April, 2021

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.

FDA faces backlash after seeking more data on an experimental ALS therapy

Bio Pharma Dive

The ALS Association demanded the FDA "move with the urgency" other agencies have in reviewing a drug from Amylyx Pharmaceuticals

Drugs 237
Insiders

Sign Up for our Newsletter

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

Development of Oncology Therapies – Tips from the FDA to Drive Success

Camargo

Cancer is not a single disease, but rather hundreds of different diseases. Thus, there will never be a single cure to cancer.

Organizing For The New Normal

Triage Cancer

It's spring. We're starting to emerge from, well, a lot of things. Over the past year, I've heard just about every kind of organizing/decluttering/reordering response to our pandemic isolation and work-from-home shifts.

UBCO researchers find a new use for waste

Scienmag

Pulp mill waste hits the road instead of the landfill Credit: UBCO Waste materials from the pulp and paper industry have long been seen as possible fillers for building products like cement, but for years these materials have ended up in the landfill.

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

Social media and prescription drugs: A study

World of DTC Marketing

QUICK READ: A two-month analysis of social media and prescription drugs found the number one reason online health seekers use social media is to share and ask questions about medication side effects. I also found an abundance of medication misinformation based on personal experiences and hearsay.

Drugs 231

More Trending

2020 505(b)(2) NDA Approvals: A Year in Review, and What a Year It Was!

Camargo

In 2020, CDER approved 68 NDAs that used the 505(b)(2) pathway, representing important advances in patient care across a wide range of therapeutic areas. 505(b)(2) Drug Improvement Approvals by Year.

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.

Death, Disability Among Side Effects of Chinese COVID-19 Vaccines, Leaked Documents Reveal

BioSpace

Leaked documents from provincial and municipal governments in China reveal a slew of previously unreported severe adverse events related to COVID-19 vaccines made and administered in China

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

The clock is ticking on healthcare’s excessive profiteering

World of DTC Marketing

QUICK READ: There is so much money in healthcare that every company wants their share even if patients get hurt. The amount of money Pfizer is going to make from their vaccine borders on obscene while PBMs quietly take a cut of every Rx transaction without really adding any value.

Lilly to seek first approval of an autoimmune drug for hair loss

Bio Pharma Dive

Two Phase 3 trials have now shown that Lilly's autoimmune drug baricitinib may effectively treat alopecia areata. But the FDA's concerns with so-called JAK inhibitors could complicate a review

Trials 222

In the News: March 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. Rare Disease Clinical Trials Most Often Terminated Due to Regulatory and Recruitment Issues.

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. .

mRNA Tech Used in COVID-19 Vaccines Could be Used to Cure HIV, Cancer and More

BioSpace

Researchers are leveraging the messenger RNA (mRNA) technology used to develop the Pfizer-BioNTech and Moderna COVID-19 vaccines for possible treatments for a range of other diseases, including HIV and cancer

RNA 112

Call for fire: ONR tests virtual training systems for JTACs, fire support marines

Scienmag

Credit: (Photo: David Taylor/Phocus Video) ARLINGTON, Va.–The –The Marine scanned the open field and spotted an enemy tank approaching. Using a handheld tablet, he called for an air strike. A helicopter quickly flew in and launched a rocket, destroying the tank.

Pharma’s social irresponsibility

World of DTC Marketing

QUICK READ:There are times when I really want to quit working in the industry and the latest news about pharma is aiming at U.S. lawmakers to stop the global push to lift intellectual property through a waiver for Covid vaccines is just the latest.

Researchers lay out hypothesis for rare side effect linked to AstraZeneca vaccine

Bio Pharma Dive

The EMA has reiterated the benefits of the shot outweigh the risks, but the safety concerns are another hurdle to the vaccine's rollout in Europe

Using PK Modeling and Simulation to Plan Studies for Pediatric Patient Populations

Camargo

Conducting a clinical study in a pediatric patient population requires careful planning, as providing a benefit to a child without causing harm is a weighty responsibility.

Beyond Reference Management: How Literature Management is a Win for the Life Science Organization

Pharma R&D Today

Scientific literature is a critical component to virtually all aspects of a life science enterprise, including Medical Affairs, Pharmacovigilance and R&D.

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

A protein with a dual role: Both repair and mutation

Scienmag

Credit: © Terence Strick The Mfd protein repairs bacterial DNA, but can also, to scientists’ surprise, promote mutation. Bacterial mutations can lead to antibiotic resistance.

DNA 74

Congratulations Manny Award winners

World of DTC Marketing

QUICK READ: The MedAd News Manny Awards were last night. Congratulations to the winners, but the bar has been set higher if pharma is to really demonstrate they care about patients. Award winners should see their awards as a head nod and understand they have a LOT more work to do.

Positive data in hand, TG Therapeutics readies MS drug for FDA review

Bio Pharma Dive

If approved, TG's drug would join Roche's fast-selling Ocrevus and Novartis' newer entrant Kesimpta as one of a newer class of multiple sclerosis therapies

Drugs 208

Is disability the last bastion of the representation debate?

Pharma Phorum

From #MeToo to Black Lives Matter, as a society we have been discussing the relationship between representation and equality more than ever over the last few years. .

Vaccines Won’t Protect Millions of Patients With Weakened Immune Systems

NY Times

Many cannot produce enough infection-fighting cells to fend off the coronavirus. But researchers are testing one therapy that may help: monoclonal antibodies.

CEOs of COVID-19 Vaccine Makers See Boost in Salaries

BioSpace

BioSpace takes a look at the annual compensation for the chief executive officers of vaccine developers

Changing the paradigm: Microbiome modulation may become the next ‘pillar’ in cancer treatment

BioPharma Reporter

Insights have been gained into the role of the microbiome in disease states such as cancer, and strategies to manipulate the microbiome are quickly emerging, though optimal approaches are not yet known, said experts during an AACR 2021 event this week. Bio Developments

The danger of COVID conspiracy theorists

World of DTC Marketing

QUICK READ: At times, the public health response to coronavirus (COVID-19) has been scary, characterized by antimask behavior, antivaccine beliefs, conspiracy theories around the development of the vaccine, and a general belief that even COVID numbers are false.

Sanofi buys an mRNA startup in another bet on 'off-the-shelf' cell therapy

Bio Pharma Dive

Tidal Therapeutics is the second biotech developing more convenient cell therapies that the French pharma has recently acquired, part of a broader expansion in oncology

Digital tool will be tested against COVID-19 ‘brain fog’

Pharma Phorum

Learning about system stability from ants

Scienmag

Large-Scale Study Finds One-Third of COVID-19 Patients Suffer Neurological Damage

BioSpace

Six months after a COVID-19 diagnosis, more than 33% of people exhibited some form of brain damage, according to a study appearing in Lancet Psychiatry

105
105

Fitted Filtration Efficiency of Double Masking During the COVID-19 Pandemic

JAMA Internal Medicine

This quality improvement study compares the fitted filtration efficiency of commonly available face masks worn singly, doubled, or in combinations

67

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.

5 takeaways from AACR, one of the year's top meetings on cancer drugs

Bio Pharma Dive

The American Association for Cancer Research's virtual conference featured new data on an emerging immunotherapy target, a new kind of cell therapy and a KRAS reboot