Manufacturing: Page 24
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Regulators recall valsartan after finding impurity tied to cancer risk
EU authorities linked the impurity to manufacturing changes made six years ago by a Chinese producer of the drug's active pharmaceutical ingredient.
By Suzanne Elvidge • July 19, 2018 -
Hikma ramping up injectable opioid output after shortages
The AMA declared drug shortages to be a national public health emergency last month, and the stream of opioids available to providers has continued to dry up.
By Rebecca Pifer Parduhn • July 19, 2018 -
FDA creates task force to combat drug shortages
The group will look at factors such as payer reimbursement policies and incentives to encourage investment in manufacturing.
By Suzanne Elvidge • July 13, 2018 -
WuXi adds to its dealmaking hot streak
A new manufacturing agreement with Immune Therapeutics tasks WuXi with supplying the biotech's lead antibody.
By Suzanne Elvidge • July 12, 2018 -
Endocyte expands supply deal for VISION prostate cancer trial
A German specialist will produce the clinical and commercial supply of a radioactive isotope needed for Endocyte's therapy.
By Suzanne Elvidge • July 12, 2018 -
Novartis partners with French CDMO to bolster CAR-T supply
A deal with Cell for Cure is aimed at complementing the pharma's existing CAR-T production sites in New Jersey and Germany.
By Ned Pagliarulo • July 12, 2018 -
New FDA guidance aimed at advancing gene therapy
A suite of new and updated agency documents brings the prospect of more gene therapy approvals closer.
By Suzanne Elvidge • July 12, 2018 -
Sanofi shuts down French facility due to pollution complaint
Work at the Mourenx plant was immediately halted to sort out pollution problems associated with Depakine production.
By Suzanne Elvidge • July 11, 2018 -
Boehringer increases manufacturing capacity in China
By adding a new fill-and-finish line at its Shanghai site, the German drugmaker aims to be a "one-stop shop" for GMP contract manufacturing.
By Suzanne Elvidge • July 6, 2018 -
Dr. Reddy's recalls generic cholesterol drug from US market
More than 236,000 bottles of atorvastatin, better known by its brand name Lipitor, are affected by the recall.
By Suzanne Elvidge • July 5, 2018 -
FDA
Chinese pharma Henan Lihua hit with FDA warning letter
As a result, the company was subsequently placed on the FDA's import alert list — the eighth Chinese drugmaker to land on the list this year.
By Suzanne Elvidge • July 5, 2018 -
Catalent expands with $133M deal for Juniper
Acquiring the Boston-based company will hand Catalent a clinical development and manufacturing center in the U.K.
By Ned Pagliarulo • July 3, 2018 -
Courtesy of Sanofi
Sanofi expands China presence with new R&D hub
It's a bet on the growing role China looks set to play in global clinical trials of new medicines.
By Ned Pagliarulo • July 2, 2018 -
WuXi strikes manufacturing collaboration with Harbour BioMed
It's the latest manufacturing partnership the Chinese CDMO has inked this year amid a major expansion of its global footprint.
By Suzanne Elvidge • June 28, 2018 -
Plasticell leads UK gene therapy manufacturing consortium
The biotech is working with academia to improve its manufacturing technology.
By Suzanne Elvidge • June 27, 2018 -
GE to spin off healthcare unit in latest restructuring
Moody's and investors applauded the move, which comes amid a reboot of the health division.
By Meg Bryant • June 27, 2018 -
Q&A
Sanofi Pasteur on dengue and the changing vaccine landscape
The French pharma's vaccine unit has faced significant backlash, but remains a major player in the global market. The chief commercial officer of North America talked to BioPharma Dive about the business.
By Lisa LaMotta • June 25, 2018 -
Mustang opens CAR-T manufacturing plant, with focus on lead candidates
By year's end, the biotech expects to start processing patient cells and file its first Investigational New Drug Application for one of its therapies.
By Jacob Bell • June 24, 2018 -
FDA pulls back biosimilar draft guide amid industry concern
The agency appears to be sympathetic to the cost concerns raised by biosimilar drugmakers, saying it will address them in future guidance.
By David Lim • June 22, 2018 -
Boehringer invests $268M to further build out biologics
Several expansions of the German pharma's biologics business reflect how the large-molecule drugs have beefed up its bottom line.
By Jacob Bell • June 22, 2018 -
Enthusiasm for GSK's Shingrix has supplies falling short
Despite a shortage, the 2018 supply will still be sufficient to vaccinate more patients than last year.
By Suzanne Elvidge • June 22, 2018 -
New drug shortages on the rise in 2017, after years of steady declines
A damaging hurricane season, along with manufacturing woes at a key plant, contributed to the uptick, even as the number of ongoing shortages dropped.
By Suzanne Elvidge • June 21, 2018 -
Antibiotic supply chains in need of better management, report finds
Improved demand planning and sourcing strategies could help lower costs and improve distribution, according to a new white paper.
By Kate Patrick Macri • June 21, 2018 -
Emulate raises $36M to develop organ-on-chip tech
The cash will help broaden the functionality of Emulate's tech, which could reduce the numbers of animals used in drug experimentation.
By Suzanne Elvidge • June 21, 2018 -
Vertex opens doors to new research site in San Diego
Research at the new complex, which is one of three hubs for the biotech, will focus on cystic fibrosis as well as other therapeutic areas, including pain.
By Suzanne Elvidge • June 19, 2018
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