Articles by Amy Ritter, PhD - BioPharm International

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Articles by Amy Ritter, PhD

The Economic Contribution of the US Biopharmaceutical Industry

Jul 19, 2011

The negotiations under way to control government spending and reduce the deficit have the potential to impact pharmaceutical revenues. A proposal is on the table to increase drug rebates under Medicare Part D as a means of controlling the overall costs of the Medicare program. The Pharmaceutical Research and Manufacturers of America (PhRMA) is opposed to such measures, concerned that a decrease in revenues could damage a healthy and growing industry and that the ripple-effects from a slowdown in biopharmaceutical growth could negatively impact an already fragile economy. In a press release, PhRMA president and CEO John J. Castellani issued the following statement:

FDA Q11 Draft Guidance Available for Comment

Jul 12, 2011

FDA issued a draft guidance, entitled ?Q11 Development and Manufacture of Drug Substances,? which is now available for comment according to a notice published on June 29, 2011, in the Federal Register. The draft guidance was developed in conjunction with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and describes approaches to developing process and drug substance understanding. It also provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD).

House Committee Expands Investigation into Tainted Heparin

Jul 12, 2011

Members of the House Energy and Commerce Committee are expanding their investigation into the 2008 entry of contaminated heparin from China into the United States (US) market.

FDA Issues Draft Guidance on Nanotechnology

Jun 21, 2011

Nanotechnology is science involving particles less than 100 nm in size. It is an emerging technology that is finding applications in medical products, food packaging, and cosmetics. Nanoscale materials can have different chemical, physical, or biological properties than their conventionally-scaled counterparts. As a first step in providing regulatory clarity about the use of such technology, FDA issued a draft guidance, titled "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology" on June 9, 2011. The guidance lists points that FDA will consider when determining whether a product applies nanotechnology, and explains rationales for those points.

J&J Ordered to Pay $327 Million Penalty in False-Claim Suit

Jun 14, 2011

A South Carolina court found that Ortho-McNeill-Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson (J&J), violated state consumer-protection laws by using misleading marketing for its antipsychotic drug, Risperdal. Janssen Pharmaceuticals, the maker of the drug, received a Warning Letter from FDA in April 2004 over misleading product claims made in a ?Dear Doctor? letter that the company sent to healthcare providers in November 2003. According to FDA, the Janssen promotional material minimized the risks of hyperglycemia-related adverse events associated with Risperdal, and misleadingly claimed that Risperdal was safer than other atypical antipsychotics.

Mylan Plans Direct Entry Into Indian Market

Jun 7, 2011

Mylan, a generic-drug manufacturer, announced that it will be rebranding its Hyderabad, India-based subsidiary, Matrix Laboratories, as Mylan. In a company press release, Mylan Chairman and CEO Robert J. Coury states: ?This rebranding will lay the groundwork for continued expansion in India through our entry into the Indian commercial market with our own prescription pharmaceuticals within the next 12 months.? Matrix Laboratories is a supplier of active pharmaceutical ingredients (APIs), and a producer of APIs used to make generic antiretroviral therapies for the treatment of HIV/AIDS. Mylan acquired 51.5% of Matrix?s shares in 2007, and the remainder of its shares in 2009.

House Introduces Bill on Regenerative Medicine

May 24, 2011

On May 12, 2011, a bill was introduced in the US House of Representatives to launch a national strategy for the development of regenerative medicines.

FDA Issues Guidance on Bioequivalence Studies

May 17, 2011

This month, FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications (ANDAs). The guidance is meant to clarify the requirements for the submission of bioequivalence data that were published in 2009 (1). Federal regulations require that all bioequivalence studies performed for a given agent be submitted as part of the ANDA, regardless of whether the study confirms that the product is equivalent to the reference listed drug (RLD).

Federal Appeals Court Lifts Ban on Funding for Embryonic Stem Cell Research

May 10, 2011

On Apr. 29, 2011, a federal appeals court has lifted a ban on federal funding for embryonic stem cell (ESC) research. The move was celebrated by researchers hoping to use such cells for research, but it is likely that the decision will be appealed. Embryonic stem cells are pluripotent cells derived from embryonic tissue in a process that usually results in the destruction of the embryo. The ban on funding did not apply to stem cells derived from adult tissue.

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