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Karyopharm Therapeutics announced that the U.S. FDA has approved oral XPOVIOTM (selinexor), a nuclear export inhibitor, in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM). https://www.globenewswire.com/news-release/2019/07/03/1878060/0/en/Karyopharm-Announces-FDA-Approval-of-XPOVIO-selinexor-for-the-Treatment-of-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma.html Alexion’s Soliris received FDA approval for an additional indication last week. The drug is now approved to treat neuromyelitis optica spectrum[…]
For the month of June hiring in Regulatory continued to be strong, with a continued need for Labeling and Regulatory Advertising & Promotions professionals, along with clinical Regulatory Strategy people at the Director level. Most of the hiring demand is still coming from the Boston area and SF Bay Area, with a handful of positions[…]
AMAG Pharmaceuticals announced that the U.S. FDA has approved Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist, to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. https://www.amagpharma.com/news/amag-pharmaceuticals-announces-fda-approval-of-vyleesi-bremelanotide-injection-for-acquired-generalized-hypoactive-sexual-desire-disorder-hsdd-in-premenopausal-women/ Alexion’s drug Ultomiris has snagged a priority review from the FDA to treat atypical hemolytic uremic syndrome (aHUS), an ultra-rare disease that can cause progressive damage[…]
The Dichotomy of Inertia When it rains, it pours; most are familiar with this phrase. It’s what we use to describe the inertia of negative circumstances building and snowballing. Can you think of the equivalent phrase used to describe the opposite? The experience of positive inertia? “Just look at the bright side”… “turn lemons into[…]
Blueprint Medicines announced it has submitted a NDA to the FDA for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, and fourth-line GIST. https://www.drugs.com/nda/avapritinib_190614.html?utm_source=ddc&utm The FDA announced that generic drug applicants will now have access to more information from the agency when deciding[…]
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[…]