Manufacturing: Page 28
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Parexel finds new CEO in INC Research vet
With more than two decades of CRO experience, Jamie Macdonald takes the top spot at Parexel on the heels of its private equity buyout.
By Jacob Bell • March 8, 2018 -
FDA recognizes GMP inspections by 4 more EU states
The move expands the number of EU regulators the FDA says can reliably conduct inspections of drug manufacturing facilities to 12.
By Ned Pagliarulo • March 8, 2018 -
TaiMed's HIV biologic secures FDA nod
The approval showcases how China-based manufacturers of biologic drugs are moving up value chains to produce novel drugs.
By Randi Hernandez • March 7, 2018 -
Pfizer Hospira plant faces another recall
The McPherson, Kansas facility has been plagued by problems, resulting in potentially unsafe medicines being sold to hospitals.
By Lisa LaMotta • March 1, 2018 -
Kodak touts study to lure pharma manufacturing
The photography giant seeks a reinvention after digital innovation crippled traditional film companies.
By Jacob Bell • March 1, 2018 -
Courtesy of Regeneron Pharmaceuticals
Regeneron links rise in Eylea safety reports to syringes
A recent spate in cases of intraocular inflammation among patients taking the eye drug led the biotech to conduct a review of its production processes.
By Ned Pagliarulo • March 1, 2018 -
Merck KGaA injects $47M into Asian manufacturing efforts
Capacity expansions in Asia could help speed up drug production timelines for both the domestic and foreign biologics markets.
By Randi Hernandez • March 1, 2018 -
Drug compounding oversight rises, but spotty: Pew
A new report highlights the challenges and safety issues still prevalent in compounding pharmacies.
By Jacob Bell • Feb. 26, 2018 -
Lonza adds new technology to Tampa facility
The CRMO adds further encapsulation capabilities to its Florida site, greatly increasing its capsule-filling expertise.
By Lisa LaMotta • Feb. 22, 2018 -
Avid tapped to produce Enzyvant's rare disease candidate
It's Avid's latest move aimed at building a presence in the CDMO space.
By Jacob Bell • Feb. 22, 2018 -
Gilead taps Sangamo to expand cell therapy after Kite buy
The big biotech is trying to expand its know-how and pipeline in its recently acquired area of cell therapies.
By Lisa LaMotta • Feb. 22, 2018 -
Biohaven teams up with Catalent on CGRP oral drug delivery
The drugmaker will use Catalent's fast-dissolving technology for rapid delivery of its migraine medication.
By Suzanne Elvidge • Feb. 22, 2018 -
CDER in warning letter frenzy as pharma struggles with quality control
While the FDA issued significantly fewer warning letters in 2017, the number coming from its CDER unit has nearly doubled since 2014, according to PwC.
By Jacob Bell • Feb. 21, 2018 -
FDA
Bayer plant flagged by FDA for poor GMP practices
As a result of the warning letter, the German giant expects a temporary effect on the supply of certain mature products.
By Jacob Bell • Feb. 15, 2018 -
Charles River boosts CRO chops with $800M deal for MPI
Acquiring MPI Research should raise Charles Rivers' profits as early as this year and expand its business with biotech.
By Ned Pagliarulo • Feb. 15, 2018 -
Bioverativ taps new manufacturer as it steps out of Biogen's shadow
The spinoff-turned-Sanofi-company could pay more than $100 million to Oxford BioMedica for lentiviral vector production.
By Jacob Bell • Feb. 15, 2018 -
FDA
LakePharma launches biomanufacturing center with new facility
The biologics specialist plans to add 100 jobs by 2020 to staff the new center, which will focus on supporting Phase 1 clinical trials.
By Suzanne Elvidge • Feb. 15, 2018 -
Sponsored by Patheon
Create brand sustainability with softgel technology
Three emerging trends that are shaping society and the pharmaceutical industry create a convincing argument for the use of softgel technology.
Feb. 13, 2018 -
FDA warning letter details violations at Celltrion plant
Issuance of the warning letter to Celltrion is causing a headache for Teva, which uses the Korean drugmaker to produce API for its biosimilar candidates and fremanezumab.
By Ned Pagliarulo • Feb. 8, 2018 -
Citing lower tax rate, Amgen plans new biomanufacturing plant
The biotech says it will invest more in the U.S., although the $3.5 billion in total capital expenditures planned over the next five years is in line with past spending.
By Ned Pagliarulo • Feb. 8, 2018 -
Isotope manufacturing headed back to US following new FDA approval
The agency OK'd the RadioGenix System, which produces a radioisotope used in more than 80% of nuclear medicine imaging in the U.S.
By Jacob Bell • Feb. 8, 2018 -
Novo earmarks $65M to expand NC production facility
The Danish drugmaker is already in the midst of a major build out of a new API production plant nearby to support its diabetes portfolio.
By Suzanne Elvidge • Feb. 8, 2018 -
Drug distributors join group to mitigate opioid crisis
A newly formed coalition, called Allied Against Opioid Abuse, includes distributors, care providers and pharmacists who seek to stem opioid abuse.
By Kate Patrick Macri • Feb. 7, 2018 -
Celltrion biosimilars plant hit with FDA warning letter
The South Korean drugmaker doesn't expect the warning to impact its ability to supply Pfizer with Inflectra, the companies' Remicade copy.
By Ned Pagliarulo • Feb. 1, 2018 -
Pfizer's manufacturing fix clears path for Momenta's Copaxone generic
The big pharma remedied issues at its McPherson plant, meaning the launch of 40 mg Glatopa could come "at any time."
By Jacob Bell • Feb. 1, 2018
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