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Tag: clinical trials


News

Can a Moderna co-founder change the CRO game?

February 29, 2024

Via: Biopharma Dive

When you’re looking to make changes to how clinical trials are run, it’s helpful to work with one of the top minds in the industry. By welcoming Robert Langer to its advisory board, that’s exactly what Lindus Health hopes to […]


News

FDA approves Allecra’s combination antibiotic Exblifep for complicated UTIs

February 28, 2024

Via: PMLiVE

The antibiotic combination has been approved for adults with cUTIs, including the kidney infection pyelonephritis, which is most commonly caused by gram-negative bacteria. UTIs are a common infection and typically require antibiotics for treatment. Accounting for approximately 19% of all […]


Cell and Gene Therapy, Industry

Bayer receives U.S. FDA Breakthrough Therapy designation for BAY 2927088 for non-small cell lung cancer harboring HER2 activating mutations

February 27, 2024

Via: World Pharma News

Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, […]


FDA, Regulations

FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

February 26, 2024

Via: PMLiVE

Simlandi has been approved by the regulator to treat rheumatoid arthritis, idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. Biosimilars, according to the FDA, are biological products that are highly similar to […]


News

NGM to go private through deal with investment firm

February 26, 2024

Via: Biopharma Dive

Founded in 2007, NGM took a broad approach to its drug research, assembling a pipeline that spans from solid tumors to retinal diseases to liver and metabolic disorders. NGM raised a few hundred million dollars in private funding before going […]


FDA, Regulations

FDA’s Drug Safety Priorities for 2023

February 21, 2024

Via: Biopharm International

On Feb. 15, 2024, FDA’s Center for Drug Evaluation and Research (CDER) released its report, Drug Safety Priorities FY23. The report describes the center’s key safety programs and activities involved in promoting and protecting public health and dealing with the […]


Clinical Trials, Research and Development

FDA puts hold on Rapt trials of drug for eczema, asthma

February 20, 2024

Via: Biopharma Dive

Analysts have followed Rapt as they view its drug, an oral pill dubbed zelnecirnon, as a possible competitor to Dupixent in conditions like eczema. Dupixent, which was developed by Sanofi and Regeneron, is a multibillion-dollar product approved for a range […]


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 […]


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 […]


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 […]


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 […]


FDA, Regulations

5 FDA decisions to watch in the first quarter

January 4, 2024

Via: Biopharma Dive

Biotechnology is often described as an “innovation” industry, dependent on companies’ ability to invent and develop new medicines. By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while […]


Cell and Gene Therapy, Industry

FDA approves two cell-based gene therapies for sickle cell disease

December 11, 2023

Via: PMLiVE

Affecting approximately 100,000 people in the US, SCD is a life-long, genetic disease that causes red blood cells to take a distinct crescent shape, which can block blood vessels and affect the way oxygen is carried around the body. The […]


Cell and Gene Therapy, Industry

New data in C3G sets up filings for Novartis’ Fabhalta

December 11, 2023

Via: Pharmaphorum

The results from the phase 3 APPEAR-C3G study showed that Fabhalta (iptacopan) met its primary objective of an improvement of protein in the urine (proteinuria) compared to placebo at six months, setting up filings for regulatory approval. Last week, targeted […]


Industry, Pharma

ASH23: Pharma branding, Editas’ high bar and clinical trial diversity

December 11, 2023

Via: Biopharma Dive

At the American Society of Hematology’s annual meeting, pharmaceutical branding is inescapable. Johnson & Johnson’s and GSK’s new logos are splashed across the side of phone charging stations. Sanofi, among others, let attendees know via hand sanitizer stands that it […]


Cell and Gene Therapy, Industry

CRISPR eyes autoimmune disease in revamp of cell therapy plans

December 5, 2023

Via: Biopharma Dive

CRISPR Therapeutics achieved a major scientific milestone last month with the U.K. approval of Casgevy, the first in the world for a CRISPR medicine. Wall Street analysts are expecting a similar outcome with U.S. regulators. Yet the sales outlook for […]


Clinical Trials, Research and Development

Revolutionizing clinical trials: Unlocking peak efficiency with total laboratory automation in bioanalysis

December 4, 2023

Via: Biopharma Dive

With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples. As the chief scientific officer of large-molecule bioanalysis, Dr. Tom Zhang leverages his expertise to promote ever-evolving automation technologies. He […]


Cell and Gene Therapy, Industry

AbbVie to expand solid tumour portfolio with $10bn ImmunoGen acquisition

December 1, 2023

Via: PMLiVE

The definitive agreement grants AbbVie access to ImmunoGen’s antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx), which received accelerated approval from the US Food and Drug Administration last year to treat platinum-resistant ovarian cancer. ADCs are a new class of cancer therapies […]


Cell and Gene Therapy, Industry

FDA to investigate risk of T-cell malignancy from CAR-T cell immunotherapies

November 30, 2023

Via: PMLiVE

Following reports from clinical trials and post-marketing adverse event data sources, the wide probe is directed at patients who received treatment with all currently approved BCMA- or CD19-directed autologous CAR-T cell immunotherapies. CAR-T-cell therapy is a type of immunotherapy that […]


Cell and Gene Therapy, Industry

Stem cell therapy trial shows promising results for treating progressive MS

November 28, 2023

Via: PMLiVE

Results from the trial show potential for developing an advanced cell therapy treatment for the condition. Affecting around two million people globally, MS is a neurodegenerative condition that affects the brain and spinal cord. Around two-thirds of people with MS […]