Tue.Aug 16, 2022

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‘Treg’ cell therapy: bringing CAR-T to autoimmune disease

Bio Pharma Dive

At least seven companies, including five richly funded startups, are developing cell-based treatments for inflammatory conditions, making it one of biotech’s most competitive fields.

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Injectable opportunities for CMOs despite internal capacity of big pharma sponsors

Pharmaceutical Technology

Even giant pharma companies with large internal production capabilities are leaning on outsourcing to meet market demand for huge numbers of injectables, including high-value biologics and Covid-19 vaccines, according to a GlobalData analysis. Large (market cap $10–100bn) and mega-cap (market cap >$100bn) sponsors also require contract manufacturers and packagers with specialist injectable capabilities in the case of cell and gene therapies, as shown in the report titled Contract Injectable Pack

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Merck pays startup Orna $150M as ‘circular RNA’ attracts industry interest

Bio Pharma Dive

The pharmaceutical company has formed an alliance with Orna and invested $100 million in its Series B round, hoping the young biotech’s approach could lead to multiple new vaccines and drugs.

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More big wins for the AstraZeneca-Daiichi Sankyo collaboration

Pharmaceutical Technology

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn. This was followed by a further deal for the global development and commercialisation of another ADC, datopotamab deruxtecan (DS-1062) in 2020, with a deal value of up to $6bn.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Amid market turbulence, a Flagship startup pushes off an IPO with a new fundraise

Bio Pharma Dive

Senda Biosciences decided to raise a $123 million Series C round rather than test public markets with an initial offering, its top executive said.

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August 16, 2022: Biostatistics Core Develops Tools and Strategies for Common Research Challenges

Rethinking Clinical Trials

In connection with the NIH Pragmatic Trials Collaboratory’s annual Steering Committee meeting and 10th anniversary celebration, we asked Dr. Liz Turner and Dr. Patrick Heagerty to reflect on the role of the Biostatistics and Study Design Core Working Group in helping the Demonstration Project teams design trial and analyze the data, and to discuss their focus for the Core’s future contributions to pragmatic clinical trials.

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Q32 Bio and Horizon partner to develop autoimmune disease treatment

Pharmaceutical Technology

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Furthermore, Q32 will oversee the conduct of all programme-linked works. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Pha

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Ventyx touts early data for potential rival to Bristol Myers psoriasis drug

Bio Pharma Dive

The biotech plans to start Phase 2 studies for a drug it believes may more effectively hit its target than Bristol Myers’ deucravacitinib, a skin disease treatment regulators could approve next month.

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Scotland becomes the first country to offer tampons and pads for free, officials say

NPR Health - Shots

Studies have shown that a significant number of people struggle to afford menstrual products, and going without can cause people to miss school or work. (Image credit: Jeff J.

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Opinion: As a pediatric cancer researcher, I admired the FDA. Then I got ALS

STAT News

Amyotrophic lateral sclerosis (ALS), as I have unfortunately come to learn, is a terrible disease with no cure. Some exciting treatments are on the horizon, but the Food and Drug Administration’s Office of Neuroscience , which has the task of overseeing the development of new ALS drugs in the U.S., has repeatedly failed to take aggressive steps to greenlight these experimental therapies.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Buy a rural hospital for $100? Investors pick up struggling institutions for pennies

NPR Health - Shots

Some rural hospitals are in such bad shape, they're selling for next to nothing. One company is snapping several distressed or closed hospitals in rural Tennessee, hoping to turn a profit.

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STAT+: Cepheid faces fresh criticism over the pricing of its TB diagnostics

STAT News

A controversy has broken out over a diagnostic for tuberculosis that, until recently, had been subsidized by the World Health Organization — the latest flare-up over access to a medical product in mostly poor countries. At issue is a TB test developed by Cepheid, which reached a 10-year deal with the WHO in August 2012 to supply its GeneXpert diagnostic to dozens of low- and middle-income countries.

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How can we help humans thrive trillions of years from now? This philosopher has a plan

NPR Health - Shots

William MacAskill's book, What We Owe the Future , urges today's humans to protect future humans — an idea he calls longtermism. Here are a few of his hardly modest proposals.

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FDA grants swift review to Lynparza in first-line prostate cancer

pharmaphorum

AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its use broadened if a new marketing application is approved by the FDA. The US regulator has started a priority review of Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone as a first-line treatment for metastatic castration-resistant prostate cancer (mCRPC) based on the results of the PROpel trial.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Millions of Americans will soon be able to buy hearing aids without a prescription

NPR Health - Shots

A new FDA rule allows adults with perceived mild to moderate hearing loss to buy hearing aids over the counter. Efforts to make them more affordable and accessible have been in the works for years.

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Auransa, Polaris harness AI, quantum computing to discover cancer drugs

BioPharma Reporter

The AI and QC specialists have joined to use AI and QC in order to discover biological pathways relevant to the treatment of triple-negative breast cancer.

Drugs 120
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Title X advocates worry that birth control may go the same way as abortion

NPR Health - Shots

A Supreme Court ruling overturned Roe v. Wade. Now there's a big push to increase funding for Title X, a federal program that offers birth control and other reproductive care to low-income patients.

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Moderna’s next-gen COVID-19 booster becomes first authorized Omicron-specific bivalent vaccine

BioPharma Reporter

The first Omicron bivalent COVID-19 vaccine has been authorized: with the UKâs regulatory agency giving the green light to Modernaâs Spikevax Bivalent Original/Omicron booster shot.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Over-the-counter hearing aids expected this fall in U.S.

STAT News

Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule finalized Tuesday. The Food and Drug Administration said the new regulation cuts red tape by creating a new class of hearing aids that don’t require a medical exam, a prescription and other specialty evaluations. The devices will be sold online or over-the-counter at pharmacies and other retail stores.

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FDA Inspections Back Up To Speed (Except Those Now Deemed Unnecessary)

FDA Law Blog

By Douglas B. Farquhar — Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. That impression was corroborated this week at the GMP by the Sea conference when Douglas Throckmorton, Deputy Director for Regulatory Programs at FDA’s Center for Drug Evaluation and Research, stated that domestic FDA inspections of facilities have been performed

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Pregnancy tests are routine before many surgical procedures. But Dobbs has raised the stakes of a positive result

STAT News

Monica da Silva, a critical care and cardiac anesthesiologist at the University of Alabama at Birmingham, was counseling a patient who had been in a car accident. She had suffered a broken bone and while it wasn’t an emergency, she needed urgent surgery. Just before they headed to the operating room, however, the patient’s pregnancy test came back unexpectedly positive.

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UK Approves First Omicron-Targeting COVID-19 Booster

XTalks

Health regulators in the UK have become the first in the world to approve Moderna’s next generation COVID-19 vaccine booster that includes targeting of the Omicron variant. The vaccine, known as mRNA-1273.214 or Spikevax Bivalent Original/Omicron, is a next-generation bivalent vaccine that contains mRNA-1273 (Spikevax) and a vaccine candidate targeting the Omicron variant of concern (BA.1).

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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A complicated fall vaccine campaign: Updated Covid boosters, flu shots, and how to time the jabs

STAT News

For the health officials who steer vaccination campaigns, it’s going to be a complicated fall. The U.S. plan to roll out updated Covid-19 boosters will not only coincide with the logistical tangle of the regular flu shot drive, but will also face questions about when people should get the new shots to provide themselves with the best protection through our third Covid winter.

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Is there enough monkeypox vaccine to go around? Maybe yes, more likely no

NPR Health - Shots

Only one company makes the currently used monkeypox vaccine. Supply is limited in wealthy nations like the U.S. Less well-off nations, like Nigeria, where the outbreak began, have no vaccines at all.

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Opinion: STAT+: Clinical validation will save digital health’s reputation

STAT News

The meteoric rise of telehealth and other types of virtual care during the Covid-19 pandemic sparked some of the highest funding in digital health’s history. This avalanche of investment — akin to the boom in electronic health record systems more than a decade ago — created a media frenzy , with health care and consumer media outlets creating the impression that digital health will solve the industry’s problems.

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Some 2,000 mental health care clinicians in California are on strike

NPR Health - Shots

Clinicians say their employer, Kaiser Permanente, is breaking state law by taking too long to connect patients with therapists. They say patients have to wait up to eight weeks to get an appointment.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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STAT+: Merck, a loser in the Covid vaccine race, reinvests in mRNA through a Cambridge startup

STAT News

Among the most notable aspects of the Covid-19 vaccine race was who won it: Pfizer and two small biotechs, while most of the world’s largest and oldest vaccine makers either waited too long or picked older and ultimately less effective technologies. Since then, there’s been a minor gold-rush for mRNA among legacy makers. Last year, GSK expanded a collaboration with CureVac, one of the first mRNA startups, and Sanofi bought another called Translate Bio for $3.2 billion.

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Merck makes circular RNA play with $3.5bn Orna alliance

pharmaphorum

Merck & Co has ramped up its involvement in the RNA category, partnering with US biotech Orna Therapeutics in a deal valued at up to $3.5 billion, including $150 million upfront. It has also invested another $100 million in the three-year-old Cambridge, Massachusetts-based biotech, by participating in a $221 million Series B round. One of the unexpected consequences of the COVID-19 vaccine race was that some top-tier vaccine companies like Merck, GSK and Sanofi ended up trailing the field, a

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Brewing data battles, One Medical’s dueling offers, and monkeypox bottleneck

STAT News

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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How to keep your pets safe from monkeypox — and what to do if they get it

NPR Health - Shots

Animal carriers of the virus include various rodents, dogs, primates, hedgehogs and shrews, according to the Centers for Disease Control and Prevention.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.