November, 2020

Stem cell therapy for ALS fails a large clinical trial

Bio Pharma Dive

The therapy's developer, Brainstorm Therapeutics, blamed the setback on better-than-expected results from placebo-treated patients. The biotech still sees a path forward, however

AstraZeneca, Oxford coronavirus vaccine prevents COVID-19, though study results raise questions

Bio Pharma Dive

Data from two late-stage trials showed the shot to be, on average, 70% effective against COVID-19, an encouraging finding. The lower dose tested, however, outperformed a higher dose

Trials 260
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Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine

NY Times

The first shots could be given as early as Dec. 21, if authorization is granted.

Optimism on Pfizer COVID vaccine is unwarranted

World of DTC Marketing

SUMMARY : Pfizer’s 90 percent effectiveness is very impressive, but the rate is based on a relatively small number of people and the data has not been peer-reviewed but today headlines rule the news, not content.

In the News: October 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. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning.

Iceland to become centre for sleep research

Scienmag

Impact Assessment of Decentralized Clinical Trials (DCT)

VirTrial

Clinical research sites continually strive to improve patient recruitment and engagement practices for clinical trials in an effort to provide sponsors with the critical data they need to bring new medications to market safely.

More Trending

McKinsey Proposed Paying Pharmacy Companies Rebates for OxyContin Overdoses

NY Times

Court filings reveal consultants’ talk of a records purge during the opioid crisis, and shed new light on sales advice given to the billionaire Sackler family and their drug company, Purdue Pharma.

Politicians are killing people

World of DTC Marketing

Politicians stupidity is leading to more COVID-19 deaths here in the U.S. and eventually we have to hold them accountable for their ignorance and lies.

Nonclinical Pulmonary Drug Delivery: Setting Up Your Inhalation Drug Study for Success

Camargo

Most are familiar with, know someone who uses, or take “pumps” themselves to prevent or relieve shortness of breath after an effort or during allergy season.

The biggest trees capture the most carbon: Large trees dominate carbon storage in forests

Scienmag

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Comparing COVID-19 Vaccines: Timelines, Types and Prices

BioSpace

As the Pfizer-BioNTech COVID-19 vaccine is being evaluated by the U.S. FDA and the Moderna vaccine is soon to follow, here’s a look at several of the top COVID-19 vaccine candidates and where they stand as of today

Pfizer and BioNTech's coronavirus vaccine works. Here's what we still don't know.

Bio Pharma Dive

An early analysis found the companies' shot more than 90% effective in preventing COVID-19. Beyond that highly encouraging number, however, there were few other details

Colchicine added to UK’s COVID-19 ‘RECOVERY’ trial

Pharma Times

Commonly used anti-inflammatory drug added to list of potential treatments

Drugs 113

Health misinformation online abounds

World of DTC Marketing

SUMMARY : In a 2019 Pew Research Center poll, more Americans said they consider made-up news a bigger problem than terrorism, illegal immigration, racism, and sexism. And 68% said disinformation greatly impacts people’s confidence in government institutions.

Juvenile Nonclinical Studies: What’s Involved, and How do I Proceed?

Camargo

So you’ve determined that you need to perform juvenile animal toxicity studies as part of your nonclinical program. The next step is understanding why these studies are required and how they should be designed. Why Are Juvenile Nonclinical Studies Needed?

Drugs 139

Researchers find connection between household chemicals and gut microbiome

Scienmag

Credit: WSU PULLMAN, Wash. – A team of researchers for the first time has found a correlation between the levels of bacteria and fungi in the gastrointestinal tract of children and the amount of common chemicals found in their home environment.

New Pfizer Results: Coronavirus Vaccine Is Safe and 95% Effective

NY Times

The company said it planned to apply for emergency approval from the Food and Drug Administration “within days

Drugs 114

Coronavirus vaccine from Pfizer, BioNTech prevents COVID-19, early results show

Bio Pharma Dive

An interim analysis conducted after 94 cases of COVID-19 in Pfizer and BioNTech's large study found their vaccine to be more than 90% effective

SARS-CoV-2 Causes Heart Damage in 20% of People with Mild or No COVID-19 Symptoms

BioSpace

COVID-19 is a cardiac condition as much as it is a pulmonary or respiratory disease.

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Pharma’s golden handcuffs

World of DTC Marketing

People who stay with a company just because of their salary and benefits are not the kind of people that are needed to make the leap from good to great.

Third Plasma Donation Drive from Shincheonji Church Expected to Gather 4,000 Donors

The Pharma Data

DAEGU, KOREA, November 09, 2020 /24-7PressRelease/ — South Korean religious group Shincheonji Church of Jesus has announced their third convalescent plasma donation drive to take place for 3 weeks starting November 16th at an Indoor Athletics Center in Daegu.

Possible 1,000-kilometer-long river running deep below Greenland’s ice sheet

Scienmag

Credit: Christopher Chambers et al, The Cryosphere, November 12, 2020. Computational models suggest that melting water originating in the deep interior of Greenland could flow the entire length of a subglacial valley and exit at Petermann Fjord, along the northern coast of the island.

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The Husband-and-Wife Team Behind the Leading Vaccine to Solve Covid-19

NY Times

The German company BioNTech, founded by two scientists, has teamed up with Pfizer on a vaccine that was found to be more than 90 percent effective

Pfizer invests in Homology and adds to its gene therapy ambitions

Bio Pharma Dive

Along with an equity investment, Pfizer will get first dibs on any potential transaction involving Homology's lead programs, which the biotech is developing for a rare metabolic disorder

SSRI Antidepressants May Be Effective Early Treatments for COVID-19

BioSpace

Researchers at Washington University School of Medicine in St. Louis published the results of a clinical trial evaluating an antidepressant, fluvoxamine, for early treatment for COVID-19

The Covid-19 vaccine numbers game

World of DTC Marketing

SUMMARY: The numbers game for COVOD-19 vaccine makers has started but what most of the public, and the media, don’t understand is that the preliminary numbers don’t mean a damn thing until they are peer-reviewed.

J&J launches Phase 3 trial for 2-dose COVID-19 vaccine

BioPharma Reporter

Johnson & Johnson has launched a second global Phase 3 trial for its Janssen COVID-19 vaccine candidate: this time exploring a 2-dose regimen (its existing Phase 3 trial explores a 1-dose regimen). Bio Developments

Trials 113

MHRA looks to AI to hunt for COVID-19 vaccine side effects

Pharma Phorum

The UK drugs regulator has awarded a £1.5 million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”.

Politics, Science and the Remarkable Race for a Coronavirus Vaccine

NY Times

The furious race to develop a coronavirus vaccine played out against a presidential election, between a pharmaceutical giant and a biotech upstart, with the stakes as high as they could get

UniQure's gene therapy for hemophilia B meets first goal in key study

Bio Pharma Dive

The results are first to emerge from a late-stage test of a hemophilia B gene therapy, and show UniQure's treatment can restore clotting protein levels to mild or even near normal levels

Sunshine Vitamin Could Help Boost Immunity in Fight Against COVID-19

BioSpace

A recent study found that Vitamin D deficiency may be associated with an increased COVID-19 risk

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Pfizer’s ad first step in restoring trust

World of DTC Marketing

SUMMARY: Pfizer’s ad in newspapers around the U.S. shows that they are ready to lead the fight against COVID-19 and in the process establish that their vaccine is safe and has been well tested. Pfizer ran an ad today that is superb.

COVID-19 vaccine hope for older adults: following release of AstraZeneca, Pfizer, Moderna clinical trial data

BioPharma Reporter

Study data from leading COVID-19 vaccine candidates suggests they may be effective in older people. Bio Developments

Airflow studies reveal strategies to reduce indoor transmission of COVID-19

Scienmag

Scientists studying the aerodynamics of infectious disease share steps to curb transmission during indoor activities. Credit: Kelby Kramer and Gerald J. Wang VIRTUAL MEETING (CST), November 22, 2020 — Wear a mask. Stay six feet apart. Avoid large gatherings.

Bill Gates, the Virus and the Quest to Vaccinate the World

NY Times

The billionaire is working with the W.H.O., drugmakers and nonprofits to defeat the coronavirus everywhere, including in the world’s poorest nations. Can they do it

Pfizer strikes a deal with newly formed China biotech

Bio Pharma Dive

The deal, which has Pfizer paying as much as $70 million, is the latest in a series of moves by big pharma companies to forge a stronger position in the world's second-largest drug market