Manufacturing: Page 36
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FDA
Indian drugmaker stages worker strike to avoid FDA inspection
But the regulator caught on, eventually placing Vikshara Trading on two import alert lists and issuing a warning letter to the firm.
By Ned Pagliarulo • May 11, 2017 -
Parexel cutting up to 1,200 jobs, moving positions to 'lower-cost locations'
The CRO expects the cuts to save up to $85 million in 2018.
By Jacob Bell • May 11, 2017 -
Opinion
How track-and-trace can revolutionize business
The concept of tracking-and-tracing, or serialization, was initially developed for a specific purpose – battling counterfeit drugs – but this technology shows promise to be useful for much more.
By Allen Jacques and Dilip Tavargeri • May 4, 2017 -
Pfizer making progress on Hospira manufacturing issues, execs say
Integration of the 2015 acquisition has been hampered by ongoing challenges in meeting the FDA's manufacturing standards.
By Ned Pagliarulo • May 4, 2017 -
Dr. Reddy's manufacturing facility flagged for procedural problems
The Food and Drug Administration issued a Form 483 for the big generics developer's Bachupally, India plant.
By Jacob Bell • May 4, 2017 -
GSK invests $139M to boost lupus drug production
The British drugmaker cited increased demand and growing sales for Benlysta as reasons for the expansion.
By Suzanne Elvidge • May 4, 2017 -
Shire conservative as it navigates Baxalta integration
Manufacturing synergies led to higher gross margins early in 2017, but the Irish pharma doesn't expect that trend to continue for the remainder of the year.
By Jacob Bell • May 3, 2017 -
Sun Pharma tripped up by Form 483 at Dadra unit
The Indian drugmaker has been struggling to bring its manufacturing facilities up to the FDA's standards, hurting efforts to ramp up offerings in the U.S.
By Ned Pagliarulo • April 27, 2017 -
Lonza cites issues at MD plant for 'softer' Q1 performance
The big drug manufacturer is working to quickly address the issues at one of its largest plants as it looks to double down on biopharma production.
By Jacob Bell • April 27, 2017 -
Daiichi Sankyo to invest $135M in ADC manufacturing expansion
Antibody drug conjugates are a big part of the Japanese pharma's early-stage pipeline in oncology — an area in which the company hopes to become more competitive.
By Ned Pagliarulo • April 27, 2017 -
LabCorp bolsters biologics capacity of Covance unit in UK
Higher demand for biologic drugs led to the expansion, the lab and drug development giant said.
By Suzanne Elvidge • April 27, 2017 -
Biopharma opening up to new ways of partnering on R&D
A report from Deloitte found the number of early-stage, science-focused collaborations to have increased rapidly over the past 10 years.
By Ned Pagliarulo • April 20, 2017 -
FDA explains why it rejected AstraZeneca's ZS-9
The agency released a Form 483 on Wednesday detailing the manufacturing faux pas that led to the hyperkalemia drug's dismissal for a second time.
By Jacob Bell • April 20, 2017 -
Fujifilm invests $130M in manufacturing expansions
The Japanese film company turned pharma developer is planning expansions at sites in Texas and the U.K.
By Jacob Bell • April 20, 2017 -
Cobra invests $19M to boost gene therapy manufacturing
As more cell and gene therapies near regulatory review and commercial use, contractors are ramping up their production capabilities to meet demand.
By Suzanne Elvidge • April 20, 2017 -
GE acquires British cold chain specialist, deepening cell therapy push
The tech and manufacturing giant is building up its manufacturing and delivery capabilities in cell therapy, aiming to capitalize on the growing market.
By Ned Pagliarulo • April 13, 2017 -
In more bad news, Mylan receives CRL for Indian facility
The FDA criticized the drugmaker for not addressing the root cause of many of the manufacturing violations at its Maharashtra, India, plant.
By Jacob Bell • April 13, 2017 -
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
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