Sat.Feb 20, 2021 - Fri.Feb 26, 2021

FDA lays out shortened path for testing vaccines against new coronavirus variants

Bio Pharma Dive

Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance

Trials 258

The health care industry should also invest more preventative health

World of DTC Marketing

SUMMARY: In a recent study by The Harris Poll on behalf of TIME, the overwhelming majority of Americans (78%) admitted to delaying routine medical services and health care appointments due to the coronavirus pandemic.

Insiders

Sign Up for our Newsletter

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

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.

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

Why this week's FDA meeting on J&J's coronavirus vaccine will be important

Bio Pharma Dive

The FDA is widely expected to authorize the drugmaker's one-dose shot. But the advisory committee meeting beforehand will offer a window into debate over several key issues

Jazz Pharma uses flying pig for huge grey area DTC

World of DTC Marketing

SUMMARY: One of the biggest complaints people have about their health is the lack of sleep caused by many factors, from diet and weight to chronic stress. DTC for a product that can keep people awake for nine hours is a message for potential abuse.

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

More Trending

Top Moderna executive to leave company later this year

Bio Pharma Dive

Tal Zaks, the biotech's chief medical officer for the past six years, will depart in September after playing a high-profile role in the company's coronavirus vaccine development

Drug side effects should be easier to understand

World of DTC Marketing

SUMMARY: Per the Times, “what if consumers could calculate the benefits and risks of taking a prescription drug as easily as they can gauge the carbohydrates and calories in an Oreo cookie?” ” Drug facts boxes are needed, but the FDA disagrees.

'Vaccines are working': UK unveils real-world data from vaccination campaign

BioPharma Reporter

Real-world data from England shows that the Pfizer/BioNTech vaccine offers 'clear protection from first dose' and may help interrupt transmission; while Scottish data shows the first doses of vaccines led to a substantial fall in hospital admissions. Bio Developments

Israel Real-World Study: Pfizer-BioNTech COVID-19 Vaccine Prevents 98.9% of Deaths

BioSpace

Israel’s Health Ministry announced results of a study in the country that showed that the Pfizer-BioNTech COVID-19 vaccine was 98.9% effective at preventing COVID-19 deaths

Moderna readies multi-pronged plan for coronavirus variants, ups vaccine production

Bio Pharma Dive

The biotech has delivered a newly developed booster shot to NIH scientists, and will test several other approaches to address emerging virus strains

Pharma’s temporary reputation bump

World of DTC Marketing

SUMMARY: Pharma’s reputation got a bump the latest Harris Poll survey shows but behind the numbers is more of a reality. Overall, about 16% of Americans had a negative or more negative view of pharma in mid-May, which was again on par with April sentiment.

Sound-frequency map for inner ear created with advanced X-ray technology

Scienmag

Credit: Hao Li Peer review/Experimental study/Cells Researchers at Uppsala University have created the first 3D map of the hearing nerve showing where the various sound frequencies are captured.

Bristol Myers Inches Toward the Future of Cell Therapy with New Manufacturing Plant

BioSpace

BMS is looking to hire "several hundred employees over the next few years," all working to ensure the production of both their clinical and commercial cell therapies

FDA review supports safety, efficacy of J&J coronavirus vaccine

Bio Pharma Dive

Agency scientists noted the shot's strong protection against severe COVID-19, even for the virus variant first detected in South Africa and known to weaken vaccine potency

A history of Johnson & Johnson

Pharma Phorum

By most measures the single largest pharma company in the world, US-based Johnson & Johnson (J&J) is also arguably one of the most well-known drugmakers among the general public. .

When foams collapse (and when they don’t)

Scienmag

High-speed video microscopy reveals the complex mechanics of foam collapse Credit: Tokyo Metropolitan University Tokyo, Japan – Researchers from Tokyo Metropolitan University have revealed how liquid foams collapse by observing individual collapse “events” with high-speed video microscopy.

70% Drop in COVID-19 Cases in UK Analyses After Just One Pfizer Shot

BioSpace

Public Health England (PHE) published real-world analyses of people in the UK who had received the first shot of the Pfizer-BioNTech COVID-19 vaccine

After FDA feedback, a biotech's ALS therapy faces murky path forward

Bio Pharma Dive

Brainstorm Cell Therapeutics said that, following a review of Phase 3 data, the agency felt the results were not enough to support an approval application

210
210

Common but not normal: It’s time to talk about maternal mental health

Pharma Phorum

As part of our Patients Insights series, the founder and CEO of Motherhood Understood shares her experience of postpartum depression, talks about the power of peer support, and explains what the wider healthcare community could do to play their part.

COVID-19 vaccination axillary adenopathy detected during breast imaging

Scienmag

FDA Approves Third Sarepta Treatment For Duchenne Muscular Dystrophy

BioSpace

The U.S. FDA approved Sarepta Therapeutics’ Amondys 45 (casimersen) for patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation amenable to exon 45 skipping

Regeneron wins FDA OK in lung cancer for immunotherapy rival to Merck's Keytruda

Bio Pharma Dive

The approval of Libtayo in first-line lung cancer will pit Regeneron's drug, developed in partnership with Sanofi, against Merck's top-selling immunotherapy Keytruda

Drugs 203

Wayra, GE Healthcare launch accelerator programme for digital health start-ups

Pharma Times

Edison Accelerator to support start-ups to develop AI applications for healthcare

Predicts the onset of Alzheimer’s Disease (AD) using deep learning-based Splice-AI

Scienmag

Credit: KBRI Korea Brain Research Institute (KBRI, President Suh Pann-ghill) announced that the research team led by Dr. Jae-Yeol Joo discovered new cryptic splice variants and SNVs in PLCg1 gene of AD-specific models for the first time using Splice-AI.

Gene 67

Amgen Submits Supplemental NDA for Mild-to-Moderate Psoriasis Drug Otezla

BioSpace

Otezla, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) directed for cyclic adenosine monophosphate (cAMP), may indirectly modulate inflammatory mediators in certain conditions, but the specific underlying mechanisms are not clearly understood

Drugs 94

Former AveXis executives launch gene therapy startup with uncommon targets

Bio Pharma Dive

Sean Nolan and Joe Nolan, former leaders at the Zolgensma developer, are behind Jaguar Gene Therapy, which plans to research treatments for a rare metabolic disease as well as genetically linked autism and diabetes

Altimmune begins trial of nasal vaccine for COVID-19

Pharma Phorum

Pfizer/BioNTech’s mRNA vaccine against COVID is a technical marvel – but the ultra-cool temperatures required for storage and stability has been tricky to handle.

How did dogs get to the Americas? An ancient bone fragment holds clues

Scienmag

The remains — thought to be the oldest confirmed from a dog in the Americas — support the theory that the animals may have traveled with people along a coastal route Credit: Credit: Douglas Levere / University at Buffalo BUFFALO, N.Y.

Gene 67

FDA Plans Ahead for COVID-19 Mutations with Booster Shot Guidance

BioSpace

The U.S. FDA issued new guidance for vaccine makers as it is preparing for the possibility of needing to approve COVID-19 booster shots against variants of the SARS-CoV-2 virus

Bluebird reveals new details on cancer cases in gene therapy trial

Bio Pharma Dive

Executives shared an update on the biotech's investigation of the two cases at an investor conference, rather than via a statement or regulatory filing

NHS England to trial at-home smear testing kits

Pharma Times

Over 31,000 women in London to be offered the at-home tests

Scientists found in marine mold substance that antidotes paraquat

Scienmag

Credit: FEFU press office Biologically active compounds from the marine fungus Penicillium dimorphosporum protect cells from paraquat, the highly toxic herbicide with no remedy, and might enhance the action of some drugs.

Field Trip Health’s New Psilocybin Research Facility Probes the Secrets of Shrooms

BioSpace

The world’s first legal research and cultivation facility dedicated exclusively to psilocybin-producing mushrooms (called shrooms or magic mushrooms) and other plant-based psychedelics recently opened in Jamaica

Icon to buy contract researcher PRA Health for $12B

Bio Pharma Dive

The cash-and-stock deal gives PRA shareholders roughly one-third ownership of the new company, which will be one of the larger providers of contract research support

Health at every size – making medicine weight inclusive

Pharma Phorum

UK-based doctor, Dr Natasha Larmie is on a mission to make medicine weight inclusive. Inspired by the Health at Every Size movement, Natasha is campaigning to take the weighing scales out of general practice and focus instead on health promoting behaviours.