Sat.Oct 09, 2021 - Fri.Oct 15, 2021

CRISPR touts new results as fresh questions surround 'off-the-shelf' CAR-T

Bio Pharma Dive

The gene editing company aims to expand its trial and add a second dose to improve effectiveness. However, safety worries have emerged since the FDA ordered CRISPR's rival Allogene to suspend clinical work

Pharma losing the battle over drug prices

World of DTC Marketing

Drugs 165
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In the News: September 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Discusses Focus Areas for PDUFA VII During Public Meeting.

Solving mystery of rare cancers directly caused by HIV

Scienmag

PITTSBURGH, Oct. 13, 2021 – For nearly a decade, scientists have known that HIV integrates itself into genes in cells that have the potential to cause cancer. And when this happens in animals with other retroviruses, those animals often develop cancer.

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Sarepta outlines final push for Duchenne gene therapy

Bio Pharma Dive

The biotech still believes a speedy approval filing for the closely watched treatment is possible, but expects to have to wait for the results of the recently launched Phase 3 trial, CEO Doug Ingram said on a conference call

DTC is evolving: 10 things you must do

World of DTC Marketing

SUMMARY : DTC marketing is evolving as patients become more thoughtful about choosing treatment options. The model of “heavy TV followed by a website designed to sell people isn’t going to work anymore.

Moderna, Racing for Profits, Keeps Covid Vaccine Out of Reach of Poor

NY Times

Some poorer countries are paying more and waiting longer for the company’s vaccine than the wealthy — if they have access at all.

More Trending

AstraZeneca immunotherapy combo extends survival in liver cancer trial

Bio Pharma Dive

The results are a rare positive result for AstraZeneca's experimental drug tremelimumab, which has come up short in a handful of other studies and cancer types

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Will pharma ever get digital?

World of DTC Marketing

SUMMARY : Digital marketing is too damn important to leave to your agency. Pharma needs to develop digital marketing expertise in-house and have marketing people integrated within each brand team. There it was again.

Samsung Biologics to help Enzolytics advance clinical development of mAbs

BioPharma Reporter

Samsung Biologics and Enzolytics have entered into a strategic CDMO partnership agreement targeting monoclonal antibody production. Upstream Processing

No return to the status quo: Why now is the time for value-based change

Pharma Phorum

Value-based, person-centred healthcare is the key to system resilience – and now is the time to make it happen. COVID-19 offers a “unique opportunity” to build healthcare systems that are both agile enough to deal with future crises and strong enough to overcome existing challenges.

eCOA clinical trials: A simple, cost-effective approach to study build

Bio Pharma Dive

This new data capture model gives clinical trial sponsors control over study build

Alzheimer’s Drug Granted FDA Breakthrough Designation as Space Heats Up

BioSpace

?The decision is based on promising results from the Marguerite RoAD and SCarlet RoAD open-label extension trials, showing a significant reduction in brain amyloid plaque in Alzheimer's patients

Using AI for mental health assessment

Scienmag

A study published today by an interdisciplinary collaboration, directed by Denis Engemann from Inria, demonstrates that machine learning from large population cohorts can yield “proxy measures” for brain-related health issues without the need for a specialist’s assessment.

WHO plans pandemic prevention study of COVID’s origins

Pharma Phorum

The World Health Organization has set up a new scientific group to study the origins of COVID-19 in the hope that it will help prevent future pandemics.

Takeda takes aim at a biotech's gene therapy work

Bio Pharma Dive

For an upfront payment of $45 million, Takeda gains access to as many as eight programs from Poseida Therapeutics and a potential method of delivering gene therapies without the help of viruses

Regeneron Antibody Cocktail a Priority for FDA with April Action Date

BioSpace

?The FDA and Regeneron are reportedly in talks to set up an advisory committee meeting to discuss the BLA ahead of the target action date

Molecular mixing creates super stable glass

Scienmag

Researchers at Chalmers University of Technology, Sweden, have succeeded in creating a new type of super-stable, durable glass with potential applications ranging from medicines, advanced digital screens, and solar cell technology.

F.D.A. Panel Recommends Moderna Booster for Certain Groups

NY Times

Those eligible for the extra shot would include adults over 65 and others at high risk — the same groups now eligible for a Pfizer-BioNTech boost. Moderna Inc Food and Drug Administration Vaccination and Immunization Drugs (Pharmaceuticals) Coronavirus (2019-nCoV

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FDA panel endorses second shot for adults who received J&J vaccine

Bio Pharma Dive

Agency advisers unanimously supported offering a second dose of J&J's coronavirus vaccine to adults who previously received it, though guidance could change as regulators evaluate mixing boosters

Research Roundup: T-Cell Immune Response to COVID-19 Vaccines and More

BioSpace

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

Hormel Foods Partners with Better Meat Co. To Bring Mycoprotein Products to Market

XTalks

Hormel Foods Corporation’s 199 Ventures which is the company’s venturing company, is entering the plant-based protein sphere by partnering with The Better Meat Co. Together, they will bring new mycoprotein and plant-based protein products to the market.

Why Lie On Your Clinical Research Resume When Applying For Lower Level Positions? Makes ZERO Sense!

Clinical Trial Gurus

Lying on your clinical research resumes is probably the worst decision one can make when trying to start their clinical research career. You will not fool anyone if given enough time

FDA advisers unanimously back Moderna booster shot for many Americans

Bio Pharma Dive

But the committee members remain opposed to broad use of boosters in healthy young adults, for whom the benefits of an additional shot are less clear

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Hope Alights at ECTIRMS 2021 as Companies Present New Data

BioSpace

The 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis ran from October 13 to 15, with companies globally presenting cutting-edge studies on MS

Topelia Australia launches US$25M Series A call for COVID-19 ATT Ziverdox

Pharma Mirror

SYDNEY,Topelia Australia, a biotech company established to commercialise a novel ATT treatment for Australians in quarantine, has launched an investment program designed to keep the invention Australian owned – while rolling out treatment to the world.

IGC Announces Results of its 2021 Annual Stockholders Meeting

BioTech 365

IGC Announces Results of its 2021 Annual Stockholders Meeting IGC Announces Results of its 2021 Annual Stockholders Meeting POTOMAC, Md.–(BUSINESS –(BUSINESS WIRE)–#Alzheimers–India Globalization Capital, Inc.

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Adamas, Flexion sell for $825M combined as biotech's dealmaking pace picks up

Bio Pharma Dive

After lagging for months, M&A has accelerated over the past five weeks. But the average size of each transaction remains low compared to past years, as evidenced by the dual Monday buyouts of Adamas and Flexion

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A New Pathway to Solving Chronic Neurological Diseases - Maybe Long COVID?

BioSpace

CT38 is being studied in myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS), as well as in fibromyalgia and chronic Lyme disease

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Romaco at CIPM 2021 in Chengdu, China

Pharma Mirror

The right solution for every process step Karlsruhe/Germany, Romaco will take advantage of the upcoming CIPM 2021 (61st China International Pharmaceutical Machinery Exposition) to show its newest technologies for manufacturing and packing oral solids.

Dicerna Announces Data to Be Presented at American Society of Nephrology (ASN) Kidney Week 2021

BioTech 365

Dicerna Announces Data to Be Presented at American Society of Nephrology (ASN) Kidney Week 2021 Dicerna Announces Data to Be Presented at American Society of Nephrology (ASN) Kidney Week 2021 – Data From PHYOX™2 Pivotal Trial of Nedosiran for Treatment … Continue reading → Business Wire

FDA staff take neutral stance on Moderna, J&J boosters ahead of two-day meeting

Bio Pharma Dive

In briefing documents, agency scientists emphasized both vaccines still offer strong protection against severe COVID-19, but acknowledged potential for some added benefit with another dose

Pfizer-BioNTech Lead Globally with COVID-19 Vaccine

BioSpace

Although there are many effective and safe COVID-19 vaccines around the world, the preferred vaccine is the Pfizer-BioNTech vaccine. For that and more stories, read on

InSilicoTrials releases two new state-of-the-art simulation tools for oncology 

Pharma Mirror

Milan, InSilicoTrials has been innovating the healthcare sector for some years now, helping pharmaceutical companies reduce the time and cost of drug development using modeling & simulation.

Geron to Host a Virtual Investor Event in November

BioTech 365

Geron to Host a Virtual Investor Event in November Geron to Host a Virtual Investor Event in November FOSTER CITY, Calif.–(BUSINESS –(BUSINESS WIRE)–Geron Corporation (Nasdaq: GERN) will host a virtual investor event on November 9 at 4:00 p.m.

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Merck advantage grows as FDA approves Keytruda for first-line cervical cancer

Bio Pharma Dive

The company's immunotherapy is the only drug of its type cleared for advanced cervical cancer. Others are being tested, however

DIA Digital Technology in Clinical Trials: Integrating Connected Devices: Lessons Learned on How to Successfully Design for a Unified Experience with Robust Clinical Data

ERT