2021

Two biotechs team up to bring CRISPR to 'natural killer' cell therapy

Bio Pharma Dive

A wide-ranging alliance between CRISPR Therapeutics and Nkarta is the latest sign of interest in a fast-emerging form of cancer immunotherapy

282
282

COVID-19: Some ignored facts

World of DTC Marketing

QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Coronaviruses were first encountered in April 1930, when a strange respiratory disease ravaged poultry farms across North Dakota and Minnesota, killing tens of thousands of baby birds.

Insiders

Sign Up for our Newsletter

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

In the News: April 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA’s Accelerated Approval Program Comes Under Fire.

New research adds to evidence that POTS may be an autoimmune disorder

Scienmag

Persistent work from scientists at The University of Toledo could aid in diagnosing and treating postural orthostatic tachycardia syndrome Credit: Daniel Miller / The University of Toledo The symptoms of postural orthostatic tachycardia syndrome, or POTS, can be as varied as they are confounding.

After Months of Prodding, CDC Updates Guidance on COVID-19 Airborne Transmission

BioSpace

The CDC says that COVID-19 is an airborne threat, stating that transmission and subsequent infection can occur via inhalation of very fine respiratory droplets and aerosolized particles

114
114

Plant-based COVID-19 vaccine candidate starts rolling review with Health Canada

BioPharma Reporter

Medicago has started a rolling submission with Health Canada for its plant-derived adjuvanted COVID-19 vaccine candidate: championing a unique and versatile platform that can also be scaled up easily. Bio Developments

Millions Are Skipping Their Second Doses of Covid Vaccines

NY Times

Nearly 8 percent of those who got initial Pfizer or Moderna shots missed their second doses. State officials want to prevent the numbers from rising.

More Trending

The drug Fenbendazole can make tumors sensitive to radiotherapy just like agents of chemotherapy

Pharma Mirror

UK Vaccine Taskforce head lifts lid on Novavax deal

Pharma Phorum

The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head of the country’s Vaccines Taskforce. .

VirTrial and uMotif Partner to Further Expand Decentralized Clinical Trial Capabilities

VirTrial

Scottsdale, AZ – (March 9, 2021) – VirTrial , the leading provider of telemedicine technology, and uMotif , the patient-centric data capture platform provider, are joining forces to combine their Decentralized Clinical Trial (DCT) technologies in one seamlessly integrated solution.

Moderna founder launches new biotech, looking to cure diseases through 'endless RNA'

Bio Pharma Dive

Laronde comes equipped with $50 million in funding from Flagship Pioneering and a goal to upend how diseases are treated with long-lasting RNA medicines

RNA 273

Pfizer positions COVID vaccine as a yearly booster shot

World of DTC Marketing

QUICK READ: Pfizer is already positioning their Covid vaccine as a yearly maintenance shot. In other words, they want to milk this cash cow for every penny they can get out of the healthcare system.

FDA INTERACT Meetings: Early Interactions for Cell and Gene Therapy Sponsors

Camargo

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers.

To prevent next pandemic, scientists say we must regulate air like food and water

Scienmag

Credit: Martin Visser, Unsplash Humans in the 21st century spend most of their time indoors, but the air we breathe inside buildings is not regulated to the same degree as the food we eat and the water we drink.

University of Oxford-Novavax Malaria Vaccine Demonstrates 77% Efficacy in Children

BioSpace

The same group at the University of Oxford and the Jenner Institute that developed the AstraZeneca-Oxford COVID-19 vaccine reported that their investigational malaria vaccine, R21/Matrix-M, demonstrated 77% efficacy in children over 12 months of follow-up

Moderna to take mRNA flu and HIV vaccines into Phase 1 trials this year

BioPharma Reporter

Moderna will take mRNA flu and HIV vaccines into Phase 1 trials this year, as well as beginning a pivotal Phase 3 study for its cytomegalovirus (CMV) vaccine candidate. Bio Developments

Trials 114

Parkinson’s Disease: How close are we to a cure?

Delveinsight

Neurological disorders are the leading source of disability globally, and Parkinson’s is the fastest-growing neurological condition.

From Insurance Claim Denials to Smiles, Payment and Feeling Empowered

Triage Cancer

Have you ever received a denial from your insurance company? Me too. Just days before my scheduled breast reconstruction surgery. You probably know how I felt. Blindsided. Frustrated. Angry. . I won't make you read this whole article to learn that I appealed that denial and won.

77

Biden Backs Suspending Patents on Covid Vaccines

NY Times

The Biden administration, siding with some world leaders over the U.S. pharmaceutical industry, came out in favor of waiving intellectual property protections for coronavirus vaccines.

EU probes low platelet safety issue with COVID-19 shots

Pharma Phorum

EU regulators are reviewing reports of low blood platelets in patients who received any of the three approved COVID-19 vaccines from Pfizer/BioNTech, AstraZeneca and Moderna.

Filler 114

VirTrial Launches eConsent Solution as Stand-Alone Offering or Bundled With Its Telemedicine Platform

VirTrial

Scottsdale, AZ (March 2, 2021) – VirTrial today announced the general availability of SmartSignals eConsent, a PDF-based, clinical trial consent solution offering rapid implementation and a flexible, scalable, and lightweight design.

FDA approves first CAR-T cell therapy for multiple myeloma

Bio Pharma Dive

Approval of Bristol Myers Squibb and Bluebird bio's Abecma expands use of CAR-T treatment beyond leukemia and lymphoma

Thoughts on working with and in the pharma industry

World of DTC Marketing

THOUGHT: I love working in the pharma industry. Yes, I have been critical of the industry because I believe there is too much focus on pleasing Wall Street, yet I believe that there are some really good people starting to climb the ladder and that soon we’ll see some really substantial changes.

Drugs 165

Technology Transfer: What Is It, and How Is It Done?

Camargo

Technology transfer is a critical step in any drug development program, occurring for various reasons and at different development stages.

Climate impacts drive east-west divide in forest seed production

Scienmag

Western forests may be less able to regenerate following large-scale diebacks Credit: USGS DURHAM, N.C.

NurOwn: A Study in the Complexity of ALS Trials

BioSpace

There is also a tacit acknowledgment in the industry that the ALSFRS-R (revised) scale needs to evolve

Trials 110

Pfizer/BioNTech to trial COVID-19 vaccine in pregnant women and children

BioPharma Reporter

Pfizer and BioNTech have dosed the first participants in a Phase 2/3 study for their COVID-19 vaccine in pregnant women; and plan to trial the vaccine in children later this year. Bio Developments

Trials 114

Life-sciences pros believe in potential of AI, blockchain: survey

Outsourcing Pharma

A survey by the Pistoia Alliance indicates most professionals believe the tech can accelerate R&D, but companies are stymied by a skills gap and data bias. Markets & Regulations

Need Health Insurance? Marketplaces are Open Now!

Triage Cancer

Health Insurance Marketplaces are now open for a Special Enrollment Period (SEP). In the 36 states with Marketplaces on www.HealthCare.gov, individuals have the opportunity to buy a new health insurance policy or change policies until May 15, 2021.

81

Pfizer Will Ship Fewer Covid-19 Vaccine Vials to Account for ‘Extra’ Doses

NY Times

After the surprise discovery of an extra dose in every vial, Pfizer executives successfully lobbied the F.D.A. to change the vaccine’s formal authorization language. The company charges by the dose.

IBM-led group wins German contract for digital vaccine passport

Pharma Phorum

Germany has awarded a tender to a consortium led by IBM to develop a secure app that will provide a digital version of the country’s paper vaccine certificates. The €2.7 million ($3.2

FDA Says Data Does Not Support Changes to COVID-19 Vaccine Doses

XTalks

The US Food and Drug Administration (FDA) released a statement this week about dosing schedules for COVID-19 vaccines, saying that any dose changes would be premature.

5 FDA approval decisions to watch in the second quarter

Bio Pharma Dive

A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June

The right balance in DTC: Tv versus digital ads

World of DTC Marketing

SUMMARY: Television remains the most important medium for healthcare advertising , accounting for 54.7% of all spend in 2018, far higher than television’s 30.8% share of the advertising market as a whole.

In the News: February 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA: Sponsors Seldom Disclose RTF Letters’ Existence or Contents and Often Ignore Agency Advice.

Learning about system stability from ants

Scienmag

New Drug Approval Could Be on Horizon for Alzheimer’s after 17-Year Drought

BioSpace

A drug to halt the progression of Alzheimer’s disease will likely be approved within the next three years, and Alzheon’s ALZ-801 might be the leading candidate

Drugs 113