Sat.Aug 28, 2021 - Fri.Sep 03, 2021

At FDA meeting, gene therapy experts wrestle with field's blindspots

Bio Pharma Dive

A panel convened by the regulator suggested ways to make gene therapy research safer, but struggled to propose broader recommendations for the field

Turmoil at FDA or just another day?

World of DTC Marketing

SUMMARY: Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency because the White House is getting ahead of the agency on COVID booster shots.

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Automatic Student Loan Forgiveness for People with Disabilities

Triage Cancer

Breaking News: Thanks to a new decision by the U.S. Department of Education , many people with disabilities will receive automatic student loan forgiveness through the Total and Permanent Disability (TPD) Discharge program! What is a Total and Permanent Disability (TPD) Discharge?

Codivir Shows Promising Effect Against COVID-19

Pharma Mirror

TEL AVIV, ISRAEL / DE BILT, NETHERLANDS – Codivir, a short synthetic 16 amino-acid peptide, derived from the HIV-1 integrase, was originally discovered at the Hebrew University in Israel.

Pfizer, Merck launch large new trials of oral COVID-19 drugs

Bio Pharma Dive

Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year

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Online health seekers are having a tough time

World of DTC Marketing

SUMMARY: Online health seekers are increasing in number, but so is the prevalence of inaccurate health information. Drug side effects are among the most talked about in social media, and patients are more concerned about side effects.

Italian ‘chatbot’ predicted COVID-19 spikes, says study

Pharma Phorum

An online tool used by people in Italy to manage their potential exposure to COVID-19 using a simple chat interface has shown that it can spot emerging trends days ahead of the national surveillance system.

More Trending

Top FDA vaccine officials to leave agency as decision on COVID-19 boosters looms

Bio Pharma Dive

Marion Gruber and Phil Krause, two veteran vaccine reviewers, are unexpectedly leaving the agency at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter

Revive Therapeutics reports progress with Phase III COVID-19 trial

Outsourcing Pharma

A leader from the rare and infectious disease treatment specialist talks about ongoing research into a potential treatment for mild-to-moderate COVID-19. COVID-19

Funding round swells digital health firm Whoop’s value to $3.6bn

Pharma Phorum

Fitness wearable company Whoop has raised another $200 million in funding that will help fund its expansion into international markets – and take on deep-pocketed rivals like Amazon, Apple and Google.

Study: COVID-19 Deaths Likely Due to Extremely High Viral Load

BioSpace

new study on COVID-19 behavior has found that patients affected by the virus might have died due to a buildup of coronavirus directly in the lungs and not because of a secondary infection

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Moderna founder's next big play in RNA raises $440 million

Bio Pharma Dive

Just a few months out of stealth mode, Laronde and its "endless RNA" technology have caught the attention of well-known investors like Fidelity, T. Rowe Price Associates and Invus

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Purdue Pharma Is Dissolved and Sacklers Pay $4.5 Billion to Settle Opioid Claims

NY Times

The ruling in bankruptcy court caps a long legal battle over the fate of a company accused of fueling the opioid epidemic and the family that owns it.

Drugs 99

Real-world study suggest AI may improve atrial fibrillation screening

Pharma Phorum

An artificial intelligence algorithm already shown to be able to detect atrial fibrillation (AF) in clinical testing has also shown its worth in a real-world setting, according to its developers.

3 Ways to Encourage Positive Mental Health at Work

BioSpace

The pandemic and its subsequent effect on the workplace has been the source of stress for many professionals and executives in various industries

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What to expect at the FDA's two-day meeting on gene therapy safety

Bio Pharma Dive

A group of advisers convened by the regulator will spend Thursday and Friday weighing a range of safety worries with gene therapy, and how best to prevent them

Ivermectin Demand Surges Though It Doesn’t Work for Covid-19

NY Times

Prescriptions for ivermectin have jumped to more than 88,000 per week, some pharmacists are reporting shortages and people are overdosing on forms of the drug meant for horses.

Best Practices for Respiratory Testing in ALS Clinical Trials

ERT

August 30, 2021. Amyotrophic Lateral Sclerosis (ALS) patients experience a progressive loss of functioning in the brain and spinal cord, leaving many with respiratory failure.

Janssen Wins FDA Approval for Long-Acting Schizophrenia Drug

BioSpace

FDA greenlit Janssen’s Invega Hafyera, the first long-acting antipsychotic drug of its kind that provides six months’ control of symptoms with a single dose

With safety worries mounting, FDA limits who can take certain immune-regulating drugs

Bio Pharma Dive

The agency has new rules for who can take Pfizer's Xeljanz, Eli Lilly's Olumiant or AbbVie's Rinvoq after a large study raised concerns about the safety of so-called JAK inhibitors

FDA clears J&J’s twice-yearly Invega for schizophrenia

Pharma Phorum

One of the biggest challenges to treating schizophrenia is non-compliance with treatment, but Johnson & Johnson’s pharma unit Janssen is trumpeting a new version of its Invega drug that could solve that problem.

How the UAE is Growing Climate-Proof Food in the Desert

XTalks

Desert farming has existed for thousands of years , but one center in Dubai has created desert farming equipped to handle rising temperatures and extreme weather events.

Moderna COVID Vaccine Stimulates Twice the Antibody Response as Pfizer-BioNTech

BioSpace

Belgium researchers compared the Moderna and Pfizer-BioNTech COVID-19 vaccines and found that the Moderna jabs generated twice the antibodies than the Pfizer-BioNTech vaccine

Pfizer, marking fast research pace, starts key trial of RSV vaccine

Bio Pharma Dive

The pharma company is in a tight race with rivals, including GSK, to become the first with an approved shot for the infectious disease

Plant-based biopharma firm iBio licenses novel antibody targeting regulatory T cells

BioPharma Reporter

Anti-CD25 antibodies have emerged as one of the most promising next-generation cancer therapeutics, says US plant-based manufacturer of therapeutics and vaccines, iBio, as it enters the field. Bio Developments

Purdue bankruptcy court hands immunity to Sackler family

Pharma Phorum

A US federal judge has approved a bankruptcy settlement for Purdue Pharma that grants the Sackler family that owned the business immunity from any further civil lawsuits accusing them of contributing to opioid epidemic – to the consternation of campaigners.

Startup Runs with Old Novartis Muscle Loss Drug to Fight Obesity

BioSpace

Newly launched Versanis Bio is aiming to turn a Novartis drug that was once developed to help with muscle loss and weakness into an anti-obesity treatment

Settling lawsuit, AstraZeneca and European Commission agree on coronavirus vaccine delivery

Bio Pharma Dive

The U.K.-based based drugmaker fell behind on its promise to supply 300 million doses by the end of June to countries in the trading bloc. Now, it's set to reach that target by March 2022

Joe Rogan, A Podcasting Giant Who Has Been Dismissive of Vaccination, Has Covid

NY Times

“I got fevers, sweats, and I knew what was going on,” he said in a video on Instagram on Wednesday, after returning from a series of shows in Florida.

Novartis and the NHS sign ‘landmark’ deal for cholesterol drug

Pharma Times

Treatment could help 300,000 patients over three years

Drugs 87

AstraZeneca and Thermo Fisher Partner to Match Patients to Precision Therapies

BioSpace

The duo’s mission is to identify more patients who could benefit from precision medicines by deploying more CDx tests to healthcare providers

Astellas again hits pause on gene therapy trial

Bio Pharma Dive

The company is holding off dosing more patients with AT132, a potential treatment for a deadly neuromuscular disease, after one recently experienced a serious adverse event in the form of unusual liver function

Partnership fights to amplify Black women’s voice in breast cancer research

Outsourcing Pharma

The #BlackDataMatters movement aims to improve outcomes for Black women living with breast cancer by increasing their presence in vital clinical research. Patient centricity

IQVIA launches AI-powered medical information contact centre

Pharma Times

AI tech designed to improve patient and HCP experience

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U.S. Officials Rush to Reassure as Mu Variant Grabs International Headlines

BioSpace

The Mu variation is the fifth strain to be designated as a "variant of interest" by the World Health Organization

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FDA scrutiny, Merck approval lead Roche to pull Tecentriq in breast cancer

Bio Pharma Dive

While FDA advisers voted in April to keep Tecentriq available for use in triple-negative breast cancer, the Swiss pharma said changes in how the disease is treated spurred it to withdraw the indication

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The Cocaine Was Laced With Fentanyl. Now 6 Are Dead From Overdoses.

NY Times

The deaths over three days in Suffolk County reflect a dangerous shift in the street-drug marketplace, according to police and prosecutors.

Drugs 87