Study suggests COVID-19 vaccination lowers incidence of arterial thromboses
Pharma Times
AUGUST 12, 2024
A second dose of the vaccine lowered the incidence of conditions such as heart attack or stroke
Mon.Aug 12, 2024
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FDA approves Ascendis drug for rare endocrine condition
Bio Pharma Dive
AUGUST 12, 2024
The clearance of Yorvipath for hypoparathyroidism was some time coming for Ascendis, which had resubmitted after receiving a rejection last year.
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Era of ADCs: Pharma companies innovate to stand out in a buzzing market
Pharmaceutical Technology
AUGUST 12, 2024
As antibody drug conjugate (ADC)-centred deals dominate the oncology space, biotechs are using newer targets and linkers to differentiate themselves.
Pfizer builds case for RSV shot with data from immunocompromised adults
Bio Pharma Dive
AUGUST 12, 2024
Results from a Phase 3 study could help Pfizer broaden use of its vaccine Abrysvo to younger adults whose medical history puts them at higher risk.
Leap Consulting launches practice to assist labs with FDA’s LDT ruling
Pharmaceutical Technology
AUGUST 12, 2024
Leap Consulting Group has launched a practice aimed at guiding Clinical Laboratory Improvement Amendments-certified labs (CLIA) in adhering to the US Food and Drug Administration’s (FDA) Final Rule over the classification of laboratory-developed tests (LDTs).
Following FDA rejection, a journal retracts papers on MDMA-assisted therapy
Bio Pharma Dive
AUGUST 12, 2024
Editors at Psychopharmacology cited "unethical conduct" that the study authors didn't disclose when submitting the papers. Lykos Therapeutics says it filed a complaint with a third party to review the way the journal came to its decision.
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Startup Halda raises $126M to advance new type of targeted cancer therapy
Bio Pharma Dive
AUGUST 12, 2024
Technology emerging from Yale researcher Craig Crews’ labs will be used to target prostate and breast cancer in early clinical trials.
Blue Earth and Seibersdorf expand radiopharmaceutical manufacture deal
Pharmaceutical Technology
AUGUST 12, 2024
Blue Earth Therapeutics' collaboration with Seibersdorf Labor will include the production of investigational 225Ac-based radioligand therapy.
Ascendis scores hard-fought FDA nod for hormone replacement therapy Yorvipath
Fierce Pharma
AUGUST 12, 2024
Ascendis Pharma should be well prepared for the U.S. | After two delays, the FDA has finally signed off on Ascendis Pharma's hormone replacement therapy Yorvipath, also known as TransCon PTH, which is the first approved product for hypoparathyroidism in adults in the U.S.
FDA approves Sandoz’s Enzeevu as Eylea biosimilar saga continues
Pharmaceutical Technology
AUGUST 12, 2024
As Regeneron and Bayer fend off competition for Eylea copycats in the courts, Sandoz says Enzeevu will be a “key biosimilar value driver.
The New Age of Decentralized Clinical Trials
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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
NICE updates on controversial multiple myeloma decisions
pharmaphorum
AUGUST 12, 2024
Three controversial decisions by NICE on NHS use of new multiple myeloma therapies are heading for the end of comment and appeals processes.
Patient with rare neurodegenerative disorder improves with non-profit’s ASO therapy
Pharmaceutical Technology
AUGUST 12, 2024
Seizures in a patient with KIF1A-associated neurological disorder (KAND) fell from 100 – 290 a day to under 30 per week after treatment.
FDA clears first anaphylaxis nasal spray at second attempt
pharmaphorum
AUGUST 12, 2024
ARS Pharma gets FDA approval for epinephrine nasal spray neffy, the first needle-free alternative to EpiPen-style autoinjectors for serious allergic reactions.
FDA rejects Lykos MDMA therapy, asks for another Phase III trial
Pharmaceutical Technology
AUGUST 12, 2024
The company plans to ask the US FDA to reconsider its request for an additional Phase III trial for the approval of its MDMA capsules.
Daxxify maker Revance agrees to $924M buyout by private skin care company Crown Laboratories
Fierce Pharma
AUGUST 12, 2024
After treading the commercial path alone for the past year and change, Revance Therapeutics, maker of the Botox rival Daxxify, has agreed to fly the Crown Laboratories flag. | Revance and Crown Laboratories—a privately held skin care company with multiple marketed products of its own—are merging, the companies said in a release Monday. Under the deal, which has won the unanimous blessing of Revance’s board of directors, Crown will enter a tender offer to acquire all outstanding Revance stock for
Sable Therapeutics and Columbia sign deal on obesity treatments
Pharmaceutical Technology
AUGUST 12, 2024
Sable Therapeutics has signed an agreement with Columbia University to develop new polycation nanomedicines aimed at treating obesity.
Hypercube — Tackling AI Hallucinations in Medical Summaries
XTalks
AUGUST 12, 2024
Mendel AI and the University of Massachusetts Amherst (UMass Amherst) have published key data on addressing the critical issue of hallucinations in AI-generated medical summaries using a pioneering artificial intelligence (AI) framework called “Hypercube”. This collaboration is a step forward in ensuring the reliability and safety of AI applications in healthcare.
Pfizer touts positive topline data for RSV vaccine Abrysvo
Pharmaceutical Technology
AUGUST 12, 2024
Abrysvo was found to be safe in immunocompromised adults at risk for developing RSV-associated lower respiratory tract disease.
The New Age of Decentralized Clinical Trials
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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.
After icodec rejection, Novo Nordisk plots 2024 FDA filing for once-weekly insulin and semaglutide combo
Fierce Pharma
AUGUST 12, 2024
Despite hitting a roadblock on the path to approval for its once-weekly insulin icodec in the U.S., Novo Nordisk is continuing to move full speed ahead with a combo treatment pairing the drug with | Despite hitting a roadblock on the path to approval for its once-weekly insulin icodec in the United States, Novo Nordisk is continuing to move full speed ahead with a combo treatment pairing the drug with its unstoppable GLP-1 semaglutide.
FDA approves IASO Bio’s IND for equecabtagene autoleucel
Pharmaceutical Technology
AUGUST 12, 2024
IASO Biotherapeutics has secured the US Food and Drug Administration (FDA) approval equecabtagene autoleucel (Eque-cel).
Maintaining a Specialty Medication Regimen
Pharmaceutical Commerce
AUGUST 12, 2024
In this part of his Pharma Commerce video interview, Josh Marsh, Vice President and General Manager of Cardinal Health Sonexus Access and Patient Support, discusses the impact technology has in relation to patients sticking to their medication plan.
FDA approves IASO Bio’s IND for equecabtagene autoleucel
Pharmaceutical Technology
AUGUST 12, 2024
IASO Biotherapeutics has secured the US Food and Drug Administration (FDA) approval equecabtagene autoleucel (Eque-cel).
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Another AIM defection as BiVictriX plans to delist
pharmaphorum
AUGUST 12, 2024
BiVictriX is the latest UK biotech to say it wants to cancel its AIM-listed shares and go private in pursuit of better financing opportunities.
UCL study reveals routine blood tests could improve early cancer diagnosis
Pharma Times
AUGUST 12, 2024
Bowel cancer was the most common cancer to be identified in both men and women
Ajinomoto will lay off 71 staffers in CA to streamline CDMO business following $620M Forge Biologics buy
Fierce Pharma
AUGUST 12, 2024
Following last year’s acquisition of viral vector and plasmid specialist Forge Biologics, Japan’s Ajinomoto Bio-Pharma Services is streamlining its business in San Diego. | Following last year’s acquisition of viral vector and plasmid specialist Forge Biologics, Japan’s Ajinomoto Bio-Pharma Services is streamlining its business in San Diego. As a result, 71 California-based staffers—or 13% of the company’s overall workforce—are set to lose their jobs, Ajinomoto said in a memo shared with Fierce
MSD adds bispecific cancer antibody via $1.3bn Curon deal
pharmaphorum
AUGUST 12, 2024
MSD adds a bispecific antibody for blood cancers and autoimmune diseases to its pipeline via a $1.3bn licensing deal with Curon Biopharma.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Pfizer, looking to expand RSV vaccine's reach, touts its benefits in immunocompromised adults
Fierce Pharma
AUGUST 12, 2024
Locked in a closely watched respiratory syncytial virus (RSV) vaccine competition, Pfizer aims to expand the reach of its offering Abrysvo. | Locked in a closely watched RSV vaccine competition, Pfizer aims to expand the reach of its offering Abrysvo. Monday, Pfizer said Abrysvo elicited a strong response in adults with compromised immune systems.
Article retractions muddy MDMA waters after FDA denial
pharmaphorum
AUGUST 12, 2024
Journal retracts three articles on MDMA-assisted psychotherapy, shortly after FDA blocks approval of @Lykos_PBC's therapy for PTSD
Genetic causes of colorectal cancer revealed in new study
Drug Discovery World
AUGUST 12, 2024
A new study has provided the most comprehensive analysis to date of the genetic makeup of colorectal cancer (CRC), providing unique understanding of its response to treatment. The research was led by UK universities, including the University of Oxford, The Institute of Cancer Research, London, the University of Manchester and the University of Leeds.
Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious
FDA Law Blog
AUGUST 12, 2024
By Sara W. Koblitz — In the world of patent term extensions, every day considered part of the regulatory review period is important, as that day—either in whole or in part—gets added back to the patent upon approval of the product. In the veterinary world, where rolling applications are common, the testing phase is usually particularly important because the review phase, which starts only when the last component of the rolling New Animal Drug Application (NADA)—called the Administrative NADA—is
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
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