Latest News in the pharma Industry

Policy & Regulation

Novartis receives EU approval for Cosentyx label update

Novartis receives EU approval for Cosentyx label update

6 Jul 2017

Label update includes 52 week data from CLEAR study demonstrating long-term superiority of Cosentyx versus Stelara in psoriasis.

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Specialist CRO expands pharmacovigilance capabilities

Specialist CRO expands pharmacovigilance capabilities

6 Jul 2017

Pharma clients now have direct and immediate access to a fully compliant safety database without needing to invest in their own system or use an interim solution to ensure compliance.

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BIOCAD’s rituximab biosimilar to receive MA in India

BIOCAD’s rituximab biosimilar to receive MA in India

4 Jul 2017

First shipment of BIOCAD’s Acellbia to India is scheduled for September 2017.

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Lilly's Olumiant gets the thumbs up in Japan for the treatment of rheumatoid arthritis

Lilly's Olumiant gets the thumbs up in Japan for the treatment of rheumatoid arthritis

3 Jul 2017

In clinical studies, baricitinib has demonstrated significant improvement in the signs and symptoms of RA compared to standard-of-care therapies.

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FDA approves Vectibix for use in wild-type RAS metastatic colorectal cancer

FDA approves Vectibix for use in wild-type RAS metastatic colorectal cancer

2 Jul 2017

First-and-only fully human monoclonal anti-epidermal growth factor receptor antibody approved by the FDA for this patient population.

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Novartis receives EU approval for first-line use of Zykadia in ALK-positive advanced NSCLC

Novartis receives EU approval for first-line use of Zykadia in ALK-positive advanced NSCLC

29 Jun 2017

In ALK-positive advanced NSCLC patients, Zykadia demonstrated superior median progression-free survival compared with SOC chemotherapy with maintenance.

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QS Pharma receives approval from EMA for commercial manufacture

QS Pharma receives approval from EMA for commercial manufacture

27 Jun 2017

The CDMO is now approved to manufacture medicinal products for the US, Europe and Japan.

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Technology selection identified as biggest hurdle in serialization race for compliance

Technology selection identified as biggest hurdle in serialization race for compliance

26 Jun 2017

Resourcing the deployment of serialization systems and processes also cited as a significant barrier to compliance with European FMD,

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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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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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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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