BioSpace News Archive

FDA

Pfizer Snags FDA Approval for New Lung Cancer Drug Vizimpro

The U.S. Food and Drug Administration approved Pfizer’s once-per-day oral medication Vizimpro, a first-line treatment for patients with a rare form of lung cancer, the company announced late Thursday.

September 28, 2018
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2 min read
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Alex Keown
Deals

Roche Focuses on T Regulatory Cells in $758 Million Acquisition of Tusk Therapeutics

Swiss-based Roche announced it is buying UK-based Tusk Therapeutics in a deal that could hit $758 million (U.S.).

September 28, 2018
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3 min read
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Mark Terry
Business

Dance Biopharm Holdings announces the appointment of Anne Whitaker as Chief Executive Officer

Dance Biopharm Holdings Inc. is pleased to announce that Anne Whitaker has been appointed as a Director and Chief Executive Officer.

September 28, 2018
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4 min read
Business

Fermentalg and ADL BioPharma announce a majormanufacturing alliance to produce Omega 3 food supplements

Fermentalg and ADL BioPharma today announced the signing of a long-term manufacturing contract to produce Fermentalg’s algal oil DHA ORIGINS®.

September 28, 2018
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3 min read
Deals

PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) on September 25, 2018

PTC Therapeutics, Inc. today announced that on September 25, 2018 it approved non-statutory stock options to purchase an aggregate of 122,200 shares of its common stock to 33 new employees.

September 28, 2018
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1 min read
FDA

FDA Approves Libtayo® (cemiplimab-rwlc) as First and Only Treatment for Advanced Cutaneous Squamous Cell Carcinoma

Libtayo is the third anti-PD-1 approved in the U.S.

September 28, 2018
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19 min read
FDA

FDA Approves Genentech’s Xolair (Omalizumab) Prefilled Syringe Formulation

Xolair, the only biologic approved for both allergic asthma and chronic idiopathic urticaria indications, is now also approved in a prefilled syringe (PFS) formulation

September 28, 2018
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8 min read
FDA

FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

First drug granted approval under FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs, instituted to spur development of antibiotics for unmet medical needs

September 28, 2018
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4 min read
Policy

Advisory - EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Patients need to check their device to confirm that it can be removed from the carrier tube with ease

September 28, 2018
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3 min read
Deals

Takeda Establishes Record Date for the Extraordinary General Meeting of Shareholders

Company Announces Record Date and Highlights Significant Progress To-Date

September 28, 2018
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4 min read