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FDA, Regulations

FDA Grants Orphan Drug Designation to First-in-Class Treatment for Eosinophilic Esophagitis

January 31, 2024

Via: Biopharm International

Revolo Biotherapeutics announced on Jan. 30, 2024 that FDA has granted Orphan Drug Designation to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo focuses on developing therapies that reset the immune system […]


Cell and Gene Therapy, Industry

FDA Give Guidance on Human Genome Editing in Gene Therapies

January 31, 2024

Via: Biopharm International

FDA published a final guidance document, Human Gene Therapy Products Incorporating Human Genome Editing, on Jan. 30, 2024. The document provides recommendations for developing gene therapy products incorporating genome editing (GE) of human somatic cells. Recommendations include information needed in […]


Cell and Gene Therapy, Industry

Regeneron to acquire 2seventy’s cell therapy pipeline

January 30, 2024

Via: Biopharma Dive

Regeneron Pharmaceuticals is expanding its cell therapy research, announcing a deal Tuesday to acquire the drug pipeline of 2seventy Bio and bring on many of the smaller biotechnology company’s employees. The experimental cell therapies Regeneron acquires will be housed in […]


Cell and Gene Therapy, Industry

CAR-T for lupus: the ‘tip of the iceberg’ for cell therapy in autoimmune disease

January 30, 2024

Via: Biopharma Dive

The clue came, as they often do, from an unexpected source. Some sixteen months ago, a small study of five people in Germany pointed to a new direction for the high-profile field of cell therapy. The study showed a cellular […]


Cell and Gene Therapy, Industry

AstraZeneca, Daiichi aim for first pan-tumor ADC approval

January 29, 2024

Via: Biopharma Dive

The Food and Drug Administration could soon decide on whether to make AstraZeneca and Daiichi Sankyo’s drug Enhertu available for any solid tumor with a specific genetic signature. The partners on Monday said the FDA is reviewing their request to […]


Biotech, Industry

CG Oncology prices larger-than-expected $380M IPO in hopeful sign for biotech

January 24, 2024

Via: Biopharma Dive

Cancer drug developer CG Oncology has raised $380 million in an initial public offering than was larger than it expected, a positive sign for a sector that’s struggled to generate demand from Wall Street investors recently. The company on Wednesday […]


Cell and Gene Therapy, Industry

FDA orders new cancer warnings for CAR-T therapies

January 23, 2024

Via: Biopharma Dive

The CAR-T therapies — Abecma and Breyanzi from Bristol Myers Squibb, Carvykti from Johnson & Johnson and Legend Biotech, Kymriah from Novartis, and Tecartus and Yescarta from Gilead — can drive deep and durable responses in patients with lymphoma, leukemia […]


Clinical Trials, Research and Development

Trial raises hopes for simple Alzheimer’s blood test

January 23, 2024

Via: Pharmaphorum

Testing a person’s blood for a protein called phosphorylated tau could provide a means of large-scale screening for Alzheimer’s disease (AD), according to a new study. The immunoassay – which has been developed by California biotech ALZpath – focuses on […]


Industry, Vaccines

NHS catch up campaign launched for missed MMR vaccines

January 22, 2024

Via: Pharma Times

The NHS has announced the launch of its new catch up campaign to get millions of children booked in for their missed measles, mumps and rubella (MMR) vaccine. The new campaign aligns with the health services efforts to protect children […]


Pricing, Regulations

Pharma CEOs may be subpoenaed as IRA dispute rumbles on

January 22, 2024

Via: Pharmaphorum

The independent Vermont lawmaker is calling on J&J’s Joaquin Duato and Merck’s Robert Davis to explain personally why their medicines generally cost much more in the US. The two CEOs refused to testify in front of the HELP committee last […]


Mergers and Acquisitions

BridgeBio strikes drug royalty deal for cash infusion

January 18, 2024

Via: Biopharma Dive

BridgeBio Pharma has agreed to sell future royalties on an experimental rare disease drug in exchange for $500 million if the medicine, called acoramidis, receives Food and Drug Administration approval. The financing was extended by asset manager Blue Owl Capital […]


Cell and Gene Therapy, Industry

Gene therapy biotech Jaguar spins out manufacturing company

January 18, 2024

Via: Biopharma Dive

Jaguar Gene Therapy is spinning out a new company to handle the specialized work of manufacturing cell and gene therapies, launching Wednesday a wholly owned subsidiary called Advanced Medicine Partners. The spinout, which is backed by investors Deerfield Management, Arch […]


Cell and Gene Therapy, Industry

First CRISPR drug Casgevy gets swift second approval

January 17, 2024

Via: Pharmaphorum

Casgevy (exagamglogene autotemcel or exa-cel) became the first drug based on the CRISPR/Cas9 gene-editing technology to be approved towards the end of last year, when it was cleared by the FDA for sickle cell disease (SCD). The UK was the […]


Biotech, Industry

AI Biotech Secures Funding to Speed Up Stem Cell Therapy Development

January 16, 2024

Via: Biopharm International

CellVoyant—an artificial intelligence (AI) first biotechnology company spun out of the University of Bristol—has raised £7.6 million in seed funding to speed up the development of novel cell therapies. According to a Jan. 16, 2024 press release, the funding was […]


Industry, Pharma

AI could revolutionise pharma compound synthesis

January 16, 2024

Via: Pharmaphorum

Their novel approach to high-throughput experimentation (HTE) could do away with the current need to run trial-and-error experiments to see how chemicals used to make medicines react with one another, predicting their behaviour virtually, and has been described in a […]


Biotech, Industry

Newly optimistic, biotech investors weigh lessons of sector’s downturn

January 11, 2024

Via: Biopharma Dive

The J.P. Morgan Healthcare Conference, a yearly temperature taker for the biotechnology industry, had a different feel in 2024. For the first time in awhile, young drugmakers and their backers were optimistic the sector’s downturn might finally be over. An […]


FDA, Regulations

FDA to Import Syphilis Drug, Extencilline, From France Amid Shortage

January 11, 2024

Via: Drugs.com

Amid an ongoing shortage of the first-line treatment for syphilis in the United States, the U.S. Food and Drug Administration will allow the importation of a different syphilis drug from a French drugmaker. In a letter from Laboratoires Delbert, the […]


Industry, Pharma

5 questions facing pharma in 2024

January 10, 2024

Via: Biopharma Dive

The arrival of powerful new drugs for obesity has reshaped the pharmaceutical industry, transforming Eli Lilly and Novo Nordisk into the sector’s most valuable companies and sending others scrambling to catch up. Analysts predict that so-called GLP-1 drugs like Lilly’s […]


Pricing, Regulations

FDA authorises Florida’s request to import cheaper prescription drugs from Canada

January 9, 2024

Via: PMLiVE

Prescription drug pricing has been an ongoing issue in the US, which is reportedly spending more than double the average amount spent by other OECD member countries on prescription medicines per capita. Florida’s Canadian Prescription Drug Importation Program, which will […]


News

Merck pays $680M for struggling cancer biotech Harpoon

January 8, 2024

Via: Biopharma Dive

In 2028, Merck faces the possible loss of market exclusivity for its biggest product, Keytruda, which accounted for nearly half of its pharmaceutical revenue over the first nine months of 2023. Aiming to maintain its market share, Merck has been […]