Manufacturing: Page
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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 -
India's Semler sues FDA for $50M over suspicious spreadsheet
Semler is taking on the FDA over actions the CRO says were spearheaded by a disgruntled employee.
By Suzanne Elvidge • Feb. 1, 2018 -
Pharma tees up US capital spending, yet details remain vague
Pfizer, Merck and AbbVie have independently pledged to invest a combined $15.5 billion in domestic capital projects over the next five years.
By Ned Pagliarulo • Feb. 1, 2018 -
Baxter will import IV saline bags in wake of supplier difficulties
Hurricane Maria battered Puerto Rico's supply chains, making procurement of needed health supplies from the island's manufacturing facilities difficult.
By Rich Weissman • Feb. 1, 2018 -
FDA turns to drug packaging in bid to combat opioid crisis
The regulator aims to check abuse of Imodium by changing how the drug is packaged, and is considering similar approaches for immediate release opioids.
By Suzanne Elvidge • Jan. 31, 2018 -
FDA
FDA changes biologics inspections from biennial to risk-based
"While this means the inspection frequency for some establishments will be reduced, for some facilities it may increase," FDA chief Scott Gottlieb said.
By David Lim • Jan. 26, 2018 -
Chinese drugmakers tap GE tech, seeing biologic boom ahead
Zhejiang-based Clover BioPharmaceuticals is the latest to install GE Healthcare's "FlexFactory," aiming to ramp up GMP production of biologic medicines.
By Ned Pagliarulo • Jan. 25, 2018 -
Pfizer's EpiPen woes creep into Canada
A shortage of the epinephrine auto-injectors is the latest manufacturing issue to hit the big pharma.
By Jacob Bell • Jan. 25, 2018 -
FDA skewers Chinese API maker for lax quality control
Regulators noted that, by producing multiple drug products in the same space, there was a chance for "life-threatening" cross-contamination.
By Jacob Bell • Jan. 18, 2018 -
Ipca Labs buys North Carolina manufacturer for $9.7M
Pisgah Labs specializes in production of API and intermediates, giving the Indian drugmaker new manufacturing capabilities in the U.S.
By Ned Pagliarulo • Jan. 18, 2018 -
With eye to Brexit, Almac to invest $42M in Ireland site
Located in Dundalk, Ireland, the CDMO's newly inspected facility is slated to be ready for operation by January 2019.
By Ned Pagliarulo • Jan. 18, 2018
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