Manufacturing: Page 45
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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 -
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 -
Deep Dive
Kite, 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 -
French regulators flag critical compliance violations at Chinese heparin plant
The French National Agency for Medicines and Health Products Safety recommended a product recall of drugs manufactured at the Dongying City plant.
By Shalina Chatlani • March 3, 2016 -
Sandoz issues major recall for hypertension drug made in India
The recall comes almost a year after the FDA issued a warning letter to three Mylan plants in India for manufacturing violations.
By Nicole Gray • Feb. 25, 2016 -
First human trial of optogenetics to treat blindness set to launch
RetroSense Therapeutics plans to test a new gene therapy for the treatment of a degenerative blindness disease in a trial which could have broad implications for the field of optogenetics.
By Ned Pagliarulo • Feb. 25, 2016 -
Cipla snatches 1st US manufacturing plant as part of 'landmark acquisition'
The acquisition of the plant in Long Island comes in the wake of Cipla's deals to buy a pair of American biopharma firms—and in the midst of ongoing troubles with the FDA.
By Sy Mukherjee • Feb. 18, 2016 -
Sun Pharma to seek re-inspection of non-compliant Halol plant
Sun Pharma previously received a warning letter from the FDA due to quality and compliance issues at its Halol manufacturing facility in Gujarat, India.
By Ned Pagliarulo • Feb. 18, 2016 -
Eight pharma suppliers band together to improve packaging testing, compatability
Led by a Canadian pharma manufacturer, the newly formed Matrix Alliance includes pharma suppliers from around the world.
By Nicole Gray • Feb. 18, 2016 -
Pfizer issues major recall of children's Advil in Canada
The recall stemmed from a change in the emulsifying agent for the liquid suspension dose, which caused separation and clumping in the bottle.
By Nicole Gray • Feb. 18, 2016 -
Deep Dive
Chasing blockbusters: Does pharma need to change its success strategy?
A new book focusing on the best ways to bring value to healthcare highlights several warning signs that biopharma may want to note as it tries to build winning drugs in a more demanding R&D landscape.
By Sy Mukherjee • Feb. 18, 2016