Latest News in the pharma Industry

Policy & Regulation

UK Supreme Court rules in Lilly's favour on Alimta vitamin regimen patents

UK Supreme Court rules in Lilly's favour on Alimta vitamin regimen patents

9 Jul 2017

Actavis's products directly infringe Lilly's vitamin regimen patents in the UK, France, Italy and Spain.

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Almac Discovery granted Orphan Drug Designation for ALM201 programme in ovarian cancer

Almac Discovery granted Orphan Drug Designation for ALM201 programme in ovarian cancer

7 Jul 2017

ALM201 is a therapeutic peptide developed to mimic some of the properties of the naturally occurring protein FKBPL.

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Impax launches additional strengths of generic Focalin XR extended-release capsules CII

Impax launches additional strengths of generic Focalin XR extended-release capsules CII

6 Jul 2017

Company has immediately initiated commercialization activities.

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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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