Please login to the form below
Breakthrough Therapy Designation
This page shows the latest Breakthrough Therapy Designation news and features for those working in and with pharma, biotech and healthcare.
FDA approves intramuscular administration of Merck’s MMRV vaccines
The decision from the FDA comes just two weeks after it granted breakthrough therapy designation to Merck and Moderna’s investigational personalised mRNA cancer vaccine, in combination with Merck’s Keytruda,
Latest news
-
Moderna/Merck’s skin cancer therapy given FDA breakthrough therapy designation
Moderna and Merck – known as MSD outside the US and Canada – have said their investigational personalised mRNA cancer vaccine, in combination with Merck’s Keytruda, has been given breakthrough therapy designation ... A breakthrough therapy
-
Pfizer’s multiple myeloma treatment granted FDA Breakthrough Therapy Designation
Pfizer’s investigational cancer immunotherapy, elranatamab, has received a Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory multiple myeloma (RRMM), the ... cancer.”. In
-
Boehringer Ingelheim enrols first patient in pulmonary fibrosis phase 3 trial
BI 1015550 was granted Breakthrough Therapy Designation by the US Food and Drug Administration in February 2022.
-
BioMarin’s application for haemophilia A gene therapy accepted by FDA
The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to valoctocogene roxaparvovec in March 2021, complementing the Breakthrough Therapy Designation it received in 2017. ... The therapy has also received orphan drug designation from
-
Merck’s sotatercept shows promise as pulmonary arterial hypertension add-on treatment in phase 3 trial
Sotatercept has been granted Breakthrough Therapy designation by the US Food and Drug Administration, as well as Priority Medicines designation by the European Medicines Agency for the treatment of PAH. ... We are moving with urgency on our regulatory
More from news
Approximately 5 fully matching, plus 98 partially matching documents found.
Latest Intelligence
-
Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019
Nine US, four EU and one Japanese Orphan Drug designation. Four US Breakthrough Therapy designations. ... This determination may mean that instead of expedited review because of AR-101’s Breakthrough Therapy designation, the filing may be given a
-
Drug launches to watch in 2019
Analysts say the market could eventually be worth $4.8bn annually. The FDA granted AR101 Fast Track Designation for peanut allergy in September 2014 and Breakthrough Therapy Designation for peanut allergy ... Upadacitinib is already in a phase 3 trial in
-
Bluebird Bio: on the cusp of a gene therapy revolution
There is no question that these products are truly groundbreaking: three have FDA Breakthrough Therapy Designation and two have the similar PRIME designation from the EMA. ... The sickle cell programme has also been named on the FDA’s Regenerative
-
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
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.
More from intelligence
Approximately 0 fully matching, plus 6 partially matching documents found.
Subscribe to our email news alerts
-
Pharmacovigilance Manager
- Highly competitive salary
-
Pharmacovigilance Project Lead
- Highly competitive salary
- Associate Director - Global Healthcare Consulting
- Highly competitive salary
-
Technical Sales Representative
- Highly competitive salary
-
Senior Medical Writer
- Highly competitive salary
- Early Access Program - Regulatory Affairs (EAP-RA)
- Highly competitive salary
-
Omnichannel Account Director
- £55,000 - £65,000 yearly
- Strategy Director - Healthcare Advertising
- Highly competitive salary
- AbbVie’s Parkinson’s disease therapy application rejected by FDA
- MHRA to introduce new UK clinical trials framework
- Roche and Eli Lilly to collaborate on Alzheimer’s disease blood test
- Novo Nordisk suspended from ABPI over ‘serious’ code of practice breaches
- 2023 PM Society Awards – winners announced
- Pfizer pays Royalty Pharma $475m following US approval of migraine nasal spray
- Virtual Patient Engagement Program: A Customer Story
- Putting Skin in the Game at AAD 2023
- FDA proposes improvements for oncology clinical trials supporting accelerated approval
- NHS England announces rare genetic disorder fast-tracking service
- NICE sees ‘promise’ in four UTI tests that could help in fight against AMR
- Connectome competitiveness
- Team ITG appoints Gerhard Arnhofer as head of customer strategy for life sciences division
- Locus Biosciences announces first patient treated in urinary tract infection trial
- Trust me, I’m from pharma
- FDA and CDC investigate potential safety concern for Pfizer/BioNTech’s COVID-19 vaccine
- Pfizer and Astellas’ Xtandi shows promise in phase 3 prostate cancer study
- Sobi’s Kineret granted FDA Emergency Use Authorisation for COVID-19 related pneumonia
PMHub
Graphite Digital
We’re a digital CX agency collaborating with healthcare and pharmaceutical organisations to help them connect more deeply with their audiences...
Latest intelligence
- Virtual Patient Engagement Program: A Customer Story
- Our client wanted to better understand the needs, preferences, and treatment gaps among adult patients with a rare genetic disease......
- Humancomms for humancare?
- Paul Hutchings, founder of fox&cat, writes on the role of humour in healthcare comms: PharmaComms 2023...
- Rare diseases: not so rare after all
- The brave new world addressing rare diseases – a way ahead to better and more inclusive treatment...
