Manufacturing: Page 49
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Deep Dive
Best of BD: Is the current antibiotic pipeline really that bad? [INFOGRAPHIC]
Antibiotics "have suffered market withdrawals at triple the rate of all other FDA-approved drugs," says Kevin Outterson -- even in the glory years of the '80s and '90s.
By Sy Mukherjee • Nov. 11, 2014 -
Actavis to cut more jobs, this time in New York
There are lay-offs scheduled for three facilities in New York as Actavis continued to integrate the recently-acquired Forest Labs into its business.
By Nicole Gray • Oct. 24, 2014 -
Deep Dive
Best of BD: Biosimilars in China: The coming revolution
Despite a less rigorous approach to approving biosimilars, China has several approved follow-on biologics—and a growing number of biotechs want to develop biosimilars that meet global standards.
By Nicole Gray • Oct. 22, 2014 -
FDA
US orders 3 state-of-the-art labs to ramp up Ebola drug ZMapp production
The Biomedical Advanced Research and Development Authority (BARDA) has reached out to three advanced biology labs for detailed production plans for ZMapp.
By Nicole Gray • Oct. 20, 2014 -
Game on: Amgen sues Sanofi, Regeneron over PCSK9 cholesterol drug patent
The battle between Amgen's evolocumab and Sanofi/Regeneron's alirocumab heats up.
By Sy Mukherjee • Oct. 17, 2014 -
Indian pharma: We're stymied by 'overzealous' drug regulators
High-level Indian delegates to last week's CPhI conference in Paris are calling for harmonized regulatory guidelines, especially around quality control issues.
By Nicole Gray • Oct. 16, 2014 -
Deep Dive
How 2 companies are revolutionizing flu vaccine manufacturing
A French biotech start-up teamed up with an academic lab—and literally shifted the paradigm for how influenza vaccines can be manufactured. Is a universal flu shot now within reach?
By Nicole Gray • Oct. 10, 2014 -
FDA
Deep DiveFlu vaccine development as a hotbed of innovation: Who knew?
The Tamiflu debacle has sullied influenza vaccine makers' reputations. But there's a surprising amount of innovation going on in this R&D field.
By Nicole Gray • Oct. 9, 2014 -
BI spending $1.26 million to expand Respimat inhaler production
The expansion will create 100 new jobs and help balance out the 600 job cuts in Germany that Boehringer announced last week.
By Nicole Gray • Oct. 1, 2014 -
Report: 700-plus biosimilars in development worldwide
Thomson Reuters Bioworld reports that 245 biopharma companies are at work on biosimilars -- a market segment with projected sales of $25 billion by 2019.
By Nicole Gray • Sept. 30, 2014 -
Indian government: Major US think tank 'smeared' our pharma industry
Researchers from the American Enterprise Institute (AEI) published a list of allegedly substandard drugs sold by India to several mid-income countries. Indian officials were not pleased.
By Nicole Gray • Sept. 30, 2014 -
Deep Dive
ICYMI: How one Shanghai pharma became a model for malaria drug production
With half the world at risk for malaria, large-scale treatment production is crucial. Pharma companies in China and France are collaborating to make it happen.
By Nicole Gray • Sept. 18, 2014 -
Advanced Cell Tech scores US patent for dendritic cell manufacturing
The patent covers a novel approach to commercial-scale manufacturing of an allogenic, off-the-shelf immunotherapy platform.
By Nicole Gray • Sept. 9, 2014 -
Roche cuts jobs in Spain in response to price controls
Spanish officials have negotiated lower prices for drugs, as well as how much money the government pays for them.
By Nicole Gray • Sept. 4, 2014 -
BI's Ohio plant plagued by continuing woes
Although Boehringer sold its Ben Venue Labs manufacturing plant to Hikma in July, it is still responsible for recalling suspect products that have already been distributed through the facility.
By Nicole Gray • Sept. 3, 2014 -
Alexion reprimanded for lax manufacturing practices
This is the second time in two years that FA inspectors have cited Alexion for not complying with good manufacturing practices (GMP).
By Nicole Gray • Aug. 27, 2014 -
Hospira wins temporary restraining order against Precedex generics
A federal judge has issued a temporary restraining order blocking the FDA's decision to allow generic versions of Hospira's IV sedative.
By Sy Mukherjee • Aug. 20, 2014 -
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
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