Neurology | Phase III Developments | UNITED STATES

Pfizer Inc

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U.S. FDA Accepts Regulatory Submission for Tanezumab

Lead Product(s): Tanezumab

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 02, 2020

Details:

The tanezumab regulatory submission encompasses data from 39 Phase 1-3 clinical studies evaluating the safety and efficacy of tanezumab among more than 18,000 patients.

Vtv Therapeutics

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vTv Therapeutics to Present More Clinical Data from STEADFAST Study of Azeliragon at the Alzheimer's Association International Conference

Lead Product(s): CAS 603148-36-3

Therapeutic Area: Neurology Product Name: TTP488

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 27, 2020

Details:

The poster presentation will highlight additional analyses of the clinical data from the STEADFAST Study of azeliragon showing the relative contribution of the effects on individual test items, as well as on the higher level cognitive and/or function domains.

Biogen

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Biogen to Present Data at Virtual 2020 Alzheimer’s Association International Conference Highlighting Comprehensive Approach to treat AD

Lead Product(s): Aducanumab

Therapeutic Area: Neurology Product Name: BIIB037

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 24, 2020

Details:

Biogen’s AD portfolio of investigational assets includes aducanumab, an investigational treatment that, if approved, could meaningfully change the course of the disease.

Heron Therapeutics

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Heron Therapeutics Receives Positive CHMP Opinion for ZYNRELEF™ (HTX-011) for the Management of Postoperative Pain

Lead Product(s): Bupivacaine,Meloxicam

Therapeutic Area: Neurology Product Name: Zynrelef

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 24, 2020

Details:

The CHMP's positive opinion is based on the results of Heron's two Phase 3 studies of ZYNRELEF.

Eli Lilly

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Data from Lilly at Alzheimer's Association International Conference 2020® (AAIC® 2020) to Showcase Clinical Advances in Alzheimer's Resear...

Lead Product(s): Solanezumab,Gantenerumab

Therapeutic Area: Neurology Product Name: LY2062430

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2020

Details:

The data highlights Lilly's Alzheimer's program focused on developing both disease-modifying therapies that slow clinical progression by targeting the underlying causes of Alzheimer's disease and novel diagnostics and biomarkers to enable a timely and more accurate diagnosis.

Biohaven Pharmaceuticals

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Biohaven Completes Enrollment Ahead of Timelines in International Phase 3 Clinical Trial of Verdiperstat in Multiple System Atrophy

Lead Product(s): Verdiperstat

Therapeutic Area: Neurology Product Name: BHV-3241

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2020

Details:

Verdiperstat is an investigational drug and potential first-in-class myeloperoxidase inhibitor designed to target sources of neuroinflammation that contribute to brain cell death in neurodegenerative diseases including MSA and amyotrophic lateral sclerosis (ALS).

Avenue Therapeutics

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Avenue Therapeutics Announces Publication of Phase 3 Bunionectomy Study Results

Lead Product(s): Tramadol Hydrochloride

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2020

Details:

The objective of this Phase 3 study was to compare the analgesic benefit and tolerability of two doses of IV tramadol to placebo in adult patients undergoing bunionectomy, an orthopedic surgical model. Eligible patients were randomized to IV tramadol 50 mg, 25 mg or placebo.

Osmotica Pharmaceutical Corp.

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Osmotica Pharmaceutical US LLC Announces FDA User Fee Goal Date of December 29, 2020 for Arbaclofen Extended Release Tablets

Lead Product(s): Baclofen

Therapeutic Area: Neurology Product Name: AERT

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 20, 2020

Details:

Osmotica Pharmaceuticals plc is developing arbaclofen ER tablets for the treatment of spasticity in patients with MS. This program aims to demonstrate the clinical efficacy and safety of arbaclofen ER tablets in patients with spasticity due to MS.

Principia Biopharma

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Sanofi Has a $50B Biotech Buyout Budget, with Principia Top of the List

Lead Product(s): PRN2246

Therapeutic Area: Neurology Product Name: PRN2246

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Sanofi

Deal Size: $50,000.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition July 16, 2020

Details:

Principia’s pipeline is built upon the idea of using BTK inhibitors to curb B-cell attacks against healthy tissues.

Biogen

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Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease

Lead Product(s): Aducanumab

Therapeutic Area: Neurology Product Name: BIIB037

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 08, 2020

Details:

Biogen has requested Priority Review. If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.

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Pfizer Inc

U.S. FDA Accepts Regulatory Submission for Tanezumab

Vtv Therapeutics

vTv Therapeutics to Present More Clinical Data from STEADFAST Study of Azeliragon at the Alzheimer's Association International Conference

Biogen

Biogen to Present Data at Virtual 2020 Alzheimer’s Association International Conference Highlighting Comprehensive Approach to treat AD

Heron Therapeutics

Heron Therapeutics Receives Positive CHMP Opinion for ZYNRELEF™ (HTX-011) for the Management of Postoperative Pain

Eli Lilly

Data from Lilly at Alzheimer's Association International Conference 2020® (AAIC® 2020) to Showcase Clinical Advances in Alzheimer's Resear...

Biohaven Pharmaceuticals

Biohaven Completes Enrollment Ahead of Timelines in International Phase 3 Clinical Trial of Verdiperstat in Multiple System Atrophy

Avenue Therapeutics

Avenue Therapeutics Announces Publication of Phase 3 Bunionectomy Study Results

Osmotica Pharmaceutical Corp.

Osmotica Pharmaceutical US LLC Announces FDA User Fee Goal Date of December 29, 2020 for Arbaclofen Extended Release Tablets

Principia Biopharma

Sanofi Has a $50B Biotech Buyout Budget, with Principia Top of the List

Biogen

Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease