Manufacturing: Page 46
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Chinese pharma company slapped with import ban by FDA
Zhejiang Hisoar Pharmaceutical is the 41st Chinese pharma manufacturer added to the import ban list.
By Ned Pagliarulo • Jan. 21, 2016 -
Off-label use of Avastin in India hospitalizes 15, sales halted in two states
Roche's Avastin is commonly used off-label to treat wet age-related macular degeneration (AMD), but the FDA has not approved it for that purpose.
By Nicole Gray • Jan. 19, 2016 -
Taiwan election results buoy biotech sector, president-elect seen as major ally
President-elect Tsai Ing-wen has said that she wishes to boost Taiwan's biotechnology industry.
By Nicole Gray • Jan. 19, 2016 -
Pfizer CEO: Our CAR-T development method could give us a leg up over Kite, Juno, Novartis
"None of the other companies have that capability," said Pfizer chief Ian Read at the JPMorgan Healthcare Conference, referring to partner Cellectis' more universal approach to CAR-T.
By Sy Mukherjee • Jan. 14, 2016 -
Bayer opens OTC drug manufacturing plant in China
The plant is Bayer's second-largest facility in the Asia-Pacific region, and will produce OTC drugs and traditional Chinese medicines.
By Ned Pagliarulo • Jan. 14, 2016 -
Deep Dive
Warning letters reveal some of the FDA's biggest problems with Indian drugmakers
Nearly a third of the warning letters issued by the FDA's Center for Drug Evaluation and Research stemmed from violations of safe manufacturing practices at India-based facilities.
By Ned Pagliarulo • Jan. 13, 2016 -
FDA
FDA flags manufacturing deficiencies of Chinese drug supplier
The warning letter from the FDA reveals Zhejiang Hisun Pharmaceutical had been the subject of 61 complaints from 2012 to 2014.
By Ned Pagliarulo • Jan. 13, 2016 -
Baxter again forced to recall IV solutions due to insect presence
About 284,000 units of Baxter's intravenous solution have been recalled.
By Nicole Gray • Jan. 12, 2016 -
Allergan acquires Anterios to enhance neurotoxin delivery, bolsters Botox portfolio
Anterios' platform enables Botox and other neurotoxins to be delivered through the skin, rather than by injection.
By Nicole Gray • Jan. 12, 2016 -
J&J may sell off its Noramco manufacturing unit in $800 million deal
That's according to sources familiar with the situation, Reuters reports. The unit produces active ingredients for painkillers.
By Sy Mukherjee • Jan. 7, 2016 -
India's Cadila to snap up plant, animal health products from Pfizer spinoff Zoetis
Cadila will pay $29 million in a deal expected to close sometime in the first quarter.
By Ned Pagliarulo • Jan. 7, 2016 -
Deep Dive
3 key biopharma manufacturing stories to keep an eye on in 2016
From compliance issues abroad to the developmental challenges of groundbreaking new therapies, here are some of the most important issues to watch in the world of biopharma manufacturing in the coming year.
By Sy Mukherjee • Jan. 7, 2016 -
In efficiency bid, Novartis selling Alcon unit to Recipharm in $20M deal
Recipharm will expand its presence in France—one of its seven key operational regions.
By Nicole Gray • Jan. 7, 2016 -
Deep Dive
The year ahead: 11 execs & experts predict what's in store for biopharma in 2016
With a record-setting year behind us, we can only imagine what’s ahead for the industry in the coming months. Fortunately, industry execs and experts from Sanofi, Boehringer, Bain, amfAR, Novocure, and others shared some of their own predictions with BioPharma Dive.
By Nicole Gray • Jan. 4, 2016 -
Deep Dive
11 biopharma execs & experts look back on 2015: A record year for record-breaking
We spoke with bigwigs from Sanofi, the Biosimilars Council, Novocure, Accenture, Bain, amfAR, Boehringer Ingelheim, and more on what they considered the most significant events that drove biopharma this past year.
By Nicole Gray • Dec. 22, 2015 -
With eye on the future, AstraZeneca to beef up manufacturing, R&D presence in China
Investing directly in manufacturing and R&D capabilities in the country is seen as critical for future drug approvals in the market.
By Nicole Gray • Dec. 17, 2015 -
Mylan to Strides: Help us cover the tab for your noncompliant plants
There were signs of problems at several Bangalore-based facilities before Mylan acquired Strides Arcolabs in late 2014.
By Nicole Gray • Dec. 16, 2015 -
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
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