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Tag: biotech


Cell and Gene Therapy, Industry

Gene Therapy Brings Hearing to Kids With Congenital Deafness

January 25, 2024

Via: Drugs.com

Five of six Chinese children born deaf due to a rare genetic defect now have the ability to hear, thanks to an experimental gene therapy. The therapy involved a hollowed-out virus loaded with a healthy version of the gene responsible […]


Cell and Gene Therapy, Industry

Lilly gene therapy finding puts focus on hearing loss treatment pipeline

January 24, 2024

Via: Biopharma Dive

An 11-year-old boy who was born deaf can hear after receiving an experimental gene therapy, developer Eli Lilly reported on Tuesday. The boy, identified as Aissam Dam by The New York Times, was the first participant treated in a small […]


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 […]


Mergers and Acquisitions

Sanofi snaps up Inhibrx and its rare disease drug for $2.2bn

January 23, 2024

Via: Pharmaphorum

France’s Sanofi – a major player in the rare disease category – is offering $30 per share for La Jolla, California-based Inhibrx, which had a closing price of just over $33 yesterday. The cash deal values the company at $1.7 […]


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 […]


Biotech, Industry

BridgeBio raises $1.25bn, and other biotech financings

January 19, 2024

Via: Pharmaphorum

Blue Owl Capital and Canada Pension Plan Investment Board have stepped in to bulk up cash reserves at BridgeBio as it prepares for the launch of acoramidis for transthyretin amyloid cardiomyopathy (ATTR-CM) and a market showdown with much larger rival […]


Industry, Pharma

FDA turns down Satsuma’s nasal migraine treatment

January 19, 2024

Via: Pharmaphorum

The drug – a new dry powder intranasal formulation of the well-established migraine therapy dihydroergotamine mesylate (DHE) – was submitted for approval in the US last March as an easy-to-use, portable treatment option for acute migraine attacks, with or without […]


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 […]


Biotech, Industry

A South Korean investment firm starts first US biotech fund

January 18, 2024

Via: Biopharma Dive

Mirae Asset Capital Life Science, a new venture capital fund, launched on Thursday, joining several other new firms that have recently emerged with plans to invest in drug startups. The fund is a spinout of Mirae Asset Financial Group, a […]


Industry, Pharma

CDER Approved 55 Novel Drugs in 2023

January 18, 2024

Via: Biopharm International

FDA’s Center for Drug Evaluation and Research (CDER) published its New Drug Therapy Approvals 2023 report on Jan. 16, 2024 highlighting new drugs approved in 2023. CDER approved 55 novel drugs during the year and expanded indications or patient populations […]


Mergers and Acquisitions

Bora Pharmaceuticals Fuels Global Expansion with Acquisition in US

January 17, 2024

Via: Biopharm International

Taiwan’s largest pharmaceutical manufacturer, Bora Pharmaceuticals, has announced the approval by its Board of Directors for the acquisition of generics manufacturer, Upsher-Smith, which is based in Minnesota, USA, for a total of $210 million. According to a Jan. 16, 2024 […]


Biotech, Industry

Kyverna sets plans for IPO in test of biotech market

January 17, 2024

Via: Biopharma Dive

More than two years after the bottom fell out for biotech stocks, the market for IPOs is showing early signs of life, though investors are generally looking for more well-established companies than in the past. Four of the five companies […]


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 […]


FDA, Regulations

FDA says no ‘clear relationship’ between GLP-1 drugs and suicide risk

January 12, 2024

Via: Biopharma Dive

The concerns over suicide ideation — thinking about or planning suicide — emerged last year when the Icelandic drug agency reported to the EMA two cases in people taking GLP-1s. One was taking Saxenda, Novo Nordisk’s daily weight-loss shot, and […]