Come meet Regulatory Professionals at the DIA EuroMeeting in Basel

Regulatory Professionals, part of the Clinical Professionals Group will be exhibiting at the DIA Europe 2018 conference in Basel, Switzerland on the 17th – 19th April. Visit The Clinical Professionals Group at Stand 6 In attendance: Josh Craven – Clinical Professionals / Regulatory Professionals Mos Francis – Only Medics Sarah Goddard – Clinical Professionals /

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Sanofi and Regeneron to receive review from EU regulators for Dupixent and Cemiplimab

Sanofi and Regeneron have announced that EU regulators have agreed to review Dupixent for asthma and cemiplimab for advanced cutaneous squamous cell carcinoma. The French pharmaceutical company is seeking approval for Dupixent as an supplementary maintenance treatment in certain adults and adolescents, aged 12 years old and higher, with inadequately controlled moderate-to-severe asthma. The drug

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European Medicines Agency backs strengthened regulatory measures for valproate

An announcement from the EMA has endorsed strengthened regulatory measures for prescribing valproate to women who are pregnant and of child-bearing age. The agency’s Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed strengthened measures to avoid pregnant women being exposed to the drug. Under the new measures proposed by the

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US FDA gives Fast Track designation to Boehringer Ingelheim’s nintedanib

Boehringer Ingelheim announces the FDA has granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD). The FDA’s Fast Track designation enables development of new therapies that treat serious conditions and fulfil an unmet medical need in an effort to get treatments to those in need sooner.

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MSD receive FDA fast track review for Keytuda to treat cervical cancer

US regulators will conduct a priority review of MSD’s Keytruda to treat patients with advanced cervical cancer. The company is seeking approval for the drug’s use in patients with cervical cancer who experience disease progression during or post chemotherapy. The FDA’s decision marks the first filing acceptance and priority review issued for an anti-PD-1 therapy

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Three treatments by Ipsen, Eisai and Bayer for thyroid cancer all recommended for NHS use by NICE

NICE has recommend that three separate treatments for thyroid cancer should be made available for use on the NHS: Ipsen’s Cometriq, Bayer’s Nexavar, and Eisai’s Lenvima. The former two were previously only available via the Cancer Drugs Fund (CDF), and Eisai’s finally gains approval after delays of over two years. Eisai’s tyrosine kinase inhibitor was

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