BioSpace News Archive

Genetown

Sunovion Announces Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution Now Available in the U.S. for the Treatment of COPD

LONHALA MAGNAIR is the first nebulized long-acting muscarinic antagonist (LAMA) available for the treatment of COPD in the U.S.

April 3, 2018

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12 min read

Business

Cellectis and Allogene Therapeutics Intend to Continue Strategic Cancer Immunotherapy Collaboration to Accelerate Development and Commercialization of Allogeneic Off-the-Shelf CAR T Therapies

Allogene intends to assume from Pfizer the global strategic collaboration agreement originally formed with Cellectis in 2014

April 3, 2018

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7 min read

Ampio Updates Regulatory and Clinical Activities

Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announces the Company has retained PAREXEL® (www.parexel.com/) to assist in preparing and presenting the Biologics License Application (BLA) for Ampion™ for the treatment of osteoarthritis-of-the-knee (OAK) to the FDA.

April 3, 2018

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6 min read

Policy

Gliknik Announces Issuance of U.S. Patent for Use of Recombinant IVIG Mimetics

Patent covers uses of recombinant compounds with at least two human IgG1 Fc domains that bind receptors found on immune cells

April 3, 2018

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2 min read

Business

Oncternal Therapeutics Further Strengthens Leadership with Additions to Board of Directors

William R. LaRue and Charles Theuer, M.D., Ph.D., Bring Broad Experience in Executive Leadership, Corporate Finance and Oncology Drug Development

April 3, 2018

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3 min read

Drug Development

ReWalk Launches Clinical Study for Its ReStore Soft Exo-Suit System

Study of new powered soft exo-suit for stroke rehabilitation is intended to provide clinical data for upcoming FDA submission

April 3, 2018

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7 min read

FDA

FDA Grants Orphan Drug Designation for Tetra Discovery Partners’ BPN14770 for the Treatment of Fragile X Syndrome

BPN14770 is a selective small molecule inhibitor of the phosphodiesterase type-4D (PDE4D) subtype.

April 3, 2018

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4 min read

Drug Development

Allergan and Richter Announce Positive Topline Results from Third of Three Pivotal Trials of Cariprazine in Bipolar I Depression

Primary endpoint was met in the study evaluating patients with acute bipolar I depression treated with cariprazine 1.5 mg versus placebo.

April 3, 2018

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14 min read

FDA

US FDA Approves BYDUREON for Use with Basal Insulin in Patients with Type 2 Diabetes with Inadequate Glycemic Control

DURATION-7 study results showed significant HbA1c reduction when BYDUREON was added to insulin glargine therapy vs insulin glargine alone

April 3, 2018

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8 min read

Biotech Bay

ReShape Lifesciences Continues Expansion in Middle East with Approval of ReShape Balloon in Saudi Arabia

Initial Stocking Order Received from Dar Al Zahrawi Medical Co LLC, KSA

April 3, 2018

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4 min read