Pharmaceutical Technology

NOVEMBER 2, 2022

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

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Bio Pharma Dive

NOVEMBER 2, 2022

Lusaris Therapeutics is launching with $60 million to develop an under-the-tongue form of 5-MeO-DMT, a psychoactive compound found in the glands of the Sonoran Desert toad.

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Development 286

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 2, 2022

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, […].

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Bio Pharma Dive

NOVEMBER 2, 2022

Manufacturing problems continue to weigh on Novo’s Wegovy launch as competition looms from Eli Lilly’s fast-selling diabetes medicine Mounjaro.

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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

Clinical Research

Pharmaceutical Technology

NOVEMBER 2, 2022

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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Bio Pharma Dive

NOVEMBER 2, 2022

The biotech’s transition from drug delivery specialist to maker of novel medicines led to competing neuroscience and oncology divisions. The latter will soon become a separate company.

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Bio Pharma Dive

NOVEMBER 2, 2022

In cutting jobs, the biotech joins a lengthening list of drug companies forced to trim their workforce this year. It plans to stop work on an antibody cancer drug to focus resources on two other candidates.

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Pharmaceutical Technology

NOVEMBER 2, 2022

The pharmaceutical community has reached somewhat of a turning point as it commercialises a growing number of speciality medicines relying on complex new treatment pathways. With this comes new hope for previously underserved patient populations. But educating the world of physicians about these new medicines and collaborating with healthcare professionals on trials and other important initiatives is critical to their commercial success.

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Bio Pharma Dive

NOVEMBER 2, 2022

The drugmaker agreed to pay $200 million upfront and potentially billions more to license the technology and knowhow from Arcturus to make preventive shots for COVID-19, influenza and other respiratory infections.

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Pharmaceutical Technology

NOVEMBER 2, 2022

Ascletis Pharma has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its drug candidate for Covid-19. The company made the submission after the pre-IND consultation with the regulatory agency. An oral small molecule inhibitor, ASC11 acts on 3-chymotrypsin like protease (3CLpro). The international intellectual property rights for the drug are owned by the company.

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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

Clinical Trials

NPR Health - Shots

NOVEMBER 2, 2022

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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pharmaphorum

NOVEMBER 2, 2022

Digital therapeutics are rapidly coming into the foreground to treat a variety of conditions. Ben Hargreaves discovers how chronic pain could be a key area for digital therapeutics, as they offer non-addictive and effective relief from the condition. The struggle to manage pain for individuals has been one that goes back a long way in history, with one of the earliest recorded medical prescriptions being for opium.

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NPR Health - Shots

NOVEMBER 2, 2022

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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STAT News

NOVEMBER 2, 2022

Editas Medicine’s new leadership team on Wednesday reiterated a promise to deliver clinical updates on two CRISPR-based treatments before the end of the year — data the troubled biotech hopes will ease investor doubts about its gene-editing technology. Other CRISPR companies command multibillion-dollar valuations, but Editas, one of the originals, trades below its IPO price after years of management upheaval and clinical delay.

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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.

Clinical Supply

NPR Health - Shots

NOVEMBER 2, 2022

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.

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AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 2, 2022

Care-Keralam, the Ayush cluster in Kerala, will shortly fine-tune its strategies to build ‘Kerala Brand of Ayurveda Products’ for international marketing and to increase the quantity of exports of traditional and herbal drugs from Kerala to global markets. Similarly, the cluster will create a ‘Kerala Label’ for Ayurveda drugs manufactured by small-scale manufacturers (SMEs) in […].

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STAT News

NOVEMBER 2, 2022

Dani Yuengling, a 35-year-old South Carolinian, had a family history of fatal breast cancer. So when she noticed a lump in one of her breasts, she immediately made an appointment to see her doctor. Though her biopsy was covered by insurance, she still had to pay $5,169 out of her own pocket. If she hadn’t used her insurance, Yuengling would have saved $3,000.

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NPR Health - Shots

NOVEMBER 2, 2022

Advocates for inoculation are distressed by what they see as a new political focus on an old public health measure.

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Vaccination Vaccine 133

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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.

Clinical Trials

STAT News

NOVEMBER 2, 2022

The federal government is officially reducing Medicare payments to physicians next year by 4.5%, but doctors and their lobbyists are ready to blitz Congress over the next two months to convince lawmakers that those cuts should be averted — again. Medicare signaled these cuts were coming over the summer and finalized them this week in a new regulation.

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pharmaphorum

NOVEMBER 2, 2022

One of the highlights of Eli Lilly’s third-quarter results was the rapid uptake of new type 2 diabetes therapy Mounjaro, which added more than $97 million in US sales alone in what has been described as “viral” take-up by the drugmaker. Lilly’s head of diabetes, Mike Mason, said on the company’s results call that the rollout of Mounjaro (tirzepatide) was “really unprecedented” for a new diabetes therapy in the US, and had been driven by “tremendous

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STAT News

NOVEMBER 2, 2022

A blockbuster weight-loss medicine led to dramatic effects for adolescents diagnosed with obesity, a result that will likely widen the use of an in-demand drug — and fan a debate over whether someone’s body weight should be treated as a disease. The drug, a weekly injection called semaglutide, led to a 17% reduction in body mass index compared to placebo in a study of about 200 people between the ages of 12 and 18.

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pharmaphorum

NOVEMBER 2, 2022

Citeline and Norstella have completed a merger, first announced in June, to create one of the largest players in the pharmaceutical intelligence category. Citeline provides intelligence, data and software for clinical trials, development and regulatory compliance and was formerly part of Informa was called Pharma Intelligence ahead of a rebranding earlier this year.

Clinical Trials 101

Clinical Trials Clinical Trials Marketing Life Science 101

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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.

Clinical Supply

STAT News

NOVEMBER 2, 2022

The hype around psychedelic therapy has been put to the test, with the publication Wednesday of the largest-ever study of psilocybin to treat depression. The Phase 2 trial found that the drug was effective — it reduced or eliminated symptoms in the short term in more than one-third of patients who took the highest dose — but not as dazzlingly powerful as earlier smaller studies had suggested.

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NPR Health - Shots

NOVEMBER 2, 2022

Carolyn Hax's mother was battling ALS. That also took a toll on Hax herself, though she continued to work. A colleague that she didn't know well took notice and kept checking in until Hax was better.

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STAT News

NOVEMBER 2, 2022

It’s tough times to be a public biotech, especially a small one. As the market cratered over the past year and a half, hundreds of companies watched their valuations plummet to the point that, at least by stock market metrics, they’re worth less than the cash they have in the bank. Now, one biotech investor is proposing a novel solution: Just give that cash back.

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pharmaphorum

NOVEMBER 2, 2022

CVS Health and Walgreens have become the first two US pharmacy chains to agree a settlement worth nearly $10 billion to answer allegations they played a role in the opioid epidemic that has claimed tens of thousands of lives. CVS and Walgreens both said that the agreements in principle could resolve all the opioid-related lawsuits they are facing from states, subdivisions and Native American tribes.

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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.

Clinical Trials

STAT News

NOVEMBER 2, 2022

In the future, getting a flu shot might be as easy as opening the mailbox and slapping a skin patch on your arm. Immunizations shipped to doorsteps around the globe is the dream of Michael Schrader, chief executive and cofounder of Vaxess. For more than a decade, the Cambridge, Mass., startup — whose name is a portmanteau of “vaccine” and “access” — has inched toward the creation of a vaccine that’s easy to use, doesn’t require refrigeratio

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pharmaphorum

NOVEMBER 2, 2022

In its first set of quarterly results since it separated from its consumer health business, GSK has exceeded analysts’ estimates, with a healthy rise in revenue and profit driven by shingles vaccine Shingrix. The UK pharma group – now a therapeutics and vaccines pure-play since the spin-off of Haleon in July – also raised its financial forecasts for the full year for the second time in consecutive quarters, as third-quarter revenues climbed 18% to £7.8 billion (around $8.9 billion) against

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STAT News

NOVEMBER 2, 2022

Hospitals that decide to convert to a new type of rural provider won’t have to report quality metrics next year, but they also won’t qualify for a popular drug discount program — a likely dealbreaker for some. That’s according to Medicare’s final rule laying out the parameters for so-called Rural Emergency Hospitals, a designation that takes effect Jan. 1, 2023 for facilities that opt in.

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Drugs 102

pharmaphorum

NOVEMBER 2, 2022

Wednesday 2 nd November heralds the start of Anthropy 2022 at The Eden Project. With pharmaphorum fully in attendance today, expect coverage of a wide range of topics, within a variety of formats, all united by a shared goal of seeking sustainable change for Britain, whilst bearing in mind her role upon the global stage at this critical juncture in history.

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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.

Clinical Trials