Month: October 2016

Do we need to revise human genetics?

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The normal human genome contains about 54 mutations that might sicken or even kill their bearer, but they don’t. Recently, medical genetics has been evolving, as the fast pace of genomic research has packed the literature with thousands of gene mutations associated with disease and disability. Many such associations are solid, but many others once suggested to be dangerous or even lethal are turning out to be not so through the Exome Aggregation Consortium, or ExAC.

ExAC combines sequences for the protein-coding region of the genome — the exome — from more than 60,000 people into one database, allowing scientists to compare and understand how variable they are. The resource is having tremendous impacts in biomedical research, by helping scientists to eliminate bogus disease–gene links, and generating new discoveries. By looking more closely at the frequency of mutations in different populations, researchers can gain insight into what many genes do and how their protein products function. ExAC has turned completely revised how we look at genetics, as instead of starting with a disease or trait and working backwards to find its genetic underpinnings, researchers can start with mutations that look like they should have an interesting effect and investigate what might be happening in the people who harbour them.

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Merck launches Biosimilars Clarified, a new online educational resource about biosimilar medicines for patients and the healthcare community

Merck has announced the launch of Biosimilars Clarified, a new educational website for patients, caregivers and the healthcare community that is designed to provide clear, concise and straightforward information about biosimilar medicines. Biosimilars Clarified is designed to help answer questions about biosimilars to the patients to help improve knowledge about the use of biosimilars in the treatment of different diseases.

ABITEC announces extension of product portfolio and enters new market

ABITEC’s R&D continues to develop innovative products that meet the ever evolving demands of the pharmaceutical market. The expansion of their non-ionic High HLB surfactant line, ACCONON®, offers a product that can be used in solid formulation as a high melt emulsifier and bioavailability enhancer.  ABITEC is also introducing to market their first line of functional lipid excipients for parenteral applications, INJECTA™.

First human clinical trial for nicotinamide riboside

In the first controlled clinical trial of nicotinamide riboside (NR), a newly discovered form of Vitamin B3, researchers have shown that the compound is safe for humans and increases levels of a cell metabolite that is critical for cellular energy production and protection against stress and DNA damage. The trial showed that the NR vitamin increased NAD+ metabolism by amounts directly related to the dose, and there were no serious side effects with any of the doses. The next step will be to study the effect of longer duration NR supplementation on NAD+ metabolism in healthy adults.

FDA awards 21 grants to stimulate product development for rare diseases

The USFDA Announced that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry with research spanning domestic and international clinical sites. The FDA awards the grants through the Orphan Products Clinical Trials Grants Program to encourage clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases.

Corden Pharma Expands Highly Potent API Capabilities

Corden Pharma has completed a new highly potent API process bay for category 4 compounds. This new investment comes after the completion in early 2016 of a new CTD2 facility for the handling (development/manufacturing) of oral solid dosage drug product manufacturing of highly potent and oncology compounds in its Plankstadt (Germany) facility, along with further expansion of capabilities in handling sterile oncology drug products at Latina (Italy).

Juniper Pharma Services Offers Granulation Capabilities

UK-based contract development and manufacturing organization (CDMO) Juniper Pharma Services has added a roller compactor to its enabling technologies platform. The company has purchased a Gerteis Mini-Pactor to expand its granulation capabilities and support recent capability. The Mini-Pactor offers the latest in dry granulation technology, which improves the material handling and processing characteristics of poor-flowing materials, such as amorphous solid dispersions and low dose compounds including potent materials.


JAK Inhibitors: New Lifeline for Hair Loss Treatment

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Janus Kinase (JAK) inhibitors are the ones that inhibit the functional activity of enzymes that belong to Janus Kinase family such as JAK1, JAK2, JAK3 and TYK2 by interfering in the JAK-STAT signaling pathway. JAK Inhibitors are used for the treatment purpose in cancer and inflammatory diseases like rheumatoid arthritis.

Studies conducted by team of Professor Angela Christiano at Columbia University suggested that JAK Inhibitors are also beneficial for treatment of autoimmune dermatological disease like alopecia Areata, a condition in which body’s natural immune system starts attacking hair follicles that lead to loss of hair on scalp or on other parts of body. JAK Inhibitors target the enzymes that are found inside the hair follicles, and bring out the follicles from Telogen to Anagen phase and promote active and healthy hair growth.

Ruxolitinib (Jakafi) is under development by Incyte Corporation. The drug is already marketed for Myelofibrosis and PolycythaemiaVera by the brand name Jakafi in United States and Jakavi by Novartis outside United States.  Tofacitinib (Xeljanz) is under development by Pfizer, the drug is marketed for rheumatoid arthritis in US with brand name Xeljanz and is filed for the approval for same indication in EU. In March 2016, Aclaris officially announced the acquisition of JAK Inhibitor compound, Vixen that has been developed by Columbia University for Alopecia Areata, Androgenetic Alopecia and other dermatological conditions.

With the rapidly growing middle aged population, changing lifestyles, presence of pollutants and chemicals in air and water globally; it is quite evident that people suffer from hair loss related problems more frequently. This can lead to mega demand and supply ratio for the hair loss treatment and drugs, which can propel the market in all seven key regions of USA, Europe and Eastern Regions of globe.

Insight by:
Anurag Mathur
Associate Analyst
DelveInsight Business Research



Liquid Biopsy: Revolutionary Technique for Cancer Diagnosis

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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
Associate Analyst
DelveInsight Business Research

DelveInsight’s Launch of Its New & Improved Report Store

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DelveInsight is delighted to announce the launch of its report store. Our report store is collection of 3000+ analytical reports from the pharmaceutical as well as biotechnological industry. The store lets you browse through the vast collection of reports, gives you an overview of the different types of reports on offering, and provides an idea of the report through the ‘Table of Contents’ and ‘Summary’ to help you in choosing a report that suits best to one’s need. These reports are not only high on quality, but also contain real time updated information till the date of delivery. For DelveInsight, customer satisfaction is paramount, for which we provide one on one interaction of client and the analyst.

Salient Features of DelveInsight’s Report Store:

  • DelveInsight report store is a comprehensive database of our reports that include API insights, epidemiology reports, market insights, drug insights, MOA and Indication insights etc.
  • The search can be customized as per the needs, in terms of type of report, date of publishing, price as well as sort the reports alphabetically. The reports can be seen in groups of 10, 25 or 100, so that your search is simplified.
  • While browsing for any report, DelveInsight provides a myriad of options so that the customer is thoroughly satisfied; report store has an overview of the report that details the areas covered.
  • Table of contents is also present, which allows the customer to browse the report content and topic covered, as well as provide an overview of the report through list of tables and figures.
  • There is a feature of “Enquire before buying” and “Request Sample Pages” tabs that lets you connect with the support team for further clarification, and better insight.
  • The customers also have the liberty to buy directly through the DelveInsight’s site, and can pay through PayPal or opt for wire transfer.

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Business Cocktail

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Bayer Partners with DelSiTech to Develop Innovative Drug Delivery Technology for Ophthalmology

Bayerhas partnered with a Finnish drug delivery and drug developmental company,DelSiTechLtd., through a Collaboration and Technology Licence Agreement. The agreement gives Bayer’s compounds a worldwide application of DelSiTech’s Silica Matrix drug delivery platform, especially in ophthalmology. DelSiTech is entitled to receive a number of undisclosed milestone payments triggered by the successful completion of different stages of development, and Bayer will fund all developmental and commercialization costs of the collaborative projects.

Amgen and Arrowhead Pharmaceuticals Announce Two Cardiovascular Collaborations

The collaboration of Amgen and Arrowhead Pharmaceuticals is for the development and commercialization of RNA interference (RNAi) therapies for cardiovascular disease.Under one agreement, Amgen receives a worldwide, exclusive license to Arrowhead‘s novel, RNAi ARC-LPA program. These RNAi molecules are designed to reduce elevated lipoprotein. Under the second agreement, Amgen receives an option to a worldwide, exclusive license for RNAi therapy for an undisclosed genetically validated cardiovascular target. In both agreements, Amgen will be wholly responsible for clinical development and commercialization.

Allergan, AstraZeneca Enter Licensing Agreement for MEDI2070

Allergan and AstraZeneca have entered an agreement for the global rights to MEDI2070, an anti-IL-23 monoclonal antibody currently in Phase II development for the treatment of moderate-to-severe Crohn’s disease and ulcerative colitis and other related conditions. AstraZeneca will receive $250 million upfront and potential payments of as much as $1.27 billion, including launch milestones of up to $435 million and sales-based milestones of $725 million, as well as royalties on product sales.

Lexicon Pharma announces Agreement to Buy Out Remaining Obligations to Symphony Icon

Lexicon Pharmaceuticals, Inc. has announced that it has entered into an agreement to buy out its remaining obligations under its clinical development financing arrangement with Symphony Icon Holdings LLC upon regulatory approval in the United States for the marketing and sale of telotristat ethyl. Under the buyout arrangement, Lexicon will make a single payment to Symphony Icon of $21.013 million upon U.S. regulatory approval of telotristat ethyl.

The Global M&A Frenzy Drops in the 3rd Quarter, Companies Wary of Overpaying

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The value of announced mergers and acquisitions (M&A) worldwide fell 27% to $753 billion in the third quarter of 2016, as the companies have become apprehensive in terms of overpaying, which totally prevented the repeat of last year’s deal-making frenzy. The Thomson Reuters M&A data is of the view that the frenzy that drove mergers and acquisitions in 2015 has subsided. Even though the M&A activity remains healthy, the companies have started to become more selective in their decisions. The largest deal in2016 was in the third quarter, when the German drug maker Bayer A.G. conducted a takeover of Monsanto Company, the U.S. seed maker. The deal is also the on-record biggest all-cash deal till date. Another factor that has weighed on M&A this year is the reluctance seen in the United States and several other countries who went on to seek a crack on deals that aid tax avoidance or risk harming national security.

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