Indian firm Strides Acrolab gets FDA nod for generic cancer drug

Indian drug firm Strides Arcolab announced it had received approval from the USFDA for the its generic Fluorouracil Injection which will be used to treat various types of cancer. The company’s wholly-owned subsidiary Onco Therapies Ltd has received two approvals from the United States Food and Drug Administration for its abbreviated new drug applications (ANDA) for Fluorouracil Injection USP in two strengths. 
The approvals are for the injection in the strengths of 50 mg / ml, packaged in 10 ml and 20 ml single-dose vials and 2.5 g/ 50 ml and 5 g / 100 ml pharmacy bulk packages, it added. Fluorouracil is among the products in the drug shortage list of USFDA and according to IMS data, the US market for generic Fluorouracil is nearly $14 million.
http://health.india.com/news/indian-firm-strides-acrolab-gets-fda-nod-for-generic-cancer-drug/

Carl Zeiss opens development unit in Bangalore

Carl Zeiss has been present in India since1998,butlargely as a sales and service business. The company manufactures an array of products ranging from prescription spectacle lenses to diagnostic and surgical equipments that are used in the fields of ophthalmology, neuro-surgery and cancer treatment, and in camera lenses.
The 4.2-billion euro German manufacturing company Carl Zeiss has established a research and development unit and two manufacturing facilities in Electronics City in Bangalore. 
http://timesofindia.indiatimes.com/business/india-business/Carl-Zeiss-opens-development-unit-in-Bangalore/articleshow/14845713.cms

Finoso Pharma forms JV with CritiTech

Hyderabad-based Finoso Pharma Private Limited, a formulation development company, on Thursday formed a 50:50 joint venture (JV) with US-based CritiTech Inc, a drug development company.

The joint venture will provide alternative API (active pharmaceutical ingredient) size reduction technology and particle design services to the pharmaceutical industry with associated formulation services to meet the research and development (R&D) and the early-clinical trial supply needs.

The focus will be on generic components and on therapeutic areas including anti-cancer and lung disease areas.

http://www.business-standard.com/india/news/finoso-pharma-forms-jvcrititech/480245/

Adcock buys India drug assets for $86 mn

South African drugmaker Adcock Ingram is to buy a portfolio of about 60 medicines and a distribution network from India’s Cosme Farma for $86 million to bulk up its pres-ence in the country’s $16-billion pharmaceutical market.
Privately held and family-owned, Cosme is a pan-Indian drugs company based in Goa with offices in Mumbai. It has a sales force with about 1,000 staff, making it a smaller player in India’s vast market.
http://www.business-standard.com/india/news/adcock-buys-india-drug-assets-for-86-mn/480068/

Opto Circuits launches new cardiac device in Europe

Medical equipment maker Opto Circuits today said it has launched its automated external defibrillators under the brand 'Powerheart G5' in Europe.

The company's subsidiary Cardiac Science Corporation has launched the product which is designed to provide effective life saving aid to a person who has suffered sudden cardiac arrest (SCA), Opto Circuits said in a filing to BSE.

Commenting on the development Opto Circuits Chairman and Managing Director Vinod Ramnani said: "The Powerheart G5's combination of life saving features and intuitive controls will appeal to current and new customers in work places, public spaces and emergency services".
The company said that automated external defibrillators market is valued at USD 550 million as of 2011.
Each year as many as 7,00,000 lives are lost to SCA in Europe, it added.

http://business-standard.com/india/news/opto-circuits-launches-new-cardiac-device-in-europe/173996/on

Code to bar pharma industry from luring doctors with gifts

The move seeks to end the skewed legal regime in which a mandatory code makes it illegal for doctors to accept "favours" from the pharmaceuticals industry but there is no such deterrent for drug makers from offering inducements to medical practitioners. 
According to sources, the department of pharmaceuticals in the chemicals and fertilizers ministry has called the industry, health ministry and revenue department on July 18 to discuss the marketing practices to be enjoined upon drug-makers. 
The continuing tryst with code of ethics in the health industry is blamed on the mismatch in the "dos and don'ts" for doctors and the industry. 
http://timesofindia.indiatimes.com/india/Code-to-bar-pharma-industry-from-luring-doctors-with-gifts/articleshow/14754579.cms

Indian pharma cos secure approval for 88 ANDAs from US FDA in first half of 2012

The investments in R&D is yielding better results for the Indian pharmaceutical companies and their subsidiaries with higher approvals for ANDAs despite existing stringent approvals norms of US FDA. Indian companies managed to get 88 ANDA approvals from US FDA during the first half ended June 2012 which worked out to 41.1 per cent of the total approvals of 214 ANDAs. During first half of 2011, US FDA approved a total 238 ANDAs, out of which Indian companies received 88 final approvals.
Further, Indian pharma companies obtained 21 tentative approvals during January-June 2012 from US FDA as against 19 in the corresponding period of last year. The total tentative approvals were 49 during the first half of 2012 as compared to 50 in the last period.
Sun Pharma and its subsidiaries, including Taro Pharmaceuticals, received highest final ANDA approvals for 12 products during the first half of 2012. Aurobindo Pharma, Dr Reddy's Laboratories and Strides Arcolab got 9 final approvals each. During 2011, US FDA approved 431 ANDAs, out of which Indian companies grabbed 144 final approvals.
http://pharmabiz.com/NewsDetails.aspx?aid=69955&sid=1

GE Healthcare to add 400 jobs in India this year

GE Healthcare will increase its workforce by about 10 per cent in India to 4,400 people by the end of this year as it looks to strengthen research work in the country.
“We will be adding 10 percent more to our present strength of 4,000 employees in India by the end of this year,” GE Healthcare South Asia president and CEO Terri Bresenham said.

Bresenham said the company has plans to enhance its research and development team of 1,200 people in India.

“Out of these 400, between 150 to 200 people will be in research and development (R&D),” she added.

http://www.firstpost.com/business/ge-healthcare-to-add-400-jobs-in-india-this-year-371764.html

India to give free generic drugs to hundreds of millions

• India has put in place a $5.4-billion policy to provide free generic medicine to patients, vastly expanding access to drugs in the country, as reported Thursday in The Asahi Shimbun.
• Under the plan, doctors will be limited to a generics-only drug list and face punishment for prescribing branded medicines, and the government expects that within five years, up to half of India's 1.2 billion people are likely to take advantage of the scheme.
• "The policy of the government is to promote greater and rational use of generic medicines that are of standard quality," said L.C. Goyal, additional secretary at India's Ministry of Health and Family Welfare, adding that "they are much, much cheaper than the branded ones."
• Chris Stirling of KPMG said that "pharmaceutical firms will likely rethink their emerging markets strategies carefully to take account of this development, and any similar copycat moves across other geographies."
• "Without a doubt, it is a considerable blow to an already beleaguered industry, recently the subject of several disadvantageous decisions in India," Stirling added.
• However, he noted that "the move will please the generics manufacturers who stand to gain substantially in competing for contracts."

http://www.firstwordpharma.com/node/999234

Dr. Reddy's seeks to introduce biosimilars in developed markets

Dr. Reddy's Laboratories is planning to introduce its biosimilar drugs in developed markets, according to chairman K Anji Reddy. "The company's biosimilars business grew by 45 percent over last year and recorded sales of $26 million" in fiscal 2012, the executive stated in Dr. Reddy's annual report, adding that the treatments are available "at prices that are significantly more affordable than the corresponding innovator drugs."

Dr. Reddy's current portfolio of biosimilars is comprised of filgrastim, peg-filgrastim, rituximab and darbepoetin alfa, which are sold in 13 emerging markets. According to Reddy, the company is awaiting approvals for biosimilar filings in 20 other countries and is also making progress in regulated markets

• Last month, the company entered into a partnership with Merck KGaA's Serono division to co-develop a portfolio of biosimilar compounds in oncology, notably monoclonal antibodies. The deal includes development, manufacturing and commercialisation of the drugs globally, barring certain country exceptions. Reddy noted that "with 177 biosimilar and copy biologics, oncology is currently the largest target therapeutic area for development and marketing of biosimilars."
• Reddy also indicated in the annual report that Dr. Reddy's will enter the Japanese generic market through its joint venture with Fujifilm, "with a plan to launch the first products in the next three to four years." The drugmaker expects that the limited competition experienced by generic launches in Japan could help it achieve sustainable growth.

http://www.firstwordpharma.com/node/998803

Govt considering Rs 2,000 cr VC fund for pharma

Government  is considering forming a venture capital fund of Rs 2,000 crore to promote research and development (R&D) in the pharmaceutical sector.
Government today said it is considering forming a venture capital fund of Rs 2,000 crore to promote research and development (R&D) in the pharmaceutical sector.
http://www.moneycontrol.com/smementor/news/government-policy/govt-considering-rs-2000-cr-vc-fund-for-pharma-725707.html

Merck in talks to Buy Micro Labs

Merck & Co. Inc., the second largest drugmaker in the US is in talks to buy Bangalore-based active pharmaceutical ingredients maker Micro Labs LtdThe privately-run company aims to achieve $1 billion sales by 2015, according to its website.
In April, the company announced that it was in separate talks with GlaxoSmithKline and Teva Pharma.
http://www.domain-b.com/companies/companies_m/Merck/20120621_bangalore_based.html

India released "Guidelines on Similar Biologics"

India pavilion at 2012 BIO International Convention was inaugurated by Dr M K Bhan, Secretary, DBT on 19 June 2012 jointly organised by CII, ABLE and the Department of Biotechnology, Govt of India. All together 25 exhibitors representing different verticals of biotech industry participated at the India pavilion.
Dignitaries like Dr Kiran Mazumdar Shaw, CMD, Biocon Ltd, Mr. James C. Greenwood, President and CEO Biotechnology Industry Organization (BIO); Mr S Raghavan, Joint Secretary, DBT; Ms Anuradha Mitra, Joint Secretary and Financial Adviser, DBT ; Dr Madan Mohan, Adviser, DBT were present in the inaugural function.
On the sidelines of BIO2012, a press conference was organised to release the Guidelines on Similar Biologics.

• The guidelines were jointly prepared by Dept of Biotechnology, Ministry of Science and Technology and Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, Government of India in consultation with industry and other key stakeholders.
• These guidelines provide insights into preclinical evaluation of those recombinant products that are claimed to be already approved biopharmaceutical products, referred as “ similar biologics” and therefore partly rely on the data from the already approved products for approving safety, purity, potency and effectiveness

http://indiaeducationdiary.in/Shownews.asp?newsid=13749

Bharat Biotech and University of Maryland Accelerate Development of New Life Saving Conjugate Vaccine for Invasive Non-Typhoidal Salmonella (iNTS)

Bharat Biotech and The University of Maryland Center for Vaccine Development ("CVD") announced a significant milestone achievement- receiving a USD 4 Million Strategic Translation Award from The Wellcome Trust for clinical development of a new conjugate vaccine including initial clinical trials beginning in three years to prevent the potentially lethal infectious disease caused by invasive non-typhoidal Salmonella (NTS)Experts from Bharat Biotech and University of Maryland's are upbeat on the prospects of developing NTS Conjugate Vaccine. They stated this PPP project represents a true translational public-private partnership that not only enables potentially lifesaving vaccine technology to move towards the marketplace and to the public health arena, but also demonstrates international multi-party technology transfer collaborations to help advance its science.
http://www.indiaprwire.com/pressrelease/health-care/20120618122792.htm

India and US sign agreement on collaboration in Diabetes research

Indian and US have signed an agreement on collaboration in Diabetes Research. The agreement was signed between Ghulam Nabi Azad, Union Minister for Health and Family Welfare and Kathleen Sebelius, US Secretary, Health and Human Services during the bilateral meeting between India and the US. This is the eighth agreement between the two countries in the field of health and medicine.
The primary aim of this collaboration is to initiate a health research relationship between the two countries to generate a better understanding of the molecular and biological mechanisms underlying diabetes, to characterize the genetic, social and environmental determinants, and to identify innovative approaches for improving prevention and treatment of diabetes.

The main areas of cooperation will include identification of genetic and environmental etiologic factors and pathogenic mechanisms underlying development of diabetes and its complications; development of improved approaches and diagnostic tools to identify those with and at risk of diabetes and its complications; development and evaluation of innovative, sustainable intervention strategies for the prevention and/or treatment of diabetes and its associated co-morbidities; development and testing new treatment methodologies, including point of care and telemedicine technologies, diabetes self-management approaches, and improved technologies for insulin delivery and monitoring of glycemic control; study of the impact of social, economic, cultural and environmental factors on diabetes risk and management etc

http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/healthcare/india-and-us-sign-agreement-on-collaboration-in-diabetes-research/articleshow/14233613.cms

Shasun Pharma setting up intermediates facility in AP

Shasun Pharmaceuticals Limited is planning for backward integration by entering into manufacture of intermediates, initially with starting material for some of its key active pharmaceutical ingredients (APIs).
The company will be setting up a manufacturing facility for some of its petroleum products (for its APIs, which are used as ingredients in drugs) at Naidupeta in Andhra Pradesh with an investment of Rs 50 crore
http://www.business-standard.com/india/news/shasun-pharma-settingintermediates-facility-in-ap/477622/

Philips begins operations at greenfield healthcare manufacturing facility in India

In line with its strategy to expand the company’s industrial footprint in India, Royal Philips Electronics today announced commencement of operations at its first greenfield manufacturing facility for imaging systems in the country.

• Located in Chakan, near Pune, 200 kilometers east of Mumbai, the Philips Development and Manufacturing Centre will play an essential role in Philips’ commitment to locally develop and produce meaningful products and solutions that help improve access to healthcare for people in India and other growth geographies.
• The facility will focus on diagnostic and interventional imaging solutions, initially developed for the Indian market and then for global markets. These solutions will primarily target cardiology (catheterisation lab) and radiology (general X-ray) applications.
• The first products to be manufactured in the facility will be diagnostic X-Ray systems and the Allura FC – Philips’ first India developed catheterisation lab.Both products are aimed at the value segment in India and abroad.
• Philips conducted in-depth research to understand the on-the-ground requirements in India and worked closely with healthcare partners to gain better insight into their ‘made in India’ needs. The Pune facility will deliver this type of ‘designed for India’ product, enabling healthcare providers in the country to provide care to those communities who have not had access to high-quality healthcare in the past.

http://pharmabiz.com/NewsDetails.aspx?aid=69559&sid=2

Boehringer-Lilly alliance to launch first new diabetes drug in India

The diabetes products alliance between multinationals drug-makers Eli Lilly and Boehringer Ingelheim is set to roll out its first new product under the alliance.

Next week, Boehringer Ingelheim’s oral product Linagliptin will be available at chemists.
The product would be priced at Rs 42.70 per dose, per day.
http://www.thehindubusinessline.com/companies/article3527539.ece?homepage=true

India, Brazil to cooperate in production of essential drugs

India and Brazil have agreed to establish a working group for furthering cooperation in the areas of pharmaceuticals and life sciences. Brazil also expressed keen interest in collaboration with India in joint production of essential drugs for fighting HIV, AIDFS, malaria etc.
http://www.domain-b.com/industry/pharma/20120612_essential_drugs.html

Venus Remedies gets US patent for its new antibiotic product

Venus Remedies Limited, a research based global pharmaceutical company, has received patent from the US Patent Office for a breakthrough antibiotic product.

• The new drug product CSE1034 which is an antibiotic adjuvant entity (AAE), has been found to be effective against a wide range of drug resistant infections including the `superbugs’ like carbapenemase resistant Metallobetalactamses (MBL) strains, the company announced.
• Venus’ drug has a unique profile of action which gives it an edge over all the existing therapies. “This unique antibiotics adjuvant entity creates a synergistic effect due to its activity on AMRINGER (Acquired Multiple Resistance in Gram Negative Enterococci and Rods) which stops development and spread of bacterial resistance. Experience with clinical studies on more than 1000 patients have indicated approximately 20-30 per cent reduction in cost of therapy compared to conventional therapies being used

Venus Remedies is planning to launch this drug in India under the brand name ELORES and is planning to have a pre IND meeting with US FDA for fast track approval of this product.
http://pharmabiz.com/NewsDetails.aspx?aid=69513&sid=2

DuBiotech to ink pact with IDMA; offers array of incentives for Indian pharma companies

Dubai Biotechnology and Research Park (DuBiotech), one of the top life sciences clusters in the Middle East region embracing the biotechnology, pharmaceutical and medical device, and healthcare technology industries, is soon to enter into a memorandum of understanding (MoU) with the Indian Drug Manufacturers' Association (IDMA).

• This MoU promises to open newer avenues for the Indian life sciences community with the opportunities in the Middle East market through the platform of the DuBiotech free zone.
•  The park offers a conducive environment including an innovative academic and commercial infrastructure where Indian pharma companies can greatly benefit from, and contribute to. For example, the Nucleotide Complex in DuBiotech, the laboratory building with facilities enabling companies to conduct laboratory-based research and analysis removes the need for individual companies to build their own dedicated facilities.
• As India has a strong pharma-manufacturing industry particularly known for its generics manufacturing, DuBiotech hopes to see more R&D collaborations between Indian companies and Middle East-based academic and clinical expertise.
• As Indian companies move towards extending their abilities to develop new products, DuBiotech can assist Indian companies to easily access regional networks to connect with institutions and companies with whom they can collaborate for shared benefits

http://pharmabiz.com/NewsDetails.aspx?aid=69514&sid=2