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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[…]
It is 3pm and you’re asking yourself, “Where did the day go?” You’ve only gotten halfway through your task list, and you’re wondering how this is possible when you carefully prepared your daily goals. Everything had been planned and prioritized, yet something has robbed valuable hours of your day. A Salary.com survey showed that 60%[…]
The FDA approved Novartis’ combination treatment dabrafenib (Tafinlar) and trametinib (Mekinist) for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options. http://www.pharmacytimes.com/news/fda-approves-drug-combination-for-treating-brafpositive-anaplastic-thyroid-cancer The FDA has promised Roche/Genentech a priority review for Tecentriq plus Avastin and chemo for lung cancer, with[…]
This was a pretty busy week with an approval of a new molecular entity for Portola, a second indication approval for Novartis’s Kymriah, several new orphan drug designations, and a complete response letter for Sandoz. Here are the top regulatory news stories for this week: Portola Pharmaceuticals received FDA accelerated approval for once-rejected Andexxa, the[…]