of $10 million. Additionally, Hookipa will be eligible to receive milestone payments based upon the achievement of specified development, regulatory, and commercial milestones up to a total of more than $400 million. Gilead will fund all research and development activities. Hookipa will also be eligible to receive tiered royalties on net sales.

Hookipa Biotech AG and Gilead Sciences entered into a research collaboration and license agreement that grants Gilead exclusive rights to Hookipa's TheraT® and Vaxwave® arenavirus vector-based immunization technologies for two major chronic infectious disease indications, hepatitis B virus (HBV) and human immunodeficiency virus (HIV).

cemiplimab shows positive results in advanced cutaneous squamous cell carcinoma

Two studies evaluating cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC).

What is CSCC? CSCC is the second most common type of skin cancer in the U.S. CSCC has a good prognosis when caught early, the cancer can prove especially difficult to treat effectively when it is advanced, and patients can experience reduced quality of life due to the impact of the disease as it progresses.

What is Cemiplimab? Cemiplimab is being jointly developed by Sanofi and Regeneron Pharmaceuticals. Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 (programmed death 1)

#Cancer Cemiplimab Regeneron Sanofi

Merck and Premier Inc in Collaboration

Merck and Premier Inc are in collaboration to help reduce Clostridium difficile infection.

What is Clostridium difficile infection? Clostridium difficile is a bacteria that causes serious and life-threatening diarrhea and it has become the most common microbial cause of healthcare-associated infections.

Insights of Partnership: Merck and Premier® will develop and test the combination of a software-based platform and a coordinator to provide surveillance, consultation, support and education to patients with C. diff at participating Premier member health systems. The goal is to increase patient access to healthcare services, raise awareness of how to decrease patient risk of recurrence and help patients identify if they are having a recurrence.

The proposed C. diff intervention will be tested within volunteer Premier member health systems.

Lupin launches Solosec™ (secnidazole) in the US

Indian Pharmaceutical subsidiary company Lupin Inc launched Solosec™ (secnidazole) 2g oral granules in the US market, having received an approval from the United States Food and Drug Administration (FDA) earlier.

What is Solosec™ ? It contains Secnidazole, given as 2g oral granules, is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis (BV) in adult women. It is the first new Oral antibiotic to treat BV.

Solosec™ was generally well tolerated with a low incidence of side effects. The FDA designated Solosec™ as a Qualified Infectious Disease Product (QIDP) for the treatment of BV and granted it Fast Track designation, which made Solosec™ eligible for at least 10 years of U.S. market exclusivity.

#fda Solosec Lupin

New Study Founds Tecentriq will make Life Longer in Lung Cancer Patients

A New Clinical study found that Tecentriq (atezolizumab) when used along with carboplatin and Abraxane in Lung Cancer Patients helped live significantly longer compared to chemotherapy alone. Tecentriq is a brand of Roche.

What is NSCLC? NSCLC is abbreviated as Non Small Cell Lung Cancer (NSCLC) is a leading cause of cancer deaths globally. NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterized by flat cells covering the airway surface when viewed under a microscope.

What is Tecentriq? A monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.

#NSCLC cancer Tecentriq #Roche

Promacta receives FDA Priority Review for Severe Aplastic Anemia

US Food and Drug Administration has accepted the company's supplemental New Drug Application (sNDA) and granted Priority Review designation to Promacta® (eltrombopag) in combination with standard immunosuppressive therapy (IST) for first-line treatment of severe aplastic anemia (SAA).

What is Severe Aplastic Anemia? A life-threatening, acquired blood disorder that patient’s bone marrow fails to produce enough red blood cells, white blood cells and platelets. The cause is due to from prolonged pancytopenia.

What is Promacta? Promacta is a oral thrombopoietin receptor agonist which is used in refractory setting in Severe Aplastic Anemia.

What will happen with FDA Priority Review? If a treatment given FDA Priority review designation to issue a decision within six months of application submission, rather than ten months for standard review. As per US FDA, Priority review given to treatment of Life Threatening disease or condition.

Promacta ® is a brand of Novartis Pharmaceuticals and is marketed as Revolade® in countries outside US.

#fda #anemia

US FDA Granted Breakthrough designation to Xalkori

US Food and Drug Administration granted Breakthrough Designation to Xalkori (crizotinib) for treatment of patients with metastatic non-small cell lung cancer with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy and also also granted Breakthrough Therapy designation for XALKORI for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.

Anaplastic large cell lymphoma, is a rare type of non-Hodgkin lymphoma. Crizotinib is a tyrosine kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.

MET is a transmembrane tyrosine receptor kinase which is expressed in several types of cells. In patients with NSCLC, MET exon 14 alterations occur in approximately three percent of NSCLC tumors.

#fda #xalkori #cancer

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