21 June 2018

FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity

 

4 June 2018

FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment


15 May 2018

FDA approves first epoetin alfa biosimilar for the treatment of anemia

 

28 September 2017

Amgen And AbbVie Agree To Settlement Allowing Commercialization Of AMGEVITA™ Amgen to Begin Launching Biosimilar Adalimumab in Europe in 2018

 

22 June 2017

Pfizer Provides Update on Proposed Epoetin Alfa Biosimilar

 

05 April 2016

FDA approves Inflectra, a biosimilar to Remicade

 

01 April 2016

Samsung Bioepis’ Flixabi® Infliximab Biosimilar

Recommended for Approval in the European Union

 

17 January 2016

Samsung Bioepis’ Benepali ® the First Fusion Protein Biosimilar
Approved by the European Commission

 

6 March 2015

FDA APPROVES FIRST BIOSIMILAR ZARXIO™ (FILGRASTIM-SNDZ) FROM SANDOZ

 

 

16 February 2015

Hospira launches first biosimilar monoclonal antibody (mAb) Inflectra™ (infliximab) in major European markets

 

 

23 December 2014

FDA Approves Teva’s GRANIX® (tbo-filgrastim) Injection for Self-Administration

 

22 December 2014

Express Scripts and AbbVie Make Hepatitis C Cure Available to Millions of Patients in Need

 

 

24 July 2014

FDA accepts Sandoz’s BLA application for filgrastim biosimilar

 

2 May 2014

Hospira states EPO approval via the 351k pathway is likely during 2016

 

30 April 2014

Cristália receives ANVISA approval for biosimilar production

 

 

21 March 2014

4th Biosimilars Conference

Boston, USA

What the future holds for biosimilar development and regulation

 

 

21 February 2014

France to allow biosimilar substitution

 

3 January 2014

FDA Accepts Lilly and Boehringer Ingelheim's NDA for Lantus Biosimilar

 

 

1 February 2013

Visiongain’s 12th Biosimilars Americas Conference held in Boston on April 15th - 17th 2013, The Seaport Hotel, Boston, USA

 

1 February 2013

Biosimilars and Follow-On Biologics 2013 Americas

Commercial, Regulatory and Technical Challenges Overcome

27th February - 1st March 2013, Hilton, Boston, Financial District, USA

 

1 February 2013

HansonWade’s Demonstrate Biosimilarity Summit

12-14 February 2013

Washington, D.C.

 

21 January 2013

Applications for new human medicines and biosimilars under evaluation by the Committee for Medicinal Products for Human Use

 

 

9 November 2012

EMA’s CHMP approves 1st Imatinib

 

 

August 30, 2012

FDA approves new treatment for severe neutroprnia in certain cancer patients

 

August 8, 2012

Amgen shutting down Epogen manufacturing in Longmont

 

July 9,2012

11th Annual Biosimilars UK
Strategic planning to maximize benefits in a complex regulatory and legal environment
29th - 31st October 2012, Visiongain Conference Centre, London UK

 

July 6, 2012

The Patient Protection and Affordable Care Act and the Biologics Price Competition and Innovation Act are upheld by the US Supreme Court creating an approval pathway for biosimilar and interchangable biological products while perserving the incentives that have fueled the development of said medicines

 

July 3, 2012

Southeast Asia Pharmaceutical Forum
Beyond BRICS Economies, the Next Opportunity in Pharmerging Markets
11 – 12 September 2012, Hilton Hotel, Singapore

 

March 13, 2012

Informa Life Sciences' 9th Annual Biosimilars Update: 23-24 May 2012, Prague, Czech Republic

 

March 13, 2012

FDA issues draft guidance on post approval drug safety

 

March 13, 2012

Paper calls for continued support for development of advanced therapies

 

February 9, 2012

FDA issues draft guidance on biosimilar development

 

January 6, 2012

EU to set biosimilar drug rules by mid-year

 

December 6, 2011

Drug industry applauds FDA plans for biosimilar review

 

 

 

 

 

 

 

 

Product Candidate Acquisition: Early Stage

 

 

 

Product Candidate Acquisition: Late Stage

PREMEDIA SERVICES: AIMES AT ADDRESSING BUSINESS COMMUNICATION NEEDS

 

 

PRECLINICAL RESEARCH SERVICES: IN BIOLOGY, ADMET-PK, PHARMACOLOGY, EXPLORATORY TOXICOLOGY AND PROJECT MANAGEMENT

 

 

 

 

Services provided such as early and late stage product acquisitions, maximizing market share, and enhancing employee contributions to improve their products and services for their customers are key deliverables that Healthcare Economics will contribute to your firm to sustain a continuum of steady and consistent growth.

 

Product Candidate Acquisition: Early Stage

 

Contract manufacturing organizations (CMO) and academia are focused on conceptualizing and developing early stage product candidates that will eventually satisfy unmet medical needs.  Early stage product candidates are those products that have met and succeeded the proof of concept requirement and have been proven successfully in phase I studies.


At this stage commercial viability has yet to be proven due to the fact that many stages of development remain.  The opportunity to out-license an early stage product candidate to commercial firms is highly attractive for early stage developers and established commercial firms.


Developers seek revenue and partners in order to fulfill their mission of product development and sustained inflow of capital while biotech and pharma firms seek to supplant existing therapies at the end of their product life cycle with new and highly desirable candidates to capture market share and meet unmet medical needs. HCE with its experienced team and established networks will be instrumental in executing in-licensing, out-licensing, joint ventures, co-marketing, co-promotional, and cross licensing arrangements for business partners.

 

Product Candidate Acquisition: Late Stage

Many firms are interested in obtaining products in late stages of development.  As a point of reference products in late stages of development tend to be within and after phase II.  Typically firms choose to identify and select these product opportunities for a variety of reasons.


Paramount in the decision making process will be the likelihood that these products have a good chance to succeed and be launched within the designated markets where the firm has a competitive advantage.


CMO’s are keen to partner with established biotech & pharmaceutical firms and investment houses willing to in-license a product candidate in order to satisfy a research and development need as well as strengthening their existing pipeline.


Pharmaceutical and biotech firms may also realize synergy and seek to partner with each other in order to commercialize a product and capture a predefined market share. HCE with its experienced team and established networks will be instrumental in executing in-licensing, out-licensing, joint ventures, co-marketing, co-promotional, and cross licensing arrangements for willing partners.

 

PREMEDIA SERVICES: ADDRESSING BUSINESS COMMUNICATION NEEDS

 

Healthcare Economics  and Vakils Premedia are working together to introduce Vakils’ integrated premedia services for pharmaceutical, medical packaging firms, and all enterprises interested in expanding their communication footprint.  Vakils Premedia is a subsidiary of Vakil & Sons Pvt. Ltd. (Vakils) and has been a pioneer in the printing and publishing business for more than 66 years.

 

Vakils Premedia is a global provider of integrated premedia services for design and implementation of artwork and management services offering eDetailing, ePublishing, packaging, prepress, page composition, color management, data conversion, and cross media services aimed at addressing the firms’ business communication needs.

 

The company is equipped with best-in-class infrastructure and IT security systems. It is supported by professionals highly qualified in graphic design, software development and premedia technology. Vakils Premedia has all the modern encryption technologies and has complete data security as per ISO 27001:2013 standards. We have an experienced management team delivering IT and premedia services to customers in India, Australia, Europe, UK, USA and Asia.

 

PRECLINICAL RESEARCH SERVICES: IN BIOLOGY, ADMET-PK, PHARMACOLOGY, EXPLORATORY TOXICOLOGY, AND PROJECT MAMAGEMENT

 

Healthcare Economics  is partnering with TheraIndx offering differentiated services in Preclinical Research services in Biology, ADMET-PK, Pharmacology, Exploratory Toxicology and Project Management.

 

TheraIndx’s animal disease models play a vital role in the discovery and development of drugs, biologicals, herbals, and medical devices since they are generally a good predictor of efficacy and toxicity within humans and can be customized based upon research needs.  They are AAALAC accredited as well.

 

The firm offers a wide range of Animal disease models covering a variety of therapeutic areas such as Infection, Inflammation, Oncology, Diabetes, CNS, Obesity, Dyslipidemia, Arthritis, Medical devices and Wound healing.

 

In the current era of innovation in Lifesciences, be it drug discovery, biotechnology, medical devices or natural products, a key factor in translating an exciting idea to reality or evaluation of a newly designed molecule or product is to obtain robust and quality data from optimally designed experiments. We endeavor to meet these criteria.