Thu.Oct 13, 2022

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‘We have to find a way’: FDA seeks solutions to aid bespoke gene therapy

Bio Pharma Dive

Gene therapies could help treat many ultra-rare diseases. But they may not get developed if drugmakers can’t build a sustainable business around them, CBER director Peter Marks said at a conference.

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Oncotelic receives BARDA contract for long Covid-19 therapy development

Pharmaceutical Technology

Oncotelic Therapeutics has received a contract from the US Biomedical Advanced Research and Development Authority (BARDA) to develop OT-101 to treat long-term effects of respiratory distress after Covid-19 infection. Under the contract, the company will collect the long-term clinical data from patients with Covid-19 in Peru and Argentina, where the C001-2020-01 trial was carried out.

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Odyssey recruits news investors to fund precision drug research

Bio Pharma Dive

A $168 million Series B round brings Odyssey’s total funding to date near $400 million, helping the startup support a growing pipeline of cancer and immune disease drug candidates.

Drugs 300
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Inceptor Bio and Avectas partner for CAR-T cell therapies development

Pharmaceutical Technology

Inceptor Bio has partnered with cell engineering technology company Avectas to improve CAR-T cell therapies’ development and manufacturing to treat solid tumours. Under the collaboration deal, Inceptor Bio will use the Solupore technology from Avectas instead of electroporation for engineering T cells to yield a healthier T cell. This non-viral technology is well suited to the CAR-T cell process of Inceptor Bio.

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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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Relmada shares collapse after fast-acting depression drug fails first test

Bio Pharma Dive

The company blamed a higher-than-expected placebo response for the negative outcome, and is now pinning its hopes on two other trials that are currently underway.

Drugs 306
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UK approves prescription-only melatonin drug for childhood ADHD

Pharmaceutical Technology

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Colonis Pharma’s melatonin oral solution for the treatment of sleep-onset insomnia in children and adolescents with attention-deficit hyperactivity disorder (ADHD). The therapeutic is meant for youth with ADHD aged 6-17 years who found sleep hygiene measures inadequate.

Drugs 147

More Trending

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How evolution in finance can revolutionise energy efficiency

Pharmaceutical Technology

The 26 th United Nations Climate Change Conference (COP26), held in November 2021, saw a renewed push from global leaders to tackle global warming. Commitments including $130 trillion of private capital dedicated towards the net-zero transition were hailed as bold steps in the right direction; governments and businesses were finally rallying to get a handle on pollution.

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GoodRx launches new push to draw in doctors

Bio Pharma Dive

Targeting providers directly is a pivot for GoodRx, but the company sees an opportunity to capture more pharmaceutical advertising revenue, said executive Preeti Parikh.

Doctors 246
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Olympus EU-ME3 Ultrasound Processor, Delivers Higher Resolution Images for Endoscopic Ultrasound

Pharma Mirror

TOKYO / HAMBURG, Olympus Corporation (Olympus), a global medtech company committed to making lives healthier, safer and more fulfilling, has announced the launch of the EU-ME3, a new Endoscopic Ultrasound Processor which addresses the needs of healthcare professionals for high-quality clear images while conducting endoscopic ultrasound procedures. The EU-ME3 will be available in Europe, the Middle East, Africa, parts of Asia, and Oceania within this fiscal year.

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GSK sets high bar with trial results for RSV vaccine

Bio Pharma Dive

With data expected for several other vaccines for the respiratory disease, GSK reported positive clinical trial results showing efficacy above 80%.

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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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Vita Therapeutics raises funds for cell therapies development

Pharmaceutical Technology

Vita Therapeutics has raised $31m in a Series B financing round for the development of cell therapies for neuromuscular diseases and cancers. Led by Cambrian BioPharma and new investor Solve FSHD, the financing round has seen participation from new investors including Cedars Sinai and Riptide Ventures, along with TEDCO and other existing investors. Vita Therapeutics intends to use the funding to advance its lead pre-clinical programme VTA-100 for limb-girdle muscular dystrophy (LGMD2A) to clinic

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Pfizer, BioNTech say updated COVID booster raised omicron antibody levels in trial

Bio Pharma Dive

The findings, which were disclosed in a press release without specific data, are the first immune response results in humans for the reformulated shot targeting the BA.4 and BA.5 substrains.

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Myovant Sciences rejects $2.5bn takeover bid from Sumitomo Pharma

Pharmaceutical Technology

Myovant Sciences has rejected an acquisition offer from Sumitovant Biopharma and its wholly owned subsidiary, Sumitomo Pharma. The news of the offer came just weeks after Myovant and its partner, Pfizer , received the US Food and Drug Administration's (FDA) expanded approval of Myfembree (estradiol + norethindrone acetate + relugolix) for the management of moderate to severe pain associated with endometriosis.

Hormones 130
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Faster brain imaging technique seems to overcome limitations of current MRI scans

STAT News

Research often proceeds in a logical progression, new studies building upon a detailed understanding of the underlying processes revealed by earlier work. But a new brain imaging technique that can directly track the activity of neurons emerged from one of academics’ favorite questions: “What would happen if we tried doing it this way?

Scientist 137
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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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How a new cardiovascular filtration system is reducing stroke risk during TAVI

Pharmaceutical Technology

Based in Colleretto Giacosa, Italy, AorticLab’s innovative embolic protection device ‘Flower’ uses exclusive ‘Catch & Flow’ technology which combines cutting-edge design with an ultra-fine mesh. Folded inside the catheter tube used by a cardiologist during Transcatheter Aortic Valve Implant (TAVI) heart procedures, the device is positioned inside the aortic arch, like a flower, to reveal a close fitting exceptionally fine mesh that catches and holds tiny pieces of debris dislodged during the

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STAT+: AstraZeneca is fined by South Korea for an anticompetitive deal over a cancer drug

STAT News

South Korea’s anti-trust regulator has fined AstraZeneca and a local generic drugmaker a total of $1.8 million for striking a deal that thwarted rivals from marketing a cancer treatment, the latest instance in which a global pharmaceutical company has been cited for anticompetitive behavior. In this case, the local company, Alvogen, reportedly agreed to suspend plans to release a version of an AstraZeneca medication called Zoladex, which is used to combat prostate and breast cancer.

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Phased rollout or Big Bang? How asset finance businesses should implement new software

Pharmaceutical Technology

Asset finance businesses are inherently complex, so when it comes to implementing new software, there’s a lot that can go wrong. However, sticking with legacy systems can be even more costly. Outdated technology forces businesses to work within its constraints, instead of doing what’s best for the business. In this article, we explore how asset finance businesses can best perform a software rollout, with practical advice from Michael Mousdale, project manager at Alfa.

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Eyeballs and AI power the research into how falsehoods travel online

NPR Health - Shots

Getting a sense of falsehoods online might sound straightforward, but it isn't. Researchers use state-of-the-art algorithms but it also comes down to lots of scrolling and reading.

Research 124
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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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Grand Rounds October 7, 2022: Impact Of Handovers Of Anesthesia Care On Morbidity And Mortality (Melanie Meersch-Dini, MD)

Rethinking Clinical Trials

? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speakers. Melanie Meersch-Dini, MD. Professor. Department of Anesthesiology, Intensive Care and Pain Medicine. University Hospital Münster, Germany. Slides. Keywords. HandiCAP Trial, Pragmatic Clinical Trial. Key Points. There is an increasing frequency of surgical procedures and the need for anesthesia care, and the number of care transitions is increasing.

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What the White House sees coming for COVID this winter

NPR Health - Shots

The U.S. should prepare for a spike in COVID cases this winter as more people gather indoors and infections already begin to rise in Europe, White House COVID-19 Response Coordinator Ashish Jha says.

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Opinion: Why the U.S. needs a public benefit biopharma industry

STAT News

The biopharma industry is failing Americans, economically and medically. U.S. biotechnology and pharmaceutical companies, like all for-profit corporations, have a primary duty baked into their corporate charters: maximize profits and shareholder value. Unlike companies in other industries, however, biopharma companies have a special advantage: their products have market exclusivity upon Food and Drug Administration approval, which can be leveraged to maximize pricing for a specified period.

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Colonoscopies save lives. Doctors push back against European study that casts doubt

NPR Health - Shots

Colon cancer specialists worry that results of a study published this week in the New England Journal of Medicine could be misconstrued, and keep patients from getting lifesaving cancer screening.

Doctors 118
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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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STAT+: Flush with cash from Covid-19 vaccine, BioNTech founders have outsized ambitions

STAT News

BOSTON — BioNTech CEO Uğur Şahin had been in marathon meetings since he arrived in this city three days earlier, but if his energy had flagged it didn’t show. The clock had not even struck 8 a.m., and there was Şahin, in front of a table at the Four Seasons strewn with continental breakfast, deep in discussion with HIV expert Bruce Walker of the Ragon Institute.

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This MacArthur 'genius' grantee says she isn't a drug price rebel but she kind of is

NPR Health - Shots

Health justice lawyer Priti Krishtel doesn't believe your ability to heal should depend on your ability to pay. Her mission is to reform the patent system that drug companies use to block competition. (Image credit: John D. and Catherine T.

Drugs 105
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Opinion: The global diabetes crisis few are talking about

STAT News

In the numbers game of disease statistics, type 1 diabetes takes a back seat to type 2 diabetes, which accounts for more than 95% of diabetes cases around the globe. But the impact of type 1 diabetes (T1D), which tends to emerge earlier in life and can quickly kill an individual if it goes unrecognized or untreated, is huge. Its global burden, however, hasn’t been well understood — until now.

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GSK says RSV vaccine shows 94% efficacy in severe disease

pharmaphorum

GSK’s vaccine against respiratory syncytial virus (RSV) is one of the top prospects in its pipeline, but also one with considerable competition, so needs strong data to support the programme. Thankfully for the company, it seems to be so. This morning, GSK revealed the results from its pivotal AReSVi-006 trial of the RSV shot – called RSVPreF3 OA – having said earlier this year that the study was positive.

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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+: Alphabet’s AI predicted the structure of 200 million proteins. Can it really speed up drug discovery?

STAT News

Every two years since 1994, scientists have come together for an experiment — better described as a competition — where teams of computational biologists try to predict what proteins will look like in 3D given their amino acid sequence. In the first 24 years, none of the entrants scored better than around 40 out of 100 for the most difficult targets.

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Walgreens Looks to Expand Clinical Trial Workforce

ACRP blog

Drawing on its strong pharmacy roots, extensive retail reach, and large in-house personnel pool, Walgreens hopes its new leap into the clinical trial industry will promote patient and workforce diversity, spread the benefits of clinical trials into rural and other underserved areas, and generally elevate the profession, says Adam Samson, MS, PMP, CCDM, CCRC, CCRA, head of clinical delivery operations for the real-world evidence clinical trials sector at Walgreens.

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STAT+: Relmada antidepressant drug fails first of several late-stage clinical trials

STAT News

Relmada Therapeutics said Thursday that its experimental treatment for depression failed to achieve the primary goals of a large clinical trial, a significant setback for the company’s only medicine in clinical development. The drug, a pill called REL-1017, did not show a statistically significant, anti-depressive benefit compared with a placebo.

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Reuters Pharma 2022 – Day 2 coverage

pharmaphorum

Day 2 coverage: Click here to read Reuters: Pharma 2022 Day 1 overview. Click here or the image below to read Reuters: Pharma 2022 Live coverage. The post Reuters Pharma 2022 – Day 2 coverage appeared first on.

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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.