Manufacturing: Page 35
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CRISPR taps MaSTherCell to manufacture CAR-T therapies
The collaboration will begin with the development and manufacture of CTX101, an allogeneic CAR T-cell therapy for CD19-positve cancers.
By Barbara Boughton • June 8, 2017 -
FDA cites Braun Medical for repeat GMP violations
Inspections in 2013, 2014, 2015 and 2016 all flagged similar issues with the medical product manufacturer's production processes, triggering a warning letter.
By Ned Pagliarulo • June 1, 2017 -
Chiltern acquires Japanese CRO in Asia expansion bid
The multinational clinical services company acquired Integrated Development Associates, which has a base in Japan, Korea and Southeast Asia.
By Ned Pagliarulo • June 1, 2017 -
Merck adding more than 300 new jobs to Irish manufacturing plants
The new positions will be at two sites and include positions in engineering, operations and biochemistry, among others.
By Jacob Bell • June 1, 2017 -
FDA
Problems at Sun Pharma plant trip up drug approval
The Indian drugmaker has struggled to bring its Halol facility into compliance with FDA standards, hurting its ability to win U.S. drug approvals.
By Ned Pagliarulo • May 25, 2017 -
Granules India investing $35 million to expand Virginia facility
The investment is intended to build out the Virginia site’s R&D and manufacturing capacity as part of the company’s plans to broaden its U.S. footprint.
By Barbara Boughton • May 25, 2017 -
FDA highlights threat bacteria poses to water-based products
A recent multi-state outbreak of the Burkholderia cepacia infection has the agency warning drugmakers to thoroughly clean their equipment and establish procedures to safeguard their products' quality.
By Jacob Bell • May 25, 2017 -
J&J settles OTC manufacturing issue for $33M
A subsidiary of the pharma giant allegedly produced and distributed common OTC drugs from facilities that were out of compliance with manufacturing standards.
By Ned Pagliarulo • May 25, 2017 -
Novartis axing 250 US positions in data operations move
It's the second wave of big job cuts this month for the Swiss pharma, which is in the process of consolidating data operations to a drug development site in India.
By Jacob Bell • May 25, 2017 -
Drug supply shortage forces upheaval, care dilemmas on US hospitals
In seeking lower supply prices, group purchasing organizations decreased their ability to mitigate risk as drug manufacturers consolidated operations.
By Jennifer McKevitt • May 25, 2017 -
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
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