Top Regulatory News Stories – Week Ending April 27, 2018

The FDA has approved Helsinn’s intravenous formulation of AKYNZEO® (a fixed antiemetic combination of fosnetupitant and palonosetron) as an alternative treatment option for patients experiencing Chemotherapy Induced Nausea and Vomiting.  Oral AKYNZEO® was previously approved by the FDA as a fixed combination oral agent in 2014. https://www.helsinn.com/news-and-events/helsinn-group-announces-the-fda-approval-of-the-iv-formulation-of-akynzeo-fosnetupitant-palonosetron-in-the-united-states/

Catalyst Pharmaceuticals announced its submission of a NDA to the FDA for Firdapse (amifampridine) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome. https://www.drugs.com/nda/firdapse_180329.html

The EMA’s Committee for Orphan Medicinal Products issued a positive opinion recommending Alnylam’s early stage ALN-TTRsc02 for orphan status, with an official designation by the European Commission expected to follow.  https://endpts.com/ema-committee-recommends-alnylams-early-stage-attr-amyloidosis-drug-for-orphan-status/?utm

Glenmark Pharmaceuticals has suspended a Phase II clinical trial at a site in India following media reports that villagers were allegedly “deceived” into participating. https://www.outsourcing-pharma.com/Article/2018/04/23/Glenmark-suspends-Ph-II-clinical-trial-following-alleged-irregularities-at-Indian-site

Abeona Therapeutics Inc. announced that the EMA Committee for Orphan Medicinal Products has granted Orphan Drug Designation for Abeona’s gene therapy program ABO-202 for the treatment of subjects with neuronal ceroid lipofuscinosis, also known as Batten Disease  http://www.firstwordpharma.com/node/1558679#axzz5DVd1L9ir

The FDA ordered a partial hold on Epizyme’s lead cancer drug tazemetostat following T-cell lymphoma case  https://endpts.com/fda-orders-a-partial-hold-on-epizymes-lead-cancer-drug-tazemetostat-following-t-cell-lymphoma-case/?utm

Veloxis Pharmaceuticals announced today that the FDA has accepted their sNDA which seeks a new indication for ENVARSUS XR (tacrolimus extended-release tablets) for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants.   https://globenewswire.com/news-release/2018/04/19/1482229/0/en/FDA-Accepts-Veloxis-s-Supplemental-New-Drug-Application-for-the-De-Novo-Indication-for-ENVARSUS-XR.html

In the fifth version of FDA final guidance released Wednesday, the agency added a deadline for Type III drug master file submissions in eCTD format. https://www.raps.org/news-and-articles/news-articles/2018/4/fda-adds-submission-type-to-delayed-ectd-implement?utm

In a statement to the US Senate appropriations committee, FDA Commissioner Scott Gottlieb highlighted two issues that the agency would seek to address with additional funding:  rising drug prices and the need for real-time data:  https://www.raps.org/news-and-articles/news-articles/2018/4/gottlieb-offers-solutions-for-high-generic-drug-pr?utm

Two more top FDA officials have retired marking the latest departures in a recent exodus of senior regulators from the agency.  https://endpts.com/two-more-top-fda-officials-hit-the-exits-as-an-exodus-of-senior-regulators-continues/

In other news…

Takeda has upped its offer to buy Shire for a mix of stock and cash worth close to $65 billion, which is good enough for Shire to extend the deadline on their talks to May 8 after determining they were close to finalizing a pact.  https://endpts.com/breaking-takeda-reaches-preliminary-deal-to-buy-shire-for-close-to-65b/?utm

Fresenius Kabi AG announced Monday it will terminate its $4.3 billion merger agreement with Akorn Inc., citing an internal investigation into practices at the generics maker, including what it contends were “material breaches of FDA data integrity requirements.”  https://www.biopharmadive.com/news/fresenius-dumps-43b-akorn-merger/521932/

UCB agreed to buy an NDA-ready epilepsy therapy from Proximagen in a $370 million deal.  https://endpts.com/ucb-snags-an-nda-ready-epilepsy-drug-from-proximagen-in-370m-deal/?utm

Mylan Pharmaceuticals is laying off more than 400 employees at its Morgantown plant, according to a statement from the company https://www.wvgazettemail.com/business/mylan-to-lay-off-more-than-employees-at-morgantown-plant/article_09e5d270-6de1-54be-b0b0-cc78bf3d3f76.html

Nalproprion is buying all of Orexigen’s assets for $75 million, including worldwide rights to the weightloss drug Contrave (marketed under the brand name Mysimba in the EU). https://endpts.com/bankrupt-and-weary-diet-pill-maker-orexigen-to-sell-for-75m-to-nalpropion/?utm

The CEO of PixarBio, Frank Reynolds, was arrested and charged with securities fraud in a scheme to manipulate trading in the company’s shares:  https://patch.com/massachusetts/boston/biotech-co-promising-solution-opioids-ceo-arrested-fraud

Celldex Therapeutics is restructuring and cutting back in the aftermath of a disastrous Phase IIb readout. The company reported late Thursday that it is cutting 59 positions from its 2018 budgeted workforce, leaving it with 148 employees.  https://endpts.com/celldex-brings-out-the-ax-in-wake-of-breast-cancer-drug-disaster-chopping-a-quarter-of-its-staff/?utm

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/

 

 

Leave a Reply

Your email address will not be published. Required fields are marked *