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Eagle Pharmaceuticals announced that the U.S. FDA has granted seven years of orphan drug exclusivity in the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume and short-time 10-minute infusion formulation of bendamustine hydrochloride. https://www.biospace.com/article/releases/fda-grants-eagle-seven-year-orphan-drug-exclusivity-for-bendeka-bendamustine-hydrochloride-injection-/?s=95 OBI Pharma, Inc. announced that the FDA has granted Orphan Drug Designation for OBI-3424 for the Treatment[…]
Alkermes plc. announced that the FDA has approved Aristada Initio (aripiprazole lauroxil) extended-release product for the treatment of schizophrenia in adults. Aristada was initially approved by the FDA in 2015. https://www.nasdaq.com/article/alkermes-aristada-initio-approved-by-fda-for-schizophrenia-cm987009 The FDA has approved Merz Pharma’s sBLA for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients. https://www.thepharmaletter.com/article/fda-approves-neurotoxin-for-excessive-drooling-in-adults Mylan[…]
On Monday the FDA approved the first drug based on compounds found in marijuana. Epidiolex, made by GW Pharmaceuticals, was approved to treat two forms of severe childhood epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm Achaogen, Inc. announced that the FDA has approved ZEMDRI™ (plazomicin) for adults with complicated urinary tract infections (cUTI), including pyelonephritis.[…]
The FDA issued a Complete Response Letter for Valeant’s Duobrii, flagging questions related to the drug’s pharmacokinetics, according to a June 18 statement from the company. https://www.biopharmadive.com/news/valeant-hit-crl-fda-rejection-psoriasis-drug-duobrii/525923/ Shire announced that the FDA has approved a label expansion for CINRYZE® (C1 esterase inhibitor), making it available to help prevent angioedema attacks in children aged 6 years[…]
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,[…]
The FDA granted accelerated approval to Merck’s Keytruda (pembrolizumab) for the treatment of patients with advanced, PD-L1–positive cervical cancer with disease progression on or after chemotherapy. Keytruda was previously approved for several other oncology indications including metastatic non-small cell lung cancer, advanced melanoma, recurrent or metastatic head and neck squamous cell carcinoma, metastatic urothelial carcinoma,[…]
Eli Lilly and Incyte Corporation announced that the FDA has approved OLUMIANT (baricitinib) for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies. https://investor.lilly.com/news-releases/news-release-details/fda-approves-olumiantr-baricitinib-2-mg-tablets-treatment-adults Partner Therapeutics announced the recent FDA approval of Leukine for the treatment of adult and[…]
On Monday BioMarin received FDA approval for Palynziq to treat a rare disease known as phenylketonuria. https://seekingalpha.com/article/4177692-biomarin-keeps-fda-approval-train-rolling On Wednesday the FDA approved TherapeuticsMD’s IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause. This comes a year after the FDA issued a CRL rejection based[…]
Hi folks, I am publishing my blog a day early due to the holiday weekend. Here are the top regulatory stories for this week: On Monday Dova Pharmaceuticals announced the FDA completed their Priority Review and approved DOPTELET (avatrombopag) for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to[…]
This was a big week with the approval of three new molecular entities by the FDA while Evolus received a complete response letter. Here is my recap of the top regulatory news stories this week: The FDA approved Amgen’s Aimovig (erenumab-aooe) for the preventive treatment of migraines in adults: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm The FDA approved Pfizer’s Retacrit (epoetin[…]