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

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.

Biogen

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Biogen's Swiss Facility Ready to Help Boost Aducanumab Rollout

Lead Product(s): Aducanumab

Therapeutic Area: Neurology

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 May 07, 2020

Details:

Biogen has wrapped up construction on a "state-of-the-art" facility in Solothurn, Switzerland, that will be ready to manufacture aducanumab at scale beginning in mid-202.

Newron Pharmaceuticals

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Newron Reports Top-Line Results From Its STARS Study Evaluating Sarizotan in Patients With Rett Syndrome

Lead Product(s): Sarizotan

Therapeutic Area: Neurology

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 May 04, 2020

Details:

Results from STRIDE 3 short-term treatment of dry eye disease, along with the positive data from the previous clinical trials of EYSUVIS served as the basis for Kala’s NDA resubmission package.

PTC Therapeutics

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Part 2 of FIREFISH Shows Survival and Motor Milestones Not Seen in Natural History in Infants with Type 1 Spinal Muscular Atrophy

Lead Product(s): Risdiplam

Therapeutic Area: Neurology

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 April 28, 2020

Details:

Part 2 of pivotal study met its primary endpoint by demonstrating unsupported sitting in infants aged 1-7 months with type 1 SMA after 12 months of treatment.

Avenue Therapeutics

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Avenue Therapeutics Announces Presentation of IV Tramadol E-Posters

Lead Product(s): Tramadol Hydrochloride

Therapeutic Area: Neurology

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 April 23, 2020

Details:

Company to present e-posters highlighting efficacy and safety results from its Phase 3 program at Annual Regional Anesthesiology and Acute Pain Medicine Meeting hosted by the ASRA.

Trevena

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Trevena Announces Publication of Comprehensive Review of Oliceridine Data

Lead Product(s): Oliceridine

Therapeutic Area: Neurology

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 April 23, 2020

Details:

Overview of clinical and nonclinical data to date for oliceridine; includes efficacy data in hard- and soft- tissue surgeries, safety / tolerability data in high-risk patients .

Biogen

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Biogen delays Alzheimer's drug filing plans, shares fall

Lead Product(s): Aducanumab

Therapeutic Area: Neurology

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 April 22, 2020

Details:

Biogen had scrapped two clinical studies of the drug, aducanumab, in March 2019 after initial analysis showed the trials would not succeed.

Genentech

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FDA Sets Back Review Date for Roche’s SMA Drug by 3 Months

Lead Product(s): Risdiplam

Therapeutic Area: Neurology

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 April 07, 2020

Details:

U.S. Food and Drug Administration (FDA) extends review time for risdiplam following agreed submission of additional data, including SUNFISH Part 2.

Axsome Therapeutics

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Axsome Celebrates Migraine PhIII Win, Shifting Eyes Toward A Pair Of Q4 Submissions

Lead Product(s): Meloxicam,Rizatriptan Benzoate

Therapeutic Area: Neurology

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 April 06, 2020

Details:

AXS-07 met the co-primary endpoints of freedom from migraine pain and freedom from most bothersome symptoms as compared to placebo.

Eli Lilly

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Alzheimer’s Trial Screening Data Links High Amyloid Levels With Early Stage Disease

Lead Product(s): Solanezumab

Therapeutic Area: Neurology

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 April 06, 2020

Details:

First paper from NIH-funded “A4” study supports amyloid as target for prevention. The research in this study is funded by NIH grants U19AG010483 and R01AG063689. Clinical trial number NCT02008357.

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Pfizer Inc

U.S. FDA Accepts Regulatory Submission for Tanezumab

Biogen

Biogen's Swiss Facility Ready to Help Boost Aducanumab Rollout

Newron Pharmaceuticals

Newron Reports Top-Line Results From Its STARS Study Evaluating Sarizotan in Patients With Rett Syndrome

PTC Therapeutics

Part 2 of FIREFISH Shows Survival and Motor Milestones Not Seen in Natural History in Infants with Type 1 Spinal Muscular Atrophy

Avenue Therapeutics

Avenue Therapeutics Announces Presentation of IV Tramadol E-Posters

Trevena

Trevena Announces Publication of Comprehensive Review of Oliceridine Data

Biogen

Biogen delays Alzheimer's drug filing plans, shares fall

Genentech

FDA Sets Back Review Date for Roche’s SMA Drug by 3 Months

Axsome Therapeutics

Axsome Celebrates Migraine PhIII Win, Shifting Eyes Toward A Pair Of Q4 Submissions

Eli Lilly

Alzheimer’s Trial Screening Data Links High Amyloid Levels With Early Stage Disease