News

ICH to Hold Training Workshops for Quality Guidelines

Director General of the European Generic Medicines Association (EGA), Greg Perry, has emphasized the need for EU biosimilar guidelines for monoclonal antibodies (mAbs), as well as a harmonized, global approach to biosimilars in general, at the agency's 8th International Symposium on Biosimilar Medicines.

The European Medicines Agency (EMA) has launched a review of GlaxoSmithKline's pandemic influenza vaccine Pandemrix to investigate whether there is a link between vaccination and cases of narcolepsy, a rare sleep disorder.

Industry efforts toward global healthcare surpass average expectations.

Pending legislation may give FTC the authority to regulate all Hatch-Waxman settlements.

From weekend deliveries to nonsterile gloves, a single exception can make a product fall flat.

FDA Provides Information On Advisory Committees, Announces Public Meetings, And More.

Industry participation is crucial as USP embarks on far-reaching monograph modernization initiative. This is an online-exclusive article.

New data provide insight into pharma-industry professionals' daily lives.

The President's Council on Advisors on Science and Technology (PCAST), a group administered by the federal Office of Science and Technology Policy (OSTP), issued recommendations to improve the country's ability to accelerate vaccine production and delivery in the event of a pandemic flu outbreak.

Genzyme (Cambridge, MA) confirmed that it had received sanofi-aventis's (Paris) proposal to acquire all of its outstanding shares for $69 each.

No one can deny the power of social media; it has revolutionised communication and empowered consumers, creating a medium that allows the free flow of information with no authority to control it.

Despite the poor economic climate, large-scale mergers and acquisitions in the pharmaceutical industry struck back with a vengeance in 2009.

An upcoming summit will assess the progress and gaps in realizing the UN Millennium Development Goals, including outcomes from global health initiatives.

A roundup of developments on corporate social responsibility from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

Secretary of State Hillary Clinton details the progress and future direction of the US role in the Global Health Initiative.

Week of Aug. 23, 2010: Company and People Notes: Quark and Novartis Form Agreement; Hospira CEO Retires; And More.

The future of pharmaceutical R&D may lie in open-source research, with key data being made available to a number of people, including college students and university researchers, in an open and collaborative process.

US Department of Health and Human Services (HHS) Secretary Kathleen Sebelius released last week an examination of the federal government's system to produce medical countermeasures, or medications, vaccines, equipment, and supplies needed for a health emergency.

Regulatory Roundup: PDUFA Fees Published, And More.

GlaxoSmithKline Consumer Healthcare, Cephalon UK Ltd, and ProStraken Group plc have been accused of breaching the Association of the British Pharmaceutical Industry's (ABPI) Code of Practice.

Two new reports describe the vaccine market's recent growth and predict future market expansions.

Members of a UK trade union working at AstraZeneca have voted to strike following cuts in pension benefits.

Recent figures published by the EMA relating to centralized procedure activities for human medicines appear to show a marked slow down in the number of generic product applications started and finalized this year to date (9 and 12, respectively).

The US Food and Drug Administration and European Medicines Agency (EMA) are looking for drug manufacturing companies to participate in their joint good manufacturing practice (GMP) inspection pilot program.

The Society of Chemical Manufacturers and Affiliates (SOCMA) welcomed the signing of HR 4380, the United States Manufacturing Enhancement Act of 2010, also known as the Miscellaneous Tariff Bill (MTB) into law (Public Law 111-227) by President Barack Obama on Aug. 11, 2010.

Eli Lilly Ends Semagacestat Program; Selecta Appoints CEO; And More.

Commissioner Hamburg Says China is Improving Export Regulation

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the August 2010 edition from Lechler and Thermo Fisher Scientific.

Changing or upgrading cleanroom gloves requires time and due consideration. A good decision could improve employee satisfaction and product yields, but a bad decision could necessitate millions of dollars worth of rework, recalls, and rejects if the gloves don?t perform as expected. Personnel should consider various criteria to choose the best glove for their cleanroom.