Manufacturing: Page 44
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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 -
Major NGO drops India's IPCA Labs as a source of anti-malarials
The FDA previously flagged manufacturing violations at three of IPCA's Indian facilities.
By Nicole Gray • April 8, 2016 -
Inspections by FDA hurting Indian drug exports, says Dr. Reddy's chairman
The FDA has stepped up oversight of Indian pharmaceutical manufacturing in the past year over quality concerns.
By Ned Pagliarulo • April 7, 2016 -
Deep Dive
Why partnerships are crucial for pushing vaccine R&D forward
As development costs increase, more collaborations between pharma companies, NGOs, and governments will be needed, according to Dr. Jim Tartaglia, global VP of new vaccines projects at Sanofi Pasteur.
By Ned Pagliarulo • April 7, 2016 -
Lilly invests $40 million in Irish continuous manufacturing facility
Despite several notable advantages, the pharma industry has been slow to shift from batch processing to continuous manufacturing.
By Nicole Gray • April 7, 2016 -
Urging more robust FDA response, lawmakers warn of contaminated heparin
Tainted Chinese supplies of the drug were linked to hundreds of deaths in 2007 and 2008.
By Nicole Gray • March 31, 2016 -
As aging blockbusters come off patent, new opportunities emerge for biosim manufacturers
IMS estimates there are nearly 50 biosimilar drugs in development, which could deliver savings of up to $110 billion in the EU and US over the next five years.
By Ned Pagliarulo • March 31, 2016 -
In quest to expand diabetes market share, Novo breaks ground on $1.8b U.S. plant
The North Carolina facility will produce Novo's insulin and next-gen diabetes medicines when it is completed in 2020.
By Ned Pagliarulo • March 31, 2016 -
Indian drug regulator to begin surprise inspections at manufacturing sites
The Indian government recently banned nearly 350 drugs for safety risks, although many companies have received a stay on the restriction.
By Ned Pagliarulo • March 30, 2016 -
As vaccine scandal continues, WHO urges China to more strictly police regulations
Chinese police earlier this month uncovered an illegal vaccine ring, which distributed improperly stored and potentially compromised vaccines across China.
By Nicole Gray • March 29, 2016 -
FDA gives approval to 3-D printed prescription drug
Aprecia Pharmaceuticals has an exclusive license to use 3-D printing technology to manufacture pharmaceutical products.
By Ana Mulero • March 24, 2016 -
Deep Dive
Patent case in India highlights tensions between public health, protecting innovation
Doctors Without Borders has attempted to block Pfizer's pneumonia vaccine in India, looking to a similar Pfizer patent which the European Patent Office revoked under appeal in 2014.
By Ned Pagliarulo • March 24, 2016 -
Trial begins in federal court over $60 million heist of Lilly drugs
Two brothers allegedly broke into a Lilly warehouse using inside knowledge of Tyco security systems.
By Nicole Gray • March 24, 2016 -
Denying recent reports, India government say it hasn't promised to restrict compulsory licensing
Two U.S. business groups previously indicated India had privately promised to restrict use of the legal tool for commercial purposes.
By Nicole Gray • March 23, 2016 -
Scientists develop new type of stem cell with only half a genome
The new cells could have important implications for genetic research, particularly in precision medicine fields.
By Ned Pagliarulo • March 17, 2016 -
Amgen signs 'flexible manufacturing agreement' with CMO Patheon
Looking to supplement its own network, Amgen said the deal would provide it with greater flexibility to meet demand for its products.
By Ned Pagliarulo • March 17, 2016 -
Indian Health Ministry bans nearly 350 combo drugs
Fixed dose combinations have proliferated in India, making up nearly half of all drugs on the market in 2014 despite many being unapproved nationwide.
By Nicole Gray • March 14, 2016 -
Bispecifics emerging as alternative cancer immunotherapy to CAR-T
Roche and Amgen are pushing the development of bispecifics, a type of cancer treatment which avoids some of the individualized manufacturing headaches associated with CAR-T.
By Nicole Gray • March 11, 2016
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