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Cladribine Tablets receives positive CHMP opinion for treatment of relapsing forms of MS

Cladribine Tablets receives positive CHMP opinion for treatment of relapsing forms of MS

25 Jun 2017

Cladribine Tablets is the first and only investigational medicinal product to have shown a sustained 4 years of disease control with a maximum of 20 days of oral treatment over 2 years in clinical trials.

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Pfizer receives expanded Health Canada approval for Ibrance in HR+, HER2- metastatic breast cancer

Pfizer receives expanded Health Canada approval for Ibrance in HR+, HER2- metastatic breast cancer

25 Jun 2017

New indication supported by results of Phase III PALOMA-3 Trial of Ibrance in combination with fulvestrant.

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Sartorius Stedim Biotech introduces Sartobind cassettes

Sartorius Stedim Biotech introduces Sartobind cassettes

23 Jun 2017

New modular membrane chromatography solution for large-scale applications .

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Biogen’s Imraldi, an adalimumab biosimilar candidate referencing Humira, granted positive opinion by CHMP

Biogen’s Imraldi, an adalimumab biosimilar candidate referencing Humira, granted positive opinion by CHMP

23 Jun 2017

If approved, Imraldi will be the third anti-TNF biosimilar in Biogen’s portfolio in Europe.

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Juniper Pharma Services brings PSD-1 spray dryer online

Juniper Pharma Services brings PSD-1 spray dryer online

22 Jun 2017

The addition enables the CDMO to scale-up early-phase bench top processes to support later stage clinical development and niche, low volume manufacturing requirements.

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Aptar Pharma holds its first dermal drug delivery seminar in China

Aptar Pharma holds its first dermal drug delivery seminar in China

22 Jun 2017

Attendees learnt how Aptar's solutions could be applied to the Chinese market in a changing regulatory environment.

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FDA approves  Mydayis – a once-daily option for ADHD symptom control in patients 13 years plus

FDA approves Mydayis – a once-daily option for ADHD symptom control in patients 13 years plus

22 Jun 2017

Mydayis demonstrated improvements lasting up to 16 hours post-dose, beginning at 2 or 4 hours post-administration, compared with placebo, in total score on a skill-adjusted math test that measures attention in ADHD.

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Arcinova investment reduces R&D and manufacturing time by more than a month

Arcinova investment reduces R&D and manufacturing time by more than a month

22 Jun 2017

Arcinova has invested in a Uniqsis FlowSyn continuous flow reactor enabling them to develop and simplify the scale-up of a challenging API batch process.

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Novartis achieves regulatory milestone for AMG 334 in migraine prevention with EMA filing acceptance

Novartis achieves regulatory milestone for AMG 334 in migraine prevention with EMA filing acceptance

21 Jun 2017

AMG 334 (erenumab) is the first anti-CGRP monoclonal antibody developed for migraine prevention to receive EMA regulatory filing acceptance.

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Accelerating freeze drying cycle development with just seven vials

Accelerating freeze drying cycle development with just seven vials

21 Jun 2017

Compared with other small-scale R&D freeze dryers, the LyoCapsule lyophilizer is the only system that can monitor and independently control the wall temperature via use of the center vial product temperature.

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Takeda completes new manufacturing facilities at the Oranienburg site in Germany

Takeda completes new manufacturing facilities at the Oranienburg site in Germany

20 Jun 2017

The manufacture of solid dosage form pharmaceutical products would be transferred from the Osaka Plant to the new plant.

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QuVa Pharma announces availability of sodium bicarbonate syringe

QuVa Pharma announces availability of sodium bicarbonate syringe

20 Jun 2017

Compounded Sodium Bicarbonate PF 8.4% 50mEq per syringe is expected to help alleviate chronic drug shortage impacting the nation's hospitals.

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