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Gamida Set For Breakthrough Transplant Therapy Approval – But Cash Problems Could Hit Launch

With a new CEO at the helm, Gamida is closing in on an FDA approval, but a lack of cash could hobble its US launch efforts for allogeneic cell therapy product omidubicel.

Companies Commercial

Galecto Validates LOXL2 Targeting With Interim Myelofibrosis Phase II Success

The US biotech’s LOXL2 inhibitor candidate has reduced collagen fibrosis of the bone marrow in a small number of Phase II patients, helping validate a historically tricky approach attempted by few.

Clinical Trials Companies

Cage Fighting: Novel Drugs From MNCs, Chinese Rivals Compete In China Reimbursement Sector

After slashing the prices of their blockbuster drugs to gain wider patient access through China's main reimbursement program, multinationals are now beginning to face increasing challenges from local competitors.

China Reimbursement

Sarepta Files DMD Gene Therapy, Seeking An Accelerated Path To Market

The company is seeking FDA accelerated approval of the closely watched gene therapy based on a surrogate marker and has proposed its fully enrolled Phase III trial to serve as a confirmatory study.

Gene Therapy Rare Diseases

CTI’s Vonjo Shows Potential In Anemic Myelofibrosis Patients, Promising Further Market Growth

New data from anemic myelofibrosis patients showed the drug reduced transfusion dependence, which that could unlock a more sizeable portion of the market for CTI BioPharma.

Clinical Trials Cancer

Why Tessera Believes Its Gene Writing Platform Can Go Way Beyond CRISPR

As the first CRISPR-based therapies draw closer to approval, the Flagship-backed biotech believes its gene writing tech is the ‘definitive’ genetic medicine platform.

Gene Therapy Research & Development

Regenxbio: On The Cusp Of Becoming A Commercial Gene Therapy Player

Partnered with AbbVie on a wet AMD gene therapy, Regenxbio is also advancing wholly owned candidates for Duchenne muscular dystrophy and MPS I and MPS II.

Gene Therapy Business Strategies

Pharming’s Leniolisib On Track To Become First Disease-Modifying APDS Drug

The Dutch firm’s US filing for its first-in-class PI3K inhibitor has been accepted under priority review, bringing the asset closer to becoming the first disease-modifying option for a rare, genetic disorder.

Drug Review Companies

Peptilogics’ AI Peptide Platform Could Help Address Orthopedic Unmet Need

Emerging Company Profile: US firm Peptilogics is advancing through the clinic with its lead orthopedic anti-infective drug candidate based on an AI platform that utilizes algorithms to improve peptide design.

Emerging Company Profile Orthopedics

Amgen VP Encouraged By Initial Clinical Trial Diversity Efforts

Ponda Motsepe-Ditshego, who leads Amgen’s clinical trial diversity efforts, admits they are in early stages but noted progress internally and externally at better representing diverse patient groups.

Diversity & Inclusion Clinical Trials

Pharma Past Propels Julie Brown To GSK’s CFO Position

GSK has poached its new chief financial officer from fashion brand Burberry, but Julie Brown’s experience at AstraZeneca and Roche will give her insights into how to lead GSK into its next phase.

Executive Changes Leadership

Investors Get Selective As China Biotech Funding Rebounds

Oversee returnee-founded Chinese biotech start-ups Nuwacell and Arnatar secure $14m in series A and seed rounds respectively, while four other major deals backed by private equity and venture capital firms raise a combined $116m.

China Financing
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