Do you want patent grant in 90 days?

Accelerated patent processing at the Intellectual Property Office: Introduction of a superfast service

Reference: 2013-005

Launch date: 17 April 2013
Closing date: 12 June 2013

This consultation seeks views on a proposal to offer a premium "superfast" patent processing service which would be capable of granting patents in around 90 days, on payment of an additional fee. It also seeks views on our existing acceleration services.

The consultation is directed at all interested parties, including patent applicants, patent owners, patent attorneys, legal professionals, and any parties having an interest in the patents and patent applications of others.

http://www.ipo.gov.uk/consult-2013-superfast.pdf

Course on Clinical Engineering and Management by HLL Academy

HLL Life care, earlier known as Hindustan Latex, one of the pioneer in the contraceptive products has launched its education division as HLL Academy.


HLL Academy has launched two new courses as "Post Graduate Diploma Course in Clinical Engineering and Management (PGDCEM) and second one is Post Diploma Course in Clinical Engineering and Management (PCEM), both the courses will start from January 2012. These courses are introduced first time in india. These courses are in collaboration with Indira Gandhi National Open University (IGNOU) and will run as distance learning mode with some contact classes. Courses will cover all aspects of clinical engineering and management like pharmaceutical product development, role of clinical trial, approval of product for marketing etc.


For more free pharma resources click here

USFDA has approved Jakafi (ruxolitinib) for myelofibrosis

USFDA has recently approved Jakafi (ruxolitinib), which is the first drug approved for the specific treatment of patients with the bone marrow disease myelofibrosis.
What is myelofibrosis. It is a disease in which the bone marrow is replaced by scar tissue resulting in blood cells being made in organs such as the liver and the spleen. This disease is marked by an enlarged spleen, anemia, decreased white blood cells and platelets, and myelofibrosis-related symptoms. Symptoms of  myelofibrosis
include fatigue, abdominal discomfort, pain under the ribs, feeling full (satiety), muscle and bone pain, itching, and night sweats.
(Source: www.fda.gov)

Future of Pharmacy Education in India

Current situation of pharmacy education is really in bad shape and there are many factors behind it. Today the situation is like that M.Pharm candidates with even distinction marks in the subjects are searching jobs and are jobless even after 6-8 months of their M.Pharm. Once up on a time the pharmacy was a branch where people get job in early stage before their result come out. 5 to 6 years ago even Diploma pharmacy students could get job easily with reasonable salary.

The main reason behind this is the increase in number of colleges and stagnant increase in the pharmaceutical industry and other related branches like clinical research, bioinformatic, Pharmacovigilance etc. Few years ago there were only 100-200 seats of M.Pharm in whole Gujarat including all branches and now it has been gone above 3000 seats of M.Pharm in Gujarat only. Students are getting admission in M.Pharm very easily but not getting job after M.Pharm. 

How this problem can be solved to increase job opportunity?

The very first thing is the stop giving approval to new colleges which doesn't have proper facility and sufficient staff. Revising the syllabus to cover the new development and new subjects of recent development in pharmaceutical industry so student can think for the diversified career rather than going for traditional career mentality. There should be collaboration of industry with academic institute for benefits of both.Students should understand the situation in the industry and explore the new career opportunity.

For further resources click here 

Introduction to the Drug Master File (DMF) Webinar - November 14, 2011

On Monday, November 14, 2011 at 11:00 a.m. (ET), our CDER Small Business Assistance Program will present our webinar entitled Introduction to the Drug Master File (DMF) which will discuss all aspects of filing a DMF, including when and why to submit a DMF; requirements and recommendations for formatting and submitting original DMFs and subsequent submissions; how DMFs are reviewed and common problems.

Our presenter will be Dr. Arthur Shaw who is CDER’s DMF Expert, in addition to being a Quality Reviewer in the Office of New Drug Quality Assessment (ONDQA).  He has extensive experience in dealing with DMF filing and database issues, as well as reviewing many DMFs for technical content as part of his daily review work to support New Drug Applications (NDAs) and Investigational New Drug (IND) applications.

Dr. Shaw’s previous positions in FDA include Special Assistant in the Office of New Drug Chemistry and Review Chemist in the Division of Gastrointestinal and Coagulation Drug Products and in the Division of Pulmonary and Allergy Drug Products. Dr. Shaw received a B.S. in chemistry (with Honors) from the City College of New York and a Ph.D. in biochemistry at Cornell University.

  

Registration website: https://collaboration.fda.gov/dmf/event/registration.html

Web Address for viewing on day of event: https://collaboration.fda.gov/dmf/event/login.html

Call in numbers (listen only mode): 

Domestic: 1-800-857-0171

International: 1-517-319-9290     

Password (verbal): 2718839

For More Information: 

http://www.fda.gov/smallbusinessdrugs

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Paragraph IV certification update

USFDA has updated Paragraph IV certification list as of Nov 07, 2011. Table shows the newly added molecule.

DRUG NAME	DOSAGE FORM	STRENGTH	RLD	DATE OF SUBMISSION
Pioglitazone Hydrochloride and Metformin Hydrochloride	Extended-release Tablets	15 mg/1000 mg and 30 mg/1000 mg	Actoplus Met XR	9/23/2011
Oseltamivir Phosphate	Capsules	30 mg and 45 mg	Tamiflu	8/2/2011
Doripenem	Injection	250 mg/vial and 500 mg/vial	Doribax	10/12/2011
Dasatinib	Tablets	80 mg and 140 mg	Sprycel	6/17/2011
Fluticasone Furoate	Nasal Spray	27.5 mcg	Veramyst	7/15/2011
Ketorolac Tromethamine	Opthalmic Solution	0.45%	Acuvail	8/24/2011

Centres of Excellence and Innovation in Biotechnology (CEIB).

Department of Biotechnology (DBT) has recently launched a schemes known as Centres of Excellence and Innovation in Biotechnology (CEIB). The main aim behind this is to enhance the innovative ability of the academic institutions and individual investigators with well-developed research programme in biotechnology area.

The scheme will award funding to improve and strengthen institutional research capacity for promotion of excellence in interdisciplinary science and innovation in biotechnology field. The programme is intended for institutions with a substantial investment in, and commitment to, biotechnology research. The programme will provide flexible long-term support for highly innovative research (both basic and translational in nature) in biotechnology, which creates not only high-quality publications and intellectual property but also translational outputs through mid and high end innovation. Th scheme will provides three type of grants depending on the nature of organization, the work category etc.