Drug Development

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

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.

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.

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In a draft guidance published this week, the US Food and Drug Administration recommended that makers of transdermal and transmucosal drug-delivery systems use "an appropriate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.

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.

FDA chemistry reviewers in the Office of Generic Drugs provide an overview of common deficiences cited throughout the Chemistry, Manufacturing, and Controls section of ANDAs.

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

Pharmaceutical Technology talked to experts in siRNA-drug development to gain insight into the characteristics, processes, and challenges of this class of therapeutics.

Chemocatalytic and biocatalytic approaches in asymmetric synthesis help provide a pathway for producing single-enantiomer drugs.

Green chemistry in pharmaceutical development often centers around approaches in the synthesis of the active ingredient, but green-chemistry techniques also can be applied to drug-product manufacturing, formulation development, and drug delivery.

As emerging markets become increasingly important for the pharmaceutical majors, companies are re-evaluating their outsourcing strategies. This article is part of the 2010 Outsourcing Resources special issue.

The authors describe recent market trends and indicate the likely future direction of the pharmaceutical and biopharmaceutical industries. This article is part of the 2010 Outsourcing Resources special issue.

Merck and Sinopharm Sign Agreement; Agilent Appoints CFO; 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.

The Society of Chemical Manufacturers and Affiliates (SOCMA) expressed "strong concern" over legislation introduced in the US Senate earlier this month regarding chemical-site security.

Merck KGaA (Darmstadt, Germany), a global pharmaceutical and chemical company, completed its acquisition of Millipore (Billerica, MA), a life-science company, last Thursday for an aggregate purchase price of roughly EUR 5.2 billion ($6.7 billion).

The pharmaceutical industry?s increasing interest in inhaled drugs has prompted several researchers to propose standard dissolution-testing methods for these products.

Xcelience and Penn Form Joint Venture; Almac Appoints QA Director; And More.

The US House of Representatives passed on July 1, 2010, HR 4899, the Supplemental Appropriations Act of 2010, which included provisions restricting patent settlements between innovator-drug and generic-drug companies, a move that drew criticism from both sectors of the pharmaceutical industry.

Eli Lilly to Acquire Alnara Pharmaceuticals; Exelixis CEO Leaves for Biogen Idec; And More.

Duke University researchers have found a possible alternative to lyophilization.