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Cell and Gene Therapy, Industry

BioMarin preaches patience amid slow sales for hemophilia gene therapy

February 23, 2024

Via: Biopharma Dive

Roctavian’s approval was a scientific milestone, the culmination of years of research developing a genetic medicine for the chronic blood disease hemophilia A. Its launch, which began in Europe in 2022 and the U.S. last year, has been a focus […]


Cell and Gene Therapy, Industry

Johnson & Johnson’s Tecvayli receives FDA approval for reduced dosing in multiple myeloma patients

February 23, 2024

Via: PMLiVE

The regulator’s decision means that RRMM patients who have achieved a complete response or better for at least six months can receive a 1.5mg/kg dose of the BCMA-targeting bispecific antibody every two weeks. More than 35,000 new cases of multiple […]


Cell and Gene Therapy, Industry

NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease

February 21, 2024

Via: Biopharma Dive

A new research paper offers the most thorough look yet at a study that sparked the drug industry’s recent experimentation with cell therapy for autoimmune diseases. The paper, which was published in The New England Journal of Medicine on Wednesday, […]


Cell and Gene Therapy, Industry

AstraZeneca gets new Tagrisso OK as drug succeeds in another trial

February 20, 2024

Via: Biopharma Dive

Tagrisso is at the center of AstraZeneca’s oncology resurgence. The drug, which first won approval in the U.S. in 2015, is the company’s second highest selling product, after the diabetes and kidney disease treatment Farxiga. It has become a go-to […]


Cell and Gene Therapy, Industry

FDA Approves Amtagvi, First Cell Therapy for Skin Cancer

February 20, 2024

Via: Biopharm International

On Feb. 16, 2024, FDA announced the approval of Iovance Biotherapeutics’ Amtagvi (lifileucel), which the agency said in a press release is the first cellular therapy indicated for treating adult patients with unresectable or metastatic melanoma that has been previously […]


Cell and Gene Therapy, Industry

Tagrisso-chemo cleared in US as 1st-line lung cancer therapy

February 19, 2024

Via: Pharmaphorum

The US regulator has approved the drug after a priority review on the strength of data from the FLAURA 2 study showing that the combination of EGFR inhibitor Tagrisso (osimertinib) and chemo cut the risk of disease progression or death […]


Cell and Gene Therapy, Industry

Gene-editing firm Prime Medicine files $140m public offer

February 15, 2024

Via: Pharmaphorum

The Cambridge, Massachusetts-based company is offering 19.2 million shares at $6.25 each and has scaled up its earlier expectations for the proceeds from $125 million. Prime Medicine is working on a pipeline of 18 programmes aimed at correcting pathogenic mutations […]


Biotech, Industry

Hunting a non-opioid painkiller, a biotech reveals plans to chase Vertex

February 14, 2024

Via: Biopharma Dive

A little over four years ago, biotechnology giant Amgen retreated from neuroscience research, halting much of its work developing treatments for diseases of the brain and trimming associated staff. Amgen’s pivot proved a boon for a small startup that was […]


Cell and Gene Therapy, Industry

BioNTech and Autolus enter CAR-T cell therapy collaboration worth over $250m

February 13, 2024

Via: PMLiVE

Both companies have entered into a license and option agreement, as well as a securities purchase agreement, in connection with the collaboration. Under the terms of the agreement, BioNTech will purchase $200m of Autolus’ US depositary shares in a private […]


Biotech, Industry

Alys launches with $100M and a pipeline of skin disease drugs

February 12, 2024

Via: Biopharma Dive

Six biotechnology startups are merging into a new skin drug developer called Alys Pharmaceuticals, which launched on Monday with $100 million from European life sciences investment firm Medicxi. Alys was formed out of the merger of a group of biotechs […]


Cell and Gene Therapy, Industry

Scientists develop micofluidic chip to make cell therapy safer

February 12, 2024

Via: Pharma Times

Researchers from the Massachusetts Institute of Technology (MIT) and the Singapore-MIT Alliance for Research and Technology have developed a plastic microfluidic chip to improve the safety and effectiveness of cell therapy treatments for patients living with spinal cord injuries. In […]


Cell and Gene Therapy, Industry

FDA fast-tracks GSK’s chronic hep B therapy bepirovirsen

February 12, 2024

Via: Pharmaphorum

The fast-track designation from the US regulator recognises that bepirovirsen is the only single agent in phase 3 that has shown the potential to achieve a “functional cure” when combined with standard CHB therapies based on oral nucleoside or nucleotide […]


Industry, Vaccines

Americans Have One Trusted Source for Info on COVID Vaccines

February 8, 2024

Via: Drugs.com

A doctor or nurse might be the only person capable of convincing a vaccine-hesitant person to get the COVID jab, a new study shows. Those who trust the medical profession are most likely to get vaccinated against COVID, despite their […]


Cell and Gene Therapy, Industry

Gene editing biotech Metagenomi pulls off nearly $94M IPO

February 8, 2024

Via: Biopharma Dive

CRISPR gene editing captured headlines in recent months with the landmark approval of Casgevy, the first medicine made from the Nobel Prize-winning technology. But that milestone was only part of a larger story, of which an emerging generation of drugmakers […]


Cell and Gene Therapy, Industry

AstraZeneca to invest $300M in US cell therapy plant

February 7, 2024

Via: Biopharma Dive

AstraZeneca is ramping up in cell therapy after a late entrance to the field. In 2022, it made its first significant acquisition in the area, buying up privately held Neogene Therapeutics. And the follow year, it formed a partnership with […]


Industry, Vaccines

Vaccines May Work Better if Arms Are Alternated for Each Shot

February 6, 2024

Via: Drugs.com

When getting vaccines, switching arms for each dose may produce greater immunity than having the jabs delivered into the same arm. That’s the finding from a new study that looked at the first two doses of COVID vaccines. Those who […]


Cell and Gene Therapy, Industry

4DMT gene therapy cuts need for Eylea in wet AMD trial

February 5, 2024

Via: Pharmaphorum

On the strength of the results, 4DMT is planning to start a phase 3 trial of the gene therapy by the end of the first quarter of 2025. The data from the phase 2 PRISM study comes from a cohort […]


Industry, Vaccines

Positive efficacy results for R21/Matrix-M malaria vaccine published in The Lancet

February 5, 2024

Via: PMLiVE

R21, which uses an adjuvant developed by Novavax to boost immune response, became the second malaria vaccine to be prequalified by the World Health Organization’s (WHO) in December 2023, following the organisation’s prequalification of the RTS,S/AS01 vaccine in July 2022. […]


Industry, Pharma

Brain drug developer Alto Neuroscience prices $129M IPO

February 2, 2024

Via: Biopharma Dive

Another biotechnology company has hit Wall Street via an initial public offering, the third to do so this year in an uptick of IPO activity that suggests rebounding investor interest in life sciences stocks. Alto Neuroscience raised about $129 million […]


Biotech, Industry

Arch, a prolific biotech creator, is raising $3B for startup investing

February 2, 2024

Via: Biopharma Dive

Arch Venture Partners, one of the biotechnology sector’s most prolific company creators, is raising a new $3 billion fund, according to a regulatory filing. The fund, which would be Arch’s 13th, is being put together less than two years after […]