News

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.

Making highly potent active pharmaceutical ingredients (HPAPIs) can be costly because the process often requires equipment specialized to achieve containment and extra attention to safety concerns. Pharmaceutical professionals may wonder whether disposable components, which have reduced the cost of some operations, might be appropriate in the manufacture of HPAPIs.

Novartis has been told off by the FDA in a letter about a social media Facebook widgit that appears on the company?s Tasigna website.

Sen. Michael Bennet (D-CO) introduced a bill earlier this month, the Drug Safety and Accountability Act of 2010, which is designed to improve regulatory oversight of drug-manufacturing facilities and improve related quality standards and monitoring.

Merck & Co. (Whitehouse Station, NJ) has received letters from the US Department of Justice (DOJ) and the US Securities and Exchange Commission (SEC) seeking information about "activities in a number of countries" with reference to the Foreign Corrupt Practices Act.

This week, the US Food and Drug Administration published on its website a summary of good manufacturing practices for the holding and distribution of drug products.

Penwest and Endo to Merge; Watson Makes Senior Appointments; And More.

In a draft guidance published this week, the US Food and Drug Administration recommended that makers of transdermal and transmucosal drug-delivery systems use "an appropriate scientific approach" during product design, development, and manufacturing to minimize the amount of residual drug substance present at the end of the products' labeled use periods.

FDA Approves Flu Vaccines; Caraco Names COO; And More.

Legislative efforts to modernize provisions in the Toxic Substances Control Act of 1976 (TSCA), which involve chemical safety and reporting requirements is drawing criticism from the chemical industry.

The Senate Appropriations Committee approved a measure last week that would restrict the use of certain patent settlements by innovator-drug companies under which innovator-drug companies pay generic-drug companies to delay the entry of a generic product in so-called "pay-for-delay" cases.

The UN Global Compact, a corporate-social-responsibility initiative, releases a management model to help businesses implement sustainability principles.

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

A recently released study by Accenture shows that sustainability is becoming an increasingly important part of the strategies and operations of companies.

Industry's focus on cost cutting has led to a dangerous gap in training and knowledge.

Cases of overlooking proper packaging, reconstitution, directions, and dissolution.

Manufacturers and regulators on both sides of the ocean move to ensure the safety of heparin and other globally distributed drug products.

Industry can meet its responsibility to society by considering innovative pricing and partnerships.

Three therapies under review could help Americans attain a healthy weight.

Before embarking on an outsourcing relationship, it's important to be aware of FDA's expectations.

With more hands in the manufacturing pot, a good contingency plan is crucial to success.

The FDA has approved the first generic version of the blockbuster low molecular weight heparin Lovenox (enoxaparin sodium), much to originator sanofi-aventis's displeasure.

Merck and Sinopharm Sign Agreement; Agilent Appoints CFO; And More.

French pharma giant Les Laboratoires Servier SA has been accused of providing "misleading" and "incorrect" information during the EC's antitrust investigation.

In 2009, the European Commission (EC) Customs Union seized 11,462,533 medicines and medical products for suspected violations of intellectual property (IP), according to the Commission's annual report on EU Customs Enforcement of Intellectual Property Rights, which was published last week.

A new report from the International Data Corporation (IDC) shows that life-science companies are increasingly using third-party outsourcing firms to augment or replace their information technology services.

European Medicines Agency Issues Drug Review Update; And More

Researchers claim that a dissolving microneedle patch may be able to offer improved vaccination against influenza compared with traditional needles, and also allow people without medical training to easily and safely administer the vaccine.

Pfizer Ends Second Tanezumab Clinical Program; Catalent VP Joins USP Panel; And More.

ICH Draft Residual Solvents Guideline Published; And More.