Alkermes plc. announced that the FDA has approved Aristada Initio (aripiprazole lauroxil) extended-release product for the treatment of schizophrenia in adults. Aristada was initially approved by the FDA in 2015. https://www.nasdaq.com/article/alkermes-aristada-initio-approved-by-fda-for-schizophrenia-cm987009
The FDA has approved Merz Pharma’s sBLA for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients. https://www.thepharmaletter.com/article/fda-approves-neurotoxin-for-excessive-drooling-in-adults
Mylan Pharmaceuticals’ manufacturing facility in Morgantown, WV, received an FDA Form 483 listing inspectional observations, some of which were due to failures of its quality control unit. https://www.raps.org/news-and-articles/news-articles/2018/6/mylan-pharmaceuticals-draws-form-483-for-poor-qual
Cellerant Therapeutics announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for romyelocel-L (human myeloid progenitor cells) for the prevention of serious bacterial and fungal infections in patients with de novo acute myeloid leukemia (AML) undergoing induction chemotherapy. https://www.businesswire.com/news/home/20180702005248/en/Cellerant-Therapeutics-Announces-FDA-Grants-Regenerative-Medicine
Fortress Biotech announced that the FDA has granted Fast Track Designation to Fortress subsidiary Cyprium Therapeutics’ (“Cyprium”) Copper Histidinate, also referred to as CUTX-101, for patients diagnosed with classic Menkes disease who have not demonstrated significant clinical progression. https://globenewswire.com/news-release/2018/07/02/1532384/0/en/Fortress-Biotech-Announces-Cyprium-Therapeutics-CUTX-101-Copper-Histidinate-Granted-FDA-Fast-Track-Designation-for-Treatment-of-Classic-Menkes-Disease.html
The FDA announced that it has limited the use of Roche’s Tecentriq (atezolizumab) and Merck’s Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. https://www.raps.org/news-and-articles/news-articles/2018/7/fda-limits-the-use-of-tecentriq-and-keytruda?feed=Regulatory-Focus
Bristol-Myers Squibb announced that the European Commission (EC) has expanded the indication for Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP), and to include a powder for oral suspension formulation. https://www.businesswire.com/news/home/20180705005122/en
Clovis Oncology announced that the EMA has validated the application for a Type II variation to the marketing authorization for Rubraca® (rucaparib) to include maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum based chemotherapy. This validation confirms the submission is complete and begins the EMA’s centralized review process. https://www.businesswire.com/news/home/20180705005115/en
ReCor Medical announced that the FDA approved the company’s new study of the Paradise Ultrasound Denervation System for the treatment of hypertension: RADIANCE-II. https://www.biospace.com/article/releases/recor-medical-announces-fda-approval-of-ide-for-pivotal-study-of-paradise-ultrasound-denervation-system-for-treatment-of-hypertension/
Australia’s Therapeutic Goods Administration (TGA) announced Thursday Janssen’s Erleada (apalutamide) became the first medicine evaluated via a new work-sharing pilot with Canada, Singapore and Switzerland regulators to be registered in the Australian Register of Therapeutic Goods. https://www.raps.org/news-and-articles/news-articles/2018/7/erleada-gains-first-approval-under-new-tga-work-sh?feed=Regulatory-Focus
The FDA finalized guidance to help sponsors understand how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs). https://www.raps.org/news-and-articles/news-articles/2018/7/fda-finalizes-guidance-on-gdufa-ii?feed=Regulatory-Focus
In other news…
A district court judge ordered AbbVie to pay a $448 million disgorgement for using anticompetitive tactics to delay generic competition for its blockbuster testosterone replacement therapy Androgel. https://www.raps.org/news-and-articles/news-articles/2018/7/abbvie-ordered-to-pay-448m-in-androgel-generic-de
Contract manufacturer Catalent inked $133M deal to buy Juniper Pharmaceuticals https://endpts.com/catalent-inks-133m-deal-to-buy-juniper-pharmaceuticals-adding-uk-development-services/
TRIGR Therapeutics and ABL Bio Corporation jointly announced that it had entered into a binding agreement for TRIGR to license the global commercial rights to ABL Bio’s pipeline of novel therapeutic antibodies to treat cancer. https://www.businesswire.com/news/home/20180702005992/en/TRIGR-Therapeutics-ABL-Bio-Announce-Global-Oncology
Regulus Therapeutics said that it will cut around 60% of its workforce while also pausing clinical programs: https://www.firstwordpharma.com/node/1577196
Teva announced that it is relocating its US corporate headquarters from North Wales, Pennsylvania, to Parsippany-Troy Hills, New Jersey, after the latter state agreed to give the drugmaker $40 million in tax breaks. https://www.firstwordpharma.com/node/1577043
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