USA Archives

News and Trends 31 Jan 2023

Stemline Therapeutics’ breast cancer treatment approved

The Menarini Group, an Italian pharmaceutical and diagnostics company, says that the U.S. Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline Therapeutics, a wholly-owned subsidiary […]

January 31, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 31 Jan 2023

Stargardt disease treatment gets FDA fast track

Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation (FTD) for MCO-010. MCO-010 is an ambient-light activatable multi-characteristic opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for the treatment of Stargardt disease to […]

January 31, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 31 Jan 2023

Abbisko Therapeutics receives breakthrough therapy designation for CSF-1R inhibitor

Abbisko Therapeutics Co., Ltd. has announced that its CSF-1R inhibitor Pimicotinib has been granted the breakthrough therapy designation from the FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. The designation approval is based on results from the phase Ib clinical trial of TGCT cohort for Pimicotinib. […]

January 31, 2023 - 4 minutesmins - By Jim Cornall

CRISPR Therapeutics, CRISPR-Cas9, genome editing, biotech

News and Trends 20 Jan 2023

Aldevron launches type-V CRISPR Nuclease

Aldevron, which develops and manufactures plasmid DNA, RNA and proteins for the biotech industry, has launched Eureca-V Nuclease, the wild-type MAD7 CRISPR Type-V nuclease, licensed from Inscripta, at Research Grade, with GMP to follow.   Aldevron’s launch at Advanced Therapies Week of Eureca-V Nuclease expands the toolkit of available CRISPR nucleases for therapeutic, diagnostic, and agricultural […]

January 20, 2023 - 2 minutesmins - By Jim Cornall

glioblastoma oncolytic virus transgene 2

News and Trends 20 Jan 2023

New drug could replace current standard for treating brain cancer

Glioblastoma (GBM) is a WHO grade IV brain tumor with dismal prognosis. Although post-surgical radiation chemotherapy combined with temozolomide is the standard line of treatment, GBM cells surviving radiotherapy contribute to tumor progression and recurrence even more aggressively. Researchers have now unveiled the mechanism of radioresistance in glioblastoma cells, identifying therapeutic targets to overcome radioresistance. […]

January 20, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 19 Jan 2023

Pathalys Pharma brings in $150M for SHPT trials

Pathalys Pharma, Inc. and Launch Therapeutics (Launch Tx) have announced a collaboration to advance phase 3 clinical trials for upacicalcet (designated PLS240 for clinical trials) for the treatment of secondary hyperparathyroidism (SHPT) in patients on hemodialysis. Launch Therapeutics is backed by funds managed by global investment firm Carlyle and its life sciences franchise Abingworth. Pathalys […]

January 19, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 12 Jan 2023

Team wins $149M contract for National Institute of Neurological Disorders and Stroke

A team consisting of Battelle, AmplifyBio and Andelyn Biosciences has won a seat on an eight-year, $149 million indefinite delivery, indefinite quantity (IDIQ) contract vehicle for the National Institute of Neurological Disorders and Stroke in the U.S. As one of the prime contractors on the multi-award IDIQ, the team will provide manufacturing and nonclinical support […]

January 12, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 11 Jan 2023

Lifesciences and biotech in 2023

A Q&A with Bill Coyle, principal, ZS. ZS is a management consulting and technology firm focused on transforming global healthcare. In some ways, 2022 could be seen as a challenging year—at least financially—in biotech. Do you see those trends continuing? Although we see overall sentiments to invest in biotech turning positive in 2023 after a […]

January 11, 2023 - 7 minutesmins - By Jim Cornall

News and Trends 9 Jan 2023

BD and CerTest Biotec receive emergency use authorization for mpox test

BD (Becton, Dickinson and Company), and CerTest Biotec have announced emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a molecular polymerase chain reaction (PCR) assay for mpox virus detection. The VIASURE Monkeypox Virus Real Time PCR Reagents for BD MAX System is now available for BD MAX System users. “The […]

January 9, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 9 Jan 2023

Rani Therapeutics provides pipeline update

Rani Therapeutics Holdings, Inc. has completed a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) with respect to RT-102, the RaniPill GO containing a proprietary formulation of human parathyroid hormone (1-34) analog (PTH) for the potential treatment of osteoporosis, and provided a corporate update. Following feedback from the meeting with […]

January 9, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 5 Jan 2023

Researchers discover new type of CRISPR gene scissors

Scientists at the Helmholtz Institute Würzburg in Germany, and Benson Hill, Inc. (Missouri) and Utah State University in the U.S., have found a nuclease, which they dubbed Cas12a2, that represents an entirely new type of CRISPR immune defense. Unlike any other previously known nuclease of the CRISPR-Cas immune system, the source of ‘gene scissors,’ Cas12a2 […]

January 5, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 4 Jan 2023

Infex’s novel AMR drug candidate MET-X receives FDA QIDP designation

Infex Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted qualified infectious disease product (QIDP) designation to MET-X, the company’s broad spectrum metallo-beta-lactamase (MBL) inhibitor. Infex Therapeutics’ MET-X is a resistance bypass treatment that targets Gram-negative Enterobacterales. These pathogens produce MBL enzymes to deactivate beta-lactam antibiotics and evade antibiotic clearance of […]

January 4, 2023 - 2 minutesmins - By Jim Cornall

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USA

Stemline Therapeutics’ breast cancer treatment approved

Stargardt disease treatment gets FDA fast track

Abbisko Therapeutics receives breakthrough therapy designation for CSF-1R inhibitor

Aldevron launches type-V CRISPR Nuclease

New drug could replace current standard for treating brain cancer

Pathalys Pharma brings in $150M for SHPT trials

Team wins $149M contract for National Institute of Neurological Disorders and Stroke

Lifesciences and biotech in 2023

BD and CerTest Biotec receive emergency use authorization for mpox test

Rani Therapeutics provides pipeline update

Researchers discover new type of CRISPR gene scissors

Infex’s novel AMR drug candidate MET-X receives FDA QIDP designation

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10 oncology deals in 2025 spotlight where industry leaders are betting big

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

10 oncology deals in 2025 spotlight where industry leaders are betting big

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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