Sat.Jul 02, 2022 - Fri.Jul 08, 2022

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10 clinical trials to watch in the second half of 2022

Bio Pharma Dive

The biotech industry's downturn accelerated in the first half of the year. Important study readouts for Eisai, Gilead, Merck and Seagen, among others, could determine whether the slump will endure.

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Is biotech facing a long bear market?

Pharmaceutical Technology

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7. Elsewhere, San Diego, California-based Heron Therapeutics announced restructuring and layoffs for 34% of its workforce.

Marketing 324
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Misjustice benefits pharma

World of DTC Marketing

Endpoint News reported “Three major drug distributors are off the hook for what may have been a $2.5 billion payment after a federal judge found them not liable for the opioid epidemic in parts of West Virginia, one of the hardest-hit areas of the country. This is beyond outrageous it’s a classic example of abuse of power. Despite distributing more than 51.3 million doses of oxycodone and hydrocodone to pharmacies in Cabell County and the city of Huntington over less than a decade, M

Pharmacy 238
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These Microbes Could Make You More Attractive to Mosquitoes, Mice Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

Mosquitoes are the world’s deadliest animal. Over 1 million deaths per year are attributed to mosquito-borne diseases, including malaria, yellow fever, dengue fever, Zika, and chikungunya fever. [link] How mosquitoes seek out and feed on their hosts are important factors in how a virus circulates in nature. Mosquitoes spread diseases by acting as carriers of […].

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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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With $100M AstraZeneca deal, a biotech and its investors engineer another buyout

Bio Pharma Dive

An entity originally known as Teneobio has now been the focus of three acquisition deals with large pharmaceutical companies since 2021, capitalizing on the industry’s growing interest in dual-acting antibody drugs.

Engineer 324
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GSK acquires US-based Sierra Oncology for $1.9bn

Pharmaceutical Technology

GlaxoSmithKline (GSK) has completed the acquisition of all outstanding shares of US-based Sierra Oncology in a deal totalling $1.9bn (£1.6bn), in cash. In April this year, GSK entered an agreement for the acquisition of Sierra Oncology for $55 per share. The conclusion of the deal comes after the shareholders of Sierra Oncology approved the takeover on 29 June this year.

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Head Injuries Can Rewire Whole-Brain Networks in Mice, Important New Maps Reveal

AuroBlog - Aurous Healthcare Clinical Trials blog

We know the brain changes after traumatic injury, and now we have maps from mice showing what that change looks like. A team of scientists has traced connections between nerve cells throughout the entire brain of mice, showing that distant parts of the brain become disconnected after a head injury. The stunning visualizations of brain-wide […].

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After a lengthy drought, could biotech M&A be on the upswing?

Bio Pharma Dive

With at least 14 buyouts worth $50 million or more, the second quarter was one of the busiest three-month periods for acquisitions in recent years. Some industry watchers expect that pace to continue.

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Russia’s focus on domestic pharma production could shield it from sanctions’ effects

Pharmaceutical Technology

Russia is an already insular country and its worldview has tended to be self-contained, but this has hardened in the face of recent sanctions and counter-sanctions imposed during the war with Ukraine. Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on

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Pharma’s spend on AI in drug discovery ‘could top $3bn by 2025’

pharmaphorum

The pharmaceutical industry is increasingly relying on artificial intelligence to power its drug discovery and development efforts, and its spend in this area has created a multibillion-dollar market for AI technologies. That’s the conclusion of a GlobalData report , which notes that AI is being used to enhance computer-aided drug design (CADD) in a bid to reduce the time and costs involved in getting a new drug to market.

Drugs 131
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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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Lenire Bimodal Neuromodulation Device by Neuromod Improves Tinnitus Symptoms in Clinical Trial

XTalks

Lenire is a non-invasive, bimodal neuromodulation device that works by using two paired stimuli to stimulate nerves for tinnitus treatment. Photo courtesy Neuromod Devices Ltd. Tinnitus — frequently referred to as “ringing in the ears” — happens when no corresponding external sound exists. People with tinnitus may not only have the sensation of ringing in their head, but also other sounds like hissing, buzzing, whistling or chirping.

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Vertex, continuing its rebound, cleared to resume testing of diabetes cell therapy

Bio Pharma Dive

The decision by U.S. regulators is the latest boost for a company whose shares have climbed more than 30% during the biotech sector’s worst downswing in years.

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Brii Bio acquires Vir’s antibody rights for Hepatitis B in Greater China

Pharmaceutical Technology

Brii Biosciences (Brii Bio) has exercised an option for the acquisition of exclusive development and marketing rights for Vir Biotechnology’s investigational antibody, VIR-3434, for Hepatitis B in Greater China, under a partnership agreement. Following the option exercise, Vir will receive the option exercise fee, regulatory and commercial milestone payments as well as tiered royalties on net product sales from Brii Bio.

Antibody 279
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AstraZeneca agrees $1.3bn deal to buy oncology player TeneoTwo

pharmaphorum

AstraZeneca has signed a deal to buy US biotech TeneoTwo in a deal worth up to $1.27 billion that will boost its position therapies for haematological cancers. The big pharma is paying $100 million upfront for the company, and offering up to $805 million in milestone payments if TeneoTwo’s drug candidates meet development objectives, plus up to $360 million if they hit sales targets.

Antibody 124
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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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How PlantX is Leading the Plant-Based E-Commerce Industry

XTalks

Plant-based e-commerce platform PlantX recently announced a partnership with ice cream brand Dream Pops at its multi-brand pop-up retail initiative in Venice Beach, California. The Pop-up Initiative was launched in April following the successful pilot tenancy program promoting PlantX’s partner brands and now welcomes new brand partners on a two-to-three-month rotational basis.

Branding 105
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Two cancer biotechs merge, raise cash as sector-wide downturn continues

Bio Pharma Dive

Syros Pharmaceuticals and Tyme Technologies, shares of which trade near all-time lows, will combine and raise about $130 million from private investors to stay afloat.

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Brii Bio introduces Covid-19 combination therapy in China

Pharmaceutical Technology

Brii Biosciences and TSB Therapeutics have commercially launched a long-acting neutralising antibody therapy combination, amubarvimab/romlusevimab, for Covid-19 in China. The two non-competing SARS-CoV-2 monoclonal neutralising antibodies, amubarvimab and romlusevimab are obtained from convalesced Covid-19 patients. The company developed these antibodies in partnership with Tsinghua University and the 3rd People’s Hospital of Shenzhen.

Antibody 264
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Partners come on board GSK’s plan for Stevenage life science hub

pharmaphorum

GSK’s recently-unveiled plan to develop a bioscience cluster close to its main R&D site in Stevenage, UK, has moved closer to fruition, now that the first partners have joined the initiative. The asset management arm of Swiss back UBS has formed a joint venture with property developer Reef Group that will develop the 33-acre campus in Stevenage, Hertfordshire.

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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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It’s Time to Harness Data to Improve Clinical Trial Patient Diversity

ACRP blog

“The time for pontification is over when it comes to improving diversity in the clinical trial population,” says Reginald Swift, PhD, founder and CEO of Rubix Life Sciences. “Underserved populations needed these therapies yesterday and the next generation requires us to step up,” he adds. While he’s a big fan of diversifying the clinical trial workforce as one way to promote diversity, Swift warns industry must also find new ways to reach out to new, potential trial participants in traditionally

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Radius, fending off activists, outlines pitch for $890 million buyout

Bio Pharma Dive

The biotech detailed the process that led to its take-private offer last month, aiming to win the support of shareholders, including two firms that have pushed for change.

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EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

Pharmaceutical Technology

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain. The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive recommendation in

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FDA backs pharmacist prescribing of Paxlovid for COVID

pharmaphorum

Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug. The regulator has revised the emergency use authorisation (EUA) for Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to patients, providing they can provide recent health records and a list of current medicines they are taking.

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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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Follow-Up Data on Bayer’s Larotrectinib Hints at Potentially Curative Impact

BioSpace

BioSpace connected with Theodore Laetsch, M.D., lead investigator of the pediatric larotrectinib trial (SCOUT), to gain more insight into the drug, the trial and how patients' lives are being affected.

Trials 102
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FDA, under fire for Aduhelm approval, starts review of another Alzheimer's drug

Bio Pharma Dive

The regulator could clear Biogen and Eisai’s lecanemab by early January. A decision before Phase 3 results could amplify the criticism the agency already faces, however.

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Europe is seeing a hiring boom in pharmaceutical industry data analytics roles

Pharmaceutical Technology

Europe was the fastest growing region for data analytics hiring among pharmaceutical industry companies in the three months ending May. The number of roles in Europe made up 11.8% of total data analytics jobs - up from 11.1% in the same quarter last year. That was followed by North America, which saw a -0.4 year-on-year percentage point change in data analytics roles.

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Ensuring successful digital outreach and retention in atopic dermatitis trials

pharmaphorum

Trial organisers face intense competition to find and recruit eligible patients for atopic dermatitis studies. With more than 500 dermatology clinical trials currently underway, it is often heard that there is a ‘’competition for participants’’. Yet evidence from research studies and a survey with 4,000+ atopic dermatitis patients conducted by Clariness shows that this ‘race to recruit’ is actually not the primary reason for the growing discontinuation rate of atopic dermatitis trials.

Trials 118
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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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FDA Clears Vertex to Continue Dosing in Diabetes Cell Therapy Trial

BioSpace

The FDA lifted its clinical hold on Vertex Pharmaceuticals' Phase I/II clinical trial of VX-880, a pancreatic islet cell replacement therapy for people with Type I Diabetes (TID).

Trials 98
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CureVac sues rival COVID-19 vaccine maker BioNTech for patent infringement

Bio Pharma Dive

The biotech, whose own efforts to develop a COVID-19 vaccine have faltered, claims its inventions were crucial to the development of BioNTech’s top-selling coronavirus shot.

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Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Pharmaceutical Technology

Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients. The treatment is indicated as extended adjuvant treatment for adults with early-stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy.

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Astellas teams up with UK biotech Mogrify on hearing loss project

pharmaphorum

Cell therapy specialist Mogrify has struck a deal with Japanese drugmaker Astellas to look at ways to deploy regenerative medicine to treat hearing loss caused by factors such as chronic exposure to loud noises. The two partners will take an in vivo approach to the problem of so-called sensorineural hearing loss (SNHL) looking at ways to replace sound-detecting hair cells in the inner ear (cochlea) that become damaged in this type of deafness.

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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.