Bio Pharma Dive
JULY 29, 2022
After discussions with the FDA, the biotech aims to submit an application this fall — sooner than expected and ahead of a Phase 3 study that’s now ongoing.
Pharmaceutical Technology
JULY 29, 2022
Pfizer has reported a 53% operational growth in revenues to $27.7bn in the second quarter (Q2) of 2022 compared to $18.9bn in the same quarter last year. The rise in revenues was chiefly driven by robust contributions from Covid-19 therapies Paxlovid and Comirnaty. On an operational basis, the revenues rose by $128m or 1%, excluding Paxlovid and Comirnaty’s contributions.
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Bio Pharma Dive
JULY 29, 2022
Imbruvica, long one of AbbVie’s top-selling medicines, has ceded market share in treating chronic lymphocytic leukemia to AstraZeneca’s Calquence.
Pharmaceutical Technology
JULY 29, 2022
The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease. A decision from the regulatory agency on approval for the treatment is anticipated on 23 May next year.
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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 29, 2022
Health officials are gearing up for a fall vaccination campaign and aim to deploy shots modified to better match circulating omicron subvariants.
Pharmaceutical Technology
JULY 29, 2022
The rate at which children are being identified with autism spectrum disorder (ASD) has tripled in the past two decades. While the prevalence was 1 in 150 children in 2000, it reached the rate of 1 in 44 in 2018, in the US, according to the Centers for Disease Control and Prevention. Some people with ASD can experience acute agitation and crisis behaviours.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 29, 2022
Schizophrenia Awareness Day, marked on 25 July, is a national observance that aims to raise awareness about this mental illness. Schizophrenia is a chronic brain disorder that affects a person’s ability to function, such as thinking and feeling. According to GlobalData’s Epidemiology and Market Size database, epidemiologists estimate there are more than 21 million prevalent cases within the tracked 16 countries.
STAT News
JULY 29, 2022
Precision medicine — tailoring a treatment to an individual’s disease — requires understanding the individual’s biological characteristics. Although medicine and biotech are making significant progress in this area, they have historically been limited by few genetic samples and insights from patients of diverse backgrounds, particularly in therapeutic categories including cardiometabolism, inflammation, and other diseases with a disproportionate incidence among underr
Pharmaceutical Technology
JULY 29, 2022
Last week, CAMP4 Therapeutics announced the close of a $100 million Series B round , which will be used to advance their regulatory RNA (regRNA)-focused programs. Their use of regRNA technology provides a unique approach to treating rare conditions like urea cycle disorders. CAMP4’s CSO David Bumcrot PhD tells Pharmaceutical Technology that the company plans to see clinical trials go forward for their urea cycle disorder programs late next year.
NPR Health - Shots
JULY 29, 2022
The Americans With Disabilities Act turns 32 this year, and while its anniversary is one to be celebrated, it also calls for a reflection on what more can be done for disability rights.
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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 29, 2022
As the full consequences of the COVID-19 virus started to emerge, and many industries found themselves having to either suspend operations or move to remote working, the biopharma sector found itself on the front line facing unprecedented challenges. The need for the sector to rapidly research, develop and test new vaccines had always been of critical importance, but in the context of a global pandemic and national lockdowns, it became even more so, with each part of the supply chain required to
NPR Health - Shots
JULY 29, 2022
The country's monkeypox outbreak can still be stopped, U.S. health officials said Thursday, despite rising case numbers and so far limited vaccine supplies.
Pharmaceutical Technology
JULY 29, 2022
Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing. Despite the advanced stage of Covid-19 vaccination programmes in richer countries, which would suggest an approaching drop-off in contract manufacturing demand, there is s
STAT News
JULY 29, 2022
Twice, Janet Handal thought she would get a reprieve from semi-lockdown life. The first was when she was vaccinated in January, 2021. But a negative antibody test quickly dashed those hopes; the same immunosuppressants she took to prevent her body from rejecting a kidney transplant also prevented it from responding adequately to vaccines. So the 71-year-old New Yorker turned her attention to a drug, then in clinical trials, designed to protect immunocompromised people like her, enriching their b
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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.
Pharmaceutical Technology
JULY 29, 2022
Novartis has expanded its research-based partnership with the University of California, Berkeley, US, to discover new therapeutic modalities and address ‘undruggable’ disease targets. Based on the successes over the last five years, the alliance will develop new technologies to discover next-generation therapies. The merged team of researchers is analysing various disease targets in cancer, as well as other ailments that have escaped conventional small-molecule compounds and drug discovery app
STAT News
JULY 29, 2022
Among the small bunch of billionaires that the local biotech industry has created, Tim Springer may be the only one who regularly rides his bike to work in the Longwood Medical Area, where his ID tag identifies him simply as a “staff scientist.” Springer, a 74-year-old professor at Harvard Medical School and a research lab chief at Boston Children’s Hospital, is a heads-down scientist and entrepreneur with some notable quirks.
Antidote
JULY 29, 2022
The process of getting a new drug to market is an expensive one. Between 2009 and 2018, U.S. biopharmaceutical companies spent about $1 billion per drug according to an analysis published in JAMA , and other studies have found that it can cost up to $2.8 billion to bring a new therapy to market. In 2019 alone, research and development spending totaled $186 billion for the global pharmaceutical industry.
STAT News
JULY 29, 2022
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.
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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.
Drug Channels
JULY 29, 2022
This week, I’m rerunning some popular posts while I prepare for today's live video webinar: Specialty Drugs Update: Trends, Controversies, and Outlook. Note that the forecasts below did not account for policy changes that could further reduce pharmaceuticals' share of U.S. healthcare spending. Click here to see the original post from April 2022.
STAT News
JULY 29, 2022
Sarepta Therapeutics said Friday that it intends seek regulators’ approval for its gene therapy to treat Duchenne muscular dystrophy earlier than expected — a risky move but one that could help the company reach the market much faster. In early Friday trading, Sarepta shares rose 12% to $96.50.
Pharmaceutical Commerce
JULY 29, 2022
OptimizeRx’s Steve Silvestro on how the healthcare sector is performing when it comes to patient care, and how the use of technology can positively impact that process.
pharmaphorum
JULY 29, 2022
Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional, and global life science communications to offer some little tips for enjoying a big business career. This post recommends setting aside regular time for reflection to critically think through major opportunities, projects and issues in order to make well-considered, high-quality decisions.
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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.
NPR Health - Shots
JULY 29, 2022
Millions of working Americans are seeing their work productivity compromised by long COVID. Now, both workers and doctors are speaking out about what COVID long-haulers need to stay in the workforce.
pharmaphorum
JULY 29, 2022
Patients with end-stage renal disease (ESRD) who are on dialysis often need to be treated with anticoagulants to prevent blood clots, but as a result, can experience bleeding side effects. Now, Ionis and Bayer think they have a new drug that could sidestep that risk. In a phase 2b RE-THINC trial, their experimental antisense-based Factor XI inhibitor fesomersen was able to achieve a “substantial and statistically significant” reduction in levels of the clotting factor, indicating it
NPR Health - Shots
JULY 29, 2022
San Francisco has declared a state of emergency and New York City called the virus an imminent threat. What is the White House's strategy to curb the monkeypox outbreak?
Pharma Times
JULY 29, 2022
The phase 1/2 study is for patients with advanced or metastatic solid tumours
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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.
NPR Health - Shots
JULY 29, 2022
There's increasing concern that the window of opportunity to contain the monkeypox outbreak in the U.S. has closed. Some experts say it's already too late.
Pharma Times
JULY 29, 2022
Investment is a key boost to the acceleration of treatment access in the UK
XTalks
JULY 29, 2022
Astellas Pharma has announced plans to build an integrated biotech facility at 480 Forbes Boulevard, South San Francisco. The new 154,000-square-foot facility will function as a West Coast center for Astella Pharma to focus on research, innovation and commercial operations across program and corporate areas. Astellas will be the only occupant of the new facility and expects the building will be finished and operational by the summer of 2023.
NY Times
JULY 29, 2022
If finalized, the agreement, along with a companion deal reached by Teva earlier this week, would send as much as $6.6 billion to communities harmed by the opioid epidemic.
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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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