Manufacturing

We speak to The European generic Medicines Association about the environment for biosimilars.

The recent amendment to Annex 1 has seen controversial changes relating to the capping of vials.

New isolator and disposable technologies are set to assume a greater role in pharma manufacturing, according to a recent conference in Germany.

The EMA's Guideline on Similar Biological Medical Products provides overarching guidance, but since its introduction a range of more specific guidelines have also been developed.

As biopharmaceuticals will soon make up 50% of new drug approvals there has been a significant rise in interest in the field of biosimilars.

The biggest differences between the development of a biosimilar and a generic medicine lie primarily in the preclinical and clinical stages.

The author describes the importance of risk management and offers strategies for risk-management preparedness in supply chains.

Why the primary defence against biosimilars is to develop better molecules that can be launched quickly.

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

What are the newest trends in pneumatic conveying of pharmaceutical powders and blends?

Leading CMOs share their experiences with regard to client expectations and performance indicators as well as strategies for adapting to the changing contract-manufacturing environment. This article is part of the 2010 Outsourcing Resources special issue.

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

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.

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).

Teva's and Sun Pharmaceuticals' motion to overturn a verdict issued against them in April 2010 for patent infringement has been denied by a US court, leaving the companies at the mercy of pharma giants Pfizer and Nycomed, who have said they will "vigorously" pursue damage claims.

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

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the July 2010 edition from Gems Sensors and Controls and Telstar.

With the right technology tools, the sponsor organization and the contract manufacturer can have self-service, on-demand, and scheduled access to all manufacturing, quality, and process-development data.

The Council of Europe (CoE) is hoping its 'Medicrime' treaty can help curb the lucrative global trade in fake medicines.

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

States can reduce their Medicaid programs' healthcare expenditures by changing laws to enable generic drugs to be substituted for branded medications more easily and quickly, according to a new study conducted by CVS Caremark, a large pharmacy healthcare provider.

McNeil Consumer Healthcare, a division of Johnson & Johnson (J&J), has once again expanded the recall of certain OTC products because of a musty or moldy odor, which has been linked to trace amounts of the chemical 2,4,6 triburomoanisole (TBA).

Merck & Co. (Whitehouse Station, NJ) released details of a restructuring plan last week, which calls for phasing out operations at eight research sites and eight manufacturing sites, resulting in a 15% reduction of its global workforce.

The Council of Europe (CoE) is hoping its Medicrime treaty can help curb the lucrative global trade in fake medicines.

The Pharmaceutical Research and Manufacturers of America (PhRMA) announced earlier this week that John J. Castellani will replace Billy Tauzin as President and Chief Executive Officer.

Last week, Senator Charles Grassley (R-IA) sent letters to 16 drugmakers, including Pfizer (New York), AstraZeneca (London), and Eli Lilly (Indianapolis), asking them about their current policies regarding whistleblowers?employees who file complaints under the False Claims Act (FCA).

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