Bio Pharma Dive
JULY 26, 2022
New companies are being built more carefully and platform technologies are less in vouge as the downturn's effects ripple through the private sector.
Pharmaceutical Technology
JULY 26, 2022
According to GlobalData’s recent Niemann-Pick Type C (NPC): Opportunity Analysis and Forecast to 2031 report, the NPC market is expected to see significant growth during 2021–31. The three major markets (3MM: the US, Germany and the UK) will increase in market size from $128.35m last year to $188.35m in 2031, at a compound annual growth rate (CAGR) of 3.9%.
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Bio Pharma Dive
JULY 26, 2022
Known as tofersen, the drug failed in the main study being used to support its approval. But an apparent effect on a protein of interest in ALS research has Biogen convinced the treatment will pass muster with regulators.
World of DTC Marketing
JULY 26, 2022
Quick Read: Amazon will dramatically expand its healthcare reach with its planned $3.9 billion acquisition of One Medical, a primary care provider with 188 offices in 25 markets nationwide but are they making a strategic move or a mistake? Telehealth has a future, but one could argue that physicians need to see patients firsthand to diagnose and evaluate patients.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Bio Pharma Dive
JULY 26, 2022
Three startups have recently emerged with plans to edit the epigenome rather than DNA directly. Here’s why that matters and what they aim to do.
Pharmaceutical Technology
JULY 26, 2022
Ginkgo Bioworks has signed a definitive agreement for the acquisition of biotechnology company Zymergen in an all-stock deal worth nearly $300m. According to the agreement, 5.25% of the pro forma merged business will be owned by the stockholders of Zymergen following the acquisition. The deal to combine two complementary companies with identical visions is anticipated to expedite the development of the innovative horizontal synthetic biology platform of Ginkgo.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 26, 2022
North America was the fastest growing region for fintech hiring among pharmaceutical industry companies in the three months ending May. The number of roles in North America made up 18.2% of total fintech jobs - up from 0% in the same quarter last year. That was followed by Europe, which saw a 2.3 year-on-year percentage point change in fintech roles.
Bio Pharma Dive
JULY 26, 2022
The highest tested dose of BridgeBio’s drug helped the bones of children with achondroplasia grow faster, leading the company to expand study enrollment.
Pharmaceutical Technology
JULY 26, 2022
NewAmsterdam Pharma has signed a definitive business combination agreement with special purpose acquisition company (SPAC) Frazier Lifesciences Acquisition (FLAC). The SPAC is sponsored by a Frazier Healthcare Partners affiliate. The deal will make NewAmsterdam Pharma a publicly listed company focusing on oral treatments for cardiometabolic diseases.
NPR Health - Shots
JULY 26, 2022
New, untested abortion bans have made doctors unsure about treating some pregnancy complications. That's led to life-threatening delays, and trapped families in a limbo of grief and helplessness.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
JULY 26, 2022
The last few months have marked the publication of research emerging from projects designed to collect and analyse genomic data on a wider scale than was previously thought possible. Scientists are not just studying specific mutations associated with medical conditions, but also establishing frameworks to understand the role of chromosomal instability and copy number changes in driving those disorders.
STAT News
JULY 26, 2022
Almost two years have passed since Dean Fritzemeier fell ill with Covid in October 2020. As the rest of the world moves on, shrugging off new variants and traveling with a vengeance, he remains trapped in a life weighed down by the virus. Fritzemeier is always tired, but can’t sleep. The 52-year-old once walked 7 miles a day, but now can only get outside if he’s pushed in a wheelchair.
pharmaphorum
JULY 26, 2022
Newly diagnosed cancer patients across the UK will get free access to digital mental health therapies, thanks to a new partnership between Macmillan Cancer Support and Big Health. The alliance, billed as the first of its kind in the UK, means that cancer patients will be able to use Big Health apps like Sleepio and Daylight, which aim to treat insomnia and anxiety using cognitive behavioural therapy (CBT) techniques.
STAT News
JULY 26, 2022
The value-based payment crusade is now two decades old. But despite the tens of billions of dollars — perhaps hundreds of billions — spent on these programs, they have done little to improve Americans’ health or lower health care costs. It is time for proponents of value-based care to call a halt to these programs until they have an answer to this question: “Why have the vast majority of value-based payment experiments failed to improve value?
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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.
NPR Health - Shots
JULY 26, 2022
The iconic singer-songwriter wasn't able to walk or talk after a brain aneurysm in 2015. Dr. Anthony Wang, a neurosurgeon, explains the challenges she faced as a musician and her remarkable comeback.
Rethinking Clinical Trials
JULY 26, 2022
At this year’s annual meeting of the NIH Pragmatic Trials Collaboratory Steering Committee, we interviewed investigators from 3 Demonstration Projects in different phases of the trial life cycle. IMPACt-LBP launched last fall and is completing its 1-year planning phase. ACP PEACE is nearing the end of its implementation phase. SPOT ended last year and published its main outcomes in February.
NPR Health - Shots
JULY 26, 2022
Amazon is buying One Medical, a primary care practice. The tech giant has already stepped into the health care world, but experts said this is a big step to expand Amazon's physical health presence.
STAT News
JULY 26, 2022
WASHINGTON — Top White House officials spent Tuesday laying out a vision for a Covid vaccine utopia. In the future they depicted, vaccines will be cheap and widely available. Instead of merely providing protection against hospitalization and death, they will stop infections from occurring in the first place. Instead of requiring a needle injection, they will be administered by nasal mist or skin patch.
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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.
ACRP blog
JULY 26, 2022
“Everything we do in clinical trials is based on statistical principles, and you have to be comfortable with” them to flourish as a clinical trial professional, says Joy Frestedt, PhD, RAC, FRAPS, CPI, FACRP, president and CEO of Frestedt Incorporated and Alimentix, the Minnesota Diet Research Center. The good news for those with a touch of phobia where numbers are concerned?
STAT News
JULY 26, 2022
Drugmaker Teva announced Tuesday that it has agreed to contribute more than $4.3 billion in cash and medications to settle lawsuits in the state and local governments and Native American tribes that claimed the company contributed to the U.S. opioid epidemic. The deal in principle would rank among the larger ones so far in a yearslong trend of companies settling the complicated lawsuits over the toll from an addiction and overdose epidemic , which has been linked to more than 500,000 deaths in t
ACRP blog
JULY 26, 2022
H1’s Director of Product Marketing, Alexandra Moens, discusses the importance of promoting diversity and how it applies to clinical trials, why the time is now for companies to take action steps to ensure a more diverse patient population, and how H1 is uniquely positioned to help companies harness existing data to significantly enhance their diversity efforts.
STAT News
JULY 26, 2022
Depending on how young you are, your mother may remember polio. Your grandmother, though, would likely shudder at the mere mention of the word, which for years evoked images of iron lungs, of paralyzed children, of summers when fevers struck fear in parents’ hearts. But if you are in your 20s, 30s, 40s, or even 50s, it’s possible you don’t know much at all about the disease caused by a trio of viruses that have long been vanquished from North America and most of the develope
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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.
XTalks
JULY 26, 2022
Monkeypox, a virus that is endemic to parts of Central and West Africa and a member of the Orthopoxvirus genus, has been spreading across the globe since May. A recent safety communication from the US Food and Drug Administration (FDA) recommends that a lesion swab would avoid much of the risk associated with false-positive or false-negative monkeypox test results.
STAT News
JULY 26, 2022
Walker Burger is beside himself with worry. The 33-year-old relies on an experimental medicine to treat an ultra-rare disease called Barth syndrome that causes an enlarged heart, muscle weakness, and a shortened life expectancy. But the Food and Drug Administration last year refused to review the drug, despite prolonged efforts by its manufacturer, Stealth BioTherapeutics, to gather hard-to-come-by clinical data on such a tiny patient population.
Advarra
JULY 26, 2022
Cannabis use has become widespread. As such, we are seeing an uptick in research examining the therapeutic effects of cannabis and its constituents. Currently, cannabis use is legal across many states in the U.S., with 37 states approving medicinal use and 18 approving recreationally. However, it’s not legal federally and is considered a Schedule I drug by the U.S.
STAT News
JULY 26, 2022
WASHINGTON – Nearly three quarters of Americans give the pharmaceutical industry credit for helping contain Covid-19 — and for a sector that’s been roundly criticized for nearly a decade, that’s a reason to celebrate. A new survey, conducted by the Harris Poll for STAT, asked more than 4,000 people what industries they credit for helping contain the coronavirus, and 71% of those surveyed said that the pharmaceutical industry deserves credit — more than the numb
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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.
BioPharma Reporter
JULY 26, 2022
Avista Therapeutics, a University of Pittsburgh Medical Center (UPMC) spinout, is teaming up with Roche to develop novel AAV gene therapy vectors for eye diseases.
STAT News
JULY 26, 2022
Cancer startups aren’t exactly underfunded — as a disease area, oncology has commanded investors’ attention for the last decade. But the American Cancer Society sees gaps.
Pharma Times
JULY 26, 2022
Funding will develop inhaled therapies using ICOone Nasal in preparation for the next pandemic
STAT News
JULY 26, 2022
Expanding new medical treatments requires pushing — and sometimes breaking — the boundaries of what currently defines therapeutics. One of those boundaries is the very definition of a cell. Until recently, cells were all-natural beings, living cell begetting living cell. That’s changing as synthetic biologists and engineers are learning to create synthetic cells that may someday change how a range of diseases are treated.
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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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