Archive for the ‘Pharma Industry’ Category

FDA Proposes Rule That Would Loosen Restrictions On Off-Label Prescription Drug Promotion

Thursday, February 21st, 2008

FDA on Friday proposed new guidelines that would allow pharmaceutical and medical device companies to market their products for off-label uses, the New York Times reports (Harris, New York Times, 2/16). Currently, physicians can prescribe medications and medical devices for off-label uses, but companies cannot market their products for such ...

Seven AZ Products To Enter Discount Not Deducted List

Wednesday, February 20th, 2008

The Department of Health have confirmed that the following products will be added to the 'List of Drugs for which Discount is not Deducted' (Part II of the Drug Tariff) with effect 1st March 2008: - Arimidex 1mg tablets - Casodex 50mg tablets - Casodex 150mg tablets - Seroquel 100mg Tablets - Seroquel 150mg Tablets - ...

Members Of The Public To Be Encouraged By Pharmacists To Report Suspected Side Effects Of Medicines, UK

Wednesday, February 20th, 2008

Medicines and Healthcare products Regulatory Agency (MHRA) is launching a six-week campaign to get community pharmacists to mention the Yellow Card (YC) Scheme when they talk to their customers about their medicines. During this week, pharmacists will receive an information pack containing updated Yellow Card reporting forms, information leaflets, and ...

FDA Proposes Rule That Would Loosen Restrictions On Off-Label Prescription Drug Promotion

Wednesday, February 20th, 2008

FDA on Friday proposed new guidelines that would allow pharmaceutical and medical device companies to market their products for off-label uses, the New York Times reports (Harris, New York Times, 2/16). Currently, physicians can prescribe medications and medical devices for off-label uses, but companies cannot market their products for such ...

Minister Harney Announces Independent Body To Begin Work Immediately To Assess Fair Community Pharmacy Dispensing Fee, Ireland

Tuesday, February 19th, 2008

The Minister for Health and Children, Mary Harney, T.D., yesterday announced a new Independent Body to recommend a new, interim community pharmacy dispensing fee. This fee will be implemented with effect from 1st March this year. The Minister said, 'The Government is firm in its view that the wholesale mark-up paid on ...

Siemens Healthcare Plans Acquisition Of CAS Innovations AG

Tuesday, February 19th, 2008

The Siemens Healthcare Sector is planning to strengthen its position in the field of computer-assisted surgery with the acquisition of CAS innovations AG. The corresponding agreement is now concluded between the two companies. The antitrust authorities still have to approve the transaction. It was agreed not to reveal the purchase ...

Collegium Pharmaceutical Inc. Announces Notice Of Allowance For U.S. Patent For Its DETERx(TM) Abuse Deterrent Sustained Release Technology

Tuesday, February 19th, 2008

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its patent application "Abuse-Deterrent Pharmaceutical Compositions of Opioids and Other Drugs", US Patent Application Number 10/614,866. The Notice of Allowance is the USPTO's official communication ...

Biotechnology Industry Seeks Passage Of Bill To Allow FDA Approval Of Generic Biotech Medications

Monday, February 18th, 2008

The biotechnology industry, which for years has opposed bills that would allow FDA to approve generic versions of biotech medications, has made such legislation a priority for 2008, the AP/Raleigh News & Observer reports. Several bills currently under consideration in Congress would allow FDA to approve generic versions of biotech ...

Rep. Stupak Calls For FDA Commissioner To Resign Amid Recent Prescription Drug Safety Issues

Monday, February 18th, 2008

House Energy and Commerce Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) on Thursday called on FDA Commissioner Andrew von Eschenbach to resign, saying that he had lost confidence in officials over the handling of investigations and oversight by the agency, the AP/Los Angeles Times reports (Thomas, AP/Los Angeles Times, ...