Trending Articles

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

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.

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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 280

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.

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.

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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More Trending

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

COVID-19 is evolving to get better at becoming airborne, new study shows

Scienmag

Results of a new study led by the University of Maryland School of Public Health show that people infected with the virus that causes COVID-19 exhale infectious virus in their breath – and those infected with the Alpha variant (the dominant strain circulating at the time this study was conducted) put 43 to 100 times […].

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.

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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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.

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.

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.

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

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 219

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

Follicular Lymphoma Market Size Anticipates Growth as the Key Companies Explores Novel Therapeutics Assets

Delveinsight

Follicular lymphoma, a sub-type of indolent B cell non-Hodgkin lymphoma (NHL), accounts for approximately 20% of the total NHL cases. It is the most frequently diagnosed indolent lymphoma. On average, each year, 15,000 new Follicular lymphoma cases are diagnosed in the US alone.

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.

The nanophotonics orchestra presents: Twisting to the light of nanoparticles

Scienmag

Physics researchers at the University of Bath in the UK discover a new physical effect relating to the interactions between light and twisted materials – an effect that is likely to have implications for emerging new nanotechnologies in communications, nanorobotics and ultra-thin optical components.

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

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.

Novartis presents new Kisqali® data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer

BioTech 365

Novartis presents new Kisqali® data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer Novartis presents new Kisqali® data showing longest median overall survival ever reported in HR+/HER2- advanced breast cancer With the MONALEESA-2 final analysis, only … Continue reading → GlobeNewswire

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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.

New combination of old drugs improves survival in patients with prostate cancer

Scienmag

Lugano, Switzerland, 19 September 2021 – A novel combination of well-known drugs prolongs survival in patients with hormone/castration-sensitive prostate cancer, according to late breaking research presented at the ESMO Congress 2021.

Biogen says experimental pain drug helps neuropathy patients in mid-stage trial

Bio Pharma Dive

With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline. Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug

Pfizer's mRNA flu vaccine candidate set to enter clinic

BioPharma Reporter

Pfizerâs mRNA flu vaccine joins candidates from Moderna and Sanofi in hoping to provide greater protection against influenza than existing vaccines. Bio Developments

Seagen and Genmab Present Interim Results From the innovaTV 205 Study for Tisotumab Vedotin Combination Therapy Treatment of Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2021

BioTech 365

Seagen and Genmab Present Interim Results From the innovaTV 205 Study for Tisotumab Vedotin Combination Therapy Treatment of Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2021 Seagen and Genmab Present Interim Results From the innovaTV 205 Study for … Continue reading → Business Wire

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AI aims to prevent unneeded treatment for deep vein thrombosis

Pharma Phorum

Researchers in the UK are working on an artificial intelligence (AI) algorithm to help diagnose deep vein thrombosis (DVT) from ultrasound images – and potentially prevent patients from receiving drugs unnecessarily.

First-line CDK 4/6 inhibition shows overall survival benefit for metastatic breast cancer

Scienmag

Lugano, Switzerland, 19 September 2021 – Adding a CDK 4/6 inhibitor to first-line hormonal treatment prolongs survival by one year for postmenopausal women with hormone receptor (HR) positive, HER2 negative advanced breast cancer, according to late breaking results of the MONALEESA-2 trial presented at the ESMO Congress 2021. (1)

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

Study: Survivors of Severe COVID-19 at Risk for Autoimmune Disease

BioSpace

?According to the study, people who get sick enough to be hospitalized due to the virus might eventually suffer from a full-blown autoimmune disease later on

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