PharmExec
SEPTEMBER 14, 2023
Lung-I Cheng, vice president of cell and gene therapy (CGT), Cencora (formerly AmerisourceBergen), discusses CGT commercialization strategies, common knowledge gaps, and what he wishes companies knew about commercialization strategies.
Fierce Pharma
SEPTEMBER 11, 2023
Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.
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MedCity News
SEPTEMBER 12, 2023
U.K. doctor David Watkins has been a public critic of Babylon Health for years, during which has received anonymous emails from Babylon employees saying that the company’s AI is a sham. After Babylon collapsed, a former employee also publicly declared that the AI engine was faulty. As a longtime skeptic of Babylon’s claims surrounding its technology, Watkins said that Ali Parsa, the company’s CEO, belongs behind bars.
European Pharmaceutical Review
SEPTEMBER 12, 2023
As part of The Future of Pharma/Biopharma Analysis 2023 , which took place on 28-29 June 2023, European Pharmaceutical Review ( EPR ) gathered an expert panel to discuss developing a modern contamination control strategy. The participants were: Dr Tim Sandle, Head of GxP Compliance at Bio Products Laboratory Limited (BPL) as moderator; Dr Edward Tidswell, Executive Director within the Microbiological Quality and Sterility Assurance organisation of Merck & Co; Frederic Ayers, Research Scienti
Copyright Clearance Center
SEPTEMBER 12, 2023
September 12, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, today announced Gold Open Access (OA) publisher Frontiers has adopted the industry-leading Ringgold Identify Database as its Persistent Identifier (PID) solution to help power its OA models by normalizing and disambiguating organization data.
Fierce Pharma
SEPTEMBER 13, 2023
For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. | For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. But on Tuesday, an FDA advisory committee agreed by a 16-0 vote that the ingredient does not work.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
European Pharmaceutical Review
SEPTEMBER 15, 2023
The CBL-0201DD Phase II study evaluating the first-in-class small-molecule drug CBL-514 for Dercum’s disease, a rare disorder, has demonstrated significant efficacy in reducing lipoma size and complete clearance. Dercum’s disease is characterised by painful lipomas developing primarily on the trunk in the body. Currently there are no approved or effective medicine, so the data from the Phase II study shows potential of a treatment for this indication.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Kroger's settlement, alongside the review of the Purdue Pharma bankruptcy case, is proof that the opioid reckoning isn't over yet.
Fierce Pharma
SEPTEMBER 15, 2023
Questions first circulated about decongestant pills containing phenylephrine in 2007. | Several companies, including Johnson & Johnson, GSK, Procter & Gamble and Walgreens, face class-action lawsuits that claim the drugmakers knew that over-the-counter cold and flu pills containing phenylephrine did not work as advertised.
MedCity News
SEPTEMBER 15, 2023
The federal government has warned hospitals that using third-party analytics tools on their websites could violate HIPAA, and more than 20 hospitals are facing class-action lawsuits over the use of these tools. But a recent analysis found that hospitals are doing a poor job of fixing their websites and preventing patient data collection.
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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.
European Pharmaceutical Review
SEPTEMBER 14, 2023
Under a new agreement, AstraZeneca is set to establish the first unsubsidised industrial-scale supply of biomethane. The pharmaceutical firm is investing greatly in its existing infrastructure to facilitate the shift to renewable gas and support a transition to 100 percent renewable energy. This includes its Macclesfield campus, the UK’s largest pharma manufacturing site.
Medgadget
SEPTEMBER 14, 2023
Researchers at the University of California San Francisco have developed a brain computer interface that can lets someone with severe paralysis communicate with both speech and facial expressions, in the form of a digital avatar. The breakthrough advances what has been possible, with previous brain computer interface systems providing speech only, and allows people to communicate more completely, encompassing facial expressions, which are an important aspect of natural communication.
Fierce Pharma
SEPTEMBER 12, 2023
The CDC wants to reset expectations for flu vaccines to correct falling uptake. | The CDC wants to reset expectations for flu vaccines to correct falling uptake. After tracking declines in vaccine use in pregnant people and children, the health body has initiated its “Wild to Mild” campaign to raise awareness of the benefits of vaccination and encourage more people to get their shots.
MedCity News
SEPTEMBER 13, 2023
Healthcare IT companies raised $1 billion in venture capital in Q2 — down slightly from the $1.3 billion raised in Q1 but up significantly from the $451.3 million raised in Q4 2022. Unsurprisingly, a lot of these investments were made in companies offering generative AI products. Another key trend was increasing cash flow to remote patient monitoring startups, likely caused by expanded reimbursement for these services.
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Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr
European Pharmaceutical Review
SEPTEMBER 12, 2023
The next generation of therapeutics has arrived: from simple design and development to theoretically unlimited targets, messenger RNA ( mRNA )‑based therapeutics offer a multitude of benefits. However, creating these innovative treatments harbours challenges. This article explores common developmental and design issues and how to mitigate difficulties before they occur.
PharmExec
SEPTEMBER 11, 2023
Integrating artificial intelligence and advanced analytics throughout operations offers pharma companies a pathway to offset impending drug patent expirations.
Fierce Pharma
SEPTEMBER 12, 2023
Xspray Pharma, before receiving an FDA slapdown in July, had expected to launch its competitor to Bristol Myers Squibb’s leukemia blockbuster Sprycel within the second half of 2023. | Xspray and BMS have settled patent litigation around their potential rivals Dasynoc and Sprycel, Xspray said Tuesday. The deal clears “all pending claims” and tees up a potential Dasynoc launch on Sept. 1, 2024, or potentially earlier under certain circumstances.
MedCity News
SEPTEMBER 11, 2023
Moderna and Immatics aim to see if the combination of their respective technologies can lead to better cancer treatments spanning multiple therapeutic modalities. Milestone payments to immunotherapy developer Immatics could top $1.7 billion.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
European Pharmaceutical Review
SEPTEMBER 14, 2023
Rimegepant (Vydura) is the “first and only NICE-recommended medicine that can help alleviate the misery of acute migraines, and may be considered a step-change in treatment,” shared Helen Knight, Director of medicines evaluation at the National Institute for Health and Care Excellence (NICE). Made by Pfizer, Rimegepant (Vydura), is recommended in NICE final draft guidance for adults who have tried at least two triptans but failed to achieve adequate relief with these medicines.
PharmaTech
SEPTEMBER 14, 2023
The companies are collaborating to apply ShapeTX’s AAVid capsid discovery platform and transgene engineering technology in addition to Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for eye diseases.
Fierce Pharma
SEPTEMBER 11, 2023
Competing to treat patients with severe eosinophilic asthma (SEA), AstraZeneca has fared well matching its IL-5 inhibitor Fasenra up against GSK’s Nucala. | AstraZeneca's Fasenra has achieved its primary endpoint in a phase 3 trial, demonstrating noninferior rates of remission in a head-to-head battle against GSK's Nucala in patients with eosinophilic granulomatosis with polyangiitis.
MedCity News
SEPTEMBER 14, 2023
This week, senators introduced a bipartisan bill that would make it a federal crime to assault hospital workers. Even though nearly 40 states have passed laws to intensify penalties for violent acts committed against healthcare personnel, there is currently no federal law protecting hospital employees from assault or intimidation.
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European Pharmaceutical Review
SEPTEMBER 12, 2023
Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months. Data predicted that in 2030, more than half of US Food and Drug Administration (FDA)-approved drugs will involve AI in their development and/or manufacturing.
Pharmaceutical Technology
SEPTEMBER 12, 2023
The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.
Fierce Pharma
SEPTEMBER 15, 2023
Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophreni | Lyndra Therapeutics is laying off staff two months after a CEO swap and as interim data from a pivotal trial for a schizophrenia drug nears. The company's lead asset is a long-acting, oral version of Johnson & Johnson's Uzedy.
MedCity News
SEPTEMBER 14, 2023
By making large amounts of diverse data widely available, healthcare institutions can feel confident about the evaluation, creation, and validation of algorithms as they’re transitioned from ideation to use.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
European Pharmaceutical Review
SEPTEMBER 12, 2023
A T-cell epitope cancer vaccine significantly improved overall survival in non-small cell lung cancer (NSCLC) compared to chemotherapy, Phase III data published in Annals of Oncology has shown. The immunotherapy activating tumour specific T-cells, off-the-shelf, neoepitope-based vaccine Tedopi ® was evaluated in HLA-A2 positive patients with advanced or metastatic NSCLC in monotherapy in third line NSCLC with secondary resistance to immune checkpoint inhibitors, in the Phase III clinical trial A
Medgadget
SEPTEMBER 14, 2023
Researchers at the National University of Singapore have developed a highly sensitive pressure sensor that can provide haptic feedback for surgeons using laparoscopic tools or for use in robotic grippers as part of robotic surgical systems. The technology is inspired by the surface of the lotus leaf, which is extremely sensitive to the pressure exerted by tiny drops of water and will repel them.
Fierce Pharma
SEPTEMBER 11, 2023
Ahead of an important advisory committee meeting, the FDA has raised serious questions about Alnylam’s bid to expand Onpattro into a much larger group of patients with transthyretin amyloidosis (AT | The FDA has raised questions about Alnylam's Onpattro as the company seeks to expand the drug into a much larger group of patients with transthyretin amyloidosis (ATTR).
MedCity News
SEPTEMBER 12, 2023
Talkiatry, Array Behavioral Care, Iris Telehealth and Quartet Health sent a letter to the DEA asking for a special registration process that would allow for the prescribing of certain controlled medications via telemedicine.
Advertiser: ZoomInfo
In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.
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