News

GlaxoSmithKline is recalling 394,230 bottles containing its antihypertensive drug DynaCirc CR (isradipine) controlled-release tablets. The lots are being recalled due to concerns regarding the level of cGMP compliance and procedural controls related to line clearance during the packing process at the Lincoln, Nebraska, facility of Novartis Consumer Health, where the product is made.

Merck KGaA announced measures intended to reduce costs and increase efficiency to ensure the long-term success of its business model. The measures announced this week are part of a comprehensive transformation program that will be implemented in two phases.

On Feb. 21, 2012, FDA announced steps the agency plans to take to increase the declining supply of certain cancer drugs. These steps came in response to President Obama's Oct. 31, 2011 Executive Order.

On Feb. 17, 2012, McNeil Consumer Healthcare, a division of McNeil-PPC, a subsidiary of Johnson & Johnson, voluntarily recalled approximately 574,000 bottles of its OTC pain reliever and fever reducer Infants' Tylenol Oral Suspension, 1 oz. Grape. The voluntary recall was initiated after consumers complained of having difficulty using the SimpleMeasure dosing system.

Pfizer has signed an agreement with the Chinese biopharmaceutical company Zhejiang Hisun Pharmaceuticals with the objective of establishing a $545-million joint venture to develop and commercialize branded generic medicines in both China and the global market.

On Feb. 21, 2011, FDA posted a copy of a Warning Letter that was sent to the chairman of the executive board of Merck KGaA on Dec. 15, 2011, regarding cGMP violations identified at three of its European facilities: MS-Corsier-sur-Vevey, MS-Aubonne, and MS-Tiburtina.

Biogen Idec to Acquire Stromedix; Mylan, Pfizer Announce Epinephrine Autoinjector Settlement Agreement; and More.

The South African government is involved in talks with the Swiss biopharmaceutical company Lonza regarding a joint venture to construct the country's first plant to manufacture APIs for antiretroviral medicines.

EMA Releases Genetic Variability Guideline.

President Barack Obama released his budget proposal for fiscal year 2013. Included in the proposed budget is a $654-million increase in FDA funding, for a total FDA budget request of $4.49 billion.

FDA has released a draft guidance for API manufacturers in response to a 2008 incident in which heparin sourced from China was adulterated with oversulfated chondroitin sulfate, causing serious adverse reactions in patients.

Alexion Completes Acquisition of Enobia Pharma; BMS Completes Acquisition of Inhibitex; and More.

With the increasing use of hot-melt extrusion, extruder manufacturers have developed mid-size twin-screw extruders that facilitate process development and scale-up to commercial processes.

The EMA has published a guideline that addresses the influence of patients? genetic variability on drug pharmacokinetics.

We need to measure the particle size of a moisture-sensitive powder. We would like to use dry analysis on our laser-diffraction system, but the particles are fragile and we're struggling to get robust results. Is wet measurement with a nonaqueous solvent the only option?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2012 edition from ACS Valves and G-Con.

Following a packaging error affecting birth-control pills, Pfizer has issued a one-million pack recall and warned women in the US who have been taking the medication during the last several months to consult with their physicians.

FDA Addresses the Regulation and Approval Process of PET Drugs.

GlaxoSmithKline released its fourth quarter and full year 2011 earnings report, which showed its return on R&D to be 12%-up from 11% in 2010, and closing in on the company's goal of a 14% return.

The European Medicines Agency (EMA) has published an implementation plan for Europe's new pharmacovigilance legislation, which comes into force in July with the aim of improving the safety and risk–benefit monitoring of drugs. The new legislation will represent the biggest change in the legal framework of the industry since EMA was first established in 1995.

AstraZeneca Restructures; Catalent Completes Expansion in Italy; and More.

Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to support the fifth authorization of the Prescription Drug User Fee Act, also known as PDUFA V. She also outlined a series of recommendations, sent to Congress in January 2012, to include in PDUFA V.

The European Commission (EC) has closed an investigation into Servier that accused the company of providing "misleading" and "incorrect" information to the EC?s pharmaceutical sector inquiry.

Pfizer announced a decrease in fourth-quarter revenues, but a slight increase in full-year 2011 revenues in its financial report on Jan. 31, 2012.

PhRMA announced that it will transition the management of its benefit–risk action team to the Centre for Innovation in Regulatory Science (CIRS). CIRS is a neutral, independent UK-based subsidiary company, forming part of the Intellectual Property and Science business of Thomson Reuters.

The US Department of Justice, on behalf of FDA, filed a consent decree of permanent injunction against the generic-drug manufacturer Ranbaxy in the US District Court of Maryland. The decree was filed on Jan. 25, 2012, and is subject to court approval.

Pfizer, Sanofi, GlaxoSmithKline, and other major pharmaceutical companies have joined forces and pledged to defeat 10 neglected tropical diseases by 2020. The consortium comprises 13 pharmaceutical companies, the United States, United Kingdom, and United Arab Emirates governments, the Bill & Melinda Gates Foundation, the World Health Organization, and several other global health entities.

The Asian nation is strategizing to take the lead over its regional competitors in pharmaceutical exports.

Amgen Agrees to Micromet for $1.16 Billion; Cephalon Issues Recall of Treanda; and More.

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