Manufacturing: Page 50
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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 -
Companies collaborate to fight multidrug-resistant pathogens
A new diagnostic test is available in Europe and coming to the U.S., but that's just the first step.
By Nicole Gray • June 22, 2014 -
Deep Dive
Theory can outrun reality on drug approval fast track
The designation can create a buzz that is often not justified.
By Nicole Gray • June 20, 2014 -
FDA seeks to widen warning on testosterone products
The agency wants the products to include a warning about blood clots in veins.
By Randy Lilleston • June 20, 2014 -
J&J rachets up R&D through 12 new alliances
The company has many collaborations underway.
By Nicole Gray • June 20, 2014 -
J&J acquires global rights to influenza drug
If approved, the vaccine would be a new treatment approach to an age-old viral condition.
By Nicole Gray • June 20, 2014
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