Lannett inks deal for generic Advair Diskus

Lannett Company (NYSE:LCI) has entered into an exclusive U.S. distribution agreement for the therapeutically equivalent generic of ADVAIR DISKUS (Fluticasone Propionate – Salmeterol Xinafoate Powder Inhaler) of Respirent Pharmaceuticals.

Under the agreement, Lannett will make an upfront payment, as well as future milestone payments, and receive a portion of the net profits once it commences distribution.

The term of the agreement is 10 years. Other terms were not disclosed.

ADVAIR DISKUS is a registered trademark of GlaxoSmithKline. It had U.S. sales of $3.6B for the 12 months ending July, 2019, according to IQVIA.

https://seekingalpha.com/news/3502818-lannett-inks-deal-generic-advair-diskus

Mallinckrodt up 5% premarket on positive Acthar Gel data

Mallinckrodt (NYSE:MNK) is up 5% premarket on announcing positive top-line findings from its observational registry to assess treatment patterns and response to Acthar Gel (repository corticotropin injection) in reducing the clinical impact of disease exacerbations in patients with multiple sclerosis (MS) relapse.

Registry data showed that patients treated with Acthar Gel reported significant improvements in symptoms associated with MS exacerbations at two months from baseline, the primary measure of the study.

The response was sustained at six months. Improvement in physical symptoms in patients treated with Acthar Gel was also reported, based on Expanded Disability Status Scale scores.

https://seekingalpha.com/news/3502825-mallinckrodt-5-percent-premarket-positive-acthar-gel-data

Minerva plunges following delay in schizophrenia drug results

Minerva Neurosciences (NASDAQ:NERV) -27.8% pre-market after disclosing a delay in issuing top-line results for its roluperidone treatment for negative symptoms in schizophrenia.

NERV says a cyber attack on one of its external contractors caused a disruption to patient recruitment in the roluperidone study, and the company now expects to complete enrollment by year-end and release study results in H1 2020.

NERV also issued data for an exploratory trial of its seltorexant treatment of patients suffering from Major Depressive Disorder, intended to generate data to assist with the planning of Phase 3 studies and not powered to detect statistical significance.

https://seekingalpha.com/news/3502829-minerva-plunges-following-delay-schizophrenia-drug-results

Ziopharm +4.0% after FDA clears IND for CD19-specific CAR-T made with RPM

Ziopharm Oncology (NASDAQ:ZIOP) gains 4.0% in premarket trading after the U.S. Food and Drug Administration allow it to proceed with a phase 1 clinical trial to evaluate CD19-specific CAR-T, produced using rapid personalized manufacture, for an investigational treatment for patients with relapsed CD19⁺ leukemias and lymphomas.

Up to 24 patients will be enrolled to evaluate infusion of donor-derived RPM CAR-T in patients with CD19⁺ leukemias and lymphomas who have relapsed after allogeneic bone marrow transplantation. This study will be conducted at The University of Texas MD Anderson Cancer Center under an investigator-initiated trial expected to begin later this year.

https://seekingalpha.com/news/3502832-ziopharm-plus-4_0-percent-fda-clears-ind-cd19-specific-car-t-made-rpm

Online brokers tumble after Schwab cuts commissions to zero

E*Trade (NASDAQ:ETFC) sinks 14%, TD Ameritrade (NASDAQ:AMTD) slides 14%, Interactive Brokers (IEX:IBKR) falls 4.6%, and Charles Schwab (NYSE:SCHW) falls 6.1% after Schwab announces that it will reduce U.S. stock, ETF, and options online trade commissions from $4.95 to zero, starting Oct. 7, 2019.

The company said there’s no minimum account size to open a full-featured Schwab brokerage account.

https://seekingalpha.com/news/3502850-online-brokers-tumble-schwab-cuts-commissions-zero

Biogen announces leadership changes

Biogen (NASDAQ:BIIB) announces an update to its senior leadership team.

Effective immediately, Alfred Sandrock, Jr., M.D., Ph.D., has been named Executive VP, R&D, in addition to his responsibilities as Chief Medical Officer.

Alphonse Galdes, Ph.D., has been appointed Executive VP, Pharmaceutical Operations and Technology.

Michael D. Ehlers, M.D., Ph.D., has decided to step down as Executive VP, R&D, and will leave Biogen effective October 11, 2019, to pursue a new career opportunity.

Sandrock joined BIIB in 1998 and has served on Biogen’s Executive Committee since 2015.

Galdes joined the company in 1995 and has served on the Executive Committee since September 2019.

https://seekingalpha.com/news/3502852-biogen-announces-leadership-changes

FDA clears Luminex’s ARIES MRSA Assay

The FDA grants 510(k) clearance for Luminex’s (NASDAQ:LMNX) ARIES MRSA Assay, an integrated, in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization.

The Luminex ARIES System is a sample to answer, real-time instrument designed to increase laboratory efficiency and  ensure result accuracy.

https://seekingalpha.com/news/3502870-fda-clears-luminexs-aries-mrsa-assay