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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[…]
Novartis’ Sandoz unit and Pear Therapeutics announced Monday that the FDA cleared their prescription-only mobile medical app, reSET-O, marking the first FDA-cleared prescription digital therapeutic for patients with opioid use disorder. https://www.firstwordpharma.com/node/1610616 Stealth BioTherapeutics announced that the FDA has granted Fast Track designation for its lead investigational candidate, elamipretide, for the treatment of dry age-related[…]
Ocular Therapeutix announced that the FDA has approved DEXTENZA (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use for the treatment of ocular pain following ophthalmic surgery. https://www.biospace.com/article/releases/ocular-therapeutix-announces-fda-approval-of-dextenza-for-the-treatment-of-ocular-pain-following-ophthalmic-surgery/?s=89 Roche’s checkpoint inhibitor Tecentriq got approval Thursday from the FDA in the first-line setting to treat non-squamous non-small cell lung cancer in combination with Avastin and chemotherapy. https://www.biopharmadive.com/news/roches-tecentriq-gets-first-line-lung-cancer-approval/543869/ The[…]
The US FDA has approved Astellas Pharma’s gilteritinib (XOSPATA) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. https://www.raredr.com/news/fda-approves-gilteritinib-treatment-adult-relapsed-refractory-aml-a-flt3-mutation?utm Pfizer received FDA approval for Daurismo (glasdegib), an oral drug for the treatment of acute myeloid leukemia (AML). This is Pfizer’s[…]