Patricia Van Arnum

Pfizer settles its litigation against Teva Pharmaceuticals regarding Pfizer's patent covering the use of Viagra.

Biogen and Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, advance plans for anti-TNF biosimilar product candidates.

AstraZeneca issues a statement regarding the launch of esomeprazole strontium in the United States.

GlaxoSmithKline plans to expand its facilities in Ware and Worthing in the United Kingdom and will build a new facility for manufacturing innovation.

Roche and Prothena sign deal worth up to $600 million to develop and commercialize antibodies that target alpha-synuclein.

Teva Pharmaceutical Industries releases a financial outlook for 2014 based on two possible scenarios concerning its multiple-sclerosis drug Copaxone (glatiramer acetate).

Annual growth in spending for medicines is expected to rise from 2-3% in 2013 to 5-7% in 2017, the highest pace of growth since 2009.

AstraZeneca, Bristol-Myers Squibb recall certain lots of of their antidiabetes drug Bydureon (eventide) due to manufacturing records that batches may contain underfilled vials.

The move follows rejection of Elan shareholders of certain key deals and withdrawal of Royalty Pharma bid.

Elan urges its shareholders to reject bid in an upcoming meeting on June 17.

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products from its facility in Ingelheim am Rhein, Germany.

The company expands to add process-development and clinical-manufacturing capabilities at its large-scale bulk biologics facility.

Company is notified of GMP violations at facility in Catania, Italy.

Maryland is the latest state to consider whether to include additional requirements for substitution of biological products.

Company considers investment in insulin cartridge-filling and insulin API manufacturing capacity in the US.

Company issues voluntary recall after learning of complaints of an uncharacteristic odor coming from Levoxyl bottles.

Novartis loses an appeal in seeking patent protection in India for its anticancer drug.

CROs are keeping pace with the increased globalization of the biopharmaceutical/pharmaceutical industry.

As biopharmaceutical/pharmaceutical companies increase their development of biologic-based drugs, companies providing analytical instrumentation and laboratory testing goods and services are, in turn, offering improved tools for biologic characterization, biomanufacturing, and related testing.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

Additional approvals in December have helped to outpace a recent high set in 2011.

The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.

FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.

Myriad Genetics reports that the US Supreme Court has granted certiorari agreeing to hear the company's gene patentability case.

The launch of a global cross-pharmaceutical Investigator Databank follows the formation of TransCelerate BioPharma, another industry collaboration to address challenges in drug development.

Watson Pharmaceuticals has completed its EUR 4.25 billion ($5.4 billion) acquisition of the Actavis Group. The combination creates the world's third largest generic-drug pharmaceutical company, with anticipated pro forma combined 2012 revenues in excess of $8 billion, according to Watson.

Ben Venue Laboratories has resumed production on a limited number of manufacturing lines in the company's Bedford, Ohio, facilities.

Merck Serono's Asceneuron is the third company to be spun off from the company's Entrepreneur Partnership Program that was launched to mitigate the impact from recent restructuring at its Geneva site.