Friday, February 17, 2012

News and Events - 14 Feb 2012




12.02.2012 19:40:00

Low official wages created a temptation for physicians, who would attract fee-paying patients by falsely categorising them as pregnant women who are exempt from the normal requirement to help pay for their drugs.

Corruption remains widespread, according to doctors, pharmacists and medical suppliers, with direct bribing by suppliers.

“The
fakellaki
system [envelopes containing cash bribes] is still operating at big hospitals in Athens, run by the heads of procurement,” says one Greek executive working for a foreign medical supplier.

Another executive says pharmacists sometimes seek reimbursement by falsely claiming medicines for fictitious or dead patients. Health insurance funds do not require verification that costly medicines are essential, resulting in fraud estimated at up to ˆ1bn a year.

Patent-protected drugs have been sold to the Greek health system in high volumes at prices which are relatively low by EU standards. One consequence was more than ˆ850m last year in “parallel exports” of medicines bought cheaply by Greek pharmacists and resold abroad. The government responded in recent months by banning foreign sales of some medicines after domestic supplies ran out.

Once patents have expired, the lack of any requirement for Greek doctors to prescribe cheaper, generic versions means patented drugs still represent nearly 80 per cent of total prescriptions in Greece, compared with less than 30 per cent in Germany. Yet generics were traditionally sold at relatively high prices, with very low discounts to patented drugs. Even after recent reforms, they are typically only a third cheaper, compared with lower rates of nearly 90 per cent less in the UK.

Vassili Kontozamanis, a former Greek drug regulator, calls for greater efforts to boost generic prescribing at lower prices, but he cautions that such moves are meeting resistance from the country’s powerful generic drug industry, which employs more than 15,000 people.

Recent government reforms have included non-binding prescription guidelines, and cuts in drug prices amounting to ˆ1bn, with the aim of reducing the state’s medicines bill to 1 per cent of GDP by the end of this year. But reforms at state hospitals are making only modest progress amid strong opposition from medical staff.

via
ft.com

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13.02.2012 15:00:00

by
Kyle Deighan


Thumbnail image for federalcircuit.jpg
On February 9, the
Federal Circuit held that AstraZeneca failed to state a claim for patent infringement under 35 U.S.C. §271(e (2 against generic pharmaceutical manufacturers that filed abbreviated new drug applications ("ANDAs" seeking approval for uses of Crestor® (rosuvastatin calcium not covered by AstraZeneca's patents. The case is
AstraZeneca Pharms. LP v. Apotex Corp.
.

AstraZeneca alleged that ANDA filings by various generics infringed or would infringe several of its patents covering methods of using rosuvastatin calcium. These patents covered methods of using rosuvastatin compounds to treat heterozygous familial hypercholesterolemia ("HeFH" and elevated C-reactive protein ("CRP" . As per the Hatch-Waxman Act, AstraZeneca filed a New Drug Application ("NDA" and obtained approval from FDA to market the drug. FDA approved several indications for using rosuvastatin calcium, including those uses claimed in AstraZeneca's patents. Additionally, FDA approved the drug for treating homozygous familial hypercholesterolemia ("HoFH" and hypertriglyceridemia, uses not covered by AstraZeneca's patents-in-suit.

Defendants filed ANDAs seeking to market generic versions of the drug, but submitted so-called Section viii Statements under the Federal Food, Drug, and Cosmetic Act ("FD&C Act" indicating they sought approval for uses not covered by the patents. In other words, the ANDA filers requested approval to treat only HoFH and hypertriglyceridemia while "carving out" the indications covered by AstraZeneca's listed patents. The ANDA filers moved to dismiss AstraZeneca's complaint for several reasons, including that the complaints failed to state a claim for patent infringement under Section 271(e (2 because the ANDA filers were not seeking approval for uses of rosuvastatin calcium claimed in AstraZeneca's patents.

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14.02.2012 0:45:25
An online Pharmacy with a wide choice of High quality European Drugs for any occasion! Orders cheap drugs from Allofdrugs! Customer Satisfaction is our primary concern!



14.02.2012 0:23:00
Drug Approval Listing



13.02.2012 8:00:00
(New York Academy of Sciences The FDA is currently working toward implementing the Biologics Price Competition and Innovation Act of 2009. The yet-to-be finalized pathway raises questions that are far more complicated than those posed by traditional, small molecule generics including what type of pre-clinical/clinical data, safety, purity, immunogenicity and potency testing will be required by the FDA in the marketing application. Additionally, non-biological complex drugs present many of the same scientific challenges to reproduce as biologics.



13.02.2012 6:00:03

Accutest Research Laboratories (I Pvt. Ltd., the leading independent and internationally accredited Contract Research Organization (CRO in India, was founded back in 1998 by Dr. Satish Sawant and Dr. Santosh Joshi and is headquartered in

Navi Mumbai
. It primarily focused in conducting Bioavailability and Bioequivalence studies for the generic pharmaceutical industry. For over a decade Accutest’s success in Bioavailability/Bioequivalence services has earned it a strong reputation in the field both in domestic and international markets. With the passage of time, the company has widened its network by introducing more diversified services that includes Clinical Trial Management, Clinical Data Management and Formulation Development. The company sets itself apart by providing its global client base a process-oriented service coupled with high quality data on drug candidates at extremely competitive prices more quickly and efficiently than its competitors. 

Post : Research Scientist at Mexico

No of Post : Two

Experience : 2 to 3 year

Job Description : 
a. 2-3 Years experience in bio-analysis
b. Should be well versed with regulatory requirements
c. Should have hands on experience of LC-MS/MS operations
d. Should be able to run the project independently
e. Should be willing to stay for 1-2 years on site in Mexico



Education : M.Pharma,

M.Sc
- Bio-Chemistry/Bio-Technology/

Life Science

Salary : As per the Qualification and Experience

Contact Details :
Executive Name : Ms. Swapna
Contact Company : Accutest Research Laborotories Pvt ltd
Address : A-31, T.T.C Industrial Area, MIDC, Khairane
Thane, Maharashtra,India 400709
Email Address :
hr@accutestindia.com

Reference Id : Research Scientist at Mexico

Deadline : 10.03.12



http://www.biotecnika.org/content/february-2012/accutest-research-laborotories-pvt-ltd-hiring-research-scientist-post-mexico#comments

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