Friday, 31 May 2013
Friday, 24 May 2013
Friday, 17 May 2013
Wednesday, 15 May 2013
BIOSIMILAR SUMMIT 2013
DOWNLOAD AGENDAS
1) 3RD BIOSIMILARS CONGRESS JUNE 25-26, click here
2) 2ND BIOBANKING CONGRESS JUNE 25-26, click here
3) CELL BASED ASSAYS CONGRESS JUNE 25-26, click here
Drug Patent Expirations for the week of May 12, 2013
|
Monday, 13 May 2013
F.D.A. Rejects Request to Block Sales of Generic Painkiller
The Food and Drug Administration announced Friday that generic versions of the painkiller Opana ER can remain on the market, dealing a blow to the brand-name manufacturer, Endo Health Solutions, which had asked the agency to declare the generic versions unsafe.
The agency also ruled that a newer, so-called tamper-resistant form of the drug sold by Endo could be misused by cutting, grinding, chewing or injecting it. Endo had asked the F.D.A. to require that older, generic forms of the drug — which did not have such tamper-resistant properties and entered the market this year — be withdrawn.
The agency’s decision came just weeks after it reached the opposite conclusion in the case of another frequently abused painkiller, OxyContin. In that case, the F.D.A. said it would not approve generic versions of OxyContin since the maker of that drug, Purdue Pharma, had introduced a new tamper-resistant formulation in 2010 that appeared to be less prone to abuse than the generic versions. The patent for the original version of OxyContin expired in April.
The agency is closely scrutinizing efforts by drug makers to develop drugs that are designed to deter abuse. This year, it released guidelines for drug makers seeking to make such drugs and has said it will work closely with companies, including Endo, that want to do so. But an agency official, Dr. Douglas C. Throckmorton, said in an interview on Friday that the F.D.A. had to ensure that these products actually worked.
“We believe that the public health value of concluding that a product is abuse-deterrent is very important,” said Dr. Throckmorton, who is deputy director of regulatory programs for the agency’s Center for Drug Evaluation and Research. However, he added, “It is very important to us to make sure that products that have that claim do so as the result of substantial scientific evidence.”
The agency said it found the reformulated Opana did prove resistant to crushing — abusers typically seek to crush or pulverize the product to release the drug’s narcotic payload — but it could still be cut, ground or chewed. The new Opana ER can also be injected or snorted, “using commonly available tools and methods.”
A spokesman for Endo did not return a call for comment on Friday. The company’s stock was down more than 5 percent at the close of trading Friday, to $34.98.
Saturday, 11 May 2013
Wednesday, 8 May 2013
Drug Patent Expirations for the week of May 5, 2013
Drug Patent Expirations for the week of May 5, 2013
Tradename | Applicant | Generic Name | Patent No. | ||||||
---|---|---|---|---|---|---|---|---|---|
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatchdatabase for complete details.
|
Monday, 6 May 2013
Procedure for Opening a Drug Store
Instructions:
- 1Decide on a local ownership or a franchise. Open a pharmacy franchise inside a department store or grocery store. Certain drug stores often associate with chain stores such as Wal-Mart.
- 2Choose a franchise or free-standing location based on good business practices for customer flow, parking and location.
- 3Complete in-state pharmacy applications. You must meet certain requirements to open a drug store, and these differ from state to state.
- 4Design the location based on pharmacy best practices. As a pharmacist, you know the importance of a patient consultation center and proper work space and storage. As a non-pharmacist businessperson, make sure you understand exactly what pharmacies require.
- 5Hire qualified staff. Make sure pharmacists and assistants meet state certification requirements. Some states require a pharmacist-in-charge.
- 6Execute an effective marketing plan. Drug store associations and marketing experts in the field can offer advice specific to this area of specialty.
- 7Ensure the presence of effective security. Drug store operations handle controlled substances, and you need to make sure you protect the premises and employees.
Things You'll Need
Tips & Warnings
- Franchise operations often come with marketing plans and support already built into the agreement.
- Make sure you and your staff have updated medical insurance, Medicaid plans and information on how they affect the dispensing of prescriptions.
- Independently-owned drug stores are not as common as they once were, but they can still succeed. Join an association that supports this kind of pharmacy operation.
- Remember that good business practices such as planning, cash flow, inventory management and taxes are just as important to a pharmacy as to any small business.
- 1
Wednesday, 1 May 2013
Drug Patent Expirations for the week of April 28, 2013
Drug Patent Expirations for the week of April 28, 2013
Tradename | Applicant | Generic Name | Patent No. | Patent Expiration | |||||
---|---|---|---|---|---|---|---|---|---|
HYTRIN | Abbott | terazosin hydrochloride | 5,412,095 | Apr 29, 2013 | |||||
HYTRIN | Abbott | terazosin hydrochloride | 5,294,615 | Apr 29, 2013 | |||||
ALVESCO | Takeda Gmbh | ciclesonide | 6,036,942 | Apr 30, 2013 | |||||
CEDAX | Pernix Therap | ceftibuten dihydrate | 5,599,557 | Apr 30, 2013 | |||||
ZETONNA | Takeda Gmbh | ciclesonide | 6,036,942 | Apr 30, 2013 | |||||
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.
|
Subscribe to:
Posts (Atom)