This week the FDA approved two new products and announced a new pilot program for orphan drug designations. Celgene received a Refusal to File letter and Allergan’s PDUFA date was delayed. And the EMA provided more details regarding their new premises in Amsterdam. Here are the top regulatory news stories for this week: KemPharm announced[…]
When you communicate with someone, what are you thinking about? Are you thinking about what you want to say or the impact you want to have? You may feel confident about your message, but will the delivery be received in the manner intended? Have you considered who your audience is – employees, managers, friends, or[…]
The FDA on Wednesday approved Biktarvy, Gilead Sciences’s once-daily, triple-combination tablet for treatment of HIV infection https://www.reuters.com/article/us-gilead-sciences-fda/u-s-fda-approves-gilead-triple-hiv-drug-rival-files-lawsuit-idUSKBN1FR3AJ? Spectrum Pharmaceuticals plans to file a BLA for approval of its chemotherapy side effect drug Rolontis later this year based upon positive results from a Phase 3 study https://www.biopharmadive.com/news/spectrum-advances-neutropenia-drug-toward-fda-filing/516408/ Zogenix has won the FDA’s breakthrough therapy designation for[…]
This week saw a rejection by the FDA for Aradigm, a clinical hold for Bellicum, and a black box warning for Intercept. In addition, the FDA granted a Breakthrough Therapy designation along with a Fast Track designation. Here are the top regulatory stories for the week: The FDA has rejected Aradigm’s inhaled antibiotic Linhaliq[…]
The amazing part about leadership is that you can challenge yourself to grow and be better every day. And you can do that easily by leading by example. I am so grateful to work with an amazing group of people. As their employer, I have a responsibility to provide them with stability, encouragement, growth,[…]
The FDA gave the green light to Boston Scientific’s first-of-its-kind electric pulse system designed to treat pain without the use of opioids. https://www.fiercebiotech.com/medtech/fda-clears-boston-scientific-s-electric-pulse-system-for-non-opioid-pain-management Roche said that the EU approved Ocrevus for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis, a form of the neurological disease that previously was without an approved medicine. https://www.reuters.com/article/us-roche-ocrevus/roches-star-ms-medicine-ocrevus-wins-eu-approval-idUSKBN1F10JN[…]
This has been a big week with the approval of three new molecular entities by the FDA and the first gene therapy approved for a genetic disease. Here are the top regulatory news stores for the week. Please note that this will be my last blog of 2017 and I will be back the first[…]
Hi folks. Here are the top regulatory news stories for this week: Pfizer Inc. announced today that the FDA has approved IXIFI™ a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab) for all eligible indications of the reference product. https://www.firstwordpharma.com/node/1529996#axzz51FIjJ9GS The FDA approved Sanofi’s rapid-acting insulin analog Admelog[…]
I am posting my regulatory news blog early since I will be out of the office tomorrow. Here are the top regulatory news stories this week: The U.S. FDA approved Mylan’s biosimilar of Roche’s blockbuster treatment for breast cancer, Herceptin. This is the eighth biosimilar to be approved by the FDA: https://www.reuters.com/article/us-mylan-nl-fda/fda-oks-mylans-biosimilar-of-roche-cancer-drug-herceptin-idUSKBN1DV5BI Sunovion received FDA[…]
Hi folks, I’m publishing my blog a day early since I will be out of the office tomorrow. Here are the top regulatory news stories for this week: Scott Gottlieb, the commissioner of the Food and Drug Administration, announced plans to speed generic versions of treatments that combine a drug and a device: https://www.forbes.com/sites/matthewherper/2017/11/28/fda-boss-aims-to-close-epipen-loophole/#4af7e7fe39f9 According[…]
