Mon.Aug 01, 2022

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Concert to seek approval for hair loss drug after second study success

Bio Pharma Dive

The biotech plans to file an application with the FDA in the first half of next year for clearance in alopecia areata, potentially positioning it to compete with Eli Lilly and Pfizer for market share.

Drugs 298
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Moderna signs contract to supply Covid-19 booster vaccines to the US

Pharmaceutical Technology

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. The contract comprises a $1.74bn award to produce and supply these vaccine doses and options to further procure up to 234 million additional doses of the company’s booster candidates. A bivalent booster candidate, the mRNA-1273.222 vaccine comprises Spikevax along with the Omicron BA.4/5 strain messenger RNA (mRNA).

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Leading with science at Regeneron turns promise to reality for patients

Bio Pharma Dive

After 20 years at Regeneron, Jennifer Davidson Hamilton is still excited by the prospect of changing patients’ lives, one unmet need at a time.

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AbbVie reports 4.5% rise in Q2 2022 net revenues

Pharmaceutical Technology

AbbVie has reported net revenues of $14.6bn for the second quarter (Q2) of 2022 as against $14bn in the year-ago quarter, indicating a 4.5% rise on a GAAP basis. Net revenue surged by 6.1% on an operational basis during the quarter. The GAAP diluted earnings per share (EPS) for the quarter ended 30 June grew by 21.4% to 0.51 from $0.42 in Q2 2021. An 11.2% surge in adjusted diluted EPS of $3.37 was reported in Q2 this year against $3.03 in the prior-year quarter.

Sales 246
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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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The promise of oral therapies for cytokine inhibition

Bio Pharma Dive

The science behind new oral therapies for cytokine inhibition and why they could be transformational for patients.

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GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Pharmaceutical Technology

GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. The company will jointly design and analyse messenger ribonucleic acid (mRNA) Covid-19 vaccines in partnership with the NIH unit National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC).

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Governments and pharma relationships and implications for antimicrobial resistance

Pharmaceutical Technology

Before the Covid-19 pandemic, government-led investment and engagement in life sciences was relatively restricted worldwide, with the industry mostly funded via private investment. The pandemic forced governments to acknowledge that this status quo had to change. Since 2020, government agencies have provided funding for expensive late-stage vaccine development and the expansion of manufacturing capacity, as well as other key pharmaceutical activities.

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FDA halts testing of Beam’s base editing cancer therapy

Bio Pharma Dive

The regulator has put on hold human testing of a blood cancer treatment known as BEAM-201, one of two that the biotech aims to bring to clinical trials this year.

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Data analytics hiring levels in the pharmaceutical industry dropped in July 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for data analytics related positions dropped in July 2022 compared with the equivalent month last year, with 64.8% of the companies included in our analysis recruiting for at least one such position. This latest figure was lower than the 68.8% of companies who were hiring for data analytics related jobs a year ago and a decrease compared to the figure of 69.7% in June 2022.

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Nuvation to cut workforce by 35% as it scraps lead drug program

Bio Pharma Dive

The company, which is led by former Medivation executives and focuses on cancer research, said the shake-up is in response to an “internal risk-benefit analysis” that raised doubts about its most advanced program.

Drugs 169
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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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STAT+: Hospitals win higher payments from Medicare after lobbying campaign

STAT News

Hospitals secured significantly larger payments from Medicare for 2023, after months of lobbying centered around arguments that inflation and the pandemic have crippled hospitals’ finances. The increase to the hospital “ market basket update ” — a key metric that determines the price growth of hospital goods and services — is the largest from Medicare since 1998, the Centers for Medicare & Medicaid Services said in the final rule that came out Monday evenin

Marketing 145
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Ipsen, continuing oncology push, pays a startup $45M for two cancer drugs

Bio Pharma Dive

The French company will work with Marengo Therapeutics in an alliance that could be worth as much as $1.6 billion.

Drugs 169
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The campaign to rename monkeypox gets complicated

STAT News

Since the earliest days of the current global monkeypox outbreak, scientists and public health authorities have been calling for the disease to be renamed, arguing that it has racist overtones and carries a stigma that will hinder efforts to stop its spread. In mid-June, World Health Organization Director-General Tedros Adhanom Ghebreyesus said his agency agreed, and would be working with partners to rename the virus itself, the disease it causes, and the two clades or strains of the virus, each

Scientist 138
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Critics say 'monkeypox' is a racist name. But it's not going away anytime soon

NPR Health - Shots

Scientists call the name "discriminatory and stigmatizing." The World Health Organization agrees. But no progress has been made on finding a new name. And some say the name doesn't need changing.

Scientist 121
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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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Synthetic mouse embryos created from stem cells — without sperm, eggs, or a uterus

STAT News

Lit from below by the microscope’s soft glow, the translucent mouse embryos looked exactly as they should. On day 3 they began to elongate, from spheres into cylinders. On one end, the neural tube started to fold around day 6, on the other a tail began to bud. By day 8, a beating heart began to circulate blood through vessels forming around the embryo’s yolk sac.

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California declares a state of emergency due to monkeypox outbreak

NPR Health - Shots

The first California case of the current outbreak of monkeypox was confirmed May 25. There are now more than 800 cases in the state, according to Gov. Gavin Newsom.

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Opinion: Fast science can be good science, even more so when lives are at stake

STAT News

Drug development has been conducted at the same slow and incremental pace for so long that some have worried that speeding it up would mean cutting corners and sacrificing patient safety or the accuracy of data collected. Then along came the Covid-19 pandemic. It raised the stakes and challenged the global health care and scientific communities to reimagine traditional development timelines.

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Alzheimer's researchers are looking beyond plaques and tangles for new treatments

NPR Health - Shots

An atlas showing how Alzheimer's changes individual brain cells could help researchers find new treatments for the disease.

Research 143
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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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Top Five Fastest Growing Beverage Companies in 2022

XTalks

Whether it’s coffee, tea, soda, beer or water, consumers have been finding ways to quench their thirst for centuries, making the beverage industry both timeless and recession-proof. The reliability of the industry, as well as the constant demand, has helped create some of the world’s most valuable and fastest growing beverage companies. As a forever evolving category, most beverage companies focus on ways to differentiate themselves from the competition.

Branding 105
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Australia's Parliament considers lifting euthanasia ban in two territories

NPR Health - Shots

Australia's Northern Territory in 1995 became the first place in the world to legalize voluntary euthanasia, but the law was quickly overturned two years later. The new bill seeks to lift the ban.

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Sarepta says early filing for DMD gene therapy is back on

pharmaphorum

Sarepta is pressing forward with a bold plan to file with the FDA for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD) in the next few months, with a view to making it available in sometime around the middle of 2023. The US biotech – which already has three antisense drugs for DMD on the market – had said earlier it was planning to delay the application into 2023, so the new announcement marks an acceleration of its plans.

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California and Illinois declare states of emergency to help fight monkeypox outbreaks

NPR Health - Shots

Monkeypox cases in California, Illinois and New York make up nearly half of the nationwide total. The governors in those states have all declared a state of emergency to help address the outbreaks.

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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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Opinion: Keeping climate provisions in the budget reconciliation act is a key step toward protecting Americans’ health

STAT News

Last week’s surprise agreement between Sen. Joe Manchin (D-W.Va.) and Senate Majority Leader Chuck Schumer (D-N.Y.) makes the pending budget reconciliation act —now called the Inflation Reduction Act — perhaps the most important health care bill considered by the Congress since the Affordable Care Act of 2010. The legislation’s specific health care provisions are historic in their own right.

Drugs 98
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Whether from an antique shop or discount store, toxic lead items are easy to buy

NPR Health - Shots

Lead is regularly found in vintage items more than 40 years old, but also in many new, cheaply made dollar-store goods. Children are especially susceptible to lead-poisoning even at low levels.

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Opinion: Americans deserve better than ‘destination hallway’ in emergency departments and hospital wards

STAT News

As the literal and figurative front door to many hospitals, the emergency department can offer a glimpse into hospitals’ future. And that future, in a word, is gridlock. Visits to emergency departments have been rising faster than population growth for more than a decade, and now number 150 million per year.

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What is C3G and what resources are available for those affected?

Antidote

Complement 3 glomerulopathy (C3G) is a rare type of kidney disease, estimated to impact just 1 to 2 million people worldwide. C3G is a genetically inherited disorder that impacts all races and genders equally, and the average patient is diagnosed between the ages of 21 and 26.

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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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With the help of a sticky, stretchy material, scientists design a continuous ultrasound system

STAT News

It took hundreds of failed experiments, sticking gummy gels to all sorts of surfaces, for scientists at Massachusetts Institute of Technology to get what they were looking for: a material so adhesive, it could cement a device to the skin for two full days while still letting sound waves pass through. The resulting platform, described in new research published in Science, can be used for tools like wearable ultrasound probes that help provide continuous, hands-free monitoring of internal tissue a

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BMS’ plan to move Opdivo into adjuvant RCC gets knocked back

pharmaphorum

Bristol-Myers Squibb has revealed that its checkpoint inhibitor combination of Opdivo and Yervoy failed a phase 3 trial as adjuvant (post-surgery) therapy for renal cell carcinoma (RCC), the most common form of kidney cancer. The disappointing outcome from the CheckMate -914 trial undermines BMS’ hopes of moving PD-1 inhibitor Opdivo (nivolumab) and CTLA4 inhibitor Yervoy (ipilimumab) treatment into earlier-stage cancers.

Trials 102
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STAT+: Major European research funders often fail to set policies or monitor progress on clinical trial transparency

STAT News

Nearly two dozen major organizations that fund medical research in Europe often failed to set policies or monitor progress for registering clinical trials and publishing study results, an issue that can lead to shortcomings in medical literature, a new analysis finds. Among 21 of the largest public and philanthropic funders, only 14 mandated prospective trial registration and just six required that trial results be made public on registries within a year of a trial’s completion.

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GSK ups sales guidance on back of Shingrix strength

BioPharma Reporter

GSKâs first quarter following the demerger of its consumer health business sees the company raise its 2022 sales guidance to between 6-8%, up from 5-7% on its previous estimation.

Sales 98
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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.