Tue.Mar 29, 2022

article thumbnail

Pfizer inflammatory disease drug hits goal in second study

Bio Pharma Dive

The drugmaker said etrasimod, an experimental medicine acquired via its Arena buyout, improved remission rates in the second of two studies meant to support its approval in ulcerative colitis.

Drugs 278
article thumbnail

Type 2 diabetes is a national health emergency

World of DTC Marketing

Healthy eating is your recipe for managing diabetes. More than 37 million Americans have diabetes (about 1 in 10), and approximately 90-95% have type 2 diabetes. Type 2 diabetes most often develops in people over age 45, but more and more children, teens, and young adults are also developing it. A study has found that people with type 2 diabetes were at higher risk of developing 57 health conditions than non-diabetics.

Insiders

Sign Up for our Newsletter

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

article thumbnail

FDA clears second COVID booster for older adults, immunocompromised

Bio Pharma Dive

Citing "some waning of protection over time," the agency authorized another dose of either Pfizer's or Moderna's shots for adults aged 50 years or older as well as for people with weakened immune systems.

152
152
article thumbnail

New liquid filling machine for sterile ophthalmic products – Oftalmica by Romaco Macofar

Pharma Mirror

Karlsruhe/Germany, Romaco Macofar’s Oftalmica was specially developed for aseptic filling of sterile eye drops, nasal sprays and injectables. Meeting all GMP requirements for safe processing of highly viscous, oily and foaming liquids, the machine additionally offers fast format changes and short cleaning times. The Oftalmica is Romaco Macofar’s latest technology for aseptic filling of sterile eye drops.

article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

Sanofi pays IGM $150M, continuing search for better antibody drugs

Bio Pharma Dive

The French pharmaceutical giant has inked its third antibody-focused deal since December, this time betting on a Californian biotech trying to pioneer a new class of medicines.

Antibody 130
article thumbnail

eTheRNA Manufacturing Announces New LNP Formulation Development and Production Service

Pharma Mirror

NIEL, BELGIUM, eTheRNA Manufacturing, a specialist RNA process developer and manufacturing member of the Belgian eTheRNA group, is introducing a new Lipid Nanoparticle (LNP) formulation development and production service to support the discovery and early pre-clinical development of RNA-based therapeutics and vaccines. This new LNP service uses eTheRNA’s proprietary lipid libraries and proprietary formulations to facilitate targeted delivery and tailored biodistribution solutions.

More Trending

article thumbnail

Vaccine equity: how the pandemic demonstrated global health inequality

pharmaphorum

With the rapid onset of the pandemic, the race to develop a viable vaccine quickly became a race to secure access to the developed vaccines. In this article, Ben Hargreaves examines how wealth determined the winners and what is now underway to help lower-income countries gain access to the available vaccines. At the beginning of the pandemic, there were two principal issues facing producing an effective vaccine: how can one be quickly developed, and how can production meet global demand?

article thumbnail

Sanofi and IGM Biosciences team up to develop antibody agonists

Pharma Times

Collaboration will involve the development of new class IgM antibodies with a view to gaining market approval

Antibody 119
article thumbnail

Ukraine war offers hard lessons for clinical research industry: H1

Outsourcing Pharma

A leader from the healthcare technology company discusses the conflictâs impact on the region and beyond and the need to better guard against interruptions.

article thumbnail

New report on tackling ethnic inequalities in diabetes care

Pharma Times

Charter for Change examines reasons for inequalities and sets out recommendations to improve diabetes care

118
118
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

FDA requests total of $8.4b for fiscal year 2023 budget

Outsourcing Pharma

The agency's requested funding for FY 2023, nearly 34% higher than for FY 2022, calls for investments in public health modernization and pandemic preparation.

article thumbnail

F.D.A. Allows Second Coronavirus Boosters for Everyone 50 and Older

NY Times

People in the age group can get the additional shot at least four months after their first booster. Those 12 and older with certain immune deficiencies are also eligible.

Drugs 87
article thumbnail

PBM Industry Update: Trends, Controversies, and Outlook (NEW Live Video Webinar)

Drug Channels

Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new video webinar: PBM Industry Update: Trends, Controversies, and Outlook. Broadcast live on April 22, 2022 , from 12:00 p.m. to 1:30 p.m. ET This page describes the event and explains how to purchase a registration to participate in the event.

article thumbnail

Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors

The Pharma Data

Ondexxya (andexanet alfa)has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the ANNEXA-4 Phase III clinical trial showing Ondexxya rapidly and markedly reversed anti-FXa activity in patients with acute major bleeding.

article thumbnail

The New Age of Decentralized Clinical Trials

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.

article thumbnail

New patent for Merlion Pharms drug XTORO

Drug Patent Watch

Annual Drug Patent Expirations for XTORO Xtoro is a drug marketed by Merlion Pharms Gmbh and is included in one NDA. There are three patents protecting this drug. This drug…. The post New patent for Merlion Pharms drug XTORO appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
article thumbnail

Pfizer Announces Positive Top-line Results from Yearlong Phase 3 Trial of Etrasimod in Ulcerative Colitis, Underscoring Best-in-Class Potential

The Pharma Data

ELEVATE UC 52 met the co-primary endpoints of clinical remission at both weeks 12 and 52 and all key secondary endpoints. – Etrasimod demonstrated a safety profile consistent with previous studies. Pfizer Inc. (NYSE: PFE) today announced positive top-line results from a second Phase 3 study of etrasimod, an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC).

Trials 52
article thumbnail

New patent for Ingenus Pharms drug CYCLOPHOSPHAMIDE

Drug Patent Watch

Annual Drug Patent Expirations for CYCLOPHOSPHAMIDE Cyclophosphamide is a drug marketed by Ani Pharms, Cipla, Hikma, Sti Pharma Llc, Amneal, Baxter Hlthcare, Jiangsu Pharms, Eugia Pharma Speclts, Ingenus Pharms Llc,…. The post New patent for Ingenus Pharms drug CYCLOPHOSPHAMIDE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
article thumbnail

Beyond Next Best Action: Achieving Omnichannel That Works

Pharma Marketing Network

Pharmaceutical companies have been successful for decades with a siloed marketing strategy. Rep-led field engagement, television advertising, and digital marketing have all been planned, executed, and measured separately, but customer expectations are changing fast. With the pandemic and the shift to mobile devices, customers are demanding more convenient and seamless ways to interact with pharma companies.

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

New patent for Almirall drug ACZONE

Drug Patent Watch

Annual Drug Patent Expirations for ACZONE Aczone is a drug marketed by Allergan and Almirall and is included in two NDAs. It is available from four suppliers. There are two…. The post New patent for Almirall drug ACZONE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
article thumbnail

Ep. 20: Cultural Competence For Global Marketing

Pharma Marketing Network

Tune in to this episode of the Pharma marketing Podcast, with our guest Wendy Pease, President of Rapport International and the author of The Language of Global Marketing for a conversation on why pharma should be thinking global from the start, addressing how to keep a consistent brand globally, and the many things that need to be considered when curating your global market.

article thumbnail

New patent for Sunovion Resp drug LONHALA MAGNAIR KIT

Drug Patent Watch

Annual Drug Patent Expirations for LONHALA+MAGNAIR+KIT Lonhala Magnair Kit is a drug marketed by Sunovion Resp and is included in one NDA. It is available from one supplier. There are…. The post New patent for Sunovion Resp drug LONHALA MAGNAIR KIT appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
article thumbnail

Does the answer to advancing rare disease treatment lie in real-world data?

pharmaphorum

What do 300 million people have in common? They are living with rare diseases that are defined by their scarcity within the general population. In the United States, this means fewer than one in 1,500 people; in the EU, fewer than one in 2,000. That is 5% of the world’s population. The rarity of these diseases means information about them is scarce, as there are often too few people in a geographic location to inform experts fully or to complete a clinical trial.

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

New patent for Impel Neuropharma drug TRUDHESA

Drug Patent Watch

Annual Drug Patent Expirations for TRUDHESA Trudhesa is a drug marketed by Impel Neuropharma and is included in one NDA. There are five patents protecting this drug. This drug has…. The post New patent for Impel Neuropharma drug TRUDHESA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
article thumbnail

eTheRNA Manufacturing extends CDMO activities in LNP field

BioPharma Reporter

eTheRNA Manufacturing, a specialist RNA process developer and manufacturing member of the eTheRNA group, has introduced a new lipid nanoparticle (LNP) formulation, development and production service.

article thumbnail

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

The Pharma Data

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 subvariant, now the dominant strain in Europe. AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a bro

article thumbnail

Prothena to begin early stage trial of Alzheimer’s disease targeted antibody

BioPharma Reporter

Prothena has announced FDA clearance of IND for PRX012, a subcutaneous anti-amyloid beta antibody under investigation for the treatment of Alzheimerâs disease (AD).

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

Federal judge enters consent decree against New Jersey raw animal food manufacturer

The Pharma Data

The U.S. Food and Drug Administration (FDA) announced today that Bravo Packing, Inc., an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Today’s action marks the first consent decree of permanent injunction against an animal food manufacturer for violating public safety standards under Part 507 (Current Good Manufacturing

article thumbnail

New blow for ALS pipeline as Biogen and Ionis candidate fails Phase 1 trial

pharmaphorum

Less than six months after the late-stage failure of tofersen, Biogen and Ionis have suffered further disappointment in the amyotrophic lateral sclerosis (ALS) pipeline after BIIB078 (IONIS-C9Rx) failed to demonstrate clinical benefit in a Phase 1 trial. In the randomised, placebo-controlled, dose-escalating trial, researchers evaluated the efficacy of the investigational antisense oligonucleotide BIIB078 as a treatment for adults with C9orf72-associated ALS.

Trials 49
article thumbnail

New nasal spray treats Delta variant infection in mice, indicating broad spectrum results

The Pharma Data

Researchers have shown a new compound delivered in a nasal spray is highly effective in preventing and treating COVID-19 caused by the Delta variant in mice. The researchers, including at UBC, Université de Sherbrooke, and Cornell University, believe this is the first treatment of its kind proven to be effective against all COVID-19 variants of concern reported to date, including alpha, beta, gamma and delta.

article thumbnail

ten23 health expands Swiss sterile drug product manufacturing site

BioPharma Reporter

CDMO ten23 health is further expanding its drug product manufacturing site in Visp, Switzerland.

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.