Please login to the form below

Not currently logged in
Email:
Password:

breakthrough therapy

This page shows the latest breakthrough therapy news and features for those working in and with pharma, biotech and healthcare.

FDA awards another non-opioid pain drug breakthrough status

FDA awards another non-opioid pain drug breakthrough status

The US regulator yesterday awarded Concentric Analgesics and its pipeline drug CA-008 in post-surgical pain with an FDA Breakthrough Therapy designation (BTD). ... The Breakthrough Therapy designation is based on phase Ib placebo-controlled clinical

Latest news

  • FDA gives breakthrough status to Xolair for food allergies FDA gives breakthrough status to Xolair for food allergies

    FDA gives breakthrough status to Xolair for food allergies. Food allergies could open up big new market for biologic. ... Roche and Novartis’fast-maturing allergy drug Xolair has shown it’s still got plenty more to offer after picking up an FDA

  • Ionis and Roche gain PRIME status for Huntingdon’s disease candidate Ionis and Roche gain PRIME status for Huntingdon’s disease candidate

    PRIME stands for ‘Priority Medicines’and the fast-track system has been working for two years, and has similarities to the FDA’s Breakthrough Therapy designation. ... The news is welcome for Roche and Ionis, particularly as the FDA hasn’t yet

  • Bluebird’s first gene therapy gets European fast track Bluebird’s first gene therapy gets European fast track

    The therapy also has Breakthrough Therapy Designation status with the FDA, and US filing is expected to follow close behind Europe. ... Bluebird Bio: on the cusp of a gene therapy revolution (PME July/August Digital Edition).

  • The year of the blockbuster The year of the blockbuster

    More than half of the projected blockbusters have been granted priority review, breakthrough therapy or fast-track designations  by the US FDA. ... shown in that setting based  on which the US FDA granted Hemlibra breakthrough therapy designation in

  • Roche’s MabThera ends drug drought for serious skin disease Roche’s MabThera ends drug drought for serious skin disease

    The results were published in The Lancet last year. Rituximab is the first new therapy for PV in more than 60 years, and the first biologic drug for the disorder, according ... Its importance as a new treatment option is reflected by the FDA’s awarding

More from news
Approximately 6 fully matching, plus 64 partially matching documents found.

Latest Intelligence

  • Bluebird Bio: on the cusp of a gene therapy revolution Bluebird Bio: on the cusp of a gene therapy revolution

    build the infrastructure required to administer the therapy safely and efficiently to patients across the continent. ... There is no question that these products are truly groundbreaking: three have FDA Breakthrough Therapy Designation and two have the

  • Deal Watch March 2017 Deal Watch March 2017

    Sacituzumab govitecan has been awarded breakthrough therapy status by the FDA.

  • Deal Watch February 2017 Deal Watch February 2017

    IMMU-132 has FDA Breakthrough Therapy designation for the treatment of patients with TNBC who have failed prior therapies for metastatic disease and also has Fast Track status and orphan designation

  • Deal Watch January 2016 Deal Watch January 2016

    32, 000. Seres Therapeutics/ Nestle Health Science. Collaboration. Rights to market products including SER 262 (p1 for Clostridium difficile), 287, 301 and 109 (SER 109 has breakthrough therapy designation); includes $120m ... 245. Athersys/ Healios.

  • Deal Watch November 2015 Deal Watch November 2015

    The deal includes Protopic (tacrolimus) for severe eczema treatment, skin creams Locoid and Locobase and acne therapy Zineryt (erythromycin/zinc acetate). ... DX-2930 is expected to enter phase 3 studies by the end of the year and has received Fast Track,

More from intelligence
Approximately 0 fully matching, plus 9 partially matching documents found.

Latest from PMHub

  • The Heart of the Matter 7: Reality Dawns

    Similarly, we also leveraged real-world historical comparator data to mazimise a first-to-market opportunity with a breakthrough therapy designation, priority review and orphan drug designation for another rare tumor

More from PMHub
Approximately 0 fully matching, plus 1 partially matching documents found.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Cello Health Insight

Cello Health Insight is the global market research arm of Cello Health. With 35 years’ sector experience, we specialise in...

Latest intelligence

Solaris Health looks at the gene therapy revolution
Gene therapies are bringing new hope for many people with diseases caused by genetic disorders...
PM Society Digital Awards – the power of together
Our chief executive, Emma Statham, writes about the value of awards and the power of together....
Seduction_feature_image_thumb.jpg
Seduce anyone in four simple steps
You know the health of the global economy is dependent on our ability to seduce one another – don’t you? And you know that we need to be able to...

Infographics