Chinese API supplier lands in hot water with FDA

Suzhou Pharmaceuticals lacked a quality unit for starters, leading the FDA to ban the company from exporting to the U.S. 

By Ned Pagliarulo • Jan. 18, 2017

Kite confident as CAR-T readout nears

The next two months will be crucial for Kite, which hopes to secure the first approval for a CAR-T therapy in the U.S. 

By Ned Pagliarulo • Jan. 12, 2017

Daiichi closes India facility in continued R&D overhaul

The decision will affect around 170 employees at the facility, which researches infectious disease and inflammation drugs.

By Jacob Bell • Jan. 12, 2017

Orchard Therapeutics partners with Dutch CMO PharmaCell to deliver gene therapy manufacturing

The partnership is expected to advance development of Orchard's rare disease investigational drugs.

By Suzanne Elvidge • Jan. 12, 2017

Kite inks China, Japan deals ahead of possible CAR-T drug approval

Through a joint venture with China's Fosun Pharma, the CAR-T specialist gains a foothold for its lead drug candidate in the world's second biggest pharma market.

By Jacob Bell • Jan. 10, 2017

FDA releases guidance on electronic drug applications

The pharma industry may ditch paper drug applications sooner than it thinks, as the FDA pushes forward with a transition to electronic files.

By Jacob Bell • Jan. 5, 2017

FDA to drugmakers: Don't let manufacturing lead to rejection

In a year when more drugs were rejected for GMP issues than in the past, the FDA's outgoing CDER director warned companies to ensure compliance. 

By Ned Pagliarulo • Jan. 5, 2017

UK-Mexico deal to manufacture gut bug vaccines

A manufacturing agreement will expand the reach of Prokarium's diarrhea vaccine. 

By Suzanne Elvidge • Jan. 5, 2017

After FDA delays pneumonia antibiotic, Cempra's shares plummet

Some analysts contend the size and cost of the FDA's recommended safety study is impractical for the North Carolina-based biotech, likely sinking its lead product.

By Judy Packer-Tursman • Dec. 30, 2016

Vitality secures approvals for cannabinoid facility

The Los Angeles-based company is developing cannabinoid prodrugs in an effort to avoid psychoactive side effects. 

By Ned Pagliarulo • Dec. 22, 2016

FDA guidance urges vigilance to fight suspect products in drug supply chain

The agency identifies specific scenarios that could significantly increase the risk of illegitimate products entering the market and recommends how to identify them "expeditiously."

By Judy Packer-Tursman • Dec. 15, 2016

From bench to bedside

Check out the 5 must-read stories on how incubators are shaping early drug development.

By Lisa LaMotta • Dec. 12, 2016

FDA slaps Spanish API maker with warning letter

The Barcelona-based manufacturer was flagged for inadequate cleaning and equipment repair practices, as well as not providing stability data.

By Jacob Bell • Dec. 8, 2016

Sun Pharma faces new worries at key Halol plant

The large Indian drugmaker revealed the FDA has issued a Form-483 following re-inspection of the drug manufacturing facility. 

By Ned Pagliarulo • Dec. 8, 2016

Roche brings Kapa into partnership with German Merck

The Swiss biopharma has expanded two distribution deals this week, one for its own enzyme products and one for another drugmaker's diabetes technology.

By Jacob Bell • Dec. 2, 2016

West Pharma expands contract manufacturing in Ireland

Growing demand for contract manufacturing is driving the expansion. 

By Suzanne Elvidge • Dec. 1, 2016

Patheon snaps up SC manufacturing site from Roche

The Swiss pharma has been trimming its small molecule manufacturing network, tagging four plants worldwide for sale. 

By Judy Packer-Tursman • Nov. 30, 2016

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