Entrada hit with clinical hold on Duchenne drug – Endpoints News

When Entrada Therapeutics unveiled its shiny new alliance with Vertex days ago surrounding myotonic dystrophy Type I, CEO Dipal Doshi took the opportunity to spotlight a separate program in Duchenne muscular dystrophy — which he was hoping to put into the clinic in 2023.
But a clinical hold from the FDA now threatens to delay those plans.
Entrada disclosed late Monday that it received a clinical hold notice regarding its program for ENTR-601-44, barring it from starting a single ascending dose study in healthy volunteers. Shares $TRDA plummeted 32% to $13.50.
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The Asia Pacific region, which has more than 6,772 trial sites each with access to an average of 2,136 million people, has considerable underutilized capacity presenting an opportunity for growth in multinational trials in the region. 
Demand for Asia Pacific trial sites is strong with almost half of the more than 27,000 clinical trials initiated in 2021 having in Asia Pacific, according to the latest analysis from GlobalData in a new report titled State of the Global Biotech Landscape: Where the Opportunities Lie.
One of the pioneers of first-gen CAR T has now swooped in to buy a second-gen cell therapy player with some stellar scientific ties, impressive early responses and a clinical record that includes a high-profile blowup in the clinic that killed several patients.
Gilead sub Kite is putting out word today that it’s nailed down the buyout of Tmunity, a cell therapy spinout out of Penn that was derailed by lethal toxicity.
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Two biotech leaders are facing the possibility of decades in prison after a federal grand jury in Maryland indicted them on multiple charges related to a scheme to defraud investors about the potential of the drug leronlimab, a monoclonal antibody investigational drug also known as PRO 140.
CytoDyn’s former CEO Nader Pourhassan drew attention over the last two years for loudly touting leronlimab as an effective treatment for HIV, cancer and Covid-19, despite clinical data that indicated the opposite.
Roche let the air out of the TIGIT party balloon with a pair of crushing Phase III failures. Now Gilead $GILD and Arcus $RCUS are back with details of their closely-watched Phase II data in Stage IV non-small cell lung cancer, hoping to spark some renewed enthusiasm for their contender and the rest of the field.
But despite some positive results in frontline therapy for patients with high PD-L1 levels, plus a claim on a potential “new standard of care,” the mid-stage readout from the ARC-7 study won’t end the running debate that has blighted expectations for the target.
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Novartis is ringing in the new year with more job cuts, according to New Jersey state documents.
The pharma giant is axing 284 jobs in East Hanover, a township about 24 miles away from New York City. The cuts, which span Novartis Services, Novartis Pharmaceuticals and Novartis Corporation, take effect on Jan. 28, according to a notice posted last month in New Jersey’s state Worker Adjustment and Retraining Notification Act (WARN) system.
Taysha Gene Therapies CEO RA Session II has resigned following a turbulent year in which the company shelved most of its rare disease pipeline and faced criticism from families for blocking plans to restart a drug program.
Session, who will remain a member of the board of directors, will be succeeded by Sean Nolan, the board’s chairman. The changes are effective immediately, Taysha said Friday in a news release. Nolan said his plans call for expediting the company’s lead programs and strengthening a recent partnership with Astellas that brought in $50 million.
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Madrigal Pharmaceuticals says its NASH drug, resmetirom, has met its early endpoints in a Phase III trial, marking a major success in a field littered with failures in recent years. Now, the company plans to submit for accelerated approval in the first half of next year, CEO Paul Friedman said in a statement.
The biotech’s stock $MDGL was up over 200% in pre-market trading, eclipsing the $200 mark. It had closed at just under $64 on Friday.
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After committing about $2 billion for new biomanufacturing efforts, next year’s $1.7 trillion government spending bill features new pharma manufacturing efforts.
In addition to creating National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing, and providing $10 million for unannounced foreign inspection pilot, other provisions will seek to mitigate drug shortages that have hit several high-profile drugs recently.
With 2022 almost in the rearview mirror, it’s time to look ahead at what to expect in pharma marketing, advertising and drug commercialization strategies for 2023. This year marked the first full year of widely available Covid-19 vaccines — plus multiple treatments and new boosters — and while no one is suggesting the crisis is over, most agree it is at least moving toward an endemic phase.
Along with that change also comes a pendulum swing back, at least somewhat, toward pre-pandemic pharma practices. Chief among those is a return to in-person sales rep and medical liaison meetings with healthcare professionals.
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The University of Kansas
Lawrence, Kansas
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