Manufacturing: Page 38
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GSK well-positioned to weather tax changes, execs say
Tax reforms proposed by Republicans could dramatically change how the U.S. treats imports and exports, a potential headache for multinational drug firms.
By Jacob Bell • Feb. 8, 2017 -
FDA
FDA warns Italian drug manufacturer for quality lapses
FACTA Farmaceutici's quality control unit did not pass muster with the regulator in a January 2016 inspection.
By Ned Pagliarulo • Feb. 2, 2017 -
Trump pushes pharma to boost drug production in US
Markets were relieved when a meeting between President Trump and industry CEOs focused more on taxes and manufacturing than on rising drug prices.
By Ned Pagliarulo • Feb. 2, 2017 -
Sandoz subsidiary expands production at Slovenian site
Lek Pharmaceuticals said the new investment will boost capacity for antibiotics manufacturing.
By Judy Packer-Tursman • Feb. 2, 2017 -
Biosimilars: What you need to know
A closer look at what biosimilars are, who is developing them and the challenges that the industry faces.
By Lisa LaMotta • Jan. 30, 2017 -
FDA slams Jazz CMO for continued violations
U.K.-based Porton Biopharma has been on the agency's list for more than a year due to persistent cGMP issues.
By Jacob Bell • Jan. 26, 2017 -
Aptose 'reprioritizes,' delays development of lead cancer drug
The biotech lacks the resources to develop both of its cancer drugs, so it has opted to shift focus to its preclinical compound.
By Judy Packer-Tursman • Jan. 24, 2017 -
5 hurdles facing biosimilar developers
While several biosimilars are poised to enter the U.S. market, there are still plenty of challenges that are affecting this new space of drugs.
By Lisa LaMotta • Jan. 23, 2017 -
FDA
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
Deep Dive
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
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
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