Sunday, February 26, 2012

News and Events - 27 Feb 2012




24.02.2012 20:28:46


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NIB Sets Record Straight on NPDP Drugs and Payment



Nassau, Bahamas - The following is an NIB Statement on the National Prescription Drug Plan Generic Drugs and Payments:





In light of recent misinformation heard on the radio airwaves with respect to the National Prescription Drug Plan and generic drugs, The National Insurance Board wishes, once again, to provide the public with the true facts about prescription drugs supplied by the National Prescription Drug Plan.

The public should know that the Drug Plan’s formulary of medications provides more than 160 drugs and medical supplies for the treatment of eleven chronic conditions...





25.02.2012 0:12:00
There are fears that a short supply of the generic cancer drug Doxorubicin could run out within weeks. The drug is used to treat Hodgkin's lymphoma and leukaemia in children.

Friday, February 24, 2012

News and Events - 25 Feb 2012




23.02.2012 20:28:46


Screen_shot_2012-02-23_at_10.28.17_AM.png



NIB Sets Record Straight on NPDP Drugs and Payment



Nassau, Bahamas - The following is an NIB Statement on the National Prescription Drug Plan Generic Drugs and Payments:





In light of recent misinformation heard on the radio airwaves with respect to the National Prescription Drug Plan and generic drugs, The National Insurance Board wishes, once again, to provide the public with the true facts about prescription drugs supplied by the National Prescription Drug Plan.

The public should know that the Drug Plan’s formulary of medications provides more than 160 drugs and medical supplies for the treatment of eleven chronic conditions...





23.02.2012 11:54:00

Lynne Taylor


If Australia had paid English prices for the generic cholesterol-lowerer simvastatin during May 2010-October 2011, its Pharmaceutical Benefits Scheme (PBS spending could have been reduced from A$150 million to just A$20 million, says a leading health economist.

Australia's "price disclosure" policy - agreed as part of the government/research-based industry Memorandum of Understanding (MoU to reduce the prices of older PBS-listed drugs by requiring drugmakers to reveal to the government the actual price at which they sell their products to pharmacies - does reduce future prices, according to Professor Philip Clarke of the University of Melbourne, writing this week in the Medical Journal of Australia.

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22.02.2012 22:28:00
News and Announcements updated



23.02.2012 14:48:39
Mylan to launch generic Copaxone in H2 2013 [Globes, Tel Aviv, Israel] From Globes (Tel Aviv (February 22, 2012 Feb. 22--Mylan Inc. (Nasdaq: MYL announced yesterday, in its financial report for 2011, that it plans to launch a generic version of...



23.02.2012 16:43:35
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24.02.2012 22:34:00
Drug Approval Listing



24.02.2012 18:07:45
As employee benefit budgets remain tight, employers are adopting plan design changes that reduce drug benefit coverage and improve pricing, according to the Pharmacy Benefit Management Institute.



24.02.2012 18:07:45
Catalyst Health Solutions Inc said it will buy Walgreen Co's pharmacy benefits management unit for about $525 million in cash, a deal that might spur more consolidation before big generic drug launches that could boost the business.



23.02.2012 17:47:20
Over generic drug authorisations

Wednesday, February 22, 2012

News and Events - 23 Feb 2012




21.02.2012 11:00:00
The substitution of brand-name antiepileptic drugs with cheaper generic equivalents has been an ongoing point of contention among doctors, federal officials and people with epilepsy. The U.S. Food and Drug Administration claims generic antiepileptic drugs have the same dosage, purity and strength as their brand-name counterparts and the two are interchangeable...



21.02.2012 21:30:00
News and Announcements updated



22.02.2012 15:56:32
Drug maker Mylan's fourth quarter net income soars [The Pittsburgh Tribune-Review] From Pittsburgh Tribune-Review (PA (February 22, 2012 Feb. 22--Generic drug maker Mylan Inc. said it earned $129.5 million, or 30 cents a share, in the fourth...



21.02.2012 23:27:00
Drug Approval Listing



22.02.2012 0:53:18


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21.02.2012 23:19:00

Teva Pharmaceutical Industries will pay more than a quarter-billion dollars to settle close to 200 lawsuits stemming from Southern Nevada's hepatitis C outbreak.

The international generic drug-making giant reached an agreement late last week to settle with 41 plaintiffs represented by lawyers Robert Eglet and Will Kemp, who were in the middle of their third trial against Teva.

"It's been resolved," Kemp said.

The agreement was reached after several long days of talks under the direction of Chief District Judge Jennifer Togliatti.

Teva had previously settled about 120 cases, including those being handled by lawyers Ed Bernstein and Gerald Gillock.

The company had paid or set aside about $270 million to cover the lawsuits filed in Nevada, according to a Friday filing with the U.S. Securities and Exchange Commission.

The company will pay another $15 million this financial quarter, Teva USA spokeswoman Denise Bradley said in an email.

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21.02.2012 18:24:00
Generic drug maker Mylan Inc. this morning reported fourth-quarter net income rose to $129.5 million, or 30 cents per share, up from $2.6 million, or 1 cent, in the year-earlier period.

News and Events - 21 Feb 2012




17.02.2012 8:00:00
Brand and generic epilepsy drugs are equally safe and effective; but switching from a brand-name antiepileptic drug to a generic one could increase some individuals' chances of having a seizure, according to a comprehensive research review conducted by pharmacists and doctors at the University of Connecticut and Hartford Hospital.



20.02.2012 16:45:59
Police GenericA high-ranking member of a Northwest Side gang says a police crackdown has paralyzed the gang and sharply cut into its drug sales.

http://chicago.cbslocal.com/2012/02/20/gang-member-to-newspaper-police-are-serious-about-crackdown/#comments



20.02.2012 7:43:00

The most likely explanation is that the same drugs now being exposed as unsafe and ineffective have also
lost patent protection, and therefore, are no longer generating the huge advertising revenue for the networks. A significant portion of
the revenue for the broadcast networks is derived from pharmaceutical advertisements.

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Saturday, February 18, 2012

News and Events - 19 Feb 2012




17.02.2012 15:57:21
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18.02.2012 20:52:15
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17.02.2012 23:19:04

by
Brian J. Malkin


Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for dna.jpg
On February 16,
Leerink Swann's Global Healthcare Conference 2012 featured two presentations and several more private discussions featuring Center for Drug Evaluation and Research ("CDER" Director Janet Woodcock, M.D., as well as her colleagues, Steven Kozlowski, M.D., CDER's Director of Office of Biotechnology Products, and Keith Own Webber, Ph.D., CDER's Deputy Director, Office of Pharmaceutical Science, Acting Director, Office of Generic Drugs. The trio presented a discussion "Biosimilars Take the Stage" followed by Woodcock's Keynote Address on "New Trends in Drug Regulation and Innovation", and several smaller question-and-answer-format meetings regarding these topics and more. This is part one of a two-part series and concerns the biosimilars presentations. Part two will be posted on Tuesday.

Leerink's biosimilars session was moderated by Joshua Schimmer, M.D. and Jason Gerberg, J.D./M.B.A. with co-moderators Seamus Fernandez and Joseph Schwartz. Kozlowski provided some preliminary remarks followed by a question-and-answer format by the moderators. Kozlowski explained that the purpose of FDA's first set of biosimilars guidances, which we initially reported on
here, was to set the scientific framework for approaching biosimilar product development and provide some interpretations of the new statutory terminology. Kozlowski explained that FDA decided to take a "totality of the evidence" and "stepwise approach", where the structural similarity of the biosimilar, as demonstrated by the sponsor, drives the development of the clinical program to support approval.

Woodock added that FDA has had a challenge to retrain their reviewers to think of biosimilar review as an "inverted pyramid." Typical drug review includes pre-clinical studies followed by increasingly large clinical studies, culminating in pivotal, larger-scale studies to demonstrate the safety and efficacy of the product that become the focus of the approval, i.e., the regular pyramid (pre-clinical on top, phase III clinical trials on the bottom . In contrast, biosimilar product development is envisioned to be characterized as spending a bulk of the resources up front, characterizing the innovator's product and the biosimilar (i.e., the top of the pyramid to lead to smaller clinical studies to demonstrate similarity or test for immunogenicity or other elements that require testing, not duplicating the safety and efficacy testing that was already conducted by the innovator.

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17.02.2012 8:00:00
(University of Connecticut Brand and generic epilepsy drugs are equally safe and effective; but switching from a brand-name antiepileptic drug to a generic one could increase some individuals' chances of having a seizure, according to a comprehensive research review conducted by pharmacists and doctors at the University of Connecticut and Hartford Hospital.



17.02.2012 10:47:00

Kevin Grogan

AZ starts selling Arimidex direct to patients in USA

AstraZeneca has unveiled its "first-ever direct-to-patient programme", which will see the Anglo-Swedish drugmaker offer its breast cancer drug Arimidex to US patients for $40 a month.

Under the scheme, patients with a valid prescription for Arimidex (anastrozole or a generic of the aromatase inhibitor (it went off-patent in the USA in the middle of 2010 can have the branded version delivered directly to their home by pharmacy benefit management company Express Scripts. AstraZeneca says that "calls from patients seeking information on how to obtain the brand Arimidex more affordably helped spur creation of the direct-to-patient programme".

The company adds that upon further research, it felt that eligible patients could realise "significant cost savings through Arimidex Direct". However, AstraZeneca notes that "prescription insurance coverage, including Medicare and Medicaid, cannot be used for any type of reimbursement", so the scheme only applies to patients who pay out of their own pockets.

At $40 a month, the price is above the normal $10 co-payment for generic anastrozole, but well below what insured patients could pay for the branded version - the price of 30 tablets of Arimidex at drugstore.com is listed at $458.97.

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17.02.2012 15:58:47
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17.02.2012 23:32:00
Drug Approval Listing



18.02.2012 8:12:00
Generic-drug company Mylan and the Pittsburgh Post-Gazette announced Friday they have settled two lawsuits stemming from a series of



18.02.2012 1:42:35
SHANGHAI & NEW YORK--(BUSINESS WIRE --Feb 17, 2012 - Pfizer Inc. (NYSE: PFE and Zhejiang Hisun Pharmaceutical (SSE Code: 600267 , a leading pharmaceutical company in China, today signed a framework agreement, advancing their previously...

News and Events - 17 Feb 2012




15.02.2012 23:27:52

AMERICA'S Food and Drug Administration (FDA
announced late on February 14th that 19 medical practices had bought counterfeit Avastin, a popular cancer drug. The doctors and hospitals bought the bum drug from a foreign supplier, Quality Specialty Products. 

As such scares go, this one could have been worse. Avastin, marketed in America by
Genentech, is an injected drug available only in hospitals and doctors’ offices. Presumably health professionals will spot rogue bottles more quickly than the average consumer would have. So far there have been no reports of dangerous reactions, unlike some past incidents—in 2008 a sham bloodthinner made in China killed several Americans and sickened many more. 

But the news is alarming nonetheless. It is another reminder of how vulnerable the drug supply-chain remains. About 80% of ingredients for drugs bought in America are made elsewhere. Imports of drugs have grown by nearly 13% a year. Regulators have
done their best to keep up. The FDA has opened a series of offices abroad; inspections of foreign factories increased by 27% from 2007 to 2009. It is trying to foster
collaboration with foreign regulators—apparently Britain’s Medicines and Healthcare Products Regulatory Agency alerted the FDA to the counterfeit Avastin. More changes are on the way. Generic drug companies have agreed to pay the FDA a fee to increase foreign inspections, a deal that must still be approved by Congress. The FDA is also 
asking the government for more money to expand its operations in China. But change, as the recent fiasco proves, is not coming fast enough.

http://www.economist.com/blogs/schumpeter/2012/02/counterfeit-drugs#comments



14.02.2012 18:37:39

According to a new study the risk for suffering a second
femur fracture injury may be lowered when the use of bisphosphonate drugs including Fosamax® are discontinued. The research, which was presented on January 8, 2012 at the American Academy of Orthopaedic Surgeons meeting, indicates that stopping use of the medication significantly lowers the chances of suffering a second fracture.

Bisphosphonate drugs are prescribed to patients that suffer from osteoporosis, a chronic condition which causes bones to break easily. This class of drugs serves the purpose of strengthening weakened bones to prevent fractures. However, the Food and Drug Administration received reports claiming that drugs like Fosamax caused adverse side effects such as atypical femur fractures. This type of fracture typically involves sudden breaks and may include little to no trauma.

Over a three-year period, researchers evaluated 126 patients who had previously suffered femur fractures. Results of the study show that the risk of suffering a second femur fracture while not taking bisphosphonates is 18%. Individuals who continued to take bisphosphonates were at a 25.8% risk for suffering a second fracture during year one and that risk doubles after three years.

Fosamax, the most widely used bisphosphonate in the U.S., was introduced by Merck & Co. in 1995. Prior to the release of generic version, Fosamax generated $3 billion in annual sales.

In October of 2010, the FDA mandated updated warning labels for all bisphosphonate medications, including Fosamax, due to an increased number of reported femur fracture injuries allegedly caused by the medication.

Merck now faces
Fosamax lawsuits filed by women who claim that the drug company failed to properly issue sufficient warnings related to femur fracture injuries. Three bellwether trials are scheduled for this year and will aid in predicting trends for future cases.

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http://consumer-drug-report.com/content/how-risk-femur-fracture-injury-can-be-lowered#comments



16.02.2012 22:31:05
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16.02.2012 17:23:12
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14.02.2012 23:26:54

Program helps hospitals buy drugs at significant discount, reduce drug waste

Premier healthcare alliance members can purchase generic injectables with limited expiration dates for up to 35 percent less than already low prices

CHARLOTTE, N.C. (February 14, 2012 – The
Premier healthcare alliance has announced a new EXPRESSbuy™ service to its member hospitals allowing them to purchase short-dated generic injectables for 10-35 percent off its already low contracted price.




15.02.2012 16:32:21
From Associated Press (February 15, 2012 NEW YORK -- Teva Pharmaceutical Industries Ltd.'s fourth-quarter profit sank 34 percent as an acquisition by the world's largest generic drugmaker improved revenue but raised expenses. The Israeli company...



16.02.2012 0:21:00
Drug Approval Listing

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.

Continue Reading



14.02.2012 0:45:25
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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