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Failed trial nixes another FDA approval, this time for BMS’ Istodax

pharmaphorum

The HDAC inhibitor was given an accelerated approval by the FDA as a second-line PTCL therapy on the strength of overall response data, but a phase 3 study comparing Istodax to first-line chemotherapy showed no improvement on progression-free survival (PFS).

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NICE says no to AZ’s Lynparza for prostate cancer

pharmaphorum

AZ is seeking to use Lynparza in patients who had also been previously treated with the chemotherapy drug docetaxel, but NICE has concluded that the application failed to provide evidence of the PARP inhibitor’s value compared to standard therapy.

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Company profile: NeoImmuneTech

pharmaphorum

At NeoImmuneTech, a Biotech company founded in Maryland, US, in 2014, the answer to this question looks straightforward: “We believe in incremental progress”, says Dr Se Hwan Yang, president and chief executive officer of the company. Dr Se Hwan Yang, PhD, President and Chief Executive Officer, founded NeoImmuneTech in January 2014.

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MSD secures full approval for Keytruda’s use in MSI-high solid tumours

Pharmaceutical Technology

On March 27, MSD announced that the combined use of Keytruda with chemotherapy significantly improved progression-free survival versus the chemotherapy alone, as a first-line therapy for advanced or recurrent endometrial carcinoma. This announcement is not the only recent development for Keytruda.

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Merck’s targeted lung cancer drug tepotinib wins early access in UK

pharmaphorum

The EAMS – first introduced in 2014 – provides a route for drugmakers to provide earlier availability of promising new unlicensed medicines to patients with few treatment options, allowing clinicians and patients to try it before it’s been formally given the thumbs up.

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Microbiome therapies: a maturing movement

European Pharmaceutical Review

Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies.

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AstraZeneca acquires TeneoTwo in $1.3bn deal to broaden haematology portfolio

Pharmaceutical Technology

In December 2014, Amgen’s landmark FDA approval saw Blincyto (blinatumomab) approved for relapsed/refractory (R/R) B-cell progenitor acute lymphoblastic leukaemia (B-ALL), at the time being the only marketed BiTE. months vs. 4.0