Manufacturing: Page 44
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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 -
Montgomery County Planning Commission
Merck names new manufacturing head, replacing 12-year veteran
Sanat Chattopadhyay has more than 30 years of pharmaceutical experience and has been at Merck since 2009.
By Nicole Gray • March 10, 2016 -
Senate bill adding Zika to priority review program highlights R&D incentives
The tropical disease priority review program has been criticized for creating the wrong incentives for drugmakers.
By Ned Pagliarulo • March 10, 2016 -
French regulator halts manufacturing at HIV-focused biotech
A November inspection by ANSM turned up 45 manufacturing deficiencies, including five critical flaws.
By Nicole Gray • March 10, 2016 -
Counterfeit Harvoni from India found in Israel
Flagged by Swissmedic, the fake drugs were imported through a Swiss trading firm.
By Nicole Gray • March 8, 2016 -
FDA
Deep DiveKite, Juno ramping up commercial manufacturing capacity for CAR-T
Both companies expect to generate clinical data on their respective CAR-T therapies sometime in late 2016.
By Ned Pagliarulo • March 3, 2016 -
Canada's Katz hands over Rexall Health to McKesson for $2.2B
As part of the deal, McKesson will also acquire Rexall Health's 470 retail pharmacies throughout Canada.
By Shalina Chatlani • March 3, 2016 -
In major expansion, Lupin subsidiary setting up plant in Japan
Lupin's subsidiary Kyowa is setting up a manufacturing plant in Tottori, to feed the growing demand for generics in Japan, where generics currently represent 49% of drug sales volume.
By Nicole Gray • March 3, 2016 -
BMJ study: Single dose vials cost nearly $2B a year in wasted cancer drugs
Although packaged in single-dose vials, the drugs are typically administered based on patient body weight, leading to leftover medicine which is often discarded.
By Nicole Gray • March 3, 2016
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