Sat.Jan 02, 2021 - Fri.Jan 08, 2021

article thumbnail

Celgene's cell therapy spinout nets $292M from blank-check merger

Bio Pharma Dive

With additional financing, Celularity will have $372 million to back development of experimental off-the-shelf treatments for cancer and autoimmune diseases.

article thumbnail

10 things DTC marketers should focus on in 2021

World of DTC Marketing

KEY TAKEAWAY: Consumer behavior has changed due to the pandemic, and DTC marketers should be aware of how consumers will evaluate and choose prescription drugs. Many organizations have postponed market research due to the pandemic but knowledgeable DTC marketers should be aware of the progressive trends in healthcare. Here’s my list: 1ne: DTC should focus more on providing health information about advertised medications and less on “selling.” The overwhelming majority of consum

Marketing 271
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

CRUK scientists develop drug that targets KRAS pathways

Pharma Times

KRAS mutations are found in several hard-to-treat cancers

Scientist 162
article thumbnail

FDA Says Data Does Not Support Changes to COVID-19 Vaccine Doses

XTalks

The US Food and Drug Administration (FDA) released a statement this week about dosing schedules for COVID-19 vaccines, saying that any dose changes would be premature. In the statement , the FDA said that it wants to “remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.”.

Vaccine 144
article thumbnail

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

article thumbnail

5 FDA approval decisions to watch in the 1st quarter

Bio Pharma Dive

By March, the FDA expects to conclude reviews of key drugs for heart failure, Duchenne's and multiple myeloma, as well as decide on whether to clear Biogen's controversial Alzheimer's treatment.

article thumbnail

Covid vaccine profits and the strain on supply channels

World of DTC Marketing

SUMMARY: Pfizer and Moderna will sell $28 billion of Covid-19 vaccines this year. Pharma companies will make an estimated $40 billion on the global COVID-19 vaccine market this year, which will be split between Johnson & Johnson, AstraZeneca, Novavax, and others. Wall Street has been speculating for a long time on which pharma company is going to make the most from the development of a Covid-19 vaccine.

Vaccine 266

More Trending

article thumbnail

AstraZeneca/Oxford University's COVID-19 vaccine set for UK rollout

Pharma Times

Shot was approved by MHRA on 30 December

Vaccine 141
article thumbnail

Pfizer beats Sarepta to the start of first late-stage Duchenne gene therapy trial

Bio Pharma Dive

The first patient enrolled in a Phase 3 trial of Pfizer's treatment was given the experimental one-time therapy on Dec. 29.

article thumbnail

The future of pharma depends on its employees

World of DTC Marketing

MINUTE READ: Big pharma should take a good, hard look at small biotech companies and try to better understand how they succeed and are able to make strategic decisions faster without multi-levels of bureaucracy. This week a person with whom I have the highest level of respect because of her emotional and marketing intelligence landed a position with a small biotech company as Global Marketing Director.

article thumbnail

WHO weighs in on COVID-19 vaccine second dose delay

BioPharma Reporter

The World Health Organizationâs vaccine advisory group recommends the two doses of the Pfizer/BioNTech vaccine should be delivered 21 to 28 days apart: although it adds that the maximum time period between doses could be up to six weeks in some situations.

Vaccine 140
article thumbnail

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

article thumbnail

EMA launches review of BMS’ Opdivo for oesophageal cancer

Pharma Times

Company is aiming for approval in the adjuvant setting

140
140
article thumbnail

5 questions facing gene therapy in 2021

Bio Pharma Dive

Gene therapy developers will need to address a series of setbacks that have shaded optimism in the sector's fast growth.

article thumbnail

New Year, New Price Hikes on Hundreds of Prescription Drugs

BioSpace

As the sun rose on a new year, approximately 70 companies raised the price of hundreds of prescription drugs by an average of 3.3%.

Drugs 139
article thumbnail

Are healthcare agencies really this clueless?

World of DTC Marketing

PONTIFICATION: Healthcare agencies need to be the agents of change and lead by example. Speculation or buying into the temporary changes brought on by the pandemic are unrealistic. I just finished reading the latest edition of MedAd News and besides being really dip pointed with the content I was extremely put back by the section on agency people speculating on the changes brought on by the pandemic.

article thumbnail

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

article thumbnail

Choosing a Baby Formula

Pharma Mirror

Infant nutrition, outside of breastfeeding, has become a hot topic recently. Families are taking a hard look at how baby formulas’ ingredients impact their children’s health and development. Concerns and Contamination Every day American parents and caregivers reach for over-the-counter baby formulas and are surprised to find chemicals, additives, and other ingredients that are known to cause health concerns.

article thumbnail

How an all-or-nothing bet on 3 Bristol Myers drugs came undone

Bio Pharma Dive

With no decision from the FDA on approval of an experimental cancer cell therapy, an agreement by Bristol Myers to pay out more money as part of its Celgene acquisition fell apart.

Drugs 351
article thumbnail

China Showcase 2021 Highlights Trends and Areas Ripe for Investment

BioSpace

Biotech growth in China continued at a rapid pace in 2020, despite COVID-19, which emerged from that country to become a global pandemic. Opportunities in China remain good and are expected to continue.

132
132
article thumbnail

Tocilizumab and sarilumab cut risk of death in severe COVID-19 patients

Pharma Times

Anti-inflammatory drugs also accelerated patients' recovery times

Drugs 129
article thumbnail

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.

article thumbnail

FDA and doctors warn against extending COVID-19 vaccine dose gap

pharmaphorum

Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK announced plans to prioritise the first doses of two approved shots. The regulator made its comments after the UK announced a policy of stretching the gap between doses of the vaccine to up to 12 weeks to ensure maximum coverage of vulnerable groups.

Doctor 126
article thumbnail

A new, well-connected biotech aims to fight cancer with viruses

Bio Pharma Dive

Founded by industry veteran Arie Belldegrun's venture capital firm, IconOVir Bio raised $77 million to push its lead drug — derived from the common cold — into clinical testing.

Drugs 344
article thumbnail

Top Life Sciences Startups to Watch in 2021

BioSpace

BioSpace is proud to present its NextGen Bio “Class of 2021,” a list of up-and-coming life sciences companies in North America that recently launched.

article thumbnail

Janssen files EGFR-targeting antibody amivantamab with EMA

Pharma Times

Submission based on results from phase I CHRYSALIS study

Antibody 129
article thumbnail

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.

article thumbnail

Pfizer/BioNTech vaccine may work against new virus mutation, scientists say

pharmaphorum

The Pfizer/BioNTech vaccine appears to work against an important mutation in the new coronavirus variants causing havoc in the UK and South Africa, according to research from the drugs giant. Findings of the lab study posted online have not yet been peer reviewed but provide some reassurance for countries like the UK, which are relying on vaccines to bring the pandemic under control.

Scientist 124
article thumbnail

Sarepta gene therapy misses goal in key muscular dystrophy study

Bio Pharma Dive

Company executives, however, blamed "improbably bad luck" for study enrollment that resulted in more older patients with milder disease receiving placebo, and pledged to press on.

article thumbnail

Operation Warp Speed in Talks with Moderna for Half-Doses of COVID-19 Vaccine

BioSpace

As Operation Warp Speed struggles to ramp up vaccinations, one of the approaches under consideration is cutting the doses of the Moderna vaccine.

Vaccine 127
article thumbnail

Angelini Pharma acquires CNS specialist Arvelle Therapeutics

Pharma Times

Key focus of the deal is focal-onset seizure treatment cenobamate

124
124
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Why cell therapy manufacture is a team sport

pharmaphorum

Louis van de Wiel, Vice President, Site Head EU Manufacturing, Kite, a Gilead Company, reveals the complexity that sits behind the process of individualised cell therapy – and why team culture makes it work. This thought leadership series has been paid and developed by Kite, a Gilead Company. In 2018, we were preparing to build a European facility to produce individualised cell therapies for the treatment of cancer.

article thumbnail

Leading $105M biotech funding, Bayer deepens cell therapy investment

Bio Pharma Dive

A Series B investment in Senti Biosciences will support the startup's research on off-the-shelf candidates, as Bayer places another bet on cell therapy.

Research 317
article thumbnail

Biopharma CEOs on What to Expect at 2021 J.P. Morgan Healthcare Conference

BioSpace

BioSpace spoke to executives from four companies about their expectations for the conference and the coming year.

118
118
article thumbnail

University of Birmingham researchers develop rapid COVID-19 RNA test

Pharma Times

Test can give accurate results in under five minutes, according to researchers

RNA 124
article thumbnail

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.