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Genentech’s blood cancer drug Polivy earned an accelerated approval from the U.S. FDA due to the complete response rate shown during clinical trials. https://www.biospace.com/article/genentech-s-blood-cancer-drug-approved-two-months-ahead-of-pdufa-date/?s=61 The FDA approved Merk’s Keytruda as a frontline treatment for head and neck cancer. Keytruda was initially approved in 2014 for advanced melanoma and has since received approvals as treatment for[…]
bluebird bio announced that the European Commission (EC) has granted conditional marketing authorization for ZYNTEGLO™ (autologous CD34+ cells encoding βA-T87Q-globin gene), a gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β0/β0 genotype. https://finance.yahoo.com/news/bluebird-bio-announces-eu-conditional-132500558.html Ridgeback Biotherapeutics LP announced that the FDA has recently granted Orphan Drug Designation[…]
AveXis/Novartis received FDA approval for Zolgensma, the gene therapy for children younger than two years old who have been diagnosed with SMA with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. The therapy will be available to patients for a cost of $2.125 million, or $425,000 per year for 5 years. https://www.biospace.com/article/novartis-sma-gene-therapy-treatment-approved-by-the-fda-will-have-a-price-of-2-125-million/ Novocure[…]
The FDA will be launching an expanded access pilot dubbed ‘Project Facilitate’ by End of May. This program is aimed at improving patient access to unapproved oncology drugs: https://www.raps.org/news-and-articles/news-articles/2019/5/fda-to-launch-expanded-access-pilot-project-facil?feed=Regulatory-Focus The FDA has granted Breakthrough Therapy Designation for Sunovion’s schizophrenia drug: http://www.wbjournal.com/article/20190513/NEWS01/190519988 Celgene reported that the FDA has granted Breakthrough Therapy designation to POMALYST® (pomalidomide) for[…]
The FDA approved two oral formulations of the Pfizer drug tafamidis (to be sold as Vyndaqel and Vyndamax) for the treatment of transthyretin amyloidosis (ATTR), a debilitating rare genetic disease. https://xconomy.com/new-york/2019/05/06/fda-oks-pfizer-rare-disease-drug-sets-up-battle-with-alnylam-akcea/?mc_cid=2ebda5e74a&mc_eid=3e3fa57749 Jacobus Pharmaceutical Co won FDA approval for the first drug to treat children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder. https://www.reuters.com/article/us-jacobus-fda/fda-grants-jacobus-pharma-approval-for-rare-disease-drug-idUSKCN1SC26U The European[…]
The U.S. FDA gave Sanofi’s dengue vaccine Dengvaxia a very narrow approval on Wedneday. The company continues to suffer from evidence that its vaccine, which took 20 years to develop, can cause severe infections in some people. https://www.reuters.com/article/us-usa-fda-sanofi-fr/sanofi-wins-fda-approval-to-sell-dengue-shot-in-parts-of-u-s-idUSKCN1S74TI?feedType=RSS&feedName=healthNews Finch Therapeutics Group announced that the FDA has granted Fast Track designation to its Full-Spectrum Microbiota® (FSM®)[…]
In my daily conversations with candidates, a recurring topic is whether they should utilize the services of a professional recruiter or apply directly online to the company’s website. What are the advantages of engaging a recruiter if they can just apply directly? After listening to their concerns and getting a better understanding of their circumstances,[…]
An Era Of Authenticity It’s probably a fair statement; if you are the kind of person who needs to read an article on how to be authentic, is the very act of reading such an article in and of itself inauthentic? Setting aside that seemingly debatable fact, the topic of authenticity is likely often discussed[…]
Hi folks! I haven’t done my regulatory news blog in a few months but I’m hoping to make it a regular thing again. Here are the top regulatory news stories this week: On Tuesday the FDA had approved Abbvie’s Skyrizi (risankizumab-rzaa) for severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.[…]
A Perpetual Prime of Life As recruiters, there is a powerful question we ask candidates which typically elicits immediate pause, reflection, and authenticity in the answer. It is a question that catches most off guard, creates a feeling of nostalgia, and sometimes even prompts a smile. “At what point in your career did you feel[…]