Sat.Dec 18, 2021 - Fri.Dec 24, 2021

US pauses distribution of Regeneron, Lilly antibodies over omicron concerns

Bio Pharma Dive

The decision follows worrisome results in lab studies that indicated omicron can evade both drugs and leaves the U.S. with fewer treatments to respond to the variant's spread

We’re tired of Covid and it’s causing patients harm

World of DTC Marketing

With days to go before Christmas, Americans are sick and tired of being sick and tired. Of reworking plans to adapt to the latest virus risks. Of searching for at-home tests and not finding them.

Insiders

Sign Up for our Newsletter

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

PDUFA VII: Implications for Developers of Cell and Gene Therapies

Camargo

One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA VII , as the reauthorization is commonly known, will cover the fiscal years 2023-2027.

Merck’s Covid Pill Is Authorized by F.D.A. for High-Risk Adults

NY Times

The F.D.A. said the drug should be prescribed mainly when other treatments were “not accessible or clinically appropriate.”. Merck & Company Inc Food and Drug Administration Pfizer Inc Coronavirus Omicron Variant Molnupiravir (Drug) Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) Paxlovid (Drug

Drugs 87

2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

Novartis wins FDA approval for new heart drug, but faces uphill sales battle

Bio Pharma Dive

Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations. But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness

Value-based healthcare can help reduce costs

World of DTC Marketing

According to the Kaiser Family Foundation (KFF), in 2021, the average cost of employee health insurance premiums for family coverage increased by 4% from the previous year to $22,221. The average annual premiums for an individual’s plan also increased 4% to $7,739 this year.

More Trending

Watch: DHC Roundtable Discussion

Pharma Marketing Network

Lewis, Founder and CEO of eHealthcare Solutions and Tap Native and the Chief Collaborator at Pharma Marketing Network, moderated a deep dive discussion on the topic of physician-level data (PLD) with a focus around drivers for the tool, its usage, and successes learnings about its function in pharma, and the where it’s heading.

Moderna vaccine weaker against omicron, but third shot boosts protection

Bio Pharma Dive

As a result of new laboratory data, the biotech company is deemphasizing more complex "multivalent" booster shots in favor of further study of its existing formulation and an omicron-specific version

No more annual flu shot? Scripps Research and collaborators find new target for universal influenza vaccine

Scienmag

Credit: Julianna Han, Ward Lab at Scripps Research LA JOLLA, CA—Scientists at Scripps Research, University of Chicago and Icahn School of Medicine at Mount Sinai have identified a new Achilles’ heel of influenza virus, making progress in the quest for a universal flu vaccine.

Bias in artificial intelligence impacts drug development: AiCure

Outsourcing Pharma

According to an expert from the clinical insights company, prejudice in AI can impact patient outcomes as well as the ability to develop effective treatments. Clinical Development

An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

Deloitte: Artificial intelligence technology investments prove top priority for biopharma leaders

BioPharma Reporter

The pandemic has focused biopharma industry minds on digital innovation, finds a Deloitte report. Markets & Regulations

COVID-19 pill from Pfizer authorized by FDA in major pandemic milestone

Bio Pharma Dive

Paxlovid is the first oral treatment for COVID-19, a potentially valuable new tool as the fast-spreading omicron variant fuels a sharp surge in cases across the U.S.

267
267

Rare dinosaur embryo exquisitely preserved inside the egg suggests bird-like pre-hatching posture

Scienmag

Over the last 100 years, many fossilized dinosaur eggs and nests have been found, but finding one with a well-preserved embryo inside is exceedingly rare. Now, researchers reporting in the journal iScience on December 21 have detailed one such specimen discovered in southern China.

F.D.A. Clears Pfizer’s Covid Pill for High-Risk Patients 12 and Older

NY Times

The first-of-its-kind treatment, Paxlovid, has been found to be highly protective against severe illness. It could be available within a few days.

Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

Sanofi buys US immuno-oncology biotech Amunix for $1 billion

Pharma Phorum

Sanofi has bolstered its immuno-oncology pipeline with a $1 billion agreement to acquire Amunix Pharma of the US – its fourth bolt-on deal of 2021.

Sanofi to buy cancer immunotherapy biotech for $1B

Bio Pharma Dive

The French drugmaker is interested in Amunix Pharmaceuticals' technology, which could allow for more precise delivery of biologic drugs into cancerous tissue

Drugs 266

Researchers lay groundwork for potential dog-allergy vaccine

Scienmag

There have been many research efforts describing the nature and progression of dog allergies, but there have been very few applied studies that use this information to try to cure people of dog allergies entirely by artificially inducing immune tolerance.

Walgreens and CVS Limit Purchases of At-Home Coronavirus Tests

NY Times

The caps come as the rapid spread of the Omicron variant has customers flocking to testing sites and pharmacies, which are struggling to keep up. Tests (Medical) Coronavirus (2019-nCoV) Shortages Drugs (Pharmaceuticals) CVS Caremark Corporation Walgreen Co

NICE backs Aimmune’s peanut allergy drug Palforzia for children

Pharma Phorum

Children in England with peanut allergies could be among the first in Europe to get access to Aimmune’s oral immunotherapy Palforzia, after the drugmaker agreed a supply deal with NHS England.

Bluebird hit with another hold for sickle cell gene therapy

Bio Pharma Dive

Study enrollment and treatment of sickle cell patients under 18 will be paused for safety reasons, another hurdle in a series of setbacks for the company

PPPL unravels a puzzle to speed the development of fusion energy

Scienmag

Researchers at the U.S. Department of Energy’s (DOE) Princeton Plasma Physics Laboratory have developed an effective computational method to simulate the crazy-quilt movement of free electrons during experimental efforts to harness on Earth the fusion power that drives the sun and stars.

Time to put patient voice first in cancer research: GRYT Health

Outsourcing Pharma

The organization is working to give oncology professionals the chance to hear directly from patients about their unique experiences, concerns, and hopes. Patient centricity

US health department backs 15 COVID-focused digital health startups

Pharma Phorum

A group of 15 digital health startups have joined a programme set up by the US federal government to address health inequality and mitigate the effects if the COVID-19 pandemic.

Duchenne patient dies in Pfizer gene therapy study

Bio Pharma Dive

The tragic news follows changes Pfizer recently made to the design of another study testing the therapy due to side effects seen in some participants

Wildlife cameras show how foxes, racoons, stone martens and domestic cats get along in Berlin before and during Covid 19 lockdowns

Scienmag

Avoid or compete, eat or be eaten, exploit or cooperate – biotic communities are shaped by species interactions in many different ways. Urban environments represent a special case as human presence and influence may have fundamentally changed the rules of the game.

Family in Nigeria Lost 3 Daughters to Sickle Cell. Can They Save a Fourth?

NY Times

About 150,000 babies are born each year in Nigeria with sickle cell, a deadly disease. Tens of thousands of them die annually before their fifth birthdays.

Mydecine, Maya team up on digital tools for psychedelic drugs

Pharma Phorum

Psychedelic medicines developer Mydecine has joined forces with digital health company Maya to make digital tools that will be used alongside its drug candidates for mental health and addiction disorders.

GSK's long-acting HIV shot approved for preventive use

Bio Pharma Dive

The landmark FDA approval makes Apretude the first injectable treatment in the U.S. for HIV pre-exposure prophylaxis

Space telescope ushers in new age of astronomy

Scienmag

A “game changing” new telescope will be blasted into space tonight to embark on a lonely 1.5-million-kilometre orbit around the Sun to provide a clearer view of the ever-expanding universe.

Dogs, VR, and rock stars: OSP’s favorite items of 2021

Outsourcing Pharma

It has been a pleasure for the OSP team to connect with a long list of fascinating industry minds and share the stories; here are a few of our favorites. Markets & Regulations

How to Generate a Good number of PCD Pharma Enquires?

Fossil Remedies

When you run a PCD Pharma Company , your prime objective is to earn profit. For that,it is essential to generate a greater number of queries. When you do it, the business performs well. When it performs well, you enhance your market position.

Novartis ups investment in gene therapy for the eye with $800M buyout

Bio Pharma Dive

The deal for Gyroscope Therapeutics, worth up to $1.5 billion, gives the Swiss pharma access to a treatment for a type of age-related blindness as well as new means of delivering drugs into the eye

Fueling the future with new perovskite-related oxide-ion conductors

Scienmag

Stable and high oxide-ion conductors based on a new hexagonal perovskite-related oxide has been reported by scientists at Tokyo Tech, Kojundo Chemical Laboratory Co. and Australian Nuclear Science and Technology Organisation (ANSTO) in a recent study.

FDA sets out its stall on digital tools for remote clinical trials

Pharma Phorum

The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic.