Boston Biomedical starts phase III study of Napabucasin
Boston Biomedical, an industry leader in the development of novel compounds designed to target cancer stemness pathways, announced dosing of the first patient in CanStem303C, a new global phase III study investigating napabucasin in combination with standard of care (Folfiri) in patients with previously treated metastatic colorectal carcinoma (mCRC). Napabucasin is an orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3.
Martindale Pharma’s clobazam oral suspension receives approval from seven European countries
Martindale Pharma, UK-based international specialty pharmaceutical company, announced the regulatory approval of its clobazam oral suspension product, Epaclob. The suspension has received approval in France, Ireland, Germany and Italy and Silocalm in Denmark, Spain and Iceland following the successful completion of a decentralised procedure (DCP). Epaclob/Silocalm are based on Tapclob, and are approved in two strengths, 5mg/5ml and 10mg/5ml. They will be supplied in packs containing dosing syringes and dosage cups to facilitate accurate dosing and aid adherence to treatment.
Merck snagged a green light for Zinplava
The anti-infectives field is heating up–and Merck’s the latest Big Pharma player to win approval for a new entrant. The medicine meant to reduce resistance of Clostridium difficile infection in adults. Zinplava will join a Merck anti-infectives portfolio that took shape with its early 2015 purchase of Cubist Pharmaceuticals. Zinplava also faces the prospect of competition not only from other drugs, but also from vaccines that might prevent C. Diff altogether. Pfizer and Sanofi are each working on versions, and smaller vaccine makers are in the mix, too.
Nanotechnology to improve HIV drug therapies
Researchers at the University of Liverpool, UK, are exploring the use of nanotechnology to improve administration and availability of drug therapies to HIV patients. A recent investigation conducted by Pharmacologist professor Andrew Owen and Materials Chemist professor Steve Rannard, has discovered that HIV patient groups have shown their desire to switch to nanomedicine alternatives. They are working on the development of new oral therapies, by using solid drug nanoparticle (SDN) technology. The SDN technology is anticipated to reduce both the dose and the cost per dose.
Biocon’s Malaysia insulin plant will be ready for commercial production in H2
India’s Biocon has been working for six years on a massive, $250 million facility to manufacture insulin in Malaysia and says it will soon produce commercial product there. The company’s plant is in Nusajaya, which was certified by authorities this year, and has 400 employees and represents the largest foreign investment made in Malaysia’s biotech sector to date. It also is Biocon’s first overseas biopharma manufacturing and research facility.
The recent outbreak of Dengue in Asia has brought forward the threat of mosquito bite into the spotlight again. Dengue is a kind of viral infection caused by mosquito bite, and the disease has now become a threat to about 390 million people, as these many are estimated to be infected each year. This incidence of infection in recent decades has soared and the world has been a witness to a great number of deaths globally. Asia is emerging to be the most impacted region with about 75% of the global burden of dengue.
According to World Health Organization (WHO), the number of the cases in Malaysia, Philippines, Vietnam and India has increased alarmingly, as compared to what it was two years ago. However, there is hope for its effective treatment and cure, as Sanofi Pasteur has successfully developed a vaccine after investing approximately 20 years in R&D. Sanofi Pasteur is the first company to come up with dengue vaccine named as “Dengvaxia”. According to Sanofi, they want to make the drug available to everyone, particularly to the low income countries. For this they have joined hands with a number of International Organizations like World Health Organization (WHO), United Nations Children’s Fund (UNICEF), and Red Cross.
So far, the drug has got market approval in 11 countries, including Mexico, Philippines, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand and Singapore; Mexico is the one to become the first country to license it. The company is now waiting for its approval from the Indian government which may take some more time as the government has asked to conduct more trials before granting permission.
Neil Ferguson, Director of the MRC center for Outbreak Analysis and Modeling at Imperial College London, conducted a study that used the previous data to determine its effect in various settings found out that the vaccine may not work properly in areas where there is low prevalence of dengue; the WHO has thus not recommended countries to implement a national vaccination program using Dengvaxia. Companies like Sun Pharma, Takeda and Butantan Institute, Brazil are also working on dengue vaccine and we can expect a more efficacy from their products.
Clinicians have been conducting biopsies for a long time, for diagnosing and managing cancer, as genetic profile of tumor is analyzed through biopsy. Tissue biopsy is a traditional biopsy technique which is a time consuming and lengthy procedure, and cannot be performed routinely. Liquid Biopsy is a next generation cancer test which is an alternative to tissue biopsy. It helps in early detection of various cancers such as Breast Cancer, Ovarian Cancer, Prostate Cancer and Colon Cancer as it detects mutations in fragments of tumor DNA and tumor cells.
Liquid Biopsy is recommended for monitoring treatment response, genetic changes and resistance mechanisms in the tumor. It provides complete genetic information of genes such as Epidermal Growth Factor Receptor (EGFR) and Serine/threonine-protein kinase (BRAF) expressed on various cancer cells. It is based on Polymerase Chain Reaction (PCR) amplification or Next-Generation Sequencing (NGS) technology, and involves analysis of genetic markers such as Cell Free DNA (cfDNA) and Circulating Tumor Cells (CTCs) for tumor detection. It also detects more than two mutations that can occur in some cancers such as Melanoma and Lung Cancers, which is an advantage over tissue biopsy as the latter fails to detect two to four genetic mutations.
The process involves three step procedure including phlebotomy, separation of plasma cells from blood, isolation of cfDNA and analysis of cfDNA. It provides high positive predictive value, is safe and easy to perform and provides complete tumor genetics of a patient.
Several liquid biopsies tests have been approved. Among them, Cell Search test developed by Veridex was the first liquid biopsy screening test to be approved in China in 2012 for diagnosis of Breast Cancer. In 2015, CancerIntercept developed by Pathway Genomics was approved. Recently, Cobas EGFR Mutation Test V2 developed by Roche was approved by USFDA in 2016 for diagnosis of Non-small cell lung cancer (NSCLC). Several Companies such as San Diego, OncoCyte Corp, Myriad Genetics and Veracyte are developing liquid biopsy tests, while IIlumina, Guardant Health and Inivata are raising funding for the development of liquid biopsy tests.
Insight by: Diksha Wadhwa
DelveInsight Business Research
DelveInsight is helping worldwide Pharmaceutical companies with its Market Intelligence Reports.
Infectious Diseases and Vaccines
The infectious disease (ID) vaccine pipeline is rich and robust. However, indications such as HIV, Tuberculosis and HCV have high demand for the development of a first vaccine, and even routine vaccinations, such as those for influenza can be improved in terms of safety and efficacy. Such unmet needs are driving the continued development of ID vaccines.
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The research work for curing Infectious disease has rapidly assumed a prioritized role within the overall scientific portfolio. The number of vaccines development underway has increased substantially for the HCV, HIV, Tuberculosis and Influenza infections.
Get notified about all the under development vaccines worldwide and the technology they are using, stage of development, their targets, mechanism of action with our Pipeline reports. The best strategic report that will not even give you the overall developing drug profiles but also therapeutic assessment and comparative analysis at every step such as monotherapy, combination, route of administration.
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