Last Friday, Senators Herb Kohl (D-WI) and Chuck Grassley (R-IA) reintroduced their "Preserve Access to Affordable Generics Act," which would presume that pay-for-delay settlements were illegal and give the Federal Trade Commission (FTC) the power to block them.
Company and People Notes: Pfizer Completes King Tender Offer; Cook Pharmica Names VP of R&D and CSO; and More
PTSM: Pharmaceutical Technology Sourcing and Management
A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.
Novartis Acquires Genoptix; Lilly Exec Becomes Savient CEO; and More.
FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.
Merck Teams with Parexel; Roche CFO to Retire; and More
Last Friday, French daily Le Figaro reported that sanofi-aventis intended to reach an acquisition agreement with Genzyme that would value the latter company at roughly $76 per share, or a total of $20 billion.
FDA Sets Limits for Acetaminophen in Prescription Combination Products
Equipment and Processing Report
A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.
Equipment and Processing Report
An industry expert answers a reader's question about using a volumetric dry-material feeder and jet mill to create a finished product.
Equipment and Processing Report
Improvements in analytical techniques may call for a re-evaluation of the biopharmaceutical industry saying that "the process is the product."
Last week, the US Pharmacopeia published proposed standards for the content, language, format, and appearance of prescription drug labels in an effort to enhance patient understanding and safety.
FDA Publishes CDER Presentation, and more.
Gilead Sciences to Acquire Arresto Biosciences; Sartorius Appoints Head of Lab Business; and More.
John Taylor to Serve as Acting Principal Deputy Commissioner after Joshua Sharfstein's Departure, and more.
US Senator Amy Klobuchar (D-MN) urged the US Food and Drug Administration and the pharmaceutical industry to address what she called an "unprecedented" shortage of prescription drugs, especially for chemotherapy.
FDA received the authority to mandate recalls of food under a new food-safety bill. Efforts are underway in the House to grant the agency this power for pharmaceuticals as well.
PTSM: Pharmaceutical Technology Sourcing and Management
A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.
AstraZeneca and Abbott End Program; PhRMA Elects New Members; and More.
Pfizer Recalls One Lipitor Lot; Sanofi Aventis Names Head of R&D; and More.
ICH Unveils New Website and Logo
A US Food and Drug Administration inspection completed on Dec. 9, 2010 revealed persistent deficiencies at McNeil Consumer Healthcare's Fort Washington, Pennsylvania, facility.
Thermo Fisher to Acquire Dionex; Former SOCMA CEO Joe Acker Dies; and More.
Abbott Laboratories (Abbott Park, IL), B. Braun Medical (Bethlehem, PA), and Roxane Laboratories, a subsidiary of Boehringer Ingelheim (Ingelheim am Rhein, Germany), agreed to pay the United States $421 million to settle False Claims Act allegations.
Equipment and Processing Report
Equipment and Processing Report talked to Jonathan Seville, dean of the School of Engineering at the University of Warwick, to find out how positron-emission particle tracking could help pharmaceutical manufacturers gain process understanding.
Company and People Notes: GlaxoSmithKline acquires Nanjing MeiRui Pharma; Cephalon's CEO to remain on medical leave; and more.
EMA Publishes New Transparency Policy, Releases Guideline for Biosimilar mAbs.
PTSM: Pharmaceutical Technology Sourcing and Management
A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.
On Nov. 17, 2010, Novartis (Basel) disclosed its long-term business strategy, which emphasizes diversification in what the company described as high-growth healthcare segments.
Genzyme Sells Business Unit to Sekisui Chemical; Ablexis Names VP of Research; and More.