Manufacturing: Page 49
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Finally approved: FDA says 'yes' to Impax's Parkinson's drug
After a string of setbacks, Impax finally got an FDA approval for Rytary.
By Nicole Gray • Jan. 9, 2015 -
Sponsored by
Color-Coding Technology: 50 Shades of Grey Pills?
Sponsored by: Color-coding technology may be one of the most valuable tools to consider when it comes to prescription medications. The rainbow of pills lining the shelves of our local drug stores do not simply appeal to an eccentric and liberal palate; they are a product of color-coding...
Dec. 16, 2014 -
Big pharma meets medical marijuana? Dutch firm to build cannabinoid gum factory
Axim Biotechnologies currently has a non-psychotropic cannabinoid gum on the market as a nutraceutical, and is looking to move into the medical marijuana market.
By Nicole Gray • Dec. 5, 2014 -
Deep Dive
ICYMI: Are low-cost generic drugs a thing of the past?
There's a growing sense that the covenant between companies that manufacture and market generic drugs and the consumers who rely on them is broken.
By Nicole Gray • Dec. 3, 2014 -
Sponsored by
What's Hiding in Your Prescription Pills: Color Value Reveals Chemical Purity in Pharmaceutical Grade Talc
Sponsored by: Have you ever wondered exactly what is put into all those pills and capsules that are sitting in your medicine cabinet? Looking at the packaging you will see a list of ‘active ingredients’… but what is all that other stuff? The majority of medic...
Dec. 2, 2014 -
Despite deaths, Italian regulators declare Novartis flu vaccine safe—for now
In the last two months, 19 elderly Italian people who received Novartis' flu vaccine, Fluad, have died.
By Nicole Gray • Dec. 2, 2014 -
AZ to ramp up biologics production with new plant, jobs in MD
MedImmune, AZ's biologics R&D division, will add a large manufacturing center in Frederick, MD, which could generate up to 300 new jobs.
By Nicole Gray • Nov. 24, 2014 -
Merck, NewLink strike exclusive deal to scale up Ebola vaccine production
NewLink has the vaccine. Merck has the manufacturing technology. Together, they may have a new Ebola treatment option.
By Nicole Gray • Nov. 24, 2014 -
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
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