Gene Therapy

Immunotherapy Combo from Bristol Myers Squibb Improves Survival

by Samantha McGrail

Bristol Myers Squibb recently announced that more than half (53.4 percent) of advanced renal cell carcinoma patients treated with an immunotherapy combination of Opdivo (nivolumab) and Yervoy...

BioMarin Receives FDA Complete Response Letter for Gene Therapy

by Samantha McGrail

BioMarin Pharmaceuticals recently announced that FDA issued a complete response letter for the company’s biologics license application for a hemophilia A gene therapy. In the complete response...

Johnson & Johnson Buys Momenta in $6.5B Pharma Acquisition Deal

by Samantha McGrail

Johnson & Johnson recently announced that it signed a $6.5 billion pharma acquisition deal with Momenta Pharmaceuticals Inc., a company that discovers novel therapies for immune-mediated...

Key Strategies for Advancing Gene and Cell Therapy Development

by Samantha McGrail

Experts believe that the next generation of cell and gene therapies holds significant promise for patients because this alternative treatment option represents an advancement in personalized...

Thermo Fisher Scientific to Up Manufacturing of Cell Therapies

by Samantha McGrail

Thermo Fisher Scientific and Lyell Immunopharma recently partnered to develop manufacturing processes create more effective cell therapies to benefit cancer patients. The companies main goal is to...

Pharmaceutical Mergers, Acquisitions Down in First Half of 2020

by Samantha McGrail

A recent PwC insights analysis found that the pharmaceutical merger and acquisition activity saw a notable decline in the first half of 2020, but the potential for consolidation in specific sub-sectors...

Harvard Launches Spinout to Address mRNA, CRISPR Challenges

by Samantha McGrail

Harvard University recently launched Vesigen Therapeutics, which will address the challenges of delivering RNAi, mRNA, and CRISPR technologies to intracellular targets in specific tissues of...

Is Germany’s Drug Pricing Strategy An Option for the US?

by Samantha McGrail

The German Pharmaceutical Market Restructuring Act (AMNOG) is an example of how a drug pricing strategy can be designed to better align prices with clinical benefit and is an approach the US can take...

AstraZeneca, Accent Therapeutics to Create Novel Cancer Therapies

by Samantha McGrail

AstraZeneca recently partnered with Accent Therapeutics to discover, develop, and commercialize novel cancer therapeutics targeting RNA-modifying proteins (RMPs). The companies will focus on targeting...

FDA Rejects Bristol Myers Cell Squibb’s CAR T-Cell Therapy

by Samantha McGrail

FDA recently issued a Refusal to File letter to Bristol Myers Squibb (BMS) and Bluebird Bio regarding the Biologics License Application (BLA) for idecabtagene vicleucel, a chimeric antigen receptor...

Lilly, Junshi Biosciences to Develop COVID-19 Antibody Therapies

by Samantha McGrail

Eli Lilly Company and Junshi Biosciences recently entered into an agreement to co-develop COVID-19 antibody therapies for the prevention and treatment of the novel coronavirus. For more coronavirus...

Gilead, Kite Ink Deal with oNKo-innate for Cancer Immunotherapies

by Samantha McGrail

Three pharmaceutical companies recently formed a partnership to support the discovery and development of next-generation cancer immunotherapies.  For more coronavirus updates, visit...

Cell and Gene Therapy Development Increased 20%, PhRMA Finds

by Samantha McGrail

There are 362 investigational cell and gene therapies currently in clinical development, a 20 percent increase from 2018, according to a recent report from Pharmaceutical Research and Manufacturers of...

First Gene Therapy Clinical Trial to Address Genetic Blindness

by Samantha McGrail

Oregon Health & Science University (OHSU) held the first-ever gene therapy clinical trial, BRILLIANCE, to address blindness-causing gene mutation, LCA10, according to a recent press release The...

Gene Therapy, Regenerative Medicine Markets Booming Worldwide

by Samantha McGrail

Globally, companies manufacturing gene therapy, cell therapy, and other regenerative medicines raised nearly $10 billion in 2019, the second-highest year on record, according to a recent analysis from...

FDA Develops Web-Based Resource to Support Pharmacogenetics

by Samantha McGrail

The FDA recently announced a collaboration with Radiological Health and Center for Drug Evaluation and Research to develop a web-based resource intended to support the current science in...

Children’s Hospitals Team Up to Link Patients to Clinical Trials

by Samantha McGrail

Michigan Medicine’s C.S. Mott Children’s Hospital recently announced that it has joined the top children’s hospitals from the United States, Canada, Australia, and Europe to...

FDA Aims to Bolster Gene Therapy Development with New Guidance

by Ana Mulero

US Food and Drug Administration (FDA) recently issued six final guidances and draft guidance to advance gene therapy development by clarifying the policy framework for development and...

Biotech to be ‘Extremely Active’ in 2020 Mergers and Acquisitions

by Ana Mulero

A PriceWaterhouseCoopers report predicts biotechnology firms will be “extremely active” in merger and acquisition activity and drive pharmaceutical firms’ activity in 2020. Last year...

2020 Poised to be Another Life Sciences M&A ‘Mega’ Year

by Ana Mulero

2020 will be another blockbuster year for life sciences mergers and acquisitions, according to a recent report from Ernst & Young Health Sciences and Wellness. And companies' interest in...