Manufacturing: Page 36
-
FDA warns Teva over violations at China plant
The drugmaker said it is already taking corrective action to fix the regulator's concerns, which are related to manufacturing control and sampling processes.
By Ned Pagliarulo • April 13, 2017 -
Could organs on a microchip help test for toxins? The FDA wants to find out
The regulator will collaborate with the private Emulate, Inc. to test the company's organ-on-a-chip technology as a potential toxicology testing platform.
By Suzanne Elvidge • April 13, 2017 -
Generics maker Akorn jumps on Fresenius takeout talks
After rumors swirl, Fresenius Kabi and Akorn confirm that they are in acquisition talks.
By Suzanne Elvidge • April 10, 2017 -
Dr. Reddy's hit with another Form 483
It's the latest in a string of manufacturing problems the drug developer has faced over the past few years.
By Jacob Bell • April 6, 2017 -
New guidelines to make China a more drug-friendly market
CFDA announced draft guidelines that would allow Phase I trials in China to encourage simultaneous development alongside global trials.
By Tamra Sami • April 3, 2017 -
Warp Drive Bio teams up with GSK, taking aim at 'undruggable' targets
Together, the two companies hope to build a library of as many as 200 million souped-up compounds to screen against historically un-targetable proteins.
By Ned Pagliarulo • March 30, 2017 -
Agenus trims staff, narrows focus in restructuring
The biotech will close a facility in Basel, Switzerland as it consolidates to push two checkpoint inhibitor candidates through clinical development.
By Ned Pagliarulo • March 30, 2017 -
Novartis, Aurobindo drugs hit by EMA-advised suspensions
The agency claims four years of bioequivalence data from an Indian contract research organization were not satisfactory, and released a 32-page list of drugs that could face suspension.
By Jacob Bell • March 30, 2017 -
Lilly touts $850M manufacturing investment as CEO stumps for tax reform
The Indianapolis drugmaker plans to continue expanding its diabetes manufacturing, announcing details to its 2017 plans in a move likely to please President Trump.
By Ned Pagliarulo • March 24, 2017 -
FDA
Control over production data still tripping up foreign drug manufacturers with FDA
Warning letters sent to two drugmakers in India and China show a lack of data controls and failure to investigate test results are still common problems with foreign suppliers.
By Ned Pagliarulo • March 23, 2017 -
FDA bans Divi's Labs plant, dealing another blow to India's quality credibility
Efforts by the Indian drugmaker to right manufacturing violations clearly haven't been enough to keep it off the agency's bad side.
By Jacob Bell • March 23, 2017 -
Valeant hopes for August approval of eye drug
Manufacturing problems at a Tampa, FL facility tripped up Valeant's application last year, but, with a PDUFA date now set, those issues look to be resolved.
By Ned Pagliarulo • March 23, 2017 -
Who stands to benefit from Mylan's EpiPen recall?
A voluntary recall of Mylan's EpiPen could mean trouble for the drugmaker and a boon for its competitors.
By Suzanne Elvidge • March 23, 2017 -
FDA hands AstraZeneca's ZS-9 another setback
The agency issued a complete response letter to AstraZeneca for its hyperkalemia drug, giving it a second rejection.
By Jacob Bell • March 17, 2017 -
FDA warns two manufacturers from China, India for GMP lapses
Continuing a trend of stepped-up oversight, drug manufacturers from India and China have been frequently tripped up by FDA standards.
By Ned Pagliarulo • March 16, 2017 -
Takeda teams up with venture firm on drug discovery unit
The Japanese pharma has been narrowing its focus to three core therapeutic areas as part of a broader restructuring aimed at revitalizing the veteran company.
By Ned Pagliarulo • March 16, 2017 -
Sun Pharma gets ray of good manufacturing news
While some reforms still need to be addressed, the FDA intends to lift a ban that has been in place for more than three years on the company's Mohali facility.
By Jacob Bell • March 16, 2017 -
GlaxoSmithKline expanding vaccine production in Hungary
Vaccines have become a larger part of the British pharma's business and will be an important source of growth as Advair's patent expiry crimps revenue.
By Suzanne Elvidge • March 16, 2017 -
Alexion to cut R&D, 7% of workforce
The moves are part of a larger restructuring effort for the embattled drugmaker, which has seen leadership turnover amid an internal investigation.
By Jacob Bell • March 14, 2017 -
Nicox resubmits eye drug to FDA after manufacturing setback
Issues with an API contractor tripped up Nicox's new drug application for Zerviate last year. With that now resolved, Nicox hopes to win secure approval.
By Ned Pagliarulo • March 9, 2017 -
Apotex invests in Florida manufacturing
The generics drugmaker is expanding its manufacturing presence in South Florida, hoping to increase its U.S. presence and Latin American influence.
By Lisa LaMotta • March 9, 2017 -
FDA
Indian drugmaker slammed for repeated GMP failures
Over the past four years, the FDA flagged violations at seven separate Wockhardt facilities, leading the frustrated regulator to demand a company-wide review.
By Ned Pagliarulo • March 9, 2017 -
Beigene plans $330M biologics facility in China
The Chinese biotech is partnering with one of the country's national Economic and Technological Development Zones to finance the plant's construction.
By Jacob Bell • March 8, 2017 -
Montgomery County Planning Commission
Report: Why Merck turned to supply chain integration to save costs
The big pharma is transforming its supply chain in and effort to cut costs and increase efficiency.
By Edwin Lopez • March 2, 2017 -
FDA
FDA, EU amendment looks to crack down on duplicate inspections
A newly minted amendment to the U.S.-E.U. Mutual Recognition Agreement allows the parties to use each others' inspection information.
By Jacob Bell • March 2, 2017
Previous
