Today’s opportunity for Indian companies in biosimilars is not much different from that of the generics industry in 1984. According to Ministry of Commerce and Industry, India’s pharmaceutical export segment has more than doubled from $ 7.8 billion in 2008 to $ 16.5 billion in 2014. With biologic treatments introduced for diseases such as diabetes, cancer, multiple sclerosis, and rheumatoid arthritis, potentially lucrative biosimilar market could emerge as another growth driver of India’s pharmaceutical sector. India has a strong potential to emerge as a key player in the manufacture and marketing of biosimilars.
There are few Indian pharmaceutical companies substantially investing resources towards expanding their biosimilar portfolios. Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company, is one of the key players in the forefront of the biosimilar segment and has developed Reditux™, the world’s first biosimilar antibody. Biocon Ltd, which received its first approval for insulin glargine in a developed market (Japan) in March this year, is gearing up to submit application for approval in Europe and the US for its four products in FY17.
To increase global reach and market acceptance of their products, Indian companies are setting up manufacturing base overseas. For example, Biocon has reportedly invested $ 200 million on its just commissioned insulin plant in Malaysia. Similarly, Cipla is investing about Rs 600 crore (Rand 1.3 billion) in the new biosimilar manufacturing facility in South Africa, which the company intends to use to serve local as well export markets such as US, Europe and Asia.
Though biosimilars have emerged as important tool to treat cancer and autoimmune diseases, they are only used by about 8 percent of patients worldwide due to the high costs of these drugs. As more companies join the bio-generics race, prices are likely to fall resulting in higher usage. Although India does not have stringent regulations, it has a big potential for biosimilars. Most innovator biotherapeutics are unaffordable to the average patient in India, even though the price in the local market is usually lower than that in Western countries.
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Teaching parents of children with autism how to interact more effectively with their offspring brings the children benefits that linger for years, according to the largest and longest-running study of autism interventions. The training targeted parents with 2–4-year-old children with autism. Six years after the adults completed the year-long course, their children showed better social communication and reduced repetitive behaviours, and fewer were considered to have “severe” autism as compared to a control group, according to results published on 25 October in The Lancet. Child psychiatrist Jonathan Green of the University of Manchester, and an investigator on the study said that even though it is not a cure, yet it does have a sustained and substantial reduction in severity and that’s important in families. Although the therapy benefited communication skills and decreased repetitive behaviours, it did not lessen anxiety.
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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.
Before approving an investigational drug, safety and effectivity needs to be proven. Something different happened with Sarepta’s Muscular dystrophy drug Eteplirsen, as its luck changed completely when the U.S. Food and Drug Administration on 19th September 2016 approved Sarepta Therapeutics’ Exondys 51 (eteplirsen) injection to treat patients with Duchenne muscular dystrophy (DMD). Exondys51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD. This is the first drug to get approved for this rare disease.
Earlier in March, 2016, FDA had declared that it was not able to decide on Sarepta’s eteplirsen and needed more time to review. In making this decision, FDA considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease for these children and the lack of available therapy. Under the accelerated approval provisions, FDA required Sarepta Therapeutics to conduct a clinical trial to confirm the drug’s clinical benefit. In a complete turn of events, FDA approved Exondys 51 (eteplirsen) for the treatment of Duchenne muscular dystrophy (DMD), leading the stock to more than double in price in just a few days.
Sarepta’s drug has many health insurance providers are on board with it, others like Anthem Inc are still questioning whether it will do its customers any good — given the drug’s accelerated approval. Additionally, on October 5, Sarepta Therapeutics and Summit Therapeutics partnered to advance the development of novel therapies for the treatment of Duchenne muscular dystrophy.
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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.
Sun Pharma & ICGEB announce exclusive collaboration to develop novel dengue vaccine
International Centre for Genetic Engineering and Biotechnology (ICGEB) and Sun Pharma Ltd. announced their new collaboration for development of a dengue vaccine, targeted against all the four serotypes of Dengue virus that cause disease in humans. ICGEB has developed a tailored recombinant virus-like-particle (VLP) based tetravalent dengue vaccine, containing host-receptor binding domain of envelope protein of all the four DENV serotypes. ICGEB has conducted pre-clinical studies over the past seven years and developed the existing Know-How and Patents for this dengue vaccine candidate.
Boehringer Ingelheim and Lupin Sign agreement for Diabetes Drug
Drug firms Boehringer Ingelheim and Lupin have entered into a partnership to co-market Empagliflozin used for treatment of type 2 diabetes in India. Lupin will market and sell Empagliflozin under a separate brand name Gibtulio which will be promoted by Lupin’s specialty field force. Boehringer Ingelheim will continue to sell Empagliflozin under the brand name Jardiance through their existing sales force and network
Daiichi Sankyo Announces New Strategic Immuno-Oncology Research Collaboration with AgonOx
Daiichi Sankyo announced that it has entered into a strategic collaboration with AgonOx, Inc., a privately held biotechnology company developing a pipeline of novel immunotherapy drugs targeting key regulators of the immune response to cancer, to develop an undisclosed immuno-oncology target. Daiichi Sankyo and AgonOx will collaborate on preclinical development of the program. Following preclinical assessment, Daiichi Sankyo has an exclusive option to research, develop, manufacture and commercialize the program worldwide
Catalent Pharma Solutions partners with Samsung Bioepis Co. for Commercial Biosimilar supply
Catalent Pharma Solutions announced that it is to provide fill-finish production services for the commercial supply of SB4, a biosimilar referencing Enbrel® (etanercept), on behalf of the Korea-based biopharmaceutical company Samsung Bioepis Co., Ltd. The services will be provided at Catalent’s flagship sterile pre-filled syringe facility in Brussels, Belgium. SB4 is the first etanercept biosimilar to receive regulatory approval by the European Commission (EC), as Benepali.
Celltrion Healthcare and Teva enters into exclusive business collaboration agreement for Truxima™ and Herzuma™ in the U.S. and Canada
Celltrion’s commercial partner for its second and third biosimilars for the North America market has been determined. Celltrion announced that it has selected Teva Pharmaceuticals, as its exclusive commercial partner for Truxima and Herzuma in the US and Canada. Celltrion has applied for marketing authorization from the EMA last October. Mabthera (also known as Rituxan), the reference product to Truxima, was developed by Biogen and marketed by Roche. Herzuma is a biosimilar to Herceptin, a breast cancer treatment antibody biologic drug developed by Genentech and marketed by Roche.
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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.