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Cherwell publishes Cleanroom Decontamination Guide

Cherwell publishes Cleanroom Decontamination Guide

31 Jul 2017

Guide aims to help the operator understand the complex protocols and heavily regulated procedures associated with pharmaceutical cleanrooms.

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Amgen submits sBLA for Prolia in glucocorticoid-induced osteoporosis

Amgen submits sBLA for Prolia in glucocorticoid-induced osteoporosis

31 Jul 2017

Results from the Phase III study included in the sBLA submission showed that treatment with Prolia for 12 months led to statistically significant greater gains in BMD at the lumbar spine and total hip compared to risedronate.

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STA Pharmaceutical merges with WuXi¹s Pharmaceutical Development Services Division

STA Pharmaceutical merges with WuXi¹s Pharmaceutical Development Services Division

31 Jul 2017

The merger enables STA to advance NCEs from pre-clinical stage to New Drug Application and to market faster and more efficiently for pharma and biotech customers.

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BMS and Clovis Oncology announce a broad clinical collaboration to evaluate combination of Opdivo and Rubraca

BMS and Clovis Oncology announce a broad clinical collaboration to evaluate combination of Opdivo and Rubraca

31 Jul 2017

Pivotal Phase III trials planned for 2017 will evaluate Rubraca + Opdivo, Rubraca as monotherapy, and Opdivo as monotherapy in first line maintenance treatment for advanced ovarian and advanced triple-negative breast cancers.

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Arch Biopartners' GMP manufacturing of AB569 on schedule

Arch Biopartners' GMP manufacturing of AB569 on schedule

30 Jul 2017

Dalton Pharma Services is preparing glass vials in three varying dose formulations for the clinical kits needed to support the Phase I safety trial for AB569 at the CVAMC later this year.

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Boehringer starts clinical study on interchangeability between adalimumab biosimilar candidate and US-formulated Humira

Boehringer starts clinical study on interchangeability between adalimumab biosimilar candidate and US-formulated Humira

30 Jul 2017

First study in the US to investigate an interchangeability designation for an adalimumab biosimilar candidate.

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AstraZeneca and Merck establish oncology collaboration

AstraZeneca and Merck establish oncology collaboration

30 Jul 2017

Collaboration aims to maximize the potential of PARP and MEK inhibitors in combination with PD-L1/PD-1 medicines, based on growing scientific evidence that these combinations offer new potential for the treatment of a range of tumor types.

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Torbay Pharmaceuticals opens new £26 million pharmaceutical manufacturing unit

Torbay Pharmaceuticals opens new £26 million pharmaceutical manufacturing unit

30 Jul 2017

The new facilities enable to company to further grow and flourish.

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Pall introduces proprietary bioreactor control system

Pall introduces proprietary bioreactor control system

27 Jul 2017

The mPath bioreactor control system is the first to be developed and delivered by a technology supplier specifically for their product line, allowing full access to bioreactor capabilities that current commercial solutions cannot provide.

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CPhI Annual Reports - how accurate were they 5 years on?

CPhI Annual Reports - how accurate were they 5 years on?

27 Jul 2017

The CPhI predictions foresaw advancement in QbD, continuous processing, and a dramatic rise in FDA warning letters.

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Bavarian Nordic and Janssen to develop vaccine regimens against HIV-1 and Hepatitis B

Bavarian Nordic and Janssen to develop vaccine regimens against HIV-1 and Hepatitis B

27 Jul 2017

Deal builds on ongoing collaboration to develop vaccines for Human Papillomavirus (HPV) and Ebola.

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Valeant launches Siliq Injection in US

Valeant launches Siliq Injection in US

27 Jul 2017

Dermatology unit is rebranded Ortho Dermatologics.

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