Sat.Nov 27, 2021 - Fri.Dec 03, 2021

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FDA panel, after debate, narrowly backs Merck COVID pill

Bio Pharma Dive

While agency advisers raised concerns over molnupiravir's modest benefits and potential risks, a majority felt the antiviral drug is a needed option for COVID-19 patients at high risk of severe disease.

Drugs 346
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“Patients are only numbers on an Excel spreadsheet”

World of DTC Marketing

LEAD-IN: Yesterday I had a long talk with someone who has been in the industry for over 25 years. She has decided to leave the pharma industry because she said, “patients have been reduced to numbers on an excel spreadsheet” and “I am tired of trying to get coworkers to see them as people with real needs.” According to my WordPress stats, I have over 100 readers a day.

Insulin 259
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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. When developing biologics, sponsors must manage several scientific considerations specific to large molecule products, including biochemical characterization studies to confirm structural identity, biological activity studies to confirm potency, and mechanism of action maintenance.

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GSK aim for HIV cure by 2030

Pharma Times

Following its recent approval of an injectable HIV-1 treatment from the National institute for Health and Care Excellence (NICE), GlaxoSmithKline (GSK) has high hopes in developing a cure for the virus in the future.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Heart attacks struck Sek Kathiresan's family. He's devoted his life to stopping them.

Bio Pharma Dive

After several family members had early heart attacks, Kathiresan vowed to understand why they happen. His research journey has changed medical practice and led to a new biotech startup, Verve Therapeutics, that seeks to prevent them.

Research 328
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There are instances when TV (DTC) is NOT a good idea

World of DTC Marketing

OPENING: TV is great at creating awareness, but it can also scare patients away if one of your side effects is “may lead to death.” This is one side effect that stands out when your target audience watches your spot along with “serious heart rhythm problems” and “new cancers have happened during treatment.” I understand that DTC marketers are in love with TV even though it’s becoming less effective.

Doctor 210

More Trending

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A Cure for Type 1 Diabetes? For One Man, It Seems to Have Worked.

NY Times

A new treatment using stem cells that produce insulin has surprised experts and given them hope for the 1.5 million Americans living with the disease.

Insulin 145
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Blueprint, taking aim at larger drugmakers, becomes a biotech buyer

Bio Pharma Dive

A $250 million acquisition of startup Lengo Therapeutics has given Blueprint a lung cancer drug that could compete with medicines from Takeda and J&J.

Medicine 324
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A scientific approach to irrational consumer choices

World of DTC Marketing

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Since when is consumer behavior ever scientific? According to Science Direct “participants who saw exaggerated images (in DTC ads) were more likely than those who saw no image or accurate images to overestimate efficacy.

Drugs 185
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Trial of Jazz’ cannabis drug in glioblastoma will start next year

pharmaphorum

An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. The three-year phase 2 trial will be carried out by researchers at Leeds University led by professor of clinical oncology and neuro-oncology Susan Short, and see if adding Sativex (nabiximols) to standard chemotherapy for recurrent glioblastoma can extend survival.

Trials 136
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Will High Vaccination Rates Help Spain Weather Omicron?

NY Times

Spain surpassed others in Europe by avoiding politicized debate about Covid shots. Citizens also largely heeded the health guidance from their leaders.

Vaccine 140
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GSK hires away top Pfizer vaccine scientist

Bio Pharma Dive

Philip Dormitzer, who helped Pfizer develop shots for COVID-19, RSV and influenza, will become the British pharma's head of vaccine R&D next month.

Vaccine 309
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Medscape vs. Doximity

World of DTC Marketing

SUMMARY: When it comes to reaching health care professionals, there is only one choice as far as I am concerned, and that’s Medscape. Working with them has always been a pleasure, and we can always “list match” targeted physicians. Health care professionals are going digital, and if you want to reach them, the options are growing. Lately, there has been a lot of talk about Doximity, but as the data below indicates, Medscape has much more traffic.

Vaccine 173
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Late cancer diagnoses rise as NHS struggles with COVID-19

Pharma Times

Analyses provided by UK cancer charity Macmillan has provided insights into the repercussions experienced by patients waiting to receive treatment during the COVID-19 pandemic.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Emmes Announces Completion of Third ACTT Clinical Trial for COVID-19

Pharma Mirror

Rockville, Emmes today announced that it conducted the data and statistical analysis for the third iteration of the Adaptive COVID-19 Treatment Trial (ACTT-3), using its proprietary Advantage eClinical system. The ACTT-3 trial assessed the efficacy and safety of interferon beta-1a plus remdesivir compared to remdesivir alone in hospitalized adults with COVID-19.

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Vaccine makers move quickly to confront omicron threat

Bio Pharma Dive

Several companies, including Pfizer and Moderna, are already at work adapting their coronavirus shots to the newly identified variant, which experts worry could more readily evade vaccine protection.

Vaccine 299
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Boehringer-backed digital health academy set for launch in UK

pharmaphorum

An online training academy that aims to raise the digital skills of NHS health and care workers is due to open its virtual doors next March, according to the Organisation for the Review of Care and Health Apps (ORCHA). The Digital Health Academy – developed with pharma company Boehringer Ingelheim – is part of a drive to get digital health tools and apps used more routinely in the management of health conditions, according to ORCHA.

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Possible identification of blood clot trigger for AstraZeneca COVID-19 vaccine

Pharma Times

Researchers have identified in those patients experiencing blood clots after vaccination a subsequent condition referred to as vaccine-induced immune thrombotic thrombocytopenia (VITT).

Vaccine 130
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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Medinfar awarded first ever CPhI Verified Certificate

Pharma Mirror

CPhI awards the first ever CPhI Verified certificate to Medinfar – an international pharmaceutical manufacturer of Rx, cosmetics, food supplements and veterinary products. The new certification was given after a detailed evaluation by SGS – the world’s leading verification, inspection and certification company – spanning some 14 separate criteria, including the company’s approach to quality and environmental management, supply chain, health and safety and business continuity planning.

Cosmetics 130
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Regeneron warns its antibody drug may be less potent versus omicron

Bio Pharma Dive

While Regeneron is still testing its treatment against the new variant, the biotech is readying contingency plans, including second-generation versions of its drug.

Antibody 298
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ImmunityBio and EnGeneIC to advance nanocell tech for cancer treatment and COVID-19 vaccine

BioPharma Reporter

Australian biotech EnGeneIC, which is developing its nanocell tech for use in infectious diseases (including a COVID-19 vaccine) as well as a cancer treatment, has announced a deal with US biotech ImmunityBio to develop, manufacture and commercialize the tech.

Vaccine 120
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Total UK cases of Omicron rise to nine

Pharma Times

An additional six cases of the Omicron variant have now been detected in Scotland, bringing the UK total so far to nine.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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MHRA okays GSK’s Xevudy as data suggest it works against Omicron

pharmaphorum

The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech’s antibody for COVID-19, Xevudy, which has been shown to be effective against the new Omicron strain of SARS-CoV-2 in lab testing. Xevudy (sotrovimab) is the second COVID-19 antibody to be approved by the MHRA after Roche/Regeneron’s Ronapreve (casirivimab and imdevimab), which got a green light during the summer.

Antibody 119
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Facing challenges, Deciphera cuts workforce by a third

Bio Pharma Dive

The Massachusetts biotech is eliminating 140 positions as it looks to cut costs following disappointing study results for its sole commercial product.

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Early-Stage Diabetes Treatment Wows Patients and Clinicians Alike

BioSpace

In October, Vertex Pharmaceuticals announced stunning results in a type 1 diabetes patient who had been dosed with the company’s experimental therapy.

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UK orders extra 114 million COVID-19 vaccines to combat Omicron

Pharma Times

Scientists and health experts have cautioned that the new variant could have the ability to bypass the effectiveness of vaccines that are currently available.

Vaccine 124
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Genetic testing offers powerful weapon for detecting breast cancer: Sema4

Outsourcing Pharma

A leader from the health tech solutions company explains how progress in genetic testing has helped advance the detection and prevention of breast cancer.

Genetics 115
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Former Immunomedics executive charged with insider trading around trial data

Bio Pharma Dive

Usama Malik, chief financial officer of Immunomedics from 2017 to late 2020, is charged with tipping his partner and several relatives of positive study results for the biotech's breast cancer drug.

Trials 246
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In Head-to-Head Comparison, Moderna Bests Pfizer by a Nose

BioSpace

Researchers from Harvard University and the U.S. Department of Veterans Affairs (VA) found that the Moderna mRNA vaccine was slightly better than the Pfizer-BioNTech vaccine.

Vaccine 112
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All adults to be offered COVID-19 booster jabs by end of January 2022

Pharma Times

The UK government has aimed to expand their COVID-19 vaccination programme, in accordance with guidance from the Joint Committee on Vaccination and Immunisation (JCVI).

Vaccine 119
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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.