Pharmaceutical Technology

OCTOBER 5, 2022

In 2010, two patients with end-stage refractory chronic lymphocytic leukaemia (CLL) were administered Novartis’ autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, Kymriah (tisagenlecleucel), as part of a Phase I trial. In March this year, it was reported that these two patients were still in remission, making this the longest known CLL remission after CAR-T therapy and demonstrating to the industry that long-term remission is indeed possible.

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In-Vitro In-Vivo Sales Clinical Trials 279

Bio Pharma Dive

OCTOBER 5, 2022

Spun out as part of Pfizer’s $11.6 billion acquisition, the biotech retains a pipeline of experimental neuroscience drugs and holds $258 million in cash.

Drugs 245

Drugs 245

Pharmaceutical Technology

OCTOBER 5, 2022

Bringing an end to a 13-year deliberation on a whistleblower lawsuit, Biogen recently agreed to pay a $900 million settlement , amidst increased government alertness on pharmaceutical fraud. In 2009, former Biogen employee Michael Bawduniak filed a lawsuit claiming that Biogen had violated the False Claims Act and the Anti-Kickback Statute by providing millions of dollars to healthcare providers (HCPs) as an incentive to prescribe three of its multiple sclerosis (MS) drugs.

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Bio Pharma Dive

OCTOBER 5, 2022

Carolyn Bertozzi, a Stanford scientist and co-founder of several biotechs, helped advance "click chemistry" — a concept pioneered by Morten Meldal and Barry Sharpless, with whom she shares this year's prize.

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Scientist 209

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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

OCTOBER 5, 2022

Technology is advancing the possibilities of healthcare treatments, from the development of innovative new drugs to freeing up time for doctors thanks to monitoring devices for patients with conditions such as diabetes and high blood pressure. As health services around the world seek to recover from Covid-19, many are turning to healthtech to expand treatment options and increase efficiencies.

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Bio Pharma Dive

OCTOBER 5, 2022

The diagnostic will support rollout of Enhertu, which recently became the first drug for breast tumors with low, but still detectable, levels of the protein HER2.

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Drugs Protein 140

Bio Pharma Dive

OCTOBER 5, 2022

The British drugmaker said a mid-stage study of its PD-1 inhibitor Jemperli alongside chemotherapy showed “positive headline” results, which it will present in full later.

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Trials 130

Pharma Mirror

OCTOBER 5, 2022

INCHEON, South Korea, Samsung Biologics (KRX: 207940.KS), a world-leading contract development and manufacturing organization (CDMO), is launching its new proprietary development technology platforms – S-DUAL™ and DEVELOPICK™ – at this year’s BioProcess International Conference and Exhibition in Boston. S-DUAL™ is a high-yield bispecific antibody platform with a 99% chain-pairing success rate.

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Development Manufacturing Antibody 130

Pharmaceutical Technology

OCTOBER 5, 2022

miRecule and Sanofi have entered a strategic partnership and exclusive licence agreement for the development and commercialisation of an antibody-RNA conjugate (ARC) to treat facioscapulohumeral muscular dystrophy (FSHD). Under the partnership, the anti-DUX4 RNA therapy of miRecule will be merged with the muscle-targeted NANOBODY technology of Sanofi to fuse the two molecules into an ARC using the NAVIgGator conjugation and formulation chemistry of the former.

Development 130

Development RNA Gene Therapy Sales 130

NPR Health - Shots

OCTOBER 5, 2022

A study finds small but meaningful declines in personality traits that help us navigate social situations, trust others, think creatively, and act responsibly. Young people were especially affected.

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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

Rethinking Clinical Trials

OCTOBER 5, 2022

In this Friday’s PCT Grand Rounds, Dr. Melanie Meersch-Dini of University Hospital Münster (Germany) will present “Impact of Handovers of Anesthesia Care on Morbidity and Mortality.” The Grand Rounds session will be held on Friday, October 7, 2022, at 1:00 pm eastern. Dr. Meersch-Dini will discuss the results of the HandiCAP trial (Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes), a parallel-group, randomized clinical trial of intraoperative handover of

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Trials Clinical Trials Clinical Trials 130

NPR Health - Shots

OCTOBER 5, 2022

Scientists have made a drug based on LSD that seems to fight depression without producing a psychedelic experience. (Image credit: PAUL J.

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Drugs Scientist 133

STAT News

OCTOBER 5, 2022

Following the fall of Roe v. Wade, many clinicians have become fearful and uncertain about how they are allowed to treat pregnant people with potentially life-threatening complications. These include ectopic pregnancies, which can only be treated by termination. Ectopic pregnancies are not viable, but as STAT’s Olivia Goldhill reports , some providers are cautious about immediately providing treatment in states that have passed laws that criminalized abortion, as they can risk losing thei

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Licensing Licensing 116

NPR Health - Shots

OCTOBER 5, 2022

Talk about a late bloomer. Carl Allamby, who ran an auto repair shop for more than 20 years, was recently hired as an attending physician at Cleveland Clinic's Hillcrest Hospital at age 51.

Doctors 110

Doctors Doctor 110

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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

STAT News

OCTOBER 5, 2022

Carolyn Bertozzi of Stanford University, Morten Meldal of the University of Copenhagen, and K. Barry Sharpless of Scripps Research won the Nobel Prize in chemistry on Wednesday “for the development of click chemistry and bioorthogonal chemistry,” methods that have been applied in drug development and studying disease. Click chemistry, true to its name, “clicks” together molecules much more easily and exactly than traditional chemical reactions.

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Development Scientist Research Drugs 111

NPR Health - Shots

OCTOBER 5, 2022

A new report assessed the impact of laws in the 15 states that have banned or heavily restricted abortion since June 24.

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STAT News

OCTOBER 5, 2022

Lydia Gatton’s first in vitro fertilization appointment was just a week away when the fifth-grade teacher fell to the floor in the cafeteria of Hopewell Elementary in Bettendorf, Iowa, suffering a grand mal seizure. She was rushed to the hospital, where doctors diagnosed the then 29-year-old with a brain tumor. Gatton and her husband had struggled to conceive naturally for years and completed six unsuccessful intrauterine inseminations.

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In-Vitro Doctors Doctor 111

pharmaphorum

OCTOBER 5, 2022

Sanofi has added to its rare disease pipeline by licensing an antibody-RNA conjugate (ARC) for facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder, from US biotech miRecule. FSHD is the second most common form of muscular dystrophy after the Duchenne type, and affects around 1 million people worldwide, with no approved treatments.

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RNA Genetics Dermatology Antibody 105

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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

OCTOBER 5, 2022

Modern wheelchairs have amazing capabilities. At the push of a button, they can position a user in a “standing” position, or elevate someone to eye level with a non-disabled person. It’s game-changing for wheelchair users who are looking to take care of themselves independently whenever they can. Standing technology promotes healthy circulation to avoid blood clots and bed sores, and reduces the risk of osteoporosis, urinary tract infections, and more.

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BioSpace

OCTOBER 5, 2022

Provention Bio entered a co-promotion agreement with Sanofi ahead of the possible November approval of teplizumab. If approved, the drug would be the first approved to modify T1D.

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Drugs 98

STAT News

OCTOBER 5, 2022

Health tech companies and their backers are increasingly cautious as they brace for uncertain market conditions leading into the new year. But industry gatherings are in full swing, and we’re expecting lively debate about which digital health offerings will win out as investments and contracts sink below their pandemic peak. And as two waves of federal health data rules take effect in early October and late December, providers and developers told STAT they’re getting to work ensuri

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Marketing Development 105

BioSpace

OCTOBER 5, 2022

While Biogen and Eisai's recent lecanemab data breathed new life into the anti-amyloid approach, experts say combination therapies will likely play a significant role in treating Alzheimer's disease.

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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

OCTOBER 5, 2022

Interoperability is a word you seldom hear uttered outside the health care sector (though there it seems to be on the tip of everyone’s tongues), yet it’s something that affects everyone. Interoperability is the ability — or inability, as is often the case — to easily and securely access and exchange medical data in a format that is usable and useful to the recipient.

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Doctors Doctor 98

pharmaphorum

OCTOBER 5, 2022

As we close in on Frontiers Health 2022, pharmaphorum is chatting with members of the Steering Committee to give you a sneak peek of what to expect in Milan. Interested in signing up? pharmaphorum readers get a discount through this link. As digital therapeutics come into their own, they’ve become a necessary force to be reckoned with for pharma, payers, and providers – as well as for the patients that will use them and the tech companies that make them.

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Life Science Doctors Doctor Production 98

STAT News

OCTOBER 5, 2022

Scientists rely on gene synthesis technologies as a research tool for everything from basic research to vaccine development and drug target identification. Oligonucleotides, which are pieces of DNA about 15 to 30 base pairs long, are used in gene synthesis laboratories all over the world, along with DNA strands that may be thousands of bases long. Ever since the inception of gene synthesis, there have been concerns about possible misuse of synthetic genes.

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Gene DNA Engineer Scientist 98

BioSpace

OCTOBER 5, 2022

???????TauRx announced preliminary results from the Phase III study, showing HMTM, its potent inhibitor of tau aggregates, could slow Alzheimer's disease progression or cognitive decline.

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Regulation 98

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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

pharmaphorum

OCTOBER 5, 2022

After a bumper 2021, the fall-off in digital health financing deals that started to appear early this year has continued, with the three month to send September the lowest funded quarter since the tail end of 2019. All told, digital health companies raised $2.2 billion from 125 deals in the third quarter, taking the tally for 2022 to $12.6 billion and 458 deals, respectively, according to new figures from Rock Health which point to a big pullback in late-stage deal financing.

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Marketing Research 98

BioSpace

OCTOBER 5, 2022

Nested Therapeutics, a precision oncology company targeting previously undruggable cancer targets, closed on a $90 million Series A financing, bringing total financing to $125 million since its inception in 2021.

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Protein 98

XTalks

OCTOBER 5, 2022

Amylyx Pharmaceuticals recently announced in a press release that the US Food and Drug Administration (FDA) approved Relyvrio for the treatment of adults with amyotrophic lateral sclerosis (ALS). Additionally, it has been approved with conditions as Albrioza for the treatment of ALS in Canada. ALS is a rare, progressive neurodegenerative disease that causes death of motor neurons in the brain and spinal cord.

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FDA Approval Clinical Trials Clinical Trials Trials 98

BioSpace

OCTOBER 5, 2022

After an earlier stumble this year with its investigational major depressive disorder therapeutic, Eliem Therapeutics appears to be back on track with a planned Phase II study of ETX-155.

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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