Sat.Oct 29, 2022 - Fri.Nov 04, 2022

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Building a biotech in a downturn: 3 lessons from VCs and startup CEOs

Bio Pharma Dive

In a panel discussion hosted by BioPharma Dive, venture capitalists and CEOs discussed how startups can navigate a challenging market as well as possible ripple effects from the new U.S. drug pricing law.

Marketing 362
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GSK speeds up the race to bring first RSV vaccine for older adults to market

Pharmaceutical Technology

After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. There are currently five players in the race, with vaccines in Phase III of development from GlaxoSmithKline (GSK) , Pfizer , Johnson & Johnson , Moderna and Bavarian Nordic. However, recent data from GSK’s sub-unit vaccine, GSK-3844766A, have pushed the candidate to the top, with the highest efficacy demonstrated in a pivotal trial to date.

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Newly Discovered Gut Microbe Could Be a Trigger For Rheumatoid Arthritis

AuroBlog - Aurous Healthcare Clinical Trials blog

Rheumatoid arthritis affects 1 in 100 people worldwide. It causes inflamed, painful and swollen joints, often in the hands and wrists, and can lead to loss of joint function as well as chronic pain and joint deformities and damage. What causes this condition has been unknown. [link] In our recently published study, my colleagues and […].

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Terumo Pharmaceutical Solutions expands CDMO services outside Japan for global market 

Pharma Mirror

Terumo Pharmaceutical Solutions (TPS), a division of Terumo Corporation (TSE: 4543) and a leading manufacturer of injection, primary container, and infusion therapy devices, has today announced it will expand its contract development and manufacturing services for parenteral drugs to global customers. Terumo is a well-established integrated CDMO in Japan offering end-to-end services for more than 20 years, supporting customers with pre-filled syringe (PFS) design, molding, drug preparation, fill

Marketing 130
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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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String of gene therapy deals spurs cautious optimism on Wall Street

Bio Pharma Dive

To some analysts, the recent acquisitions of Akouos and AGTC, as well as Astellas’ equity investment in Taysha, are a positive signal for an area of drug research that’s been “in investors' penalty box for much of 2022.

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Pfizer records 6% decline in revenue in Q3 2022

Pharmaceutical Technology

Pfizer has reported a 6% decline in revenue to $22.6bn in the third quarter (Q3) of 2022 as against $24bn in the same quarter last year. In the quarter, revenues rose 2% operationally on omitting contributions from Covid-19 therapies, Paxlovid and Comirnaty. Reduction in revenues from Comirnaty outside the US and reduced revenues for some Comirnaty-linked manufacturing works carried out on behalf of BioNTech, Xeljanz and Sutent worldwide were the key drivers that contributed to the revenue dec

Branding 290

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Meeting abortion patients where they are: providers turn to mobile units

NPR Health - Shots

In response to increasing abortion restrictions in the region, a Planned Parenthood chapter in Missouri and Illinois is preparing to open a mobile unit providing abortions in southern Illinois.

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Bispecific cancer drugs and gene therapy advances: What to watch at next month’s ASH meeting

Bio Pharma Dive

Competition is increasing behind newly approved drugs from Roche and J&J, while the long-term benefit of gene therapies for chronic blood disorders is being put to the test.

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MIT and Toyota Improve Robotic Grasping Techniques

Pharmaceutical Technology

Concept: Massachusetts Institute of Technology (MIT)’s Computer Science and Artificial Intelligence Laboratory (CSAIL) researchers have developed a system called ‘series elastic end effectors’ (SEED) that enable robots to use grabbed tools correctly and successfully. It was developed in partnership with the American Toyota Research Institute (a technology research unit of Toyota).

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These DNA-Damaging Molecules May Be The Link Between Colon Cancer And IBD

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists have discovered DNA-damaging molecules made by gut bacteria that may help explain why people with inflammatory bowel disease (IBD) have higher rates of colorectal cancer than those without the condition. [link] In a new study, published Thursday (27 October) in the journal Science, researchers identified a previously unknown class of DNA-damaging molecules, or genotoxins, […].

DNA 190
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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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CVS and Walgreens announce opioid settlements totaling $10 billion

NPR Health - Shots

It could amount to the last round of huge settlements after years of litigation over the industry's role in an overdose crisis linked to more than 500,000 deaths in the U.S. over the past two decades.

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What the FDA’s guidance on diversity means for rare disease sponsors

Bio Pharma Dive

Bringing more diversity to clinical trials is a slow process and it takes time to get right. Learn how Worldwide Clinical Trials can diversify the reach of your orphan drug trial.

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What can Rishi Sunak do for the UK’s pharma industry

Pharmaceutical Technology

Last week, after a tumultuous 45 days under Liz Truss’s control , the role of the UK’s Prime Minister (PM) was passed on to Rishi Sunak , in a bid to restore balance to the British economy. During her short reign, Truss’s cabinet had promised a £45 billion ($51.59 billion) mini-budget that included unfunded tax cuts for the rich, enacted a U-turn on an energy price freeze, and oversaw the largest drop in value for the British pound against the US dollar.

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Purified Sand Particles Have Anti-Obesity Effects, Scientists Confirm

AuroBlog - Aurous Healthcare Clinical Trials blog

Porous particles of silica made from purified sand could one day play a role in attempts to lose weight. Past clinical trials have already produced promising results, but the actual weight-lowering mechanism behind the potential treatment has been poorly understood. [link] To sift out the key variables, researchers have now tested a range of silica […].

Scientist 179
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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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Indiana doctor sues AG to block him from obtaining patient abortion records

NPR Health - Shots

In a new lawsuit, Dr. Caitlin Bernard says Indiana Attorney General Todd Rokita has sought health records for her patients, including a 10-year-old rape victim she treated.

Doctors 145
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FDA again delays review of Amicus rare disease drug

Bio Pharma Dive

For the second time this year, the agency has put off a decision on Amicus' therapy for Pompe disease. European regulators are also reviewing the treatment and could soon issue an opinion.

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Rankings: Research and Development

Pharmaceutical Technology

FEATURED COMPANIES COMMENDED : • Innovation • Product Launch • Safety VIEW PROFILE COMMENDED : • Business Expansion • Innovation • Investments VIEW PROFILE COMMENDED: • Social VIEW PROFILE. The Excellence Rankings celebrate the greatest achievements and innovations in the industry. The programme provides a platform to recognise the people and companies that are driving change.

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Experts call for using pharmacogenetics to develop treatments for rare diseases

AuroBlog - Aurous Healthcare Clinical Trials blog

As drug companies have embarked on an initiative to launch affordable medicines for rare diseases in India, experts have called for using pharmacogenetics to develop treatments and whole genome sequencing to identify etiologies. “Although rare diseases have a huge impact when taken together, there is a significant gap between clinical interventions and basic research.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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CDC issues new opioid prescribing guidance, giving doctors more leeway to treat pain

NPR Health - Shots

The updated recommendations seek to course correct after guidelines from 2016 were criticized for harshly limiting access to needed pain medication. (Image credit: Jose M.

Doctors 145
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Lilly sales of new diabetes drug accelerate on rising patient demand

Bio Pharma Dive

Company executives highlighted the “viral nature” of demand for Mounjaro, which was approved in May for diabetes and has also shown a strong weight-loss benefit in clinical testing.

Sales 294
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EMA grants full marketing authorisation for AstraZeneca’s Covid-19 vaccine

Pharmaceutical Technology

The European Medicines Agency (EMA) has granted full marketing authorisation (MA) for AstraZeneca ’s Covid-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]). The vaccine initially received a conditional marketing authorisation (cMA) for use in the European Union (EU). The latest approval comes after adequate data on safety and efficacy validating the vaccine’s benefits was available.

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IPC introduces draft amendment to microbial contamination in non-sterile products in IP 2022

AuroBlog - Aurous Healthcare Clinical Trials blog

In a bid to control the microbial quality of pharmaceutical products, the Indian Pharmacopoeia Commission (IPC) has come out with a draft amendment to microbial contamination in non-sterile products in Indian Pharmacopoeia (IP) 2022. The new draft amendment released by IPC on October 26, 2022 introduced changes to enumeration of aerobic microorganisms present in the […].

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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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Pfizer, BioNTech report bivalent Covid-19 booster more protective than original vaccine

STAT News

New data from Pfizer and BioNTech on their bivalent Covid-19 vaccine suggests the updated product may be more protective against more recent Omicron subvariants than the original version of the vaccine, the companies said in a statement released Friday. The companies said the levels of neutralizing antibodies that target the BA.4 and BA.5 subvariants of the SARS-CoV-2 virus were four-fold higher in people aged 55 and older who received the bivalent booster than in similarly aged people who recei

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Moderna cuts sales forecasts for its COVID-19 vaccine

Bio Pharma Dive

The biotech dialed back its financial projections after reporting lower-than-expected sales for the shot, which currently remains the company’s only marketed product.

Sales 294
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China’s biopharma industry: the small molecule renaissance in rare diseases

Pharmaceutical Technology

Small molecule approvals are on the decline in China. According to GlobalData’s Drugs Intelligence Database, from 2020 to 2022, the number of innovator small molecule approvals in China shrank by 21%. However, over the same period, approvals for innovator small molecules treating rare diseases rose by 22%, giving hope to rare disease patients. According to the GlobalData’s Drug Database, the number of innovator small molecule approvals for rare diseases rose steadily over three years, from three

Drugs 147
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RSV is surging. Here's what to watch for and answers about treatment options

NPR Health - Shots

Doctors say they are seeing an unprecedented number of cases. How concerned should parents be? Why are young children so vulnerable? What's causing this year's outbreak? We offer some answers.

Doctors 140
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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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Opinion: How the world can end Covid-19 as a public health threat

STAT News

The journal Nature published today global consensus recommendations to end Covid-19 as a public health threat. It took a panel of almost 400 independent-thinking scientists, doctors, and representatives of community groups from more than 100 countries (we were among the co-chairs) some 14 months to develop and agree on these recommendations. There have been times when we wondered if it was worth the effort.

Doctors 141
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Artiva cancels IPO plans and cuts a deal with Affimed

Bio Pharma Dive

With public offerings difficult to pull off, Artiva is focusing its energy on a cancer drug deal with the German biotech.

Drugs 345
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Intrinsic Medicine enters merger with Phoenix Biotech

Pharmaceutical Technology

Intrinsic Medicine has signed a definitive business combination agreement with special purpose acquisition (SPAC) firm Phoenix Biotech Acquisition to create a public company. The merged business will use human milk biology for the treatment of Gut-Brain Axis (GBA) disorders. The merger reflects a $136m pre-money equity price and is anticipated to offer up to $178.8m in cash held in trust to Intrinsic. .

Medicine 147
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Shanghai Disney Resort will be closed indefinitely from Halloween due to COVID-19

NPR Health - Shots

Shanghai Disney Resort, which includes Shanghai Disneyland, shopping and dining facilities, will be closed indefinitely starting on Halloween due to the coronavirus pandemic.

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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.