FDA finalizes quality guidelines for contract manufacturers

Since most pharmaceutical production is now being done by contract facilities, the agency's recommendations take on added significance.

By Judy Packer-Tursman • Nov. 30, 2016

Trial miss derails Acorda's Ampyra plans

Acorda will halt further development of Ampyra as a treatment for post-stroke walking difficulties, crimping its lifecycle management strategy.

By Judy Packer-Tursman • Nov. 21, 2016

Sanofi to halt bladder cancer drug production

The biotech's decision not to re-launch BCG in the U.S. comes after years of production issues.

By Judy Packer-Tursman • Nov. 21, 2016

Grunenthal buys Pittsburgh firm to expand pain-fighting portfolio

Thar Pharmaceuticals abandons IPO plans in favor of deal with German giant.

By Judy Packer-Tursman • Nov. 18, 2016

How tracking regulations affect medical supply chains

Original equipment manufacturers are being swamped with new demands worldwide as pharmaceutical and medical device clients demand updated equipment.

By Edwin Lopez • Nov. 17, 2016

Eagle acquires Arsia, moves in on biosimilars

The target company's technology platform will allow Eagle to soar above other biosimilar developers.

By Jacob Bell • Nov. 17, 2016

GSK consolidates R&D with "smart labs" in Philadelphia

The big pharma says $250 million effort will reduce its merger-inherited footprint of scattered R&D sites.

By Judy Packer-Tursman • Nov. 17, 2016

Boehringer moves the farm to Georgia

After completing its asset swap, the company will move its animal health headquarters from Missouri to Georgia. 

By Suzanne Elvidge • Nov. 17, 2016

Biopharma continues to thrive in CA

A new report underscores the state's strength as a hub for the sector, rivaled only by the Boston and Cambridge area. 

By Judy Packer-Tursman • Nov. 17, 2016

Report: Pharma traceability needs will drive packaging industry growth

Shifting consumer demands, an explosion of SKUs and rising regulatory concerns will bring domestic packaging machinery shipments to $8.5 billion by 2020.

By Edwin Lopez • Nov. 10, 2016

Valeant hit with another FDA warning letter

An M&A-heavy strategy appears to have led to gaps in integrating newly acquired products into Valeant's quality management systems, the FDA report suggested. 

By Ned Pagliarulo • Nov. 10, 2016

Keryx rebuilds supply for kidney drug

The Boston company previously had to halt Auryxia's supply due to manufacturing problems.

By Judy Packer-Tursman • Nov. 10, 2016

RedHill full steam ahead on stomach-illness drug

The Israeli biopharma received positive feedback during a pre-Phase 3 meeting with the FDA, and has a confirmatory study scheduled for the first half of 2017.

By Jacob Bell • Nov. 10, 2016

MaaT creates first GMP-compliant stool transfer platform

The platform allows production of clinical batches of gut bugs as the microbiome attracts increasing biopharma interest. 

By Suzanne Elvidge • Nov. 10, 2016

Top Google-searched Rxs by state: California? Viagra

Results also reflected the impact of the growing opioid crisis in the U.S. Suboxone, an addiction treatment, was the most searched drug in 14 states. 

By Judy Packer-Tursman • Nov. 4, 2016

Lonza ramps up drug manufacturing with new Swiss facility

The 14,000 square foot facility furthers the company's goals of advancing its life science offerings.

By Jacob Bell • Nov. 3, 2016

Supply chain management is a priority for GSK as Brexit looms

The British drugmaker has the looming Brexit top of mind as it enters the fourth quarter. 

By Edwin Lopez , Jennifer McKevitt • Nov. 3, 2016

Ergomed, Asarina partner on treatment for severe premenstrual syndrome

Sepranolone is the first product being developed exclusively for the often-debilitating condition.

By Judy Packer-Tursman • Nov. 3, 2016

GE expands biomanufacturing plant in Massachusetts

A larger clean room and more employee training will be part of the manufacturing expansion. 

By Lisa LaMotta • Nov. 3, 2016

Portola broadens AndexXa partnership with Daiichi

Despite hitting a setback with the FDA in August, Portola is pushing ahead with clinical studies of its Factor Xa inhibitor antidote. 

By Ned Pagliarulo • Nov. 3, 2016

Witch's brew? What drugs contain leech and lizard parts

From Gila monster spit to sloth fur, biopharma has increasingly incorporated strange additions into its drugs.

By Jacob Bell • Oct. 28, 2016

Czech drugmaker hit with FDA warning letter

While the regulator has stepped up its oversight of manufacturers in India and China, CGMP warnings to European firms are less common.

By Ned Pagliarulo • Oct. 27, 2016

EUIPO: Fake drugs threaten EU jobs

Counterfeit drugs cast an economic shadow across Europe, says a report from the European Union Intellectual Property Office. 

By Suzanne Elvidge • Oct. 27, 2016

VBL secures new Israeli manufacturing site

With a new facility in Modiin, the clinical-stage biopharma preps for commercialization of its lead cancer drug.

By Jacob Bell • Oct. 20, 2016

Dimension beefs up AAV manufacturing

The Cambridge-based gene therapy company put its first program into the clinic this year and has a number of other IND-enabling studies ongoing. 

By Ned Pagliarulo • Oct. 20, 2016