Manufacturing: Page 43
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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 -
How Aprecia Pharma hopes to tackle patient noncompliance with 3-D printed drug
Aprecia's seizure medication Spritam is the first 3-D printed drug to win FDA approval.
By Nicole Gray • May 3, 2016 -
Alexion eyes new manufacturing investment in Ireland
A number of other large pharma companies have recently expanded their manufacturing presence in the country.
By Nicole Gray • April 28, 2016 -
As new drugs take hold, Lilly ramps up R&D spend
Lilly spent nearly a quarter of its revenue on R&D in 2015 - the third highest figure in the industry.
By Ned Pagliarulo • April 28, 2016 -
Novartis aims for $1 billion in savings from centralization plans
Simultaneously, the company has consolidated the number of third-party suppliers from 100 to 3.
By Nicole Gray • April 28, 2016 -
Chinese FDA to expedite review of new hepatitis C meds
Regulatory review times in China are slow, and approval to start new trials can take over a year.
By Nicole Gray • April 25, 2016 -
Continuing scrutiny, FDA hits Sri Krishna with warning over 'serious' data violations
Inspections of the Indian drugmaker found original records discarded outside the facility.
By Ned Pagliarulo • April 21, 2016 -
China investigates 3 drugmakers for manufacturing violations, orders recall
The investigations come as China continues to deal with a nationwide scandal over the sale of illegal vaccines.
By Ned Pagliarulo • April 21, 2016 -
Sanofi to invest €300 million in Belgian biologics site
In announcing the production expansion, Sanofi also looked toward future launches of several biologics in the coming years.
By Nicole Gray • April 21, 2016 -
Swiss company Lonza Group seeking to acquire CRO Catalent: report
Lonza Group has been expanding in the U.S. recently, acquiring Arch Chemicals in 2011.
By Ned Pagliarulo • April 14, 2016 -
Two Indian generic companies bow to pressure, end appeal for compulsory licenses
BDR Pharma and Lee Pharma were seeking licenses for drugs made by Bristol-Myers Squibb and AstraZeneca.
By Nicole Gray • April 14, 2016 -
FDA advocates for adoption of speedier drug manufacturing technique
One estimate from the White House sees potential for a 40%-50% reduction in manufacturing costs.
By Ned Pagliarulo • April 14, 2016 -
In first, FDA approves Janssen's switch to continuous manufacturing for HIV drug
Vertex, another early adopter of continuous manufacturing, has been using the technique to make Orkambi since the drug's approval in July 2015.
By Nicole Gray • April 14, 2016 -
Sponsored by CRB
The Future of Dosing Technologies: Multiply your Biotech Capacity and Reduce Cost
Microneedle technology is growing in its application and will prove to be one of those disruptive technologies that we will tell our grandchildren about.
By Christa Myers, Sr. Pharmaceutical Engineering Specialist - CRB • April 12, 2016
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