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Category: Research and Development


Clinical Trials, Research and Development

Excision’s CRISPR gene editing therapy for HIV is heading into human testing after FDA clearance

September 17, 2021

Via: FierceBiotech

A CRISPR-Cas9 gene editing technology that has shown promise in clearing HIV from mice is headed into human testing. Excision BioTherapeutics will usher the CRISPR-based therapy EBT-101 into clinical trials after the FDA cleared an investigational new drug application, according […]


Manufacturing, Research and Development

AGC Biologics Expands pDNA and mRNA Manufacturing Capacity

September 14, 2021

Via: Contract Pharma

AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), unveiled expansion plans for the company’s Heidelberg facility to increase manufacturing capacities for plasmid-DNA (pDNA) and messenger RNA (mRNA) projects. With this expansion, AGC Biologics is boosting its current […]


Clinical Trials, Research and Development

Amgen, AstraZeneca dig into data from phase 3 asthma trial, emerging with evidence of efficacy in hard-to-treat subgroup

September 7, 2021

Via: FierceBiotech

Piece by piece, Amgen and AstraZeneca are building the case for their potential asthma blockbuster. The latest brick to fall into place comes from a new slice of phase 3 data, which suggests tezepelumab may be particularly effective in a […]


Manufacturing, Research and Development

Amid vaccine hoarding criticism, Biden admin plots $2.7 billion manufacturing push

September 3, 2021

Via: FiercePharma

It didn’t take long for the Biden administration to answer criticism that the United States wasn’t doing enough to ease the world’s COVID-19 vaccination shortfall. On Thursday, White House COVID response coordinator Jeff Zients revealed that the government has earmarked […]


Clinical Trials, Research and Development

Data points to big win for Jardiance in hard-to-treat heart failure

August 31, 2021

Via: Pharmaphorum

SGLT2 inhibitor Jardiance (empagliflozin) reduced a composite of cardiovascular (CV) death or hospitalisations for heart failure by a significant 21% compared to placebo in HFpEF, regardless of diabetes status, according to results presented at the European Society of Cardiology (ESC) […]


Clinical Trials, Industry, Pharma, Research and Development

Pfizer drug bests Sanofi, Regeneron’s Dupixent in head-to-head study

August 30, 2021

Via: Biopharma Dive

Abrocitinib is one of Pfizer’s top experimental therapies, pegged by the drugmaker for several billion dollars in peak annual sales in the future. But its fate, along with the fate of two other drugs from AbbVie and Lilly that are […]


Manufacturing, Research and Development

Rentschler Biopharma to Begin Construction of New Multi-Product Commercial Manufacturing Facility

August 13, 2021

Via: Biopharm International

On Aug. 12, 2021, Rentschler Biopharma announced that it has broken ground at its new production site, adjacent to its existing Milford, Mass., site where it will build the Rentschler Biopharma Manufacturing Center US, a new facility that will add […]


Manufacturing, Research and Development

Moderna Plans to Build mRNA Vaccine Manufacturing Facility in Canada

August 12, 2021

Via: Biopharm International

On Aug. 10, 2021, Moderna announced that it plans to build a messenger RNA (mRNA) vaccine manufacturing facility in Canada that will include access to the company’s mRNA development technology. The company signed a memorandum of understanding (MoU) with the […]


Clinical Trials, Research and Development

Predicting and improving clinical trial enrolment: A problem for psychiatry

August 6, 2021

Via: Pharmaphorum

The reasons behind this problem, however, are rarely studied or understood. Despite this, new strategies devised over the last five years are beginning to reverse the trend, and both reduce stigma and increase awareness to funnel new patients into these […]


Clinical Trials, Research and Development

EC Confirms Go-Live Date for Clinical Trials Information System

August 5, 2021

Via: Biopharm International

The European Commission (EC) has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022. Notification of the entry into the […]


Clinical Trials, Research and Development

Another one BiTEs the dust as Amgen pauses enrollment for phase 1 bispecific trial

August 4, 2021

Via: FierceBiotech

It’s another one gone and another one gone for Amgen, as the pharmaceutical giant reported the latest clinical stoppage for a bispecific T-cell engager, or BiTE, therapy. Amgen has stopped enrolling acute myeloid leukemia patients in a phase 1 clinical […]


Clinical Trials, Research and Development

Sage scraps 2 zuranolone trials deemed unnecessary for approval

August 3, 2021

Via: FierceBiotech

Sage Therapeutics has terminated two long-suspended phase 3 zuranolone clinical trials after talks with the FDA led it to believe it can seek approval without the data. The biotech shared the update alongside news of a delay to data from […]