Manufacturing: Page 47
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New study: Too many factories, too few inspectors for India's pharma industry
A review by Assocham/RNCOS found that there are roughly 1,500 qualified inspectors for 10,000 Indian manufacturing facilities.
By Nicole Gray • Dec. 11, 2015 -
How China is getting serious about developing quality drugs right at home
As Chinese biopharma companies experience substantial growth, China hopes to further foster a domestic drug market.
By Nicole Gray • Dec. 1, 2015 -
CAR-T companies scale up production with eye towards lowering costs
Kite Pharma has successfully cut the production time and cost of developing re-engineered T-cells for cancer treatment.
By Nicole Gray • Nov. 19, 2015 -
Roche to slash up to 1,200 jobs, shutter 4 plants in US and EU in major restructuring
The company will be charged $1.6 billion through 2021 in order to carry out the plant closures.
By Nicole Gray • Nov. 13, 2015 -
China FDA cracks down on pharmas in quality control effort
The China Food and Drug Administration (CFDA) has rejected 11 drug applications from eight companies in the midst of a major health reform initiative.
By Nicole Gray • Nov. 13, 2015 -
AstraZeneca to generics makers: Back off our 'purple pill'
AZ recently lost patent protection on its flagship Nexium (esomeprazole) in the U.S., opening the door to generic competition—and potential trademark infringement.
By Nicole Gray • Nov. 3, 2015 -
FDA alleges major violations, use of old ingredients at Chinese Pfizer plant
During an inspection in April, FDA inspectors turned up quality failures and use of expired materials at a plant in Dalian. The agency also says the plant tried to obfuscate its shortcomings.
By Nicole Gray • Nov. 2, 2015 -
The next challenge for CAR-T: Large-scale production
Experts predict that the first CAR-T therapy will be available in 2016, but production costs wil range from $50,000 to $100,000 per patient.
By Nicole Gray • Nov. 2, 2015 -
Deep Dive
Drug shortages & patent expiration: Authorized generics as more than a lifecycle strategy
We spoke with Dr. Cary Yonce, Vice President of General Therapeutics and Life Cycle Management at Sanofi, about the patient demand for generic Arava and the company's response to that demand 10 years after patent expiry.
By Nicole Gray • Oct. 27, 2015 -
Chinese firm plans large-scale production of Ebola vaccine
Tianjin CanSino Biotechnology, which is privately held, is investing $315 million in an Ebola vaccine-maufacturing facility.
By Nicole Gray • Oct. 15, 2015 -
Glaxo shutting down French research lab, laying off 70 employees
Work that was being done at the plants will shift to global hubs.
By Nicole Gray • Sept. 28, 2015 -
Study: Cancer drugs in US cost up to 6,000% of production cost
Patients in the U.S. pay more than twice as much for tyrosine kinase inhibitors (TKIs), used to treat cancer, than their European counterparts.
By Nicole Gray • Sept. 23, 2015 -
10th Indian pharma plant this year makes FDA's do-not-import list
Once again, the problem at hand is production quality.
By Nicole Gray • Sept. 15, 2015 -
Georgia opens $14M bioscience training center next to Baxalta plant
The new Bioscience Training Center is across the street from Baxalta's $1 billion biomanufacturing plant in Covington, GA.
By Nicole Gray • Sept. 11, 2015 -
Russia's Putin reiterates commitment to 90% domestic drug-making by 2020
Pharma 2020 was launched in 2011 by Vladimir Putin in order to intensify domestic investment in the national pharmaceutical industry.
By Nicole Gray • Sept. 10, 2015 -
Moody's upgrades financial outlook for biopharma industry
The ratings firm shifted the sector from "stable" to "positive" based on success of new products.
By Nicole Gray • Sept. 4, 2015 -
How 2014 became a banner year for biotech job growth in MA
The state has been a biotech petri dish for a while now—and new data shows just how much of a hub it's really become.
By Nicole Gray • Sept. 2, 2015 -
Deep Dive
Biosimilars Council chief answers 6 key questions about biosims in the US
Dr. Bert Liang spoke with us to answer questions about the rapid pace of developments as biosimilars become a permanent part of healthcare in America.
By Nicole Gray • Sept. 2, 2015 -
How do you solve a problem like drug shortages?
In 2011, there were 251 new drug shortages. That number has dwindled significantly—but there's still work to be done.
By Nicole Gray • Aug. 31, 2015 -
Tables turned: Mylan cited by FDA for quality violations at Indian plants
The regulatory warning comes with no small amount of irony.
By Nicole Gray • Aug. 19, 2015 -
UPDATE: Glaxo to reopen NC plant this weekend after Legionnaires' scare
The bacteria were found in a cooling tower, and nearly half of the plant's employees have been told to stay away until the situation is cleared up.
By Sy Mukherjee • Aug. 12, 2015 -
Where biotech is booming: From Boston, to Raleigh, and beyond
Rents in the Boston biohub are up 7.4%, compared with 2014, to $47.40 per square foot.
By Nicole Gray • Aug. 7, 2015 -
Bayer, Berkeley-based biotech labor union settle 4-year contract
It includes annual raises of at least 3.2%.
By Nicole Gray • Aug. 5, 2015 -
Aprecia's Spritam becomes first FDA-approved 3D printed medication
The drug is meant to treat various types of seizures in children and adults with epilepsy.
By Nicole Gray • Aug. 4, 2015 -
Hospira's painkiller recall is ballooning—Is Pfizer getting nervous?
Ketorolac tromethamine is a painkiller used during surgery—and is now on the FDA shortage list as Hospira has to recall even more vials of the drug.
By Nicole Gray • July 29, 2015
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