Frontida warned by FDA over GMP violations

The facility in question, while under ownership by Sun Pharma, had knowingly released 27 batches of potentially contaminated API, according to U.S. regulators.

By Suzanne Elvidge • Aug. 30, 2016

Actavis pulls Patheon-made pills

The generic drug maker, now part of Teva, pulled several lots of pills after tests revealed they didn't meet expectations.

By Lisa LaMotta • Aug. 25, 2016

Sagent recalls injectable antibiotic

One lot of Oxacillin is being pulled from the market after metal particulate was found in a vial of the drug. 

By Ned Pagliarulo • Aug. 25, 2016

Fresenius Kabi invests $250M in manufacturing expansion

The investment will add production capacity at the German manufacturer's Illinois site. 

By Suzanne Elvidge • Aug. 25, 2016

Automation drives Zenith's US expansion

Manufacturing software solutions provider Zenith Technologies recently expanded its footprint, opening two new offices on the West Coast.

By Suzanne Elvidge • Aug. 25, 2016

Pfizer to shed four Hospira sites

The move will lay off 104 people in Hospira’s former sites in Atlanta, Dallas, Los Angeles and King of Prussia, PA.

By Kirell Lakhman • Aug. 22, 2016

Piramel buys contract manufacturer Ash Stevens

The Indian company is expanding its North American presence and ability to manufacture different types of pharmaceuticals. 

By Lisa LaMotta • Aug. 18, 2016

MI Labs to biotechs: Call us home

Founded last year, Mass Innovation Labs styles itself as a “chief operating officer” for emerging companies.

By Ned Pagliarulo • Aug. 16, 2016

Novartis expands plant ahead of expected growth

The big pharma is more than doubling its capacity at one of its biologics plants to prepare for expected strong product sales. 

By Lisa LaMotta • Aug. 16, 2016

ICPE Booth A2 - ICON

Discover a convergence model driven by real-world intelligence and patient-centric innovation.

By Ramita Tandon, Executive Vice President
 Commercialisation & Outcomes, ICON plc • Aug. 16, 2016

Valeant nearing resolution of CRL, Papa says

The FDA initially rejected Valeant's application for approval of an eye drug over violations at a manufacturing facility in Tampa, FL. 

By Lisa LaMotta • Aug. 11, 2016

NIH shuts down facility used to produce drugs for clinical trials

Inspections by the FDA last year revealed serious violations of proper manufacturing processes, prompting a sweeping review of all sterile production at the national medical research agency.

By Ned Pagliarulo • Aug. 10, 2016

Pfizer temporarily shutters Indian facility after inspections

Acquired in last year's Hospira deal, the site near Chennai had previously been flagged by U.S. regulators in 2013 for manufacturing violations. 

By Ned Pagliarulo • Aug. 9, 2016

Seizing CAR-T lead, Kite readies commercial-scale manufacturing

Along with safety, the ability to quickly manufacture the first wave of CAR-T therapies will likely be a key test of commercial viability. 

By Ned Pagliarulo • Aug. 9, 2016

Pfizer cuts 151 jobs at New York plant

The cuts to the Pearl River site come as Pfizer expands its manufacturing operations elsewhere. 

By Ned Pagliarulo • Aug. 4, 2016

Teva bolsters generics consolidation with purchase of Allergan's distributor

Teva will pay Allergan $500 million for Anda Inc., the fourth largest wholesale distributor of generics in the U.S.

By Edwin Lopez • Aug. 4, 2016

Chinese drug manufacturer lies to FDA, promptly gets banned

In a particularly deadpan warning letter to Xiamen Origin Biotech, the FDA slammed the API producer for misleading customers and lying to a FDA inspector. 

By Nicole Gray , Ned Pagliarulo • Aug. 4, 2016

Keryx says Auryxia shortage 'imminent'

The company has announced that their phosphate binder Auryxia will not be available until Q4. 

By Nicole Gray • Aug. 4, 2016

Takeda hones R&D focus in $725 million restructuring

The company plans to build out three R&D hubs in the U.S. and Japan, aimed at underpinning a more global approach to partnering and collaboration. 

By Edwin Lopez • July 29, 2016

Teva will provide long-term API contracts to producers in 15 markets

U.S. regulators set the condition to ensure Teva does not use API supply contracts to force competitors to raise product prices.

By Edwin Lopez • July 28, 2016

GSK to invest $360 million in UK plants despite Brexit vote

The spending might help ease concerns about Britain's future as a pharma hub.

By Randy Lilleston • July 28, 2016

Shnaghai Fosun to buy large stake in Gland Pharma for $1.4 billion

This acquisition represents the first major purchase of an Indian manufacturing outfit by a Chinese firm. 

By Nicole Gray • July 28, 2016

EU regulator recommends market suspension for dozens of generics

The European Medicines Agency concluded bioequivalence studies conducted by an India-based contract researcher to support generic approvals were "flawed." 

By Edwin Lopez • July 25, 2016

Pfizer presses on with expansion of Irish manufacturing site

When completed, the build-out is expected to add up to 350 jobs at the Grange Castle site, according to a new report. 

By Nicole Gray • July 21, 2016

Merck KGaA building $115 million life science facility in MA

The new MiliporeSigma facility will house the M Lab Collaboration Center, one of nine such hubs planned for construction worldwide. 

By Nicole Gray • July 21, 2016