<![CDATA[ The Biotechnician - Articles]]>Wed, 17 Feb 2016 04:49:47 -0800Weebly<![CDATA[Egg-freezing technology is making headlines]]>Tue, 16 Feb 2016 07:50:58 GMThttp://www.thebiotechnician.com/articles/-egg-freezing-technology-is-making-headlines
The recent news about former beauty queen Diana Hayden’s baby being born out of her eggs frozen almost eight years ago has thrust egg-freezing technology into the limelight. Relatively lesser-known in India when compared to other reproductive technologies like surrogacy and sperm donation, egg-freezing is now being hailed as a type of ‘insurance’ for women who want to start their families later in life.
We spoke to Dr Nandita Palshetkar, an IVF specialist at Lilavati Hospital, to learn more about the egg freezing technology, the safety of it, and the future of the technology.

The Biotechnician-Do you see the egg freezing medical technology taking off across India since women are working longer than before?
Dr Nandita Palshetkar-Yes, the egg freezing technology is surely being chosen by the women across India to preserve their fertility and delay childbearing due to medical or social reasons. The crucial aspect would be to increase the awareness on this subject so that more and more women become aware of the advantages of this technology. With celebrities like Diana Hayden coming forward to represent this, it would definitely support the awareness swiftly.
The Biotechnician-What are some of the risk that women can face using this type of technology?
Dr Nandita Palshetkar-Egg freezing technology is a safe technology.
The Biotechnician-What is the future of egg freezing technology? Do you see it improving in the next 5-8 years?
Dr Nandita Palshetkar-With the changes in our society and mindset of people, we can definitely expect egg freezing technology to move forward. Women who delay childbearing due to personal reasons, or women who are diagnosed with ovarian cancer now have a solution to store their eggs before the treatment of chemotherapy begins. Literacy rate is on the rise and when we’re talking about women empowerment, this becomes the technology of choice for career oriented women.
The Biotechnician-What are some other important things Bloom Fertility Centre is focusing on?
Dr Nandita Palshetkar-Our endeavour at Bloom Fertility Centre has always been to improve success rate for our patients. We have been the pioneers to introduce many advanced technologies for the first time in Asia as well as India. We can help the couples to conceive by using the latest technology of Embryoscope, IMSI (Intracytoplasmic Morphologically Selected Sperm Injection), Assisted Laser Hatching and Vitrification amongst others.

<![CDATA[Breast Cancer Market in APAC Region Hit $1.9 Billion in 2014 and Will Reach $3.4 Billion by 2021]]>Tue, 16 Feb 2016 07:28:10 GMThttp://www.thebiotechnician.com/articles/breast-cancer-market-in-apac-region-hit-19-billion-in-2014-and-will-reach-34-billion-by-2021
The Asia-Pacific (APAC) breast cancer market will experience considerable expansion from $1.9 billion in 2014 to $3.4 billion by 2021, at a Compound Annual Growth Rate (CAGR) of 8.5% according to a new report by GBI research.
Such growth, which will occur across the APAC regions of India, China, Australia, and Japan, will be driven by aging populations, changing lifestyle habits, improved survival rates, and a number of new approvals for drugs that are expected to supplement current market leaders.

Analyst Deekshita Allavarapu says: "It is anticipated that popular drugs, such as Afinitor and Herceptin, will be used in conjunction with several promising breast cancer pipeline treatments. These include abemaciclib, buparlisib, LEE 011, olaparib, and Neuvax, all of which are forecast to be approved by 2021 and have shown significant clinical benefit in trials.

"Such therapies are on the rise due to their increased use in conjunction with chemotherapy. In addition, the strong efficacy profile of targeted therapies has resulted in favorable reimbursement and increased uptake in Japan and Australia. This is despite the drugs' premium pricing, which reflects the cost associated with their development and the significant therapeutic benefit offered."

However, the analyst notes that in India and China, even after premium targeted treatments become available, only patients in the richer territories will be given these drugs, as patients in the poorer districts will not be able to afford them due to a lack of social insurance and inadequately publicly subsidized services.

GBI Research also states that applying for reimbursement for oncology drugs in Australia is becoming more complex due to a time-consuming and complex regulatory and reimbursement process prior to access, which causes a substantial delay in patient access.

"These factors limit the uptake of premium-priced therapies, which somewhat restricts overall breast cancer market growth. Nonetheless, the sheer size of the APAC populations means that, even if a relatively small percentage of patients are eligible for treatment, there will be high levels of revenue," Deekshita concludes.

<![CDATA[Shire Partner, Shionogi, Submits New Drug Application in Japan for ADHD Treatment for Children]]>Tue, 16 Feb 2016 07:27:11 GMThttp://www.thebiotechnician.com/articles/shire-partner-shionogi-submits-new-drug-application-in-japan-for-adhd-treatment-for-children
Shire and Shionogi & Co. recently announced that Shionogi submitted a New Drug Application (NDA) for the manufacturing and marketing in Japan of S-877503 (guanfacine hydrochloride prolonged release tablets),* for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children. The Japanese clinical studies were conducted in children 6 to 12 years old with this disorder.

Shire and Shionogi, under a co-development and commercialization licensing contract signed in 2011, have been developing S-877503 as an investigational pediatric ADHD candidate. Shionogi is a Japan-based pharmaceutical company focused on the research and development of treatments for various therapeutic areas, including central nervous system disorders and infectious diseases.

"This NDA is significant for patients, Shire and Shionogi. If approved, Shire will have another key product available in Japan, increasing patient access to more of our medicines in a market incredibly important on the world's stage," said Philip J. Vickers, Ph.D., Head of Research & Development, Shire. "Fortunately, we have a strong partner for our ADHD development and commercialization efforts in Shionogi, who has been central to our growth in Japan. Shire has a number of pipeline products, in addition to S-877503, intended for Japan, so we're excited about the possibilities for addressing more unmet patient needs in this country."
Shire Japan KK, Shire's local operating company (LOC), also has investigational candidates in the pipeline for hereditary angioedema, short-bowel syndrome, convulsive seizures and hypoparathyroidism. The LOC offers two therapies of its own on the Japanese market - one for Gaucher disease and the other for thrombocythemia - and partners with several other companies to develop new products for the Japanese market.

New therapeutic options for ADHD are needed in Japan. Multiple medicines for the disorder are approved and sold in the United States and Europe. However, only two ADHD medicines have been approved in Japan, where the anticipated regulatory review process for an NDA is approximately 12 months.

<![CDATA[Miss World Diana Hayden Delivers Girl From egg Frozen 8-years ago at Bloom Fertility Centre]]>Sat, 30 Jan 2016 08:52:19 GMThttp://www.thebiotechnician.com/articles/miss-world-diana-hayden-delivers-girl-from-egg-frozen-8-years-ago-at-bloom-fertility-centre
Bloom IVF Group, one of India's leading chains of IVF centres, and their recent medical marvel was at work when Diana Hayden successfully delivered a baby girl eight years after freezing her eggs due to lifestyle reasons between October 2007 and March 2008.

Diana Hayden had consulted Dr. Palshetkar, at 32, when she read about egg freezing for the first time in 2005 and subsequently she froze 16 eggs with Bloom Fertility Centre. She chose to freeze her eggs for two reasons: She was busy with her career at that time and, more importantly, she was very clear that she was going to wait to fall in love and marry before having a baby.

Dr. Pai and Dr. Palshetkar believe that Hayden could be a poster girl for egg freezing technology. "Egg freezing for medical reasons is done frequently, but I would say that Diana is among the first to use it for lifestyle reasons," said an elated team of Bloom IVF Group.

With career-oriented women of modern age spending long span of their lives in building a successful career, complications while conceiving and getting pregnant have become a common problem. At the age she plans to start a family (30-35+ years), it gets too late as per her biological conditions. She has to face severe issues in having a successful and healthy pregnancy. Women who delay childbearing due to personal reasons, or women who are diagnosed with ovarian cancer, now have a solution to store their eggs before the treatment of chemotherapy begins.

<![CDATA[Sinovac Biotech Announces Issuance of GMP Certificate for EV71 Vaccine]]>Sat, 30 Jan 2016 08:37:07 GMThttp://www.thebiotechnician.com/articles/-sinovac-biotech-announces-issuance-of-gmp-certificate-for-ev71-vaccine
Sinovac Biotech (SVA), a leading provider of biopharmaceutical products in China, announced today that the China Food and Drug Administration ("CFDA") has issued the Good Manufacturing Practices ("GMP") certificate to Sinovac for the Company's Enterovirus 71 ("EV71") vaccine.

This marks the completion of the final step of approval prior to commercial production. The company has begun commercial production of the EV71 vaccine and expects to deliver the vaccine to the market prior to the end of the second quarter of 2016 after the lot release testing is completed. The designed annual production capacity is 20 million doses.

As previously announced, the CFDA issued the new drug certificate and production license for Sinovac's EV71 vaccine on December 30, 2015, which was followed by the public notification on the status of the GMP certification starting from January 5, 2016 to January 18, 2016.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "The issuance of the GMP certificate has allowed us to begin commercial production of the EV71 vaccine. Sinovac has referenced the highest level of domestic and international quality standards throughout the development of the EV71 vaccine candidate and has established stringent controls to ensure product quality, safety and efficacy of the vaccine. After eight years under development, the EV71 vaccine demonstrates the proven capabilities of Sinovac's research and development efforts and significant achievements in the areas of etiology, epidemiology, vaccinology and clinical application. With the clinically-proven strong efficacy profile of our EV71 vaccine, we plan to collaborate with local CDC's to increase the vaccine coverage of this product and reduce the overall number of severe and fatal cases of Hand, Foot and Mouth Disease in China. We look forward to the broad adoption of our EV71 vaccine in the China market as well as the overseas market to provide a healthier environment for children globally with the protection of our EV71 vaccine."

<![CDATA[US based Catalent Pharma opens clinical supply facility in Japan ]]>Tue, 26 Jan 2016 11:14:50 GMThttp://www.thebiotechnician.com/articles/us-based-catalent-pharma-opens-clinical-supply-facility-in-japan
New Jersey-headquartered Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, consumer health products and global clinical supply services, has introduced clinical supply services at its 200,000-sq ft cGMP facility in Kakegawa, Japan. The site, which has been providing oral drug development and manufacturing solutions for more than 40 years, will offer clinical supply solutions to meet the needs of both domestic and global clinical trial sponsors.
The facility will provide full-service solutions, including project management and clinical supply management, comparator sourcing, secondary packaging and labeling, clinical storage, distribution, and drug return and destruction.

Construction has already begun at the facility and is expected to be fully validated and operational in the second quarter of 2016. The services it is to provide will complement those from Catalent's existing footprint in Asia-Pacific, which comprise a full service primary and secondary clinical packaging and storage facility in Shanghai, a secondary packaging and clinical storage facility in Singapore, and an extensive regional depot network.

"Catalent's site in Kakegawa will play a significant role in serving the market in Japan, the second largest pharmaceutical market worldwide and a key country for new global and domestic clinical trials," commented Wetteny Joseph, Catalent's President of Clinical Supply Services. "The Asia-Pacific region is a key part of our strategic growth initiatives and our site in Japan adds to Catalent's overall clinical supply capabilities in the region, where we will continue to make investments necessary to help meet customers' existing and future clinical trial demands."

With facilities in the US, UK, Germany, Singapore, and China, and an extended network of over 50 audited depots, Catalent's clinical supply services team has the capability and expertise to handle a broad range of international compliance and distribution requirements, that can help to expedite clinical trials and ensure that customers are reliably supplied where and when needed around the globe.
<![CDATA[Amgen Sues Samsung Bioepis for patents]]>Mon, 18 Jan 2016 15:12:06 GMThttp://www.thebiotechnician.com/articles/amgen-sues-samsung-bioepis-for-patents
Samsung’s biosimilar copies of Remicade and Lantus, both among the world’s top-selling biologic drugs, are close to gaining final sales approval in the U.S. and Europe, Roh said, adding these two drugs are not subject to patent issues.

At the same time, delays in commercializing its Enbrel biosimilar overseas, which comprises a major portion of Samsung Bioepis’ immediate sales outlook, could potentially drive down the firm’s market value and initial public offering price, according to the SK analyst.
Samsung Bioepis president and CEO Ko Han-sung (Samsung Bioepis)
While facing legal hurdles in Canada, Samsung’s Enbrel biosimilar Brenzys -- to be marketed as Benepali in Europe, was recently recommended for approval by the European Medicines Agency in November 2015.

Brenzys has also begun commercial sales in Korea, upon gaining approval by the country’s Ministry and Drug Safety in December 2015.

When asked about the possibility of patent suits that may block the drug’s sales in Europe, the Samsung Bioepis spokesperson said that “legal regulations concerning biosimilar drug sales in the region are different from that of Canada.”

As for launching its Enbrel biosimilar in the United States -- which together with Canada accounts for about 50 percent of the global biologics market -- Samsung Bioepis said it is “planning to submit the drug for approval by the U.S. Food and Drug Administration in the future, though no visible steps have been taken as of now.”

However, commercializing the Enbrel biosimilar in U.S. markets in the near future will be difficult, as Amgen successfully obtained a new patent (US 8,063,182) in 2011 to extend the original drug’s patent protection deadline to Nov. 22, 2028.

At the time, the news prompted U.S.-based pharma giant Merck Co. to call off a licensing deal on an Enbrel biosimilar in development by Hanwha Chemical, prompting the Korean drugmaker to pull out from the segment.

Eyeing robust growth in the coming decade, drug developers around the world, including Samsung, have jumped into the development of biosimilars.

This new segment of replicated biologic treatments is expected to grow into a multibillion-dollar industry in the years to come. Market analyst Research and Markets forecasts that biosimilars will reach annual sales of $32 billion worldwide by 2025.
<![CDATA[CENTRE TO SET UP 6 PHARMA AND 2 MEDICAL DEVICES PARKS]]>Mon, 18 Jan 2016 12:09:28 GMThttp://www.thebiotechnician.com/articles/centre-to-set-up-6-pharma-and-2-medical-devices-parks
New parks entails investment of about Rs 30,000 crores, says Ananth Kumar while releasing the report of task force set up for the development of pharmaceutical industry.

In line with Katoch Committee recommendations to augment manufacturing capabilities of pharmaceutical industry, the centre is planning to set up six pharma parks and two clusters for manufacturing medical devices in the country. Government is going to set up six pharma parks and two medical devices parks very soon which will involve an investment of about Rs 30,000 crores, said Ananth Kumar, Minister of Chemicals and Fertilizers while releasing the report of the task force on development of manufacturing capabilities in pharmaceutical industry, on January 13, 2016 in New Delhi. The minister also assured that recommendations by Katoch Committee on bulk drugs will be implemented soon.

Ananth Kumar said, Pharma industry in the country is a sunrise industry with $ 30 billion output and the Government is supporting the industry in taking up this output to $ 55 billion by 2020. The sector is growing at the rate of 14 percent per annum and it has to show additional 1-2 percent growth every year to reach the 2020 target

To fulfil the requirement of skilled manpower for the industry, the government has taken up human resource capacity building in this sector in a big way. The Minister informed, an the last one and a half years, there have been more Niper (National Institutes for Pharmaceutical Education and Research), more students, more infrastructure and more industry participation in them.

While in the current budget, three new Niper centres in Rajasthan, Chhattisgarh and Maharashtra have been announced, the Department of Pharmaceutical will propose another three centres in Madhya Pradesh, Andhra Pradesh and Karnataka for the next financial year.

The major objective for constitution of the task force (Katoch Committee) was to identify the gaps in production of drugs, vaccines etc in various therapeutic categories and to suggest remedial action. The task force chaired by Secretary, Pharmaceuticals has given recommendations with respect to policy support, infrastructure, skill development, duty structure, policy for pricing, regularity framework and promoting research and development for three different verticals - communicable diseases, non-communicable diseases, and bio-pharma, prophylactics and over-the-counter (OTC) products. The task force has recommended that taking steps to enhance access to safe and affordable medicines is crucial for addressing the burden of communicable and non-communicable diseases.
<![CDATA[Royal Philips and EDBI to Invest in Digital Health]]>Wed, 13 Jan 2016 11:45:26 GMThttp://www.thebiotechnician.com/articles/royal-philips-and-edbi-to-invest-in-digital-health
Royal Philips and EDBI, the corporate investment arm of the Singapore Economic Development Board, have signed a Memorandum of Understanding (MoU) to jointly invest in select, high-potential digital health companies, especially in the area of Population Health Management (PHM), from around the world seeking to break into the Asian market through Singapore. Under the MoU, EDBI and Philips will focus on mid-to-late stage digital health companies, allowing them to set up base in Singapore with the goal to serve the Asian market for Population Health Management.

The agreement will also create business opportunities, advance the local healthcare ecosystem and strengthen Singapore's position as one of the leading digital health hubs in Asia.
Having been involved in supporting the Biomedical Sciences sector over the last 25 years, EDBI will leverage its extensive investment network globally and in the region to accelerate the awarded companies' growth plans. Companies will also benefit from EDBI's connections to key local and regional stakeholders to aid their business development efforts and seize new market opportunities in Asia. Philips will provide mentorship to awarded companies, helping them develop the necessary skillsets required to run a scalable and sustainable business.

The companies will benefit from the Philips HealthSuite Digital Platform - a secure, cloud-based solution that collects and analyzes health data from multiple devices - and in turn, be able to develop applications that will enhance and contribute to the platform. These companies will also gain access to Philips' global network of business partners, customers and channels, creating tremendous business opportunities for digital health companies in this growing market. "As the first of many alliances to support open innovation by large corporations in Singapore, we are pleased to partner Philips for joint investments in PHM companies.

This partnership seeks effective uses of IT, like telehealth, which empower patients with greater responsibility over their health, in line with Singapore's vision of creating citizen-centric healthcare services where healthcare is moved from hospitals to community and homes," said Chu Swee Yeok, CEO and President, EDBI. "Within Singapore's pro-business environment, large corporations and fast growing companies can co-create novel high value solutions for the Asian market. We look forward to working closely with Philips on exciting investment opportunities."

"Through this partnership with EDBI, we hope to fuel the growth of innovative digital health companies by enabling access to Philips experts, our ecosystem of healthcare solutions and our extensive global network," said Fabian Wong, Chief Executive Officer of Philips ASEAN Pacific. "This will bring us closer to achieving our vision to improving the lives of three billion people a year by 2025, while developing Singapore's workforce to further strengthen the country's position as the leading medical hub in Asia. Ultimately, both EDBI and Philips are looking to build a robust digital health ecosystem to serve the needs of a growing and aging population in Asia."
<![CDATA[Prof Xianmin Zeng Becomes Axol Bioscience's CEO]]>Wed, 13 Jan 2016 11:42:59 GMThttp://www.thebiotechnician.com/articles/prof-xianmin-zeng-becomes-axol-biosciences-ceo
xol Bioscience, a biotechnology company, specialising in the use of stem cell technology to manufacture disease relevant cell based assay systems to the drug discovery industry, has appointed Prof Xianmin Zeng as Chief Scientific Officer (CSO).

Prof Zeng is a biologist with over 15 years of academic expertise in the development of stem cell technologies and its applications. A biotech entrepreneur with an extensive list of peer-reviewed publications, she is a well-established and internationally-recognised leader in the creation of disease models for drug discovery.
Prof Xianmin Zeng
Home Stem Cells Axol Bioscience appoints Prof Xianmin Zeng as CSO US 13 January 2016 News By BioSpectrum Bureau Axol Bioscience appoints Prof Xianmin Zeng as CSO 0 Comment 0 0 0 Email Print RSS Updated on 13 January 2016 Prof Zeng is a biologist with over 15 years of academic expertise in the development of stem cell technologies and its applications id-100154984 Singapore: Axol Bioscience, a biotechnology company, specialising in the use of stem cell technology to manufacture disease relevant cell based assay systems to the drug discovery industry, has appointed Prof Xianmin Zeng as Chief Scientific Officer (CSO).

Prof Zeng is a biologist with over 15 years of academic expertise in the development of stem cell technologies and its applications. A biotech entrepreneur with an extensive list of peer-reviewed publications, she is a well-established and internationally-recognised leader in the creation of disease models for drug discovery. With Prof Zeng as Axol's CSO, the company will be able to continue to offer highly-validated products and further improve upon their current processes under her expert guidance. As a key opinion leader in the field, she will offer strategic direction to help drive Axol's product development, so as to address some of the vital challenges in the drug discovery industry. Prof Zeng will continue in her current role as Associate Professor at the Buck Institute for Research on Aging in Novato, CA where her group focuses on developing stem cell-based treatments for neurodegenerative disorders.

Having not only developed and used induced pluripotent stem cells (iPSCs) in drug discovery and to study the pathophysiology of conditions such as Parkinson's disease, her group also refined the process to enhance the safety of these cells so that they may be used in the development of replacement therapies. Prof Zeng carried out her postdoctoral research on human embryonic stem cells (ESCs) at the National Institute of Health and holds a PhD in Molecular Biology from the Technical University of Denmark. Dr Yichen Shi, CEO, Axol Bioscience said, ‘Prof Zeng is recognised globally for her wealth of experience working with both human ESCs and iPSCs. Her insight and expertise in stem cell technologies, drug discovery and neurodegenerative disease modelling will be of enormous value to the innovative work we do here at Axol. We are delighted to have Prof Zeng on board as our CSO and look forward to expanding our portfolio of highly-validated stem cells and services'.