Tue.Feb 06, 2024

article thumbnail

AstraZeneca brings its cell therapy ambitions to Maryland with $300M plant investment, 150 planned hires

Fierce Pharma

Following a slew of cell therapy biotech team-ups, AstraZeneca is taking manufacturing into its own hands. | AstraZeneca is plugging $300 million into a new facility in Rockville, Maryland, to launch its cell therapy platforms in the United States for cancer trials and future commercial supply. In turn, AZ will create more than 150 new jobs.

article thumbnail

Overcoming Hearing Healthcare Barriers to Realize Gene Therapy Promise

MedCity News

The preliminary results from three clinical trials administering gene therapy to address deafness from otoferlin mutations mark inspiring and incredible progress in hearing healthcare.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Already rolling in diabetes and obesity, Eli Lilly touts tirzepatide's midstage MASH win

Fierce Pharma

In a midstage trial, Eli Lilly’s star diabetes and weight-loss drug tirzepatide showed promise in fatty liver disease, a difficult-to-treat condition that doesn’t yet have an FDA-approved therapy.< | Eli Lilly's star diabetes and weight loss drug tirzepatide showed promise in fatty liver disease with a massive anti-MASH benefit accompanied by a "clinically meaningful" anti-fibrosis effect.

FDA 286
article thumbnail

Alternative therapies are needed to combat the impending threat of AMR

Pharmaceutical Technology

The potentially disastrous consequences of antimicrobial resistance (AMR) were highlighted at the recent World Economic Forum Meeting 2024.

135
135
article thumbnail

Roles and Responsibilities of Specialized Clinical Supply Experts

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.

article thumbnail

Eli Lilly mounts clinical and commercial case for tirzepatide as Mounjaro, Zepbound chalk up major gains

Fierce Pharma

Locked in a heated battled with Novo Nordisk’s semaglutide franchise, Eli Lilly’s tirzepatide is beginning to come into its own—both with regards to sales and amid attempts to show the dual GIP/GLP | Locked in a heated battled with Novo Nordisk’s semaglutide franchise, Eli Lilly’s tirzepatide is beginning to come into its own—both with regards to sales and amid attempts to show the dual GIP/GLP-1 agonist can strike out beyond diabetes and obesity.

Sales 278
article thumbnail

Novartis’s MorphoSys Acquisition Comes With Cancer Drugs & Antitrust Questions

MedCity News

Novartis’s €2.7B acquisition of MorphoSys brings two cancer drug candidates, one of which would give the pharmaceutical giant a way to stand apart from other myelofibrosis treatments. In a separate deal, MorphoSys sold to Incyte its rights to a partnered blood cancer drug.

More Trending

article thumbnail

Blue Cross Blue Shield of Massachusetts Introduces New Women’s Health Offerings

MedCity News

Blue Cross Blue Shield of Massachusetts has launched a new reproductive health care team and has partnered with Maven Clinic for 24/7 reproductive health support.

117
117
article thumbnail

With Merck, J&J and BMS CEOs set to testify, Sanders releases scathing report on drug prices

Fierce Pharma

Two days ahead of a Senate hearing in which CEOs from three pharma majors will testify, Sen. | Two days ahead of a Senate hearing in which CEOs from three pharma majors will testify, Sen. Bernie Sanders has released a report shedding light on the system that allows the companies to charge more for drugs in the U.S. than in any other country.

Pharma 241
article thumbnail

What Primary Care’s “Barnes & Noble Moment” Means for the Future of Digital Health

MedCity News

Primary care is essential to living healthier lives, and we need all forms of it, from small local practices to big health systems and retail chains. Ultimately, it’s going to be all primary care hands on deck, working together to make a lasting change for the health of Americans.

Retail 111
article thumbnail

As Vertex gears up for next-gen CF treatment, Trikafta sales reach $8.9B thanks to label expansions

Fierce Pharma

On a day when Vertex revealed trial data that indicate | On a day when Vertex revealed trial data that indicate its next-generation cystic fibrosis (CF) treatment will soon be ready to grab the baton, the Boston company also presented figures that show Trikafta remains formidable. In the fourth quarter, Trikafta raked in $2.33 billion in sales, bringing its 2023 haul to $8.9 billion, a 16% increase from 2022.

Sales 219
article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

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.

article thumbnail

The Correlation Between a New York State Law Repeal and Vaccine Coverage in Schools

Pharmaceutical Commerce

A cohort study investigates the impact of Senate Bill 2994A and answers the question: does the repeal of school-entry nonmedical vaccination exemptions result in a rise in school vaccinations?

110
110
article thumbnail

Incyte picks up full Monjuvi rights from partner MorphoSys for $25M

Fierce Pharma

Shortly before Novartis revealed a $2.9 billion buyout of cancer drugmaker MorphoSys, Incyte secured its own piece of the pie. | While Incyte gained more rights to lymphoma med Monjuvi, Novartis claimed the rest of MorphoSys for €2.7B on Monday. Incyte previously bought into a Monjuvi collaboration for $750 million ahead of the drug's 2020 approval.

204
204
article thumbnail

Ambience Healthcare Rakes In $70M for Documentation Tech That One Customer Calls ‘Close to Perfection’

MedCity News

SaaS startup Ambience Healthcare raised $70 million from investors including OpenAI, Andreessen Horowitz, Optum Ventures and Kleiner Perkins. The San Francisco-based company offers tools to alleviate clinicians’ burnout by helping them with documentation, coding, referrals and after-visit summaries.

article thumbnail

Cedars-Sinai mental health app launches on Apple Vision Pro

pharmaphorum

Right after the official launch of the new Apple Vision Pro mixed reality headset, Cedars-Sinai has launched a generative artificial intelligence (genAI) app that will use the technology to provide mental health support for patients.

Patients 105
article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

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.

article thumbnail

Uncovering the Hidden Insights in Clinical Trial Documents: Critical Steps to Intelligent Document Processing

MedCity News

In clinical trials, pharmaceutical companies are seeking to optimize operations and improve efficiency by automating and enhancing processes through Artificial Intelligence (AI) and Machine Learning (ML). One area where this can reap tangible benefits across clinical trials is in data processing. A typical clinical trial generates over 13,000 documents in various formats (text, voice, video, apps, and web entries), making data gathering, organization and analysis challenging.

article thumbnail

Vertex seeks swift review of new CF triple after ph3 readout

pharmaphorum

Vertex will use a priority review voucher to speed up FDA review of its new triple therapy for cystic fibrosis, which has just cleared a phase 3 programme

FDA 94
article thumbnail

Eli Lilly Fatty Liver Drug Posts Promising Early Data, But Field Is Still Competitive

MedCity News

Eli Lilly reported 74% of patients treated with tirzepatide achieved resolution of metabolic dysfunction-associated steatohepatitis, or MASH. However, the Phase 2 results showed only “clinically meaningful” improvement in resolving liver fibrosis, a key measure of the drug’s potential competitiveness in a crowded field of contenders.

article thumbnail

Health Canada approves Chiesi’s MYALEPTA for lipodystrophy

Pharmaceutical Technology

Health Canada has approved Chiesi Global Rare Diseases’ MYALEPTA as a treatment for individuals with lipodystrophy, an ultra-rare condition.

98
article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

article thumbnail

Lower BMI, Raise ROI: How Physician Practices Can Boost Revenues with Turnkey Weight Management Program [Sponsored]

MedCity News

The webinar, scheduled for March 6 at 2pm ET and sponsored by Build My Health, will discuss several topics related to weight management including: an overview of GLP-1 weight loss medication, automation in a subscription-based weight management program, and the rise of provider-to-consumer (PTC) models.

article thumbnail

Metagenomi prices IPO and NeOnc joins list of hopefuls

pharmaphorum

Gene-editing startup Metagenomi and cancer specialist NeOnc Technologies have announced the terms of their initial public offerings

96
article thumbnail

Suanfarma realigns brand to showcase innovative spirit

European Pharmaceutical Review

Suanfarma has announced a strategic rebranding initiative to reinforce Suanfarma’s position as a global player in the healthcare sector, both as a distributor of active pharmaceutical ingredients (APIs) and as a contract development and manufacturing organisation (CDMO) in the production of APIs. In this manner, Suanfarma´s sites, Cipan and Rovereto, are now acknowledged as part of a global and unified brand.

article thumbnail

More pharma M&A as Novartis snaps up MorphoSys for $2.9bn

pharmaphorum

Novartis has agreed to buy Germany's MorphoSys in a transaction that values the cancer-focused biotech at $2.

Pharma 103
article thumbnail

The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.

article thumbnail

New Year, New Aspirations

Pharmaceutical Commerce

Pharma Commerce's new style is built off of the back of our new and improved editorial calendar.

Pharma 105
article thumbnail

Pfizer partners American Cancer Society on health equity

pharmaphorum

A $15m initiative between Pfizer and the American Cancer Society aims to tackle unequal access to care in the US.

98
article thumbnail

Study reveals blood test can pinpoint cause of brain injury in newborns

PharmaTimes

Hypoxic-ischaemic encephalopathy affects around three million babies worldwide every year

109
109
article thumbnail

Why a former BMS exec calls her new CEO role ‘unfinished business’ in cancer care

PharmaVoice

With a focus on her “three pillars” of being a CEO, Caroline Loew explains how she’s building a new company culture at an Alkermes spinoff — and a pipeline that offers a next-gen approach to oncology.

69
article thumbnail

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

article thumbnail

The Value of 3PLs

Pharmaceutical Commerce

The February issue is centered around third-party logistics providers, including new dynamics and future trends that affect this key supply chain link.

59
article thumbnail

‘Beginning of the end’ for small molecules? VCs brace for Medicare investment gap

PharmaVoice

The "small molecule penalty" becomes even riskier for investors as the IRA negotiates prices, and VCs and lawmakers are looking to get a jump on those headwinds.

69
article thumbnail

Medicare Advantage Policy and Regulation Updates: What Payers Need to Know in 2024 and Beyond

Clarify Health

Medicare Advantage enrollment continues to grow. More than half of all eligible people with Medicare are in a Medicare Advantage plan. But that doesn’t mean it’s been smooth sailing for Medicare Advantage leaders. CMS continues to issue updated policies and brand-new regulations for MA plans to follow, with the overarching goal of improving transparency, easing access to care, and empowering consumer choice.

article thumbnail

Mobile Sales Enablement: Key Tools & How To Choose

Spotio

Sales continues to evolve, but one thing will always stay the same: the importance of sales enablement, i.e. the process of giving sales reps the resources they need to close deals. Think about it, without a quality sales enablement plan in place, your reps won’t be as effective as they could be, which will result in lackluster sales numbers and disappointing revenue.

Sales 52
article thumbnail

Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.