Manufacturing: Page 37
-
Struggling Ohr shutters San Diego lab
After suspending work at a lab in San Diego, the biotech cuts jobs.
By Suzanne Elvidge • March 2, 2017 -
Pfizer flagged for more manufacturing issues
The FDA slammed Pfizer in a new warning letter, stating that, among other problems, the drugmaker failed to properly investigate cardboard contaminants at a Kansas-based Hospira plant.
By Jacob Bell • March 1, 2017 -
La Jolla surges on Phase 3 results for shock patients
The San Diego-based company says its synthetic formulation of a blood-pressure regulator offers a new level of treatment for shock patients who fail first- and second-line therapies in the ICU.
By Judy Packer-Tursman • Feb. 27, 2017 -
Why drug pricing seems so complicated
Experts say pharma companies need to get better at incorporating clinical value into pricing and communicating this value.
By Judy Packer-Tursman • Feb. 27, 2017 -
Cold chain integrity, visibility top of mind for pharmaceutical shippers
Panelists representing Teva, Sandoz and freight forwarders identified top challenges in assuring drug quality at a recent conference.
By Edwin Lopez • Feb. 23, 2017 -
Pharma CEOs sign on to letter urging tax reform
Changes to the tax code, such as a move towards territorial taxation or border adjustment, could push drug manufacturers to move production back to the U.S.
By Ned Pagliarulo • Feb. 23, 2017 -
Momenta's Copaxone generic delayed following Pfizer warning letter
The FDA is unlikely to determine the drug's approval status in the first quarter, the company said.
By Jacob Bell • Feb. 23, 2017 -
Dr. Reddy's hits roadblock in re-inspection of India plant
The India-based drugmaker said the FDA issued a Form 483 over problems at a manufacturing facility first flagged by U.S. regulators two years ago.
By Judy Packer-Tursman • Feb. 23, 2017 -
Sponsored by World Courier
Global logistics strategies for cell and gene therapies
In order to ensure the success of clinical trials, another industry has to evolve: logistics.
Feb. 21, 2017 -
FDA warns another Japanese drug manufacturer over GMP flaws
Tokyo-based Sato Pharmaceutical Co. is the third Japanese drugmaker in six months to run afoul of the FDA's inspectors.
By Ned Pagliarulo • Feb. 16, 2017 -
Daiichi shutters Japanese plant amid restructuring efforts
Asubio Pharma Co. is now the second R&D closure this year for the Japanese drug manufacturer.
By Jacob Bell • Feb. 16, 2017 -
Quotient buys QS Pharma, expanding US footprint
QS Pharma is Quotients’s second U.S. acquisition in the past eight days, following right on the heels of its purchase of Florida-based SeaView Research.
By Judy Packer-Tursman • Feb. 16, 2017 -
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
Previous
