Thu.Sep 26, 2024

article thumbnail

Roche looks to grow Gazyva's reach with phase 3 lupus nephritis win

Fierce Pharma

After collecting a handful of oncology approvals since its first leukemia nod in 2013, Roche’s Biogen-partnered Rituxan successor, Gazyva, is chasing new horizons in active lupus nephritis. | In a phase 3 study called REGENCY, a statistically higher proportion of lupus nephritis patients treated with biannual intravenous Gazyva doses and standard autoimmune disease therapy achieved complete renal responses at 76 weeks compared to those treated with standard therapy alone, Genentech reported Thur

Patients 223
article thumbnail

Vicebio raises $100m for vaccines and other bio financings

pharmaphorum

Our periodic round-up of financings in the biotech sector is led by an impressive nine-figure round for UK vaccines developer Vicebio, with GC Therapeutics, Genespire, and 858 Therapeutics also in on the action.London, UK-based Vicebio raised $100 million in a Series B that will help to fund the development of its Molecular Clamp technology to produce improved, more potent vaccines that are simpler to manufacture.

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

Experts support FDA's plan for biomarker-based restriction on PD-1 drugs in stomach cancer

Fierce Pharma

The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. | The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. A group of external advisers to the FDA voted 10-2 that the use of PD-1 inhibitors in first-line, HER2-negative gastric cancer is not favorable in patients who have PD-L1-negative tumors.

FDA 210
article thumbnail

Unpacking the Epic-Particle Health Dispute: When It Started, What’s Being Alleged & What It Means for the Industry

MedCity News

Following a months-long dispute, data platform Particle Health filed an antitrust lawsuit against Epic, alleging that the EHR giant is using its dominance in the market to prevent competition in the payer platform space. Particle believes the lawsuit is an “unprecedented challenge” to Epic’s market power, while Epic thinks the startup’s claims are “baseless.

article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

AstraZeneca’s Tagrisso follows up ASCO standing ovation with key lung cancer FDA nod

Fierce Pharma

In June, at the American Society of Clinical Oncology (ASCO) conference in Chicago, when AstraZeneca discussed results from a phase 3 trial of its non-small cell lung cancer (NSCLC) blockbuster Tag | In June at the ASCO conference in Chicago, when AstraZeneca discussed results from a phase 3 trial of its non-small cell lung cancer blockbuster Tagrisso, the presentation received a standing ovation.

FDA 185
article thumbnail

MedCity Pivot Podcast: How AI Can Help in Cancer

MedCity News

Dr. Timothy Showalter talks about how AI can be a powerful force in recommending treatment for cancer patients. He is Artera’s chief medical officer and the company has built a digital pathology tool for prostate cancer patients. The post MedCity Pivot Podcast: How AI Can Help in Cancer appeared first on MedCity News.

Medical 100

More Trending

article thumbnail

Exercise Benefit in a Pill: BioAge Labs Goes Public, Raising More Than $200M for Clinical Trials

MedCity News

BioAge Labs’ lead drug candidate, azelaprag, is in Phase 2 testing in combination with Eli Lilly’s weight management medication Zepbound. The biotech’s oral drug activates a receptor it says can mimic certain biological effects of exercise. The post Exercise Benefit in a Pill: BioAge Labs Goes Public, Raising More Than $200M for Clinical Trials appeared first on MedCity News.

article thumbnail

Mirai Bio launches with plan to help genetic med developers

pharmaphorum

Flagship Pioneering's latest biotech launch, Mirai Bio, aims to help genetic medicine developers find the best way to get their drugs to patients.The new Cambridge, Massachusetts-based company – which was set up in 2021 but makes its official launch today with $50 million in funding from Flagship – applies artificial intelligence to solve the various obstacles that can block the progress of new medicines.

article thumbnail

Battle of the Budget: Employers vs. Rising Healthcare Costs

MedCity News

Don’t miss this opportunity to gain valuable knowledge and practical insights on how employers are addressing an increasingly complex healthcare budget landscape. The post Battle of the Budget: Employers vs. Rising Healthcare Costs appeared first on MedCity News.

article thumbnail

Obesity drug developer BioAge raises $198m in IPO

pharmaphorum

BioAge Labs has completed its upsized initial public offering (IPO), raising $198 million after increasing the number of shares on offer by 40%. The expansion of the listing reflects the massive investor appetite for companies with assets in the clinic for obesity and takes the on-paper value of the Richmond, California-based company above $600 million.

89
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

BetterHelp, Talkiatry Collaborate To Offer Psychiatric Services to Employers

MedCity News

Through a new partnership, employees of BetterHelp’s employer clients can access Talkiatry’s psychiatry services on an in-network basis at no extra cost. The post BetterHelp, Talkiatry Collaborate To Offer Psychiatric Services to Employers appeared first on MedCity News.

article thumbnail

Second Niemann-Pick approval brings more hope to patients

pharmaphorum

IntraBio claims FDA approval for its Aqneursa therapy for Niemann-Pick type C, the second new drug for the disease in four days

Patients 103
article thumbnail

Personalize Patient Care with Confidence Through Efficient, HIPAA-Compliant Data Usage

MedCity News

Responsible procurement and handling of data and digital marketing insights by hospitals can generate useful information to improve patient wellness and operational efficiency without compromising compliance. The post Personalize Patient Care with Confidence Through Efficient, HIPAA-Compliant Data Usage appeared first on MedCity News.

article thumbnail

AZ gets sought-after lung cancer approval for Tagrisso

pharmaphorum

AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population that until now had no targeted treatments. The US regulator has cleared Tagrisso (osimertinib) for patients with stage 3 non-small cell lung cancer (NSCLC) expressing EGFR exon 19 or exon 21 (L858R) mutations that cannot be treated with surgery and has been previously treated with chemoradiotherapy.

FDA 85
article thumbnail

How to Stay Competitive in the Evolving State of Martech

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

article thumbnail

How Health Systems Can Bridge Gaps in Health Equity

MedCity News

To effectively address health disparities, organizations must implement health equity strategies that target systemic barriers and root causes. Here are strategies that can help drive comprehensive, system-wide change. The post How Health Systems Can Bridge Gaps in Health Equity appeared first on MedCity News.

article thumbnail

MSD hits a hurdle with its LAG-3 programme

pharmaphorum

MSD's combination of PD-1 inhibitor Keytruda and experimental LAG-3 inhibitor favezelimab has failed a phase 3 trial in patients with previously treated PD-L1-positive microsatellite stable (MSS) metastatic colorectal cancer.An analysis of data from the 447-patient KEYFORM-007 study revealed that the fixed-dose combination of Keytruda (pembrolizumab) and favezelimab was unable to extend overall survival (OS) compared to standard care with kinase inhibitor regorafenib and trifluridine and tipirac

article thumbnail

Drug Solutions Podcast: Alternative Drug Delivery Methods for Biologics: Where Are We At?

PharmaTech

In this podcast episode, we discuss both the challenges of and the progress made so far by the biopharma industry toward non-parenteral means of delivering biologic drugs.

article thumbnail

Roivant’s magic trick: Finding the ‘weird-shaped’ pieces around Big Pharma’s cookie cutters

PharmaVoice

Roivant CEO Matt Gline leads the company on a unique path by placing bets on misfit drugs and technologies — and it’s working.

Leads 64
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

article thumbnail

Cell and Gene Therapy Production Facilities

PharmaTech

In this episode of the Ask the Expert video series, Peter Walters, Fellow of Advanced Therapies at CRB Group, discusses factors to be considered in constructing a new facility for cell and gene therapy production as well as using an existing facility to expand cell and gene therapy pipelines.

59
article thumbnail

FDA Approves Tagrisso for Unresectable Stage III Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer

PharmExec

Tagrisso was approved under a Priority Review based on the pivotal LAURA Phase III trial in adults with unresectable stage III epidermal growth factor receptor-mutated non-small cell lung cancer.

FDA 52
article thumbnail

Bormioli Pharma Display at CPHI Milan to Include Low-Impact, Pharma-Grade Product Range

PharmaTech

The EcoPositive range, which comprises 50% of Bormioli Pharma’s current standard catalog and is composed of three distinct sustainability approaches, offers more than 3000 industrial solutions, in glass and plastic.

Pharma 52
article thumbnail

WHO guidance aims to strengthen clinical trial ecosystem

European Pharmaceutical Review

New global guidance on best practices to improve clinical trials has been released by the World Health Organization (WHO). Fundamentally, the document offers approaches aimed at enhancing the design, conduct and oversight of clinical trials, to strengthen country-led R&D ecosystems. The guidance is relevant to clinical trials including pharmaceutical medicines, vaccines, behavioural and psychological interventions, preventive care, as well as digital and public health approaches and traditio

Safety 52
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Attracting Top Talent to Mega Campuses

PharmExec

In this part of his Pharmaceutical Executive video interview,Jonathan Scheinberg, of the Northeast Science and Technology Center, talks about strategies companies can adopt to attract and retain top talent in these competitive mega campus locations.

article thumbnail

PharmaLab Congress 2024 – what’s new for the third year in Düsseldorf/Neuss

European Pharmaceutical Review

This year, PharmaLab Congress will be offering a diverse programme to professionals from analytical and microbiological quality control in the pharmaceutical industry, from contract laboratories, authorities and service providers. In 2022 and 2023, PharmaLab attracted more participants to Düsseldorf/Neuss than ever before. On the back of this success, the 12th PharmaLab Congress will again be held on site in Düsseldorf/Neuss from 25-27 November 2024.

article thumbnail

Raising Awareness About Breast Carcinoma : A Critical Public Health Priority

Pharmatutor

Raising Awareness About Breast Carcinoma : A Critical Public Health Priority admin Thu, 09/26/2024 - 16:11 About Author Devansh Mehta, Founder Director of TRM WRITER’S LLP AND MARKETMAVERICKS DIGITAL OPC PVT LTD Address : Flat no.

52
article thumbnail

Pharmaceutical Excellence Awards 2024: West Pharmaceutical Services 

Pharmaceutical Technology

West Pharmaceutical Services is a winner in the Safety category in the 2024 Pharmaceutical Technology Excellence Awards.

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

Study Suggests Semaglutide May Reduce Opioid Overdose Risk in Patients with Type 2 Diabetes

PharmExec

A new JAMA study indicates that semaglutide produced up to a 68% lower risk of opioid overdose for patients with type 2 diabetes compared to other antidiabetic medications.

article thumbnail

PCI Pharma Invests More Than $365 Million in New and Existing Facilities in US and EU

PharmaTech

A new Center of Excellence will be established at PCI Pharma Services’ location in Rockford, Ill., and two sites in Ireland will also benefit from the investment.

Pharma 52
article thumbnail

Launch Lessons: Bringing a Targeted Oncology Therapy to Market

PharmExec

Omnichannel marketing can help companies improve HCP engagement to facilitate the delivery of effective treatment to patients who desperately need and deserve it.

article thumbnail

Sheffield A&E to implement life-saving HIV and hepatitis testing

PharmaTimes

New government scheme to offer routine opt-out blood tests

article thumbnail

ABM Evolution: How Top Marketers Are Using Account-Based Strategies

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.