ANI: Approval and Launch of Estradiol Gel, 0.1%

ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Gel, 0.1%.

ANI’s Estradiol Gel, 0.1%, is the generic version of the Reference Listed Drug (RLD) Divigel^®. The current annual U.S. market for Estradiol Gel, 0.1%, is approximately $42.3 million, according to IQVIA, a leading healthcare data and analytics provider.

https://www.biospace.com/article/releases/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-estradiol-gel-0-1-percent-/

Theravance: New Data at Congress of Parkinson's Disease and Movement Disorders

 "The data presented at this meeting continue to support ampreloxetine's potential to deliver a consistent and durable benefit to MSA patients with nOH with a favorable safety and tolerability profile," said Roy Freeman, MBChB, Professor of Neurology, Director, Center for Autonomic and Peripheral Nerve Disorders, Beth Israel Deaconess Medical Center. "MSA is a rare, debilitating disease and many MSA patients suffer from symptoms related to poor blood pressure control that have a significant impact on their quality of life."¹

Data will be presented in a poster session on Monday, August 28, 2023, starting at 1:00 PM Central European Time (7:00 AM EDT / 4:00 AM PDT / 11:00 AM GMT):

Category: Clinical Trials and Therapy in Movement Disorders (non-PD) (non-Dystonia)

• Freeman R, et al. Abstract 7

An Analysis of Subgroups of Multiple System Atrophy Patients from Ampreloxetine Phase 3 Trials

• Borin M, et al. Abstract 3

A Multiple-dose Thorough QT Study to Evaluate the Effect of Ampreloxetine on Cardiac Repolarization in Healthy Subjects

https://www.biospace.com/article/releases/theravance-biopharma-to-present-new-ampreloxetine-data-at-the-2023-international-congress-of-parkinson-s-disease-and-movement-disorders/

Orthofix: Commercial Launch of Minimally Invasive Surgery System

 Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the full commercial launch and successful completion of the first cases in the U.S. with the 7D FLASH^™ Navigation System Percutaneous Module 2.0. The Percutaneous Module 2.0 provides new planning features and increased functionality for the 7D FLASH Navigation System, allowing Orthofix to further serve the Minimally Invasive Surgery (MIS) spine market, estimated at approximately $1.8 billion in the U.S.¹

^{https://www.biospace.com/article/releases/orthofix-announces-first-cases-and-full-commercial-launch-of-the-7d-flash-navigation-system-percutaneous-module-2-0-for-minimally-invasive-surgery/}

AbbVie Submits Applications to FDA and EMA for Risankizumab (SKYRIZI®) in Ulcerative Colitis

 

• Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and key secondary endpoints as an induction and maintenance treatment^1,2
• Safety results were generally consistent with the known safety profile of risankizumab, with no new safety risks observed^1,2 
• Risankizumab is an IL-23 inhibitor being evaluated as a treatment for adults with moderately to severely active ulcerative colitis and is currently approved by FDA and EMA in Crohn's disease, psoriatic arthritis and psoriasis¹

https://www.biospace.com/article/releases/abbvie-submits-regulatory-applications-to-fda-and-ema-for-risankizumab-skyrizi-in-ulcerative-colitis/

Akero started at Buy by UBS

Target $83

https://finviz.com/quote.ashx?t=AKRO&ty=c&ta=1&p=d

Verastem, GenFleet to Advance New Programs Targeting RAS Pathway-Driven Cancers

 Synergistic Collaboration Based on Strengths of Verastem Oncology’s Pipeline and Development Expertise and GenFleet Therapeutics’ Discovery Capabilities

Exclusive Option for Verastem Oncology to License Up to Three Programs with Development and Commercialization Rights Outside China

https://www.biospace.com/article/releases/verastem-oncology-enters-discovery-and-development-collaboration-with-genfleet-therapeutics-to-advance-new-programs-targeting-ras-pathway-driven-cancers/

Gain: Reduction of Plasma Biomarker with Parkinson's Candidate

 Treatment with GT-02287 also restored glucocerebrosidase (GCase) enzymatic function, reduced aggregated α-synuclein, neuroinflammation and neuronal death, increased dopamine levels and improved motor function

Data presented at the International Congress of Parkinson's Disease and Movement Disorders^®

Gain remains on track to begin a Phase 1 clinical study of GT-02287 later this year

https://www.biospace.com/article/releases/gain-therapeutics-presents-new-preclinical-data-demonstrating-a-reduction-of-plasma-neurodegeneration-biomarker-nfl-after-administration-of-its-drug-candidate-gt-02287-in-gba1-parkinson-s-disease-model/