News

News

ADC Therapeutics Announces FDA Approval of ZYNLONTA™ (loncastuximab tesirine-lpyl) in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

ADC Therapeutics SA (NYSE: ADCT) today announced that the U.S. Food and Drug Administration (FDA) has approved ZYNLONTA™ (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low grade lymphoma and high-grade B-cell lymphoma.

4/23/2021

FibroGen Receives Rare Pediatric Disease Designation from the U.S. FDA for Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy

FibroGen, Inc. (NASDAQ: FGEN) announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with Duchenne muscular dystrophy (DMD).

4/15/2021

FibroGen Receives Fast Track Designation from the U.S. FDA for Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy

FibroGen, Inc. (NASDAQ: FGEN) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with Duchenne muscular dystrophy (DMD).

4/12/2021

Royalty Pharma Acquires OXLUMO™ Royalty Interest From Dicerna for up to $240 Million

Royalty Pharma plc (Nasdaq: RPRX) (“Royalty Pharma”) and Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) (“Dicerna”) today announced that Royalty Pharma has acquired Dicerna’s royalty interest in OXLUMO™ (lumasiran) for an upfront cash payment of $180 million and up to $60 million in contingent sales-based milestone payments.

4/8/2021

VERIGRAFT was selected as a finalist in the 2021 Lyfebulb-CSL Behring Innovation Challenge

The goal of the 2021 Lyfebulb-CSL Behring Innovation Challenge: Thriving with Transplantation is to source innovative solutions to improve outcomes and experiences for all those affected by transplantation.

4/8/2021

1910 Genetics Debuts with $26M to Accelerate the Design of Small Molecule and Protein Therapeutics Through AI, Computation and Biological Automation

Backed by M12 - Microsoft's Venture Fund and Playground Global, 1910 Genetics will scale its AI and biological automation platforms, build its world-class team, expand partnerships with biopharma companies and advance its pipeline of therapeutic programs

3/23/2021

Intra-Cellular Therapies Applies for FDA Approval of CAPLYTA® (lumateperone) for the Treatment of Bipolar Depression

ITCI submits Supplemental New Drug Applications (sNDAs) for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults.

2/22/2021

Cibus Announces Successful Field Trials for Disease Tolerant Trait in Canola

Cibus, a leader in precision gene editing in agriculture, today announced that its first field trials have confirmed greenhouse results of a non-GMO trait that provides tolerance to white mold (Sclerotinia). This milestone represents a major step in Cibus’ mission to breed a durable resistant plant with its Rapid Trait Development System (RTDSTM), as well as a breakthrough for a complex challenge that GMO and traditional technologies have been unable to fully address. This trait is among Cibus’ 14 trait products that the US Department of Agriculture, under its “Am I Regulated” process, has recently ruled were not subject to regulation under 7 CFR Part 340 and instead are regulated in the same manner as traits developed using conventional breeding practices.

1/12/2021

Existing Guidance Appropriate for Assessment of Genome Editing in Plants

Genome editing techniques that modify the DNA of plants do not pose more hazards than conventional breeding or techniques that introduce new DNA into a plant, an EFSA assessment concludes.

11/24/2020

ADC Therapeutics Announces FDA Accepts Biologics License Application and Grants Priority Review for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and granted priority review status. The FDA has set a Prescription Drug User Fee Act (“PDUFA”) target date of May 21, 2021.

11/20/2020

Royalty Pharma Reports Third Quarter 2020 Results

Royalty Pharma plc (Nasdaq: RPRX) today reported financial results for the third quarter of 2020 and updated full-year 2020 guidance for Adjusted Cash Receipts(1) (a non-GAAP financial measure).

11/10/2020

New Ventures Funds Rebrands as Scientia Ventures

New Ventures Funds has launched a new corporate brand identity and changed its name to Scientia Ventures. The new website for the firm can be found at: www.scientiavc.com. This reflects the broadening of the firm's strategic direction since launching its 3rd fund in 2017 to reflect its focus on transformational science and technology in healthcare.

10/2/2020

ADC Therapeutics Announces Presentation of Preliminary Findings from Phase 1b Clinical Trial of Camidanlumab Tesirine (Cami) in Advanced Solid Tumors at ESMO Virtual Congress 2020

ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today announced the presentation of an on-demand e-poster titled “First-in-Human Study of Camidanlumab Tesirine (ADCT-301, Cami), an anti-CD25 Targeted Therapy in Patients with Advanced...

9/17/2020

ADC Therapeutics Announces Publication Highlighting the Potential of Camidanlumab Tesirine (Cami) as a Novel Immuno-Oncology Approach for Solid Tumor Cancers

ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today announced that preclinical data related to camidanlumab tesirine (Cami, formerly ADCT-301) has been published in the Journal for ImmunoTherapy of Cancer, the online ...

9/10/2020

Intra-Cellular Therapies Announces Positive Topline Results from Study 402 Evaluating Lumateperone as Adjunctive Therapy in Patients with Bipolar Depression

Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced positive topline results from its Phase 3 clinical trial (Study 402) evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder.

9/9/2020

Royalty Pharma Announces Closing of $6.0 Billion Senior Unsecured Notes

Royalty Pharma plc (Nasdaq: RPRX) announced today that it has closed an offering of $6 billion senior unsecured notes, comprised of the following tranches (collectively, the “Notes”):

9/2/2020

Royalty Pharma and Biohaven Announce Funding Agreement Totaling Up to $450 Million

Royalty Pharma (Nasdaq: RPRX) and Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that Biohaven has secured up to $250 million in funding to advance the company’s CGRP receptor antagonist program through the development of zavegepant (formerly known as vazegepant).

8/7/2020

ADC Therapeutics Announces First Patient Dosed in Pivotal Phase 2 Portion of LOTIS 3 Clinical Trial of Loncastuximab Tesirine (Lonca) in Combination with Ibrutinib

ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today announced that the first patient has been dosed in the pivotal Phase 2 portion of LOTIS 3, a Phase 1/2 clinical trial evaluating loncastuximab tesirine (Lonca, formerly ADCT-402) in combination with ibrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL).

7/17/2020

ADC Therapeutics Announces U.S. Food and Drug Administrator Has Lifted Partial Clinical Hold on Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine

ADC Therapeutics SA (NYSE:ADCT), a clinical-stage oncology-focused biotechnology company leading the development and commercialization of next-generation antibody drug conjugates (ADCs) with highly potent and targeted pyrrolobenzodiazepine (PBD) dimer technology, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami, formerly ADCT-301) in patients with relapsed or refractory Hodgkin lymphoma (HL).

7/6/2020

New Ventures Portfolio Company, ADC Therapeutics, Completes $267 Million IPO

New Ventures Funds, a venture fund targeting investments in companies across healthcare and life sciences, is pleased to announce the IPO of its portfolio company, ADC Therapeutics (NYSE:ADCT). The company raised $267.6 million through the sale of 14,082,475 of its common shares priced at $19.00 per share.

6/30/2020