Manufacturing: Page 50
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Advanced Cell Tech scores US patent for dendritic cell manufacturing
The patent covers a novel approach to commercial-scale manufacturing of an allogenic, off-the-shelf immunotherapy platform.
By Nicole Gray • Sept. 9, 2014 -
Roche cuts jobs in Spain in response to price controls
Spanish officials have negotiated lower prices for drugs, as well as how much money the government pays for them.
By Nicole Gray • Sept. 4, 2014 -
BI's Ohio plant plagued by continuing woes
Although Boehringer sold its Ben Venue Labs manufacturing plant to Hikma in July, it is still responsible for recalling suspect products that have already been distributed through the facility.
By Nicole Gray • Sept. 3, 2014 -
Alexion reprimanded for lax manufacturing practices
This is the second time in two years that FA inspectors have cited Alexion for not complying with good manufacturing practices (GMP).
By Nicole Gray • Aug. 27, 2014 -
Hospira wins temporary restraining order against Precedex generics
A federal judge has issued a temporary restraining order blocking the FDA's decision to allow generic versions of Hospira's IV sedative.
By Sy Mukherjee • Aug. 20, 2014 -
Sanofi gears up for mass production of malaria drug
This manufacturing effort is financially supported by the Bill & Melinda Gates Foundation. Its goal is to supplement the botanical supply of key malaria treatment ingredient artemisinin.
By Nicole Gray • Aug. 19, 2014 -
FDA green lights Biogen MS drug
Plegridy is touted for being less painful for patients than Biogen's older MS blockbuster, Avonex.
By Sy Mukherjee • Aug. 18, 2014 -
Deep Dive
Black box warnings and drug market withdrawals, by the numbers
The rise of FDA-approved drug market withdrawals and black box warnings corresponds with faster approval times and a reliance on industry fees to fund the agency's budget.
By Sy Mukherjee • Aug. 15, 2014 -
All gone for now: Ebola drug ZMapp supply exhausted
Mapp Biopharmaceutical says it is out of its much-sought experimental Ebola treatment, ZMapp, after sending doses to West African countries afflicted by the epidemic.
By Sy Mukherjee • Aug. 12, 2014 -
Pfizer locks out workers at Indian manufacturing plant
There is an ongoing dispute between Pfizer’s management and the workers at the Thane plant.
By Nicole Gray • Aug. 5, 2014 -
PCI to acquire Penn Pharma
Penn brings drug development, manufacturing and packaging expertise to the merger.
By Nicole Gray • July 31, 2014 -
FDA inspects and approves two French Novosep manufacturing sites
The two sites in France are where Novasep will manufacture active pharmaceutical ingredients (API) and a newly approved new molecular entity (NME).
By Nicole Gray • July 23, 2014 -
FDA hits Italian drug manufacturer for destroying data
Trifarma, a pharmaceutical ingredients (API) manufacturer, allegedly deleted important manufacturing-compliance data.
By Nicole Gray • July 17, 2014 -
International CMOs prepare for Russian market as Pharma 2020 policy unfolds
Within six years, Russia would like to have 90% of all medications from the Essential Drug List manufactured locally.
By Nicole Gray • July 11, 2014 -
Suddenly, some cheap generics aren't so cheap
The increases have been so large that in some cases, insurance companies are requiring preapprovals for common prescriptions.
By Randy Lilleston • July 10, 2014 -
St. Jude Medical cleared by FDA
The medical device manufacturer took action in response to a warning letter about one of its facilities.
By Nicole Gray • July 8, 2014 -
J&J's DePuy Synthes cuts 400 existing jobs, creates 80 new jobs
The reorganization is a response to pressures driven in part by the Affordable Care Act.
By Nicole Gray • July 7, 2014 -
Pozen takes aspirin/omeprazole combo back to FDA
The company has addressed concerns over its manufacturing facility.
By Nicole Gray • July 2, 2014 -
Pfizer's Elelyso becomes first kosher-certified prescription drug
The medication is used for long-term treatment of the disease.
By Randy Lilleston • July 2, 2014 -
NICE changes its position on Glivec use
The agency is liberalizing its previous stance even though the drug costs more than $35,000 per year.
By Nicole Gray • June 30, 2014 -
EMA recommends approval of Lilly's Lantus biosimilar
The decision marks a landmark moment for the biosimilars industry.
By Nicole Gray • June 27, 2014 -
Generic version of Diovan from India approved by FDA
This is the first generic version of the blood pressure drug available in the U.S.
By Nicole Gray • June 27, 2014 -
Deep Dive
4 takeaways about the U.S. biosimilars market
Take a deeper look at the emerging market, which could trigger a substantial reduction in key healthcare costs.
By Nicole Gray • June 26, 2014 -
Bayer, Dimension Therapeutics collaborating on hemophilia A gene therapy
If the treatment makes it to market, it will be a major game-changer for patients.
By Nicole Gray • June 25, 2014 -
Indian Health Ministry likely to expand list of essential medications, cap costs
The decision has major implications for American drug manufacturers.
By Nicole Gray • June 24, 2014
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