Manufacturing: Page 23
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Sun Pharma recalls metformin tablets after finding contamination
In response to reports that one metformin HCl tablet had a piece of rubber glove in it, the Indian pharma's U.S. arm is recalling more than 2,500 bottles.
By Suzanne Elvidge • July 30, 2018 -
FDA
FDA puts clinical hold on Sarepta's DMD gene therapy program
The biotech has already created a plan to address the issue, with the aim of dosing patients by the end of 2018 pending an FDA go-ahead.
By Suzanne Elvidge • July 27, 2018 -
Pfizer to invest $465M in Michigan plant
A new sterile injectable manufacturing facility in the state is expected to start production in 2024, adding jobs to the area.
By Lisa LaMotta • July 26, 2018 -
Rubius buys manufacturing facility, to invest $155M
The Massachusetts-based biotech made the facility announcement the same week it raised $277 million through its IPO.
By Andrew Dunn • July 26, 2018 -
WuXi and Antengene sign cancer manufacturing agreement
In a deal focusing on China and the Asia-Pacific, WuXi will provide CMC services from preclinical to commercial.
By Suzanne Elvidge • July 26, 2018 -
FDA increases regulation on compounded drugs, issues new warning
The agency continues to increase its oversight of compounding, alerting the public to the risk of using cesium chloride as a bulk drug substance.
By Andrew Dunn • July 26, 2018 -
Elizabeth Regan/BioPharma Dive
Cambrex builds CDMO offerings with $425M Halo buy
By buying Halo, the API maker will add capabilities in specialized dosage forms as well as acquire two manufacturing plants.
By Lisa LaMotta • July 23, 2018 -
Novartis hits CAR-T manufacturing snag as Kymriah sales disappoint
Details were scant on "variability in production specifications," but the pharma said it was still able to deliver final product to most patients.
By Ned Pagliarulo • July 19, 2018 -
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 • 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
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