FDA expands Regeneron's Eylea approval
The blockbuster eye med is now indicated for an Injection prefilled syringe, which will provide physicians with a new way to administer the treatment with fewer preparation steps (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 13, 2019 Category: Pharmaceuticals Source Type: news

Safe & sterile powder transfer
How the use of aseptic split butterfly valve technology can prevent contamination (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 13, 2019 Category: Pharmaceuticals Source Type: news

Regeneron drug boosts survival of Ebola to 90 percent
A new study has shown that a pair of experimental treatments could dramatically increase the chances of surviving Ebola. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 12, 2019 Category: Pharmaceuticals Source Type: news

Amgen wins Enbrel patent protections — for now
Amgen has fought off a patent challenge from Novartis to its blockbuster anti-inflammatory, Enbrel. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 12, 2019 Category: Pharmaceuticals Source Type: news

Qualifying your cleanroom
Revised GMP guidelines will strengthen emphasis on contamination control, impacting cleanroom performance qualifications (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 12, 2019 Category: Pharmaceuticals Source Type: news

GSK announces leadership changes
GlaxoSmithKline announced that Jack Bailey, President U.S. Pharmaceuticals, has decided to step down from his role at the end of the year. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 12, 2019 Category: Pharmaceuticals Source Type: news

Natco Pharma API plant hit with Form 483
Natco Pharma has received a Form 483 with six observations from the U.S. FDA for the drugmaker ' s active pharmaceutical ingredient facility located outside Hyderabad, India. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 12, 2019 Category: Pharmaceuticals Source Type: news

2019 Pharma Innovation Awards
This year ' s winners offer slices of innovation (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 12, 2019 Category: Pharmaceuticals Source Type: news

Bayer pays $600M for stem cell therapy developer
Bayer has acquired BlueRock Therapeutics in a deal valued at $600 million that will give the drugmaker a platform to research and develop new stem cell therapies. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 9, 2019 Category: Pharmaceuticals Source Type: news

Synthorx founder mysteriously leaves Scripps Research
A lead scientist at La Jolla ’s Scripps Research has left the biomedical institute (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 9, 2019 Category: Pharmaceuticals Source Type: news

Pharma Manufacturing announces the 2019 Pharma Innovation Award winners
SCHAUMBURG, IL, Aug. 09, 2019 -- The Pharma Innovation Awards are an annual celebration of new, unique technologies contributing to advancements in risk reduction, product quality improvement and manufacturing efficiency. It ' s these advancements that support pharmaceutical companies in their quests to develop innovative, life-saving medicines. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 9, 2019 Category: Pharmaceuticals Source Type: news

What are the Pharma Innovation Awards?
The annual awards acknowledge the investment equipment vendors put into developing and improving their products (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 8, 2019 Category: Pharmaceuticals Source Type: news

After several acquisitions, Cambrex is now on track to be bought
One of the industry ’s leading small-molecule CDMOs is being acquired for $2.4 billion. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 7, 2019 Category: Pharmaceuticals Source Type: news

Teva ’s CFO resigns in the midst of ongoing financial woes
Teva Pharmaceuticals announced this week that its chief financial officer is stepping down. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 7, 2019 Category: Pharmaceuticals Source Type: news

FDA says Novartis gene therapy drug application contains manipulated data
On May 24, the FDA approved Zolgensma, a gene therapy product intended to treat children less than two years of age with spinal muscular atrophy, but was informed recently by the product ’s manufacturer about a data manipulation issue (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - August 6, 2019 Category: Pharmaceuticals Source Type: news