Manufacturing: Page 43
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India targets drugmakers with wave of inspections
At the same time, the Indian government is planning a 'comprehensive review' of existing drug laws, aiming to improve standards and the business environment.
By Ned Pagliarulo, Nicole Gray • June 23, 2016 -
Opko wins approval for kidney drug after manufacturing snag
The FDA had turned down Opko's original application due to manufacturing issues at third-party contractor Catalent.
By Nicole Gray • June 23, 2016 -
Kite Pharma opens cell therapy plant as lead CAR-T candidate gathers steam
The company expects a 2017 commercial launch for its flagship CAR-T therapy, which is currently in testing for several types of blood cancer.
By Nicole Gray, Ned Pagliarulo • June 21, 2016 -
Sponsored by ICON plc
DIA Booth #617 - ICON
Manufacturers are being forced to generate more complex and comprehensive bodies of real world evidence about drugs’ effectiveness and value.
By Ramita Tandon, Executive Vice President Commercialisation & Outcomes, ICON plc • June 16, 2016 -
Pfizer begins construction on $200 million biologics plant in MA
When completed, the facility will produce complex biologics and vaccines—a rapidly growing part of Pfizer's business.
By Ned Pagliarulo • June 16, 2016 -
EMA cites US-based Pii for manufacturing violations
This is the second time European regulators have pulled the GMP certification of a U.S. CMO within the last four weeks.
By Nicole Gray • June 16, 2016 -
Roche selling Spanish facility to CMO Famar
The Leganes site is one of four which Roche plans to close as part of a larger restructuring plan.
By Nicole Gray • June 16, 2016 -
Sponsored by CRB
Optimizing the facility of the present
There is so much debate about the facility of the future that manufacturers lose focus of the common pitfalls of young biotech commercial manufacturing facilities.
By Andrew Harris, Process Engineer - CRB • June 13, 2016 -
China's FDA cuts domestic pharma manufacturing inspections by more than half
The agency says it is finding significant deficiencies in data integrity, due to manipulation and untraceability of data.
By Shalina Chatlani • June 9, 2016 -
Sun Pharma selling off two more US facilities
The facilities are being sold to Frontida Biopharma, a Chinese CRO.
By Nicole Gray • June 9, 2016 -
Gene therapy CMO Brammer Bio moves HQ to Massachusetts
The move will position the company near others with the most promising gene therapies in development.
By Nicole Gray • June 9, 2016 -
Sanofi Pasteur starts up vaccine production at new facility in India
The Shantha plant will at first only produce doses of the pediatric pentavalent vaccine Shan5.
By Nicole Gray • June 2, 2016 -
With eye to growing Chinese market, Novartis opens major R&D hub in Shanghai
The Swiss pharma giant had committed to investing $1 billion in China back in 2009.
By Ned Pagliarulo • June 2, 2016 -
Sun Pharma continues to feel effect of Halol plant problems
Although revenue jumped in the most recent quarter, muted sales projections and slow annual growth suggested continued problems.
By Nicole Gray • June 2, 2016 -
FDA
Kite Pharma rides CAR-T momentum into ASCO
BioPharma Dive spoke to the immuno-oncology biotech to find out how its lead cell therapy is progressing as it aims for a 2017 launch.
By Nicole Gray • June 2, 2016 -
FDA warns another Indian API supplier on manufacturing lapses
Violations included an admission from an analyst at Megafine Pharma of falsifying stability testing data.
By Ned Pagliarulo • June 1, 2016 -
FDA reprimands German API supplier for manufacturing violations
Among other infractions, BBT Biotech exported APIs to the U.S. without proper stability testing.
By Nicole Gray • May 26, 2016 -
MIT lab shrinks drug manufacturing process into a small prototype machine
The portable system is roughly the size of a refrigerator but can produce hundreds of pills on demand.
By Nicole Gray • May 26, 2016 -
FDA
Aiming to make living tissue, Israeli companies test 3-D stem cell printing
Following a successful proof-of-concept, Nano Dimension and biotech Acellta are considering launching a new company to advance their high-volume 3-D printing.
By Nicole Gray • May 26, 2016 -
In reversal, Braeburn Pharma will stay in NC despite controversial law
The company had reconsidered its plans after North Carolina enacted a law overturning local anti-discrimination ordinances.
By Nicole Gray • May 19, 2016 -
Capsugel subsidiary flagged by Swedish regulator for GMP failures
The Medical Products Agency found two critical and seven major compliance violations.
By Nicole Gray • May 19, 2016 -
BMS completes $280 million biologics plant expansion in MA
Previously dedicated only to bulk biologics manufacturing, the site will now be able to support clinical trials of investigational drugs.
By Nicole Gray • May 19, 2016 -
Amid losses, Endo plans cutbacks at Par manufacturing facilities
All told, the restructuring is expected to impact about 740 jobs.
By Ned Pagliarulo • May 12, 2016 -
Sponsored by CRB
Leveraging design to minimize risk
Biotech manufacturers must find ways to minimize their risk by deferring their investment in additional capacity until absolutely necessary.
By Matt Kennedy - Associate, Bioprocess Specialist & Matt Khair - Associate, Core Team Leader, CRB • May 10, 2016 -
Biogen spinoff set to build out hemophilia pipeline
But the decision to separate the hemophilia business has left some analysts bemused over Biogen's true rationale.
By Ned Pagliarulo • May 5, 2016
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