Manufacturing: Page
-
Deep Dive
Consolidation in the CRO space a plus for biopharma
A recent spate of mergers between contract research and development organizations could spell greater efficiencies for mid-to-small pharmas in particular.
By Barbara Boughton • May 24, 2017 -
Sponsored by PPD Laboratories
PM dashboard provides visual overview of clinical trials, helping managers make more confident decisions
A visual dashboard helps clean up data and allows project managers to be more proactive in their jobs.
By Roni Robbins • May 23, 2017 -
Investors claw for Puma shares despite questions from FDA adcomm
The biotech's stock leapt more than 80% Monday morning after the FDA released documents for an upcoming advisory committee meeting. Yet, it's unclear whether the panel experts will share investors' optimism.
By Jacob Bell • May 22, 2017 -
Boehringer Ingelheim opens large manufacturing facility in China
With the new site, the German drugmaker hopes to expand its footprint in the growing Chinese pharmaceutical market.
By Barbara Boughton • May 18, 2017 -
The 'Amazon.com for scientists' just raised $24M
Scientist.com, an online marketplace for clinical research services, said the money would go, in part, to ramping up its workforce.
By Jacob Bell • May 18, 2017 -
Brammer Bio readies gene therapy manufacturing
The Cambridge CDMO is close to hitting the on switch for its gene therapy manufacturing facility, after acquiring the site from Biogen in January.
By Suzanne Elvidge • May 11, 2017 -
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
Previous
