News

Under a definitive merger agreement, Eli Lilly and Company will acquire ImClone Systems, Inc. (New York) in a cash tender offer of approximately $6.5 billion.

Rep. John D. Dingell (D-MI), chairman of the US House of Representatives Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), the chairman of the Oversight and Investigations Subcommittee, sent a letter to the US Department of Health and Human Services (HHS), questioning the US Food and Drug Administration?s use of agency resources to hire an outside public-relations firm to create a positive public image of the agency.

The electronic pedigree mandate for prescription drugs has been delayed again. California Gov. Arnold Schwarzenegger signed legislation that delays ePedigree implementation until 2015.

Also, Merck & Co. discontinues development of its obesity drug taranabant; Synthetech names Frederic Farkas director of manufacturing; more...

The European Fine Chemicals Group (EFCG) and the International Pharmaceutical Excipents Council of Europe (IPEC Europe) announced the formation of  a European Pharmaceutical Excipients Certification Project to develop advocacy and stakeholder management in Europe and to give advice to two European working teams as part of an effort to develop a certification program for manufacturers and distributors of pharmaceutical excipients.

Buoyed by increased demand for pharmaceutical outsourcing services, Ricerca Biosciences proceeds with an expansion plan.

The pharmaceutical industry faces compliance with the REACH regulation, the European Union's regulation on chemicals and their safe use. Fully understanding the requirements, achieving compliance, and developing strategies for working with suppliers are key for avoiding interruption of the supply chain.

Pharmaceutical companies want software vendors to make integrating manufacturing execution systems and enterprise resource planning systems easier.

Industry needs a standard to connect systems and equipment sooner rather than later.

Planning ahead will ensure successful efforts to improve packaging and packaging operations.

Brief pharmaceutical news items for October 2008.

To err may be human, but to really mess things up, you need management.

Can previous trends of Democratic and Republican administrations predict industry's future?

A book offers a detailed introduction to the new area of risk evaluation and mitigation strategies.

A public meeting is being held today to discuss over-the-counter cough and cold medications for pediatric use.

Also, Alpharma advises shareholders to reject King's offer; ImClone rejects raised BMS offer; Immunogen appoints Daniel M. Junius, more...

The International Electrotechnical Commission (IEC) has approved HART 7.1, the WirelessHART Communication Specification, as a Publicly Available Specification (IEC/PAS 62591Ed.1). WirelessHART is the first industrial wireless communication technology to achieve this level of approval.

Eli Lilly and Company plans to launch an online registry of its payments to physicians in 2009.

SAFC, Regis Technologies, Carbogen Amcis, Cambridge Major Laboratories, and AMRI are among the companies at CPhI Worldwide in Frankfurt this week that are moving forward with expansions.

Ionic liquids provide an alternative to certain solvents in select reactions used to synthesize intermediates and active pharmaceutical ingredients.

Counterfeiting has become the topic of conversation at all levels of the pharmaceutical industry. Considering the rising number of cases, this is hardly surprising.

Also, Zentiva accepts Sanofi's increased takeover bid, Oriel Therapeutics appoints Richard Fuller CEO, more...

In a Sept. 17 letter to FDA Commissioner Andrew C. von Eschenbach, Rep. Henry Waxman (D-CA) questions the agency's priorities, specifically poking at FDA's political appointees and whether they are promoting industry at the expense of the public's health.

On November 3, the US Supreme Court will hear the case of Wyeth v. Levine, in which the drug company has challenged the ruling of a Vermont Supreme Court decision to award Diana Levine $6.8 million.

A new study concludes that an approval pathway for affordable follow-on biologics should be based on the Hatch–Waxman Act of 1984.

In an effort to clarify its policy on the use and creation of genetically engineered animals (GE animals), the US Food and Drug Administration released the draft guidance "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs" on September 18.

The US Food and Drug Administration has issued two warning letters to Ranbaxy Laboratories.

In November, representatives to the International Conference on Harmonization will meet in Brussels, Belgium, to discuss several international cooperation initiatives, including ICH Q10: Pharmaceutical Quality System and ICH Q8R: Pharmaceutical Development.

The biopharmaceutical company ImClone Systems rejected Bristol-Myers Squibb's previously announced bid of $60 per share in cash or $4.5 billion for acquiring ImClone, citing the bid as "inadequate."

Also, Quintiles to expand Singapore operations; Christine A. Poon, chairman of Johnson & Johnson's pharmaceuticals group, to retire; more...