Top Regulatory News Stories – Week Ending November 16, 2018

The FDA granted accelerated approval to Merck’s checkpoint immunotherapy pembrolizumab (Keytruda) for the treatment of certain patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. https://www.cancerresearch.org/blog/november-2018/fda-approves-pembrolizumab-hcc-liver-cancer   Exelixis, Inc. announced that its partner IPSEN received approval from the European Commission for CABOMETYX (cabozantinib) tablets as a monotherapy for hepatocellular carcinoma in[…]

Top Regulatory News Stories – Week Ending October 5, 2018

This was a big week for Paratek Pharmaceuticals which received US FDA approval for two new molecular entities.  On Monday Paratek announced that the FDA has approved SEYSARA™ (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. https://www.nasdaq.com/press-release/fda-approves-seysara-sarecycline-for-the-treatment-of-moderate-to-severe-acne-20181002-00547     Then on Wednesday Paratek[…]

Top Regulatory News Stories – Week Ending February 9, 2018

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[…]

Regulatory Roundup: Top News Stories – Week Ending June 9, 2017

Here are the top nine regulatory news stories this week: The European Commission (EC) approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-based therapy. Full Story Here Gilead Sciences plans to submit a new triple combination HIV therapy for FDA approval[…]

Regulatory Roundup: Top News Stories – Week Ending May 12, 2017

There has been a lot of big news in the industry this week and here are some of the key regulatory highlights: The U.S. Senate confirmed Dr. Scott Gottlieb as the next commissioner of the FDA. Gottlieb, 44, served as an FDA deputy commissioner during the George W. Bush administration. He has also worked as a[…]

Regulatory Roundup: Top News Stories – Week Ending May 5, 2017

  This has been another exciting week with a flurry of regulatory activity in pharma and biotech. The FDA approved Radius Health’s drug TYMLOS to treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies.  However, this included a “black box” warning that the treatment had increased the[…]

Why and When to Choose a Niched Recruiting Firm

When looking for a new position, a person has to consider many things, one of which is whether to work with a recruiter.  And if one does decide to, then which recruiter or firm is best?  The same can be said when a company is hiring – should they use a recruiting firm, and if[…]