Articles by Chitra Sethi - BioPharm International



Articles by Chitra Sethi

House Committee Supports 12-Year Data Exclusivity Period for Biologics

Aug 3, 2009

The House Energy and Commerce Committee approved a legislative amendment that would give 12-years data exclusivity to innovator biologics. The amendment was introduced by Reps. Anna Eshoo (D-CA) and Jay Inslee (D-DC).

Sanofi to Acquire Shantha for $784 Million

Jul 27, 2009

French drug manufacturer Sanofi Aventis will purchase the Indian vaccine company Shantha Biotechnics for $784 million.

Bristol-Myers Squibb Buys Medarex for $2.4 billion

Jul 23, 2009

In an effort to boost its biologics pipeline, Bristol-Myers Squibb (BMS, New York, NY) will acquire Medarex (Princeton, NJ) for approximately $2.4 billion.

Senate Committee Approves Healthcare Bill with 12-Year Data Exclusivity for Innovator Biologics

Jul 16, 2009

The Senate?s Health, Education, Labor, and Pensions Committee yesterday passed The Affordable Health Choices Act, the committee?s healthcare reform legislation that gives 12 years of data exclusivity to innovator biologics. The committee had adopted the 12-year data protection amendment to the healthcare legislation on Monday.

Pink Slips for Genentech's Bay Area Employees

Jul 13, 2009

When Roche bought Genentech in March, layoffs were expected, and now the company has begun downsizing at Genentech?s South San Francisco headquarters.

BIO Seeking to Round Up Support for 12-Years Data Exclusivity

Jul 10, 2009

In advance of the Senate Health, Education, Labor, and Pensions Committee?s meeting to be held on Friday to consider amendments to the healthcare reform bill, including several amendments related to biosimilars, Biotechnology Industry Organization?s (BIO) President and CEO Jim Greenwood reaffirmed BIO?s support for a 12-year data exclusivity period for biologics.

Three Shared Audit Models Tested at Rx-360 Consortium's Launch Meeting

Jul 10, 2009

The newly formed Rx-360 consortium, an international consortium developed by members of the pharmaceutical and biotech industries aimed at improving global supply chain security, had an impressive turnout of over 125 people at its launch meeting in Washington, DC, on June 5. The objective of the launch meeting was to increase awareness, solicit membership, and pressure-test shared audit models.

Genzyme Recalls Fabrazyme 5 mg

Jun 30, 2009

Genzyme has voluntarily recalled all remaining stock of Fabrazyme 5 mg (agalsidase beta), with batch numbers A8049H04 and A8060H01.

OctoPlus Opens New GMP Manufacturing Facility

Jun 24, 2009

OctoPlus has started production in its new manufacturing facility in Leiden.



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