Sat.May 01, 2021 - Fri.May 07, 2021

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Two biotechs team up to bring CRISPR to 'natural killer' cell therapy

Bio Pharma Dive

A wide-ranging alliance between CRISPR Therapeutics and Nkarta is the latest sign of interest in a fast-emerging form of cancer immunotherapy.

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Pharma’s paid media fails

World of DTC Marketing

WTF? The Washington Post reported last year that health and pharmaceutical companies spent almost $1 billion on just Facebook mobile ads in 2019. A complete waste of money, time and effort. Unlike a traditional TV or radio ad, Facebook’s ad categories help those companies target their drug ads at users who likely suffer from a specific illness the drug treats.

Marketing 283
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FDA INTERACT Meetings: Early Interactions for Cell and Gene Therapy Sponsors

Camargo

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. These therapies frequently target diseases in patients that are rare (affecting fewer than 200,000 people in the US), serious, and representing an unmet medical need.

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Janssen seeks EU approval for first CAR-T therapy cilta-cel

Pharma Times

Cilta-cel is an investigational CAR-T cell therapy for the treatment of relapsed/refractory multiple myeloma

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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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Pfizer forecasts $26B in coronavirus vaccine revenue this year

Bio Pharma Dive

The sum is $11 billion higher than Pfizer had estimated in February and, if realized, would make the vaccine the highest grossing pharmaceutical product by revenue in a single year.

Vaccine 336
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Pfizer wants it all

World of DTC Marketing

QUICK THOUGHT: Pfizer has already made $24 billion from their COVID vaccine, but that’s not enough; they want more, a lot more. They are planning to increase the vaccine price, and they’re working on an oral pill that could bring in as much as an additional $2 billion. While the U.S. Government didn’t pay for development, the German Government did.

Vaccine 281

More Trending

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NurOwn: A Study in the Complexity of ALS Trials

BioSpace

There is also a tacit acknowledgment in the industry that the ALSFRS-R (revised) scale needs to evolve.

Trials 140
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Roivant valued at $7B in blank-check merger, bucking SPAC slowdown

Bio Pharma Dive

Vivek Ramaswamy's unusual biotech holding company will go public through a deal with Montes Archimedes Acquisition Corp. that nets Roivant $611 million.

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Corporations: “get healthcare costs under control”

World of DTC Marketing

SUMMARY: A new survey from the Kaiser Family Foundation and the Purchaser Business Group on Health shows signs that corporate executives might be warming to the idea of government getting more involved to rein in the excesses of the healthcare system. It’s affecting their bottom lines, and they won’t stand for that. Big changes are coming.

Marketing 277
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AZ' Tagrisso first to win MHRA approval under Project Orbis

Pharma Times

Decision brings the innovative treatment to early-stage lung cancer patients, helping to address unmet need in this setting

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

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UK ‘planning to widen AstraZeneca COVID jab restrictions’

pharmaphorum

Reports are emerging that the UK may join other countries in imposing restrictions on the use of AstraZeneca’s COVID-19 vaccine in younger people, after a fresh look at the risks and benefits of the shot. . The Joint Committee on Vaccination and Immunisation (JCVI) said last month that it is preferable for adults aged under 30 with no underlying conditions to be offered an alternative to the AZ/Oxford University adenovirus-based vaccine where available.

Vaccine 130
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Pfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine

Bio Pharma Dive

The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.

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Avance Clinical Expands Gene Technology Clinical Trial Services to Meet $17.4 billion Market Demand

Pharma Mirror

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion by 2023. Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR).

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Preliminary NICE 'no' for Merck's Bavencio

Pharma Times

The cost regulator has rejecting funding the drug as maintenance treatment of advanced/metastatic urothelial cancer

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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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Why relationships are key in rare disease patient engagement

pharmaphorum

Real-world data is a vital part of rare disease drug development, but to get a true picture of patients’ unmet needs pharma should take a broader view of their lived experiences, says Xperiome’s Jeremy Edwards. It is difficult to get data on rare diseases and the people who live with them by their very nature. But these patients face unique challenges in their everyday lives that pharma needs to account for when developing treatments, and understanding these challenges requires strong real-world

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Sage braces for make-or-break depression data

Bio Pharma Dive

The biotech's latest earnings call focused less on revenue and more on an experimental drug for depression that's close to having important study results.

Drugs 334
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How to Treat or Prevent Hearing Loss

Pharma Mirror

Are you catching yourself turning the volume up when listening to the radio or watching a TV show? Have thought about what might be the reason behind that, or have you just assumed that it is perfectly normal and that there is absolutely no reason to worry about anything? If it’s the latter, then I suggest you think twice. The simple truth is that this can actually be a rather serious problem and even if it’s not, your decision to ignore it will most definitely make it serious.

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COVID-19 May Increase Risk of Diabetes, New Study Claims

BioSpace

Patients without diabetes who develop COVID-19 may be at a higher risk of actually developing diabetes following recovery, recent study claims.

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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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Tackling diabetes & ALS with cell therapy

pharmaphorum

Israeli company Kadimastem is developing regenerative medicine therapies based on differentiated cells derived from human embryonic stem cells to treat diseases such as Amyotrophic lateral sclerosis (ALS) and diabetes. Catherine Longworth spoke with Kadimastem’s head of diabetes research, Kfir Molakandov to find out more. In the 1990s, when the first transplant of islets took place, it was hailed as the cure for diabetes.

Insulin 126
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ICER, unconvinced by Biogen data, suggests low price for Alzheimer's drug

Bio Pharma Dive

The influential watchdog group found the evidence supporting aducanumab "insufficient" to determine a health benefit and suggested the drug would be cost effective at up to $8,300 per year, well short of what some analysts are predicting.

Drugs 333
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Why Do You Hear Music In Your Ears & How To Get Rid Of It?

Pharma Mirror

If someone told you that they could hear music in their ears while stimulated by absolutely no melodies in the real world, you might think it to be cool. It’s like you always have your very own, private party. If that’s what you would think about it, though, then it means that you haven’t actually thought about it seriously and that you haven’t taken into account how scary this can be for most people, especially when they become aware of it for the first time.

Pharmacy 130
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Vectura, Inspira team up to develop inhaled COVID-19 drug

Pharma Times

The deal will see Vectura test Inspira's inhaled IPX formulation candidates

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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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performance-io adds Jason McKenna as a non-executive director

pharmaphorum

UK-based performance-io has added to its senior team through two promotions and the appointment of STEM Healthcare CEO Jason McKenna as a non-executive director. He will oversee the online performance marketing and digital benchmarking agency’s growth in the US joins Rob Wood and Barrie Brien on performance-io’s non-executive board. McKenna has been with STEM since 2010, founding it in the US and Brazil before taking over the CEO role from co-founder Rob Wood in 2018.

Marketing 119
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CSL closes deal for UniQure gene therapy in hopeful sign for M&A

Bio Pharma Dive

Completion of the buyout eases concerns the arrangement might be held up by the FTC, which has signaled it will step up scrutiny of life sciences deals.

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Pfizer/BioNTech and Moderna Seek Full FDA Approval for COVID-19 Vaccines

BioSpace

Six months after receiving Emergency Use Authorization from the U.S. FDA for COVID-19 vaccines, Pfizer/BioNTech and Moderna are planning to seek full approval for the preventative medications.

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Researchers identify new genetic target for acute myeloid leukaemia

Pharma Times

Targeting a specific mutation in the CUX1 gene may offer a ‘new therapy avenue’ for AML patients

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

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Revealing the secret cocoa pollinators

Scienmag

International research team led by Göttingen University investigates landscape and farm-level man-agement in cocoa agroforests in Indonesia Credit: Manuel Toledo The importance of pollinators to ensure successful harvests and thus global food security is widely acknowledged. However, the specific pollinators for even major crops – such as cocoa – haven’t yet been identified and there […].

Research 113
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Dyno, in demand for its gene therapy work, raises $100M for fast expansion

Bio Pharma Dive

After inking three big pharma deals within a year of launching, the Harvard spinout has the backing of Andreessen Horowitz and several other top venture investors.

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COVID-19 in the News: Heart Inflammation, Vaccine Effectiveness and More

BioSpace

There’s a fair amount of new information coming out about COVID-19 and vaccines. Here’s a roundup of some of the top stories.

Vaccine 114
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Tecentriq approved for first-line metastatic NSCLC

Pharma Times

Checkpoint inhibitor specifically approved for patients with high PD-L1 expression

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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.