Sat.Jun 26, 2021 - Fri.Jul 02, 2021

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Intellia, with first results, delivers a 'landmark' for CRISPR gene editing

Bio Pharma Dive

Results published in The New England Journal of Medicine offer the first clinical evidence that CRISPR gene editing inside the body can be safe and effective, a culmination of years of scientific research.

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Online health seekers after the pandemic

World of DTC Marketing

SUMMARY: Online health seeker numbers are still very high, indicating that people are doing their research first before asking for a prescription drug. Online health seekers trust pharma products but find product websites hard to read and inconsistent with their needs. Telehealth numbers are dropping rapidly, but people still want to use telehealth to ask for Rx renewals and ask general questions.

Doctor 217
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BioMarin resubmits haemophilia A gene therapy to the EMA

Pharma Times

Company initially withdrew a marketing authorisation application for the gene therapy last year

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Innate Pharma’s ANKET NK Engager Platform Eradicates Tumors Safely and Efficiently

BioSpace

Innate Pharma has an alternative to T cell-based immunotherapy that has the potential to quickly and safely eradicate solid and metastatic tumors in the body.

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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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5 FDA decisions to watch in the third quarter

Bio Pharma Dive

The agency is under pressure to grant full approvals to two coronavirus vaccines and faces important questions on how to handle the next Alzheimer's drugs after Aduhelm. A safety review of several arthritis medicines, meanwhile, is ongoing.

Vaccine 355
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Are Biogen employees drinking the Kool-Aid?

World of DTC Marketing

SUMMARY: The debate around Biogen’s Alzheimer’s drug continues to rage. The clinical evidence supporting the approval of the drug is at best “weak.” How could the FDA approve a drug with such poor clinical data? How can Biogen’s employees continue to work for a company that is raping taxpayers for a drug that doesn’t work?

Drugs 194

More Trending

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Blockchain: Ready to revolutionise medicinal cannabis research?

pharmaphorum

Robert Galarza outlines how blockchain technology can be utilised to verify, validate and standardise the efficacy of medical cannabis and other plant based therapies in clinical trials. . The Chinese surgeon Huo Tuo first mixed powdered cannabis with wine to make an anesthetic sometime between 140 and 208 CE. Indeed, the Chinese term for “anesthesia” (mázui ??

Medicine 130
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Gilead matches Bristol Myers in showing benefit to earlier CAR-T treatment

Bio Pharma Dive

A study of Gilead's Yescarta found the cell therapy dramatically outperformed chemotherapy and stem cell transplant in treating lymphoma, a result that could support much broader use of the drug.

Drugs 338
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Um, about that diabetes drug that helped patients lose weight

World of DTC Marketing

SUMMARY: According to the NEJM “in participants with overweight or obesity, 2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight” In the clinical study, participants were enrolled in an “intensive” behavioral study with 8 weeks low-calorie diet.

Drugs 194
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Sanofi plans €400m investment in mRNA vaccines ‘centre of excellence’

Pharma Times

Sanofi is currently collaborating with Translate Bio on a mRNA-based COVID-19 vaccine candidate

Vaccine 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Mix and match regimen of AZ and Pfizer COVID jabs works well

pharmaphorum

Giving one dose each of AstraZeneca and Pfizer COVID-19 vaccines provides good protection against the SARS-CoV-2 virus, but may be associated with more adverse reactions, according to new clinical trial data. The Com-COV trial compared two shots with Pfizer/BioNTech’s Comirnaty, two doses of AstraZeneca’s Vaxzevria, and a mixed regimen of one of each jab, and found that all were effective at stimulating a “robust” immune response against the coronavirus, according to the

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The 'dovetail' partnership meant to turn Boston Children's into a hub for gene therapy startups

Bio Pharma Dive

A five-year alliance with high-profile biotech ElevateBio is designed to get around a bottleneck that has held back the institution’s gene therapy work.

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Help Wanted: Pharma CEO who is a leader

World of DTC Marketing

SUMMARY: Leadership is the ability to influence or guide others. Too many pharma CEOs are bad leaders because they fear failure, losing power, and focus too much on metrics not important to the rank and file. Six out of 10 employees said they feel demotivated by their CEOs; 70% say CEO pay was too high in general. The median CEO of the drug companies outpaced the more modest pay gains of their employees.

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bluebird bio’s sickle cell gene therapy granted MHRA ‘innovation passport’

Pharma Times

Innovation passport designation scheme aims to reduce the time to market for promising treatments

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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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The FDA Should Fully Approve Pfizer and Moderna's Vaccines

NY Times

The Pfizer and Moderna vaccines are safe and effective. Full approval from the F.D.A. will help stop the spread of Covid-19.

Vaccine 117
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Beam, Apellis partner in deal to expand gene editing's reach

Bio Pharma Dive

The companies aim to develop therapies for complement-driven diseases, a specialty of Apellis and relatively new research ground for gene editing.

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The “business” of the pharma media

World of DTC Marketing

SUMMARY: The pharmaceutical trade publications, except STAT News and Endpoints, have remained silent on the sham approval of Biogen’s Alzheimer’s drug. Pharma trade magazines have become irrelevant, and most could care less what they print, although they try to suck up with phony awards. It’s up to people within the industry to push back and try to be the change we want and need to see.

Drugs 155
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‘Mix and match’ COVID-19 vaccine study yields promising results

Pharma Times

Mixing different vaccines produces a strong immune response against virus, according to researchers

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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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Promised EAP Date Approaching for Biogen's Highly Publicized ALS Drug

BioSpace

Tofersen is the furthest along of four ASOs currently in clinical development for ALS and as such, there is quite a bit riding on the results of the VALOR trial which has an estimated completion date of August 31st, 2021.

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Congress pressures FDA and Biogen on Alzheimer's drug approval, price

Bio Pharma Dive

The agency's decision-making process as well as Biogen's pricing of Aduhelm at $56,000 per year are both under the microscope as the repercussions of the controversial OK continue to be felt.

Drugs 315
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Why the Potential Effects of COVID-19 Vaccines on the Menstrual Cycle Are Not Concerning

XTalks

There have been growing reports of women experiencing changes in their menstrual cycle after receiving a shot of a COVID-19 vaccine. Some women have said they got their periods early following vaccination, or that their periods were unusually heavy and/or painful. There have also been reports of post-menopausal women and trans men experiencing bleeding or spotting after getting the shot.

Vaccine 105
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MSD’s Keytruda scores EU approval in certain oesophageal cancer patients

Pharma Times

Checkpoint inhibitor approved in combination with chemotherapy in the first-line setting for these patients

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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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Renal disease: the big picture

pharmaphorum

Renal diseases represent a formidable challenge on public health systems around the world. They are costly in terms of economic burden and quality of life, especially among older patient populations, and are closely linked to other chronic conditions such as cardiovascular disease and diabetes. Joan Perelló and Adam Levy explore the advancement of treatments in the renal space.

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The time is ripe for wearables in oncology clinical trials and cancer treatment

Bio Pharma Dive

Wearables can minimize trips to clinic sites and may provide study participants and cancer patients with a feeling of having more control over how they manage their own illness.

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Why Titanium Dioxide in Food is Under Review by the EFSA

XTalks

The safety of titanium dioxide in food, an additive found in thousands of ultra-processed foods, is now being questioned by the European Food Safety Authority (EFSA) after an in-house study conducted in March. In a surprising twist, the study concluded that the agency no longer considers titanium dioxide a safe food additive. So what does this mean?

Branding 105
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Jazz Pharma’s blood cancer therapy Rylaze wins US approval

Pharma Times

Rylaze has been specifically developed for patients who have developed hypersensitivity to E.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Intellia, Regeneron ace first trial with ‘in vivo’ CRISPR drug

pharmaphorum

The first ever clinical data with a CRISPR/Cas9 drug used to edit the genomes of cells within the body has yielded impressive results in patients with ATTR amyloidosis, a life-threatening rare disease. . Preliminary results from a phase 1 trial run by Regeneron and CRISPR specialist Intellia Therapeutics – co-founded by Nobel Prize winner Jennifer Doudna – showed steep reductions in a biomarker of ATTR amyloidosis disease activity with a single dose of the NTLA-2001 drug.

In-Vivo 105
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Pfizer's neuroscience spinout scores in schizophrenia

Bio Pharma Dive

Cerevel Therapeutics on Tuesday revealed positive results from an early-stage study of one of its drugs, doubling the price of the company's stock.

Drugs 306
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Lifetime of Protection Against COVID-19 May Be Possible with mRNA Vaccines

BioSpace

A new study published in Nature offers good news for those who recovered from COVID-19 and were then vaccinated with a mRNA vaccine – a booster may not be needed.

Vaccine 103
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ABPI launches updated Code of Practice

Pharma Times

The new Code has been updated to reflect changes in the pharma environment

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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.