Tue.May 18, 2021

article thumbnail

Sarepta's Duchenne gene therapy clears study hurdle, although questions linger

Bio Pharma Dive

A version of the treatment made at commercial scale looks similar to what Sarepta used in early testing. But the findings are no longer the last step before an approval filing, as the company once hoped.

article thumbnail

History of Ho Hos: One of America’s Favorite Snack Cakes

XTalks

Ho Hos , the Swiss-rolled chocolate-covered snack cake, not only has a rich filling, but also a rich history. Hostess Brands’ beloved snack cakes have filled consumers with sugar and fat for nearly 55 years and have had an undeniable impact on American snack culture. Here’s everything you need to know about the history of one of America’s favorite snack cakes.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Humira patents take center stage as House panel targets AbbVie pricing

Bio Pharma Dive

CEO Richard Gonzalez defended the company's practices, arguing its profits help spur innovation: "The products that are on the market today pay for the products of the future," he said.

article thumbnail

Thermo Fisher Plans Cell Therapy Manufacturing Site in Bay Area; Pfizer Expands Irish Plant

BioSpace

Thermo Fisher and the University of California partnered with the development and manufacturing of cell-based therapies with the construction of its 44,000 sq. ft. manufacturing facility.

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

Bristol Myers pays Agenus $200M for drug aimed at top immunotherapy target

Bio Pharma Dive

The pharma acquired rights to an experimental antibody medicine that blocks a protein, called TIGIT, that's become a focus for several cancer drugmakers.

Protein 337
article thumbnail

Experts Still Unclear on the Timing of Potential COVID-19 Vaccine Boosters

BioSpace

FDA says it is possible booster shots would be necessary for fully vaccinated individuals within a year even though vaccines are highly effective at COVID-19 prevention.

More Trending

article thumbnail

Merck’s Ken Frazier Named CEO of the Year

BioSpace

Merck Chief Executive Officer Kenneth Frazier has been named CEO of the Year by Chief Executive magazine for his longtime leadership at the pharmaceutical giant.

103
103
article thumbnail

HHS orders 6 drugmakers to repay hospitals for violating 340B discount program

Bio Pharma Dive

The administrator of the program admonished AstraZeneca, Eli Lilly, Sanofi and others for violating the program and demanded they repay affected healthcare providers.

147
147
article thumbnail

PolyPeptide Group Outlines Cost-Effective Green Methods for Peptide Synthesis

BioSpace

Recent work by the PolyPeptide Group, a Swiss contract manufacturing organization (CMO), shows that green chemistry is not only feasible, but also is economically sound.

article thumbnail

Pandemic coincided with increase in mental health problems for children

Pharma Times

New research suggests an association between the COVID-19 pandemic and a ‘sharp’ increase in mental health issues for 11 to 12 years olds

Research 105
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

How to Make a Career Change Later in Life

BioSpace

Many people stepping into middle age feel that they’re too old to make a career change, but we live in times when an average person changes up to 12 jobs in a lifetime.

103
103
article thumbnail

Synaptic transmission: Not a one-way street

Scienmag

Key synapse acts as a “smart teacher”, sending messages against the usual flow of information in the brain. – Paper published in Nature Communications Credit: Nature Protocols, in press. / IST Austria Information flows in a well-defined direction in the brain: Chemical and electrical signals are passed from one neuron to the other across the […].

91
article thumbnail

FDA Receives Slew of New Drug Applications for Bipolar Disorder, Opioid Disorder and Rare Disease

BioSpace

Several biopharmaceutical companies have submitted NDAs to the U.S. FDA covering treatment indications ranging from an opioid overdose, bipolar disorder and rare disease.

Drugs 98
article thumbnail

FDA leader: ‘stockpiling’ could transform clinical trial system

Outsourcing Pharma

In this third part of a series on the state of clinical research, the acting FDA commissioner talks about possible pathways to improving the infrastructure.

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

X-Vax Technology Prepares to Submit IND for Genital Herpes Vaccine

BioSpace

X-Vax Technology is preparing to submit an IND application to the U.S. FDA for its experimental vaccine against Herpes simplex virus 1 and 2 (HSV-1 and -2).

article thumbnail

How to become ‘ant-i-social’

Scienmag

Study shows erosion of ant genome tied to loss of functional, behavioral and social traits in 3 inquiline species Credit: Martin Bollazzi Ants are renowned in the insect world for their complex social structure and behaviors. Workers and foragers support the queen, faithfully carrying out their social roles for the overall health of the colony. […].

Genome 89
article thumbnail

BMS Dives into AI Deal with Exscientia that Could Hit $1.2 Billion

BioSpace

BMS inked a collaboration agreement with Exscientia that can leverage AI to speed the discovery of drug candidates in therapeutic areas, including oncology and immunology.

Drugs 98
article thumbnail

Novo Nordisk’s ziltivekimab hits primary endpoint in CKD trial

Pharma Times

Investigational IL-6 inhibitor reduced inflammatory biomarkers associated with atherosclerosis in CKD patients

Trials 120
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

How x-rays could make reliable, rapid COVID-19 tests a reality

Scienmag

An imaging technique pioneered by Berkeley Lab is helping reveal the best antibodies for COVID-19 detection Credit: (Credit: Berkeley Lab) Vaccines are turning the tide of the pandemic, but the risk of infection is still present in some situations. If you want to visit a friend, get on a plane, or go see a movie, […].

article thumbnail

Sanofi’s Dupixent 'rapidly' improves lung function in children

Pharma Times

Detailed results found Dupixent improved overall asthma control in children aged six to 11 years old

121
121
article thumbnail

House Oversight Committee Targets AbbVie Over Humira, Imbruvica Price Hikes

BioSpace

House Oversight and Reform Committee slammed AbbVie for price increases on its drugs Humira Imbruvica. It said the company profited from patients and taxpayers.

Drugs 103
article thumbnail

Epigenetics study draws link between hatchery conditions and steelhead trout fitness

Scienmag

Credit: Photo by WSU Photo Services PULLMAN, Wash. – Alterations in the epigenetic programming of hatchery-raised steelhead trout could account for their reduced fertility, abnormal health and lower survival rates compared to wild fish, according to a new Washington State University study. The study, published May 18 in Environmental Epigenetics, establishes a link between feeding […].

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

Iovance Biotherapeutics Faces Another Delay in BLA Submission for TIL Therapy

BioSpace

The FDA further delays Iovance’s filing for its TIL therapy as it requests additional data on the treatment’s potency assays.

98
article thumbnail

Healios raises £7m to expand digital mental health services

pharmaphorum

Digital therapy specialist Healios has raised £7 million in new financing that will be used to expand its suite of mental health services, at a time when demand is soaring in the NHS. The London-based company has developed a virtual care platform that delivers a range of services targeted at children and young people with conditions such as anxiety, low mood, autism and attention-deficit hyperactivity disorder (ADHD), as well as their families.

article thumbnail

New peanut has a wild past and domesticated present

Scienmag

Researchers dig into the past to create new varieties to improve production Credit: Andrew Davis Tucker/UGA The wild relatives of modern peanut plants have the ability to withstand disease in ways that peanut plants can’t. The genetic diversity of these wild relatives means that they can shrug off the diseases that kill farmers’ peanut crops, […].

article thumbnail

Merck extends oncology and autoimmunity collaboration with BioMed X

Pharma Times

Merck will launch an additional six research projects at the BioMed X Institute on top of its ongoing research projects

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

TTUHSC study: Virus, restrictions increase mental health risks for nursing home caregivers

Scienmag

Credit: TTUHSC No matter one’s age, race, gender, socioeconomic status or political party, COVID-19 has impacted everyone at some level. That impact has been especially palpable for the approximately 1.3 million elderly Americans who reside in the country’s 15,600 nursing homes. Inside these facilities, the forced isolation caused by COVID-19 disrupted daily routines and left […].

Nurses 71
article thumbnail

General Mills Acquires Tyson Foods’ Pet Treat Business for $1.2 Billion

XTalks

General Mills announced their acquisition of Tyson Foods’ pet treats business for $1.2 billion. The treats include the Nudges, Top Chews and True Chews, which are leaders in the natural meat treats for pets. In 2018, General Mills entered the pet food business by acquiring Blue Buffalo for $8 billion, which has been a success ever since. General Mills is also best known for their brands Cheerios, Betty Crocker, Pillsbury and more. “This acquisition advances our Accelerate strategy and furt

article thumbnail

Stunning simulation of stars being born is most realistic ever

Scienmag

First high-resolution model to simulate an entire gas cloud where stars are born Credit: Northwestern University/UT Austin A team including Northwestern University astrophysicists has developed the most realistic, highest-resolution 3D simulation of star formation to date. The result is a visually stunning, mathematically-driven marvel that allows viewers to float around a colorful gas cloud in […].

article thumbnail

Medicago, GSK’s plant-made COVID jab clears phase 2

pharmaphorum

Canadian biotech Medicago has the data it was hoping for from a phase 2 trial of its COVID-19 vaccine, partnered with GlaxoSmithKline, and is now hoping to have phase 3 data available “by early summer.” The interim phase 2 results show that two doses of the plant-derived jab stimulated neutralising antibody levels that are around 10 times higher than those in a panel of sera from patients recovering from COVID-19, with a similar response seen in adults and the elderly.

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.