Manufacturing: Page 49
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FDA
Amgen: The biotech that's getting on the biosimilar R&D bandwagon
When it comes to generics, it's hunt or be hunted. And Amgen plans to have up to five biosimilars on the market by 2019.
By Nicole Gray • March 9, 2015 -
Sponsored by
Color Consistency in Pharmaceuticals: Using Spectrophotometry for Blending Powders and Plaques
Sponsored by: We use the word "color consistency" a lot when referring to products that depend on this trait for quality assurance. In the pharmaceutical industry, color consistency means a lot more than the final color outcome of a product. Color consistency in pharmaceutical powders and pl...
March 3, 2015 -
Juno forges ahead with novel cancer therapy, opens manufacturing facility
Juno may just be a startup. But its CAR-T cancer immunotherapy platform is strong enough to give it the confidence to open its own manufacturing facility in Washington state.
By Nicole Gray • Feb. 10, 2015 -
Why the FDA wants to double inspectors at Indian manufacturing facilities
It's not because of the manufacturing-related issues you might suspect.
By Nicole Gray • Feb. 6, 2015 -
Deep Dive
Passing the torch: Ralph Neas' tenure at the Generic Pharmaceutical Association
After four years, Ralph Neas, CEO and President of GPhA, is stepping down. So what does it take to run the organization? A great deal of experience and the ability to stay on message.
By Nicole Gray • Feb. 5, 2015 -
Sponsored by
Active Pharmaceutical Ingredient Detection Using Spectrophotometers: An Investment that Pays Off
Sponsored by: Knowing the active pharmaceutical ingredients in your over-the-counter and prescription medications is a must in today’s health care industry. Mistakes in prescriptions, miscalculated doses, and drug interactions are all genuine concerns in a world where drug choices and ...
Feb. 3, 2015 -
Sanofi tops new index that measures pharma's commitment to infectious diseases
Kyorin, Bayer, and Lilly ranked towards the bottom of the list.
By Nicole Gray • Jan. 26, 2015 -
Hospira closes North Carolina plant over cost concerns
The company insists the plant's closure isn't related to regulatory concerns.
By Nicole Gray • Jan. 20, 2015 -
J&J gets $115 million cash to speed Ebola vax development
Europe's Innovative Medicines Initiative is giving J&J a big boost for Ebola vaccine manufacturing.
By Sy Mukherjee • Jan. 16, 2015 -
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
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