Top Regulatory News Stories – Week Ending October 19, 2018

The US FDA approved Pfizer’s PARP inhibitor, Talzenna (talazoparib), for patients with a germline BRCA-mutated (gBRCAm), HER2-negative breast cancer. The agency also approved Myriad Genetics’ diagnostic assay to identify the mutation.  https://www.biospace.com/article/fda-approves-pfizer-s-talzenna-for-breast-cancer/

Novartis reported it received a Complete Response Letter from the FDA for canakinumab as a potential treatment for cardiovascular risk reduction. https://www.biospace.com/article/amidst-strong-quarterly-growth-novartis-receives-fda-complete-response-letter-for-canakinumab/

Ocular Therapeutix announced the receipt of a warning letter from the FDA related to Ocular’s compliance with data collection and information reporting obligations in a post-approval Device Exposure Registry study required as a condition for approval of the PMA application for ReSure Sealant. https://www.businesswire.com/news/home/20181019005103/en

Axsome Therapeutics received and Orphan Drug Designation from the FDA for AXS-12 for the treatment of narcolepsy https://www.firstwordpharma.com/node/1597917

Albireo Pharma announced that the FDA has granted Orphan Drug Designation to lead product candidate A4250, an ileal bile acid transporter (IBAT) inhibitor, for the treatment of Alagille syndrome, a rare and life-threatening disease that affects the liver and has no approved pharmacologic treatment option. https://www.firstwordpharma.com/node/1597963

Immusoft Corporation announced that the FDA has granted it Rare Pediatric Disease Designation (RPDD) for Iduronicrin genleukocel-T, a transposon-engineered autologous plasmablasts for the expression and delivery of alpha-L-iduronidase (IDUA) to treat Mucopolysaccharidosis type I (MPS I).  https://www.businesswire.com/news/home/20181017005241/en/Immusoft-Receives-Rare-Pediatric-Disease-Designation-Treatment

The FDA’s Office of Prescription Drug Promotion (OPDP) on Wednesday released an untitled letter sent earlier this month to Eisai for a sales representative’s comments on off-label uses for Fycompa (perampanel).  https://www.raps.org/news-and-articles/news-articles/2018/10/opdp-sends-untitled-letter-to-eisai-for-sales-rep?utm

The FDA has approved and tentatively approved more generic drugs in FY 2018 than any other year prior. The 971 total includes 781 final approvals and 190 tentative approvals, which compares with 937 total in FY 2017.  https://www.raps.org/news-and-articles/news-articles/2018/10/fda-sets-record-number-of-generic-drug-approvals-a?utm

The FDA on Monday released new draft guidance to assist sponsors of  treatments for rare diseases in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings. https://www.raps.org/news-and-articles/news-articles/2018/10/rare-disease-pre-ind-meetings-fda-offers-draft-gu?utm

The FDA revealed Thursday that it’s offering a proposal to the International Council on Harmonisation — ICH — to better harmonize scientific and technical standards for generic drugs.  https://endpts.com/fda-offers-a-proposal-to-help-generic-drug-developers-get-simultaneous-approvals-in-multiple-markets/

In other news…

Novartis will acquire U.S.-based cancer drugmaker Endocyte Inc for $2.1 billion in cash as the Swiss drugmaker expands its radiopharmaceuticals business.  https://www.reuters.com/article/us-endocyte-m-a-novartis/novartis-to-buy-cancer-drugmaker-endocyte-for-2-1-billion-in-cash-idUSKCN1MS0JZ

SQZ Biotechnologies could be on the receiving end of up to $1 billion following its signing of an expansion agreement with pharma giant Roche. https://www.biospace.com/article/sqz-cozies-up-to-roche-with-expansion-agreement-of-up-to-1-billion/?utm

Pain drug developer Adynxx agreed to a merger with Alliqua to gain a public stock listing: https://www.xconomy.com/san-francisco/2018/10/12/adynxx-agrees-to-merger-with-alliqua-to-gain-public-stock-listing/?mc_cid=0288c25871&mc_eid=3e3fa57749

On the heels of data for one of its gene therapies, Audentes Therapeutics raised $150.8 million through the sale of shares last week: https://www.biocentury.com/bc-extra/financial-news/2018-10-10/gene-therapy-company-audentes-raises-151m

Six years after a spectacular debut, Warp Drive Bio is powering down and handing its pipeline over to Revolution Medicines: https://endpts.com/six-years-after-a-spectacular-debut-warp-drive-bio-is-powering-down-and-handing-its-undruggable-ambitions-over-to-revolution/?utm

Pfizer will offer early retirement incentives to some employees before beginning a series of layoffs that will shrink their workforce. https://www.biopharmadive.com/news/pfizer-to-trim-workforce-by-2-as-new-ceo-prepares-to-lead/540010/

 

 

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   You can also visit us on LinkedIn at https://www.linkedin.com/company/dennis-partners/

 

 

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