USA Archives

PBC clinical trials: Gannex doses first patient

News and Trends 16 Aug 2022

Gannex’ first patient dosed in study for treatment of primary biliary cholangitis

A study looking at a treatment for primary biliary cholangitis (PBC) has this month (August) enrolled 12 patients and is expected to be completed by the start of this year’s fourth quarter. Gannex Pharma Co., Ltd., owned by Ascletis Pharma Inc., announced yesterday (August 15) that it had finished its first dosing in the […]

August 16, 2022 - 3 minutesmins - By Liza Laws

News and Trends 16 Aug 2022

Genentech lymphoma treatment gets FDA approval

Genentech, a part of the Roche Group, says the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy. Polivy (polatuzumab vedotin-piiq), in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). The FDA […]

August 16, 2022 - 4 minutesmins - By Jim Cornall

News and Trends 16 Aug 2022

Remedium raises more funds for osteoarthritis gene therapy candidate

Remedium Bio, Inc., a biotech company developing novel gene therapies, has closed more than $2.3 million in its expanded seed round financing. Funding from the raise is being used to study Remedium’s lead product, a single-injection gene therapy potentially capable of reversing cartilage loss. The study is being undertaken in a collaboration with Tufts University […]

August 16, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 15 Aug 2022

Aptinyx fibromyalgia drug misses endpoint

Biopharma company Aptinyx Inc. says its phase 2b clinical study evaluating the effects of NYX-2925 in patients with fibromyalgia did not achieve statistically significant separation from placebo on the study’s primary endpoint. “We are very disappointed that, despite the evidence of activity observed in a prior biomarker study in fibromyalgia patients, in this follow-up phase […]

August 15, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 12 Aug 2022

Beyond Biotech podcast 9: ARCH Venture Partners, Micropep, PTC Therapeutics, Valneva

On this week’s podcast, we have conversations with ARCH Venture Partners’ managing director Kristina Burow; founder and CEO of Micropep Thomas Laurent; Kylie O’Keefe, SVP, commercial & corporate strategy at PTC Therapeutics, and Juan Carlos Jaramillo, chief medical officer of Valneva. ARCH Venture Partners closes $2.97B biotech fund ARCH Venture Partners has announced the closing […]

August 12, 2022

conveyor belt of medical vials for scale up production

News and Trends 11 Aug 2022

Regen BioPharma develops new approach for boosting CAR-T cell efficiency to treat solid tumors

Regen BioPharma, Inc. has filed with the United States Patent and Trademark Office a provisional U.S. patent application covering the company’s novel approach for enabling chimeric antigen receptor (CAR)-T cell-based therapies to kill solid tumors through prevention of a process called “T cell exhaustion.” CAR-T cells are effective at treating certain lymphomas and leukemias with […]

August 11, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 11 Aug 2022

First patient enrolled on Panbela’s trial for treatment of pancreatic cancer

Panbela Therapeutics, a U.S.-based clinical stage company, announced today (August 11) that it has enrolled its first patient in a global trial to evaluate a potential cure for pancreatic cancer. The trial referred to as ASPIRE will involve studying SBP-101, a treatment for metastatic pancreatic ductal adenocarcinoma. It is a randomized, double-blind placebo-controlled, trial with […]

August 11, 2022 - 3 minutesmins - By Liza Laws

News and Trends 11 Aug 2022

Synlogic gets Ginkgo Bioworks’ help to launch T. rex inspired synthetic biotic for gout

Synlogic, Inc. has announced a new drug candidate for the treatment of gout developed in partnership with Ginkgo Bioworks. The new candidate, SYNB2081, is a synthetic biotic and is the second product to advance to clinical development through a research collaboration between Synlogic and Ginkgo, following the investigational new drug candidate SYNB1353 for the potential […]

August 11, 2022 - 2 minutesmins - By Jim Cornall

beta-thalassemia blood APS antiphospholipid syndrome

News and Trends 11 Aug 2022

Study of drug to treat porphyria disorders initiated by Disc Medicine

A phase 2 clinical study of bitopertin in patients with erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP) has been initiated by Disc Medicine. The announcement of the study, called BEACON, was made August 10. EPP or XLP belong to a group of the porphyria disorders, which are all characterized by abnormally high levels of chemicals, […]

August 11, 2022 - 3 minutesmins - By Liza Laws

News and Trends 10 Aug 2022

Aro Biotherapeutics gets FDA orphan drug designation for treatment of Pompe Disease

Aro Biotherapeutics says the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ABX1100, an investigational Centyrin-siRNA conjugate that targets the Gys1 gene in the muscle, for the treatment of Pompe disease. “We are pleased to have received this designation and are gratified by the FDA’s recognition of the potential of ABX1100 […]

August 10, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 10 Aug 2022

GentiBio and Bristol Myers Squibb to develop engineered Treg therapies for inflammatory bowel diseases

GentiBio, Inc. has entered into a collaboration with Bristol Myers Squibb to develop new engineered regulatory T cells (Treg) therapies to re-establish immune tolerance and repair tissue in patients living with inflammatory bowel diseases (IBD). The collaboration brings together GentiBio’s engineered Treg platform for generating scalable, stable, highly-selective, and durable Tregs with Bristol Myers Squibb’s […]

August 10, 2022 - 2 minutesmins - By Jim Cornall

Approval for Small Pharma major depressive disorder clinical trials

News and Trends 9 Aug 2022

Relmada Therapeutics gets Fast Track designation for major depressive disorder treatment

Relmada Therapeutics, Inc., a late-stage biotech company addressing diseases of the central nervous system (CNS), has been given U.S. Food and Drug Administration (FDA) Fast Track designation to REL-1017, the company’s novel NMDA receptor (NMDAR) channel blocker, as a monotherapy for the treatment of major depressive disorder (MDD). “The receipt of Fast Track Designation represents […]

August 9, 2022 - 2 minutesmins - By Jim Cornall

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Gannex’ first patient dosed in study for treatment of primary biliary cholangitis

Genentech lymphoma treatment gets FDA approval

Remedium raises more funds for osteoarthritis gene therapy candidate

Aptinyx fibromyalgia drug misses endpoint

Beyond Biotech podcast 9: ARCH Venture Partners, Micropep, PTC Therapeutics, Valneva

Regen BioPharma develops new approach for boosting CAR-T cell efficiency to treat solid tumors

First patient enrolled on Panbela’s trial for treatment of pancreatic cancer

Synlogic gets Ginkgo Bioworks’ help to launch T. rex inspired synthetic biotic for gout

Study of drug to treat porphyria disorders initiated by Disc Medicine

Aro Biotherapeutics gets FDA orphan drug designation for treatment of Pompe Disease

GentiBio and Bristol Myers Squibb to develop engineered Treg therapies for inflammatory bowel diseases

Relmada Therapeutics gets Fast Track designation for major depressive disorder treatment

Subscribe to our newsletter to get the latest biotech news!

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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