PTC Therapeutics Announces the European Approval of Evrysdi for the Treatment of Spinal Muscular Atrophy

PTC Therapeutics, Inc. announced that the European Commission (EC) has granted marketing authorization to Evrysdi for the treatment of spinal muscular atrophy(SMA) in patients 2 months and older. The EC approval was based on two studies; 1) the efficacy results from the FIREFISH study in infants aged 2 to 7 months with symptomatic Type 1 SMA, and 2) the SUNFISH study in children and young adults with Type 2 or 3 SMA.
[PTC Therapeutics, Inc.]
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Outlook Therapeutics Reports Positive Safety Profile from NORSE THREE Open-Label Safety Study for ONS-5010 / LYTENAVA™ (Bevacizumab-Vikg)

Outlook Therapeutics, Inc. announced positive topline results from its NORSE THREE open-label safety study evaluating ONS-5010 / LYTENAVA™ to treat retinal diseases.
[Outlook Therapeutics, Inc.]
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Exelixis’ Partner Ipsen Receives European Commission Approval for CABOMETYX® (Cabozantinib) in Combination with OPDIVO® (Nivolumab) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

Exelixis, Inc. announced its partner Ipsen received approval from the European Commission for CABOMETYX® in combination with OPDIVO® as a first-line treatment for advanced renal cell carcinoma.
[Exelixis, Inc.]
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Pinnacle Dermatology, a Chicago Pacific Founders Portfolio Company, Acquires Ariano Dermatology in Naperville, IL

Pinnacle Dermatology, a Chicago Pacific Founders portfolio company, has acquired Ariano Dermatology, led by Dr. Moira Ariano, in Naperville, IL.
[Pinnacle Dermatology (GlobeNewswire)]
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Biofrontera Submits Application for FDA Approval of New BF-RhodoLED® XL Lamp

Biofrontera AG announced the submission for approval of a new, significantly larger red-light source for photodynamic therapy to be used in combination with Ameluz®, the BF-RhodoLED® XL, to the US Food and Drug Administration.
[Biofrontera AG (GlobeNewswire)]
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Turning Point Therapeutics Announces Initial Clinical Data from Phase I/II SWORD-1 Study of RET Inhibitor TPX-0046

Turning Point Therapeutics, Inc. a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported initial clinical data from the ongoing Phase 1/2 SWORD-1 study of its RET inhibitor drug candidate, TPX-0046.
[Turning Point Therapeutics, Inc. (Globe Newswire, Inc.)]
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Sorrento Enters Into Merger Agreement to Acquire Late-Stage Oncology Company ACEA Therapeutics

Sorrento Therapeutics, Inc. announced the signing of a merger agreement pursuant to which Sorrento will acquire ACEA Therapeutics, Inc. The acquisition will include late clinical stage drug Abivertinib, clinical stage candidate AC0058, preclinical stage candidate AC0939, and ACEA’s extensive proprietary library of small molecules, which potentially have applications for numerous human disease indications, including non-small cell lung cancer, B cell lymphomas, systemic lupus, rheumatoid arthritis, multiple sclerosis and viral infections.
[Sorrento Therapeutics, Inc. (Globe Newswire, Inc.)]
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Kite Submits Supplemental Biologics License Application to US Food and Drug Administration for Tecartus® in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia

Kite announced that it has submitted a supplemental Biologics License Application to FDA for Tecartus® for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
[Kite (BusinessWire, Inc.)]
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Vir Biotechnology Announces New Preclinical Research Demonstrating VIR-7831 Maintains Neutralizing Activity Against the SARS-CoV-2 California Variant

Vir Biotechnology, Inc. announced new preclinical research demonstrating the ability of VIR-7831, the company’s investigational SARS-CoV-2 monoclonal antibody, to maintain its neutralizing activity against a mutation in the receptor binding domain of SARS-CoV-2, called L452R, which is found in the California variant.
[Vir Biotechnology, Inc. (Globe Newswire, Inc.)]
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Foresee Pharmaceuticals Announces Dosing of First Patient in Phase II/III Clinical Trial of FP-025 for Treatment of COVID-19 Associated ARDS

Foresee Pharmaceuticals Co., Ltd. announced the initiation of patient dosing in the Phase II/III clinical trial of FP-025, its highly selective oral MMP-12 inhibitor, in adult patients with severe to critical COVID-19 with associated Acute Respiratory Distress Syndrome.
[Foresee Pharmaceuticals Co., Ltd.]
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Roche Receives Positive CHMP Opinion for Tecentriq as a First-Line Monotherapy Treatment for People with a Type of Metastatic Non-Small Cell Lung Cancer

Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of Tecentriq® as a first-line treatment for adults with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.
[Roche]
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