Manufacturing: Page 38
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Takeda, PRA expand R&D partnership into Japan
Less than half a year after first pairing up, the two companies are creating a new joint venture to support Takeda's drug development work in its home base.
By Suzanne Elvidge • Feb. 16, 2017 -
Biomarkers: What you need to know
A closer look at what biomarkers are, how they are driving the industry and who is utilizing them well.
By Lisa LaMotta • Feb. 15, 2017 -
Pfizer plans to close Australian manufacturing plant
An evaluation of manufacturing operations following the company's acquisition of Hospira led to the decision to shutter the Adelaide-based plant by the end of 2021.
By Jacob Bell • Feb. 9, 2017 -
Sanofi, Regeneron set to resubmit sarilumab
Manufacturing headaches had derailed the drug last fall, but the duo expects to send an application back to the FDA sometime this quarter.
By Suzanne Elvidge • Feb. 9, 2017 -
FDA
AMRI builds out drug discovery tech
A new alliance gives the New York-based company access to a high throughput mass spectrometry system.
By Judy Packer-Tursman • Feb. 9, 2017 -
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
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