Sat.Sep 11, 2021 - Fri.Sep 17, 2021

After talks with FDA, a biotech prepares to submit its closely watched ALS drug

Bio Pharma Dive

Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months

Drugs 282

PhRMA buys politicians and patients lose

World of DTC Marketing

SUMMARY: Three House Democrats on a key committee voted against the measure to lower drug prices as PhRMA ramped up its lobbying dollars to buy politicians.

Drugs 208
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Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 2

Camargo

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined.

Infants exposed to domestic violence have poorer cognitive development

Scienmag

COLUMBIA, Mo. While assessing a pregnant woman with premature labor in 1983, Linda Bullock noticed bruises on the woman. When she asked what happened, the woman told Bullock a refrigerator had fallen on her while cleaning the kitchen. Credit: MU COLUMBIA, Mo.

Fourth trial volunteer dies in Astellas gene therapy study

Bio Pharma Dive

The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used

DTC messages need to evolve

World of DTC Marketing

SUMMARY: With patients staying away from their doctors because of COVID, DTC messages need to add incentives and better messaging to get people to take action rather than wait. No one message will do this, however. Messages need to evolve in these special times.

How pharmacists can partner with health coaches

Pharma Mirror

What is a health coach? A health coach is someone with expertise in wellness who assists people achieve good health by being a mentor and educator on lifestyle and nutritional changes.

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FDA advisers support booster dose of Pfizer vaccine in older or high-risk adults

Bio Pharma Dive

In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19

Online health information: The game has changed

World of DTC Marketing

SUMMARY: Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high.

Best Places to Visit in Florida

Riverside Clinical Research

Florida is one of our nation’s, if not the world’s, most popular vacation destinations…and for very good reason. Although it is extremely hard to narrow down, here is a small sampling of the best places to visit if you happen to be in Florida.

Researchers infuse bacteria with silver to improve power efficiency in fuel cells

Scienmag

UCLA-led?team team of?engineers engineers and chemists has taken a major step forward in the development of?microbial?fuel microbial?fuel fuel cells — a technology that?utilizes?natural utilizes?natural

Theravance to lay off 75% of employees alongside larger restructuring

Bio Pharma Dive

The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test

Drugs 264

FDA Approves First Human Trial for Potential CRISPR-Led HIV Cure

BioSpace

?The FDA's IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy

The tech revolution reshaping European healthcare

Pharma Phorum

The European health tech industry has made a “quantum leap” into using digital health technology due to the pandemic with the help of a growing number of trailblazing entrepreneurs, according to AlbionVC.

Under the scanner: GIST scientists unravel the inner workings of DNA repair enzymes

Scienmag

DNA is the instruction manual for every living organism, guiding the development and functioning of all biological processes. In essence, it is a molecule with a double helix structure with each unit of a helix containing what are known as “DNA bases”.

DNA 77

New data from Israel, Pfizer show potent effect from third coronavirus shot

Bio Pharma Dive

The much-anticipated data arrive two days before an important FDA advisory meeting to discuss authorization of a booster dose for Pfizer's coronavirus vaccine

Growing Glioblastomas in a Laboratory: 3D Bioprinting a Better Brain Model

BioSpace

This newfound ability to take tumor cells directly from a patient and incorporate them into a more clinically accurate glioblastoma model could lead to greater patient personalization in cancer therapeutics

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Digital health approach improves neurosurgery care, says study

Pharma Phorum

Deployment of digital health technologies during the pandemic improved patient satisfaction, expanded the delivery of care and augmented training of staff at a leading neurosurgery provider in the US, according to a new study.

Pfizer UK, Entia partner on home blood monitoring device for breast cancer patients

Pharma Times

Through Entia’s virtual oncology platform, patients are able to perform their own blood tests

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Departing FDA officials, WHO leaders argue against broad rollout of COVID-19 booster shots

Bio Pharma Dive

Marion Gruber and Philip Krause, two top FDA vaccine reviewers who are unexpectedly departing this fall, joined senior WHO officials in saying booster vaccine doses are not yet widely needed

Phony Diagnoses Hide High Rates of Drugging at Nursing Homes

NY Times

At least 21 percent of nursing home residents are on antipsychotic drugs, a Times investigation found.

New research proves diet can put Type 2 diabetes into remission

Scienmag

A change in diet is proving to be a key tool in the reversal of Type 2 diabetes. Credit: UBC Okanagan A change in diet is proving to be a key tool in the reversal of Type 2 diabetes.

EU ‘negotiating with Valneva’ over COVID-19 vaccine contract

Pharma Phorum

The European Commission is reportedly in advanced discussions with French biotech Valneva about picking up the contract to supply COVID-19 vaccines that was terminated by the UK government this week.

FDA staff tight-lipped on booster shot views ahead of consequential meeting

Bio Pharma Dive

In a briefing document released Wednesday, agency reviewers did not make a strong case either for or against the broad authorization of boosters for the general public

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Retaining Biotech Employees in the New War for Talent

BioSpace

With multiple job openings across the industry, biotech and biopharma employers have to come up with different strategies to retain top talent

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Gates Foundation, Exscientia enter $70m agreement to develop COVID-19 treatments

Outsourcing Pharma

The pharma tech firm has forged a four-year partnership with the foundation to develop antivirals for COVID-19 and other viruses with pandemic potential. COVID-19

Coalition formed to represent patient interests in digital health

Pharma Phorum

Not enough is being done to ensure that patient voices are included in policymaking around digital health, says a new patient organisation in the UK, which aims to set that situation right.

Biotech funder Lightstone raises another $375M for life sciences investing

Bio Pharma Dive

The venture firm, which previously invested in Disarm Therapeutics, Ra Pharma and Tizona Therapeutics, said its third fund surpassed its target

Pfizer Vaccine Protection Wanes, C.D.C. Study Shows

NY Times

The study found that the shots’ effectiveness in preventing hospitalization fell to 77 percent from 91 percent four months after full vaccination. Vaccination and Immunization Drugs (Pharmaceuticals) Research BioNTech SE Centers for Disease Control and Prevention Pfizer Inc

FDA approves IND application for peanut allergy drug candidate

Outsourcing Pharma

The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies. Markets & Regulations

Taking stock of NHS medicines optimisation

Pharma Phorum

Given the rising cost of medicines as a share of the NHS budget in England, the establishment of ICSs provides a timely opportunity to take stock on delivering medicines optimisation at local level, says NHS Gloucestershire CCG’s Ellen Rule.

Amgen to advance KRAS drug combination after improved results in colon cancer

Bio Pharma Dive

Combining Amen's Lumakras with its drug Vectibix appeared to work better in treating colorectal cancer than Lumakras alone, spurring the biotech to unveil plans for a new Phase 3 trial

Trials 220

Novartis says its radioligand therapy boosts health-related quality of life

Pharma Times

177Lu-PSMA-617 is being evaluated for the treatment of metastatic castration-resistant prostate cancer

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Research Roundup: Link Between Herpes Simplex Virus and Neurogenerative Diseases Gets More Support

BioSpace

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones

Ahead of FDA adcomm, Pfizer, Moderna say COVID jab efficacy dips

Pharma Phorum

Pfizer and Moderna have both reported data that they say backs up the need for booster shots of their COVID-19 vaccines ahead of an FDA advisory committee meeting tomorrow, although the regulator seems less convinced.

Takeda wins FDA approval for targeted lung cancer drug

Bio Pharma Dive

Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene. Unlike J&J's drug, however, Takeda's is given orally

Study of Covid Booster Shot Benefits Fans Debate Over Extra Doses

NY Times

Independent experts, including government scientists, were skeptical of the research from Israel, which included limited data over a short period.