Top Regulatory News Stories – Week Ending July 13, 2018

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[…]

Top Regulatory News Stories – Week Ending July 6, 2018

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[…]

Top Regulatory News Stories – Week Ending June 29, 2018

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.[…]

Top Regulatory News Stories – Week Ending June 22, 2018

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[…]

Recruiter VS Applying Directly

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,[…]

Top Regulatory News Stories – Week Ending June 15, 2018

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,[…]