This week saw the approval of two new molecular entities by the FDA along with a strong advisory panel recommendation. Here is my recap of the top regulatory news stories to follow:
Valeant Pharmaceuticals has won U.S. FDA approval for its glaucoma drug Vyzulta ending a more than two-year effort to bring the drug to the market. http://www.investopedia.com/news/valeants-glaucoma-drug-wins-fda-approval/
The FDA granted the accelerated approval to AstraZeneca’s Calquence, a BTK inhibitor for the treatment of cancer patients with mantle cell lymphoma https://endpts.com/astrazeneca-gets-an-early-green-light-on-btk-blockbuster-hopeful-calquence/
Indivior’s experimental drug to help fight America’s growing opioid addiction crisis has been recommended for approval by an FDA advisory panel http://www.reuters.com/article/us-indivior-opioids/indivior-drug-to-fight-opioid-addiction-recommended-by-u-s-panel-idUSKBN1D02T0
Merck announced that it would withdraw an application for European approval of Keytruda in combination with chemotherapy as a first-line treatment of non-small cell lung cancer (NSCLC). https://www.biopharmadive.com/news/merck-pulls-keytruda-lung-combo-application-in-europe/508454/
GlaxoSmithKline received a boost for its oncology research on Thursday when an experimental drug for blood cancer received a breakthrough designation from U.S. regulators. http://www.reuters.com/article/us-gsk-cancer/gsk-gets-boost-for-early-cancer-hopes-with-breakthrough-status-idUSKBN1D20WC
China is overhauling its drug-approval system to let companies bring their treatments to market quicker and more easily. https://www.nature.com/news/china-announces-plans-to-fast-track-drug-approval-1.22888?WT.ec_id=NEWSDAILY-20171026
The US FDA announced that the agency will recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet FDA requirements. http://raps.org/Regulatory-Focus/News/2017/10/31/28791/FDA-to-Recognize-8-EU-Regulators-to-Conduct-GMP-Inspections/
According to a new report, OPDP enforcement letters have reached a record low with only two letters issued so far in 2017: http://eyeonfda.com/2017/11/opdp-enforcement-letters-at-record-low/
So far in 2017 the FDA has approved 37 new molecular entities through CDER and 13 biologic programs through CBER. There are six drugs facing FDA decisions in November as follows: https://www.biospace.com/article/6-biotechs-facing-make-or-break-fda-pdufa-catalysts-in-november
In other news…
Novartis announced plans to buy nuclear medicine company Advanced Accelerator Applications for $3.9 billion in cash. Under the deal, Novartis will gain Advanced Accelerator’s radiopharmaceutical treatment for neuroendocrine tumours Lutathera (177Lu-Dotatate). https://www.firstwordpharma.com/node/1517639
Sumitomo Dainippon acquired rights to a PhIII diabetes drug from Poxel in $300M deal https://endpts.com/in-a-strategic-switch-sumitomo-dainippon-bags-rights-to-a-phiii-diabetes-drug-from-poxel-in-300m-deal
Sarepta announced that it is teaming up with Duke University to explore new CRISPR-based methods in the hunt for an effective Duchenne muscular dystrophy therapy. https://endpts.com/expanding-its-preclinical-attack-on-duchenne-md-sarepta-grabs-a-license-for-dukes-crispr-tech
Sanofi Genzyme has retreated from its Parkinson’s deal with Voyager Therapeutics: https://endpts.com/sanofi-genzyme-retreats-from-its-parkinsons-deal-with-gene-therapy-upstart-voyager-part-of-an-845m-pact/
Cancer biotech firm Apellis Pharmaceuticals set terms for their upcoming $150 million IPO https://www.biospace.com/article/cancer-biotech-apellis-pharma-sets-terms-for-150m-ipo
Amgen and Kirin Holdings have decided to dissolve their joint venture, Kirin-Amgen. It will become a wholly-owned subsidiary of Amgen. https://www.biospace.com/article/kirin-cashes-out-of-amgen-drug-joint-venture-for-780m
AvidBiotics has decided that the company will split in two, creating one company called Xyphos to focus on cell-based therapies for cancer and another—Pylum Biosciences—taking forward its Avidocin antimicrobial protein portfolio for resistant infections. http://www.fiercebiotech.com/biotech/avidbiotics-forms-car-t-and-antibiotic-specialists-by-binary-fission
Mallinckrodt snapped up another microcap biotech, picking up Ocera’s failed drug in $117M buyout https://endpts.com/mallinckrodt-bags-another-microcap-biotech-picking-up-oceras-failed-drug-in-117m-buyout/
As part of a strategic restructuring, Proteostasis Therapeutics is laying off 13 members of its research-and-development workforce. https://www.biospace.com/article/cambridge-s-proteostasis-slashes-r-and-d-jobs-in-focus-shift?utm_source=Social_JS&utm_medium=LinkedIn&utm_campaign=Daily_Article
This is a weekly recap of selected industry news stories. You can read other additional blogs, see our recent job postings and learn more about us at www.dennispartners.com