August, 2022

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Psychedelic clinical trials: What sponsors should know when designing new protocols

Bio Pharma Dive

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area

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What to look for when hiring in pharma

World of DTC Marketing

The great resignation has not affected pharma because the jobs within the industry pay very well and most positions and employees like the benefit of having a steady job with good money.

Marketing 231
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Nanorobots: small solutions to big delivery problems

Pharmaceutical Technology

Engineering mini robots to treat diseases may seem like an element of a distant future in sci-fi novels where humans are augmented with machines, but early research to do just that is well underway. Micro and nanorobots for targeted drug delivery are meant to reach hard-to-access parts of the body.

Bacteria 284
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Testing Facility Called “Game Changer” in Regenerative Medicine

Pharma Mirror

The RegeneratOR Test Bed is an exciting game changer. The testing facility, located in North Carolina, provides supportive technology at no cost allowing companies to test and prove their cell-based products at various stages of development.

Medicine 130
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2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

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Pharma Distribution: Carving New Ground

Pharmaceutical Commerce

Pharmaceutical distribution today is anything but monolithic.

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Kerendia™ (finerenone) on mortality in patients with chronic kidney disease and type 2 diabetes

The Pharma Data

More Trending

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The futility of banner ads

World of DTC Marketing

Digital ad spending in the industry will reach $15.84 billion in 2022. Although growth in digital budgets is slowing, we estimate the category will see nearly $20 billion in spending in 2024.

Branding 223
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Tapping into pharma’s growing opportunities in digital health

Pharmaceutical Technology

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources.

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New study use musical tests for early detection of cognitive decline

Pharma Times

Researchers at Tel Aviv University used a portable brain activity-measuring device to detect cognitive decline in older people

Research 120
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Regions On Rise: Life Sciences Across US

Pharmaceutical Commerce

Exploring the competitive and unique offerings in three of the US’s lower-cost economic development regions—and how success in these areas has been boosted by COVID.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

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AMGEN ANNOUNCES TOPLINE DATA FROM LUMAKRAS® (SOTORASIB) PHASE 3 TRIAL IN NON-SMALL CELL LUNG CANCER

The Pharma Data

LUMAKRAS Met Primary Endpoint of Progression-Free Survival, Demonstrating Superiority Over Standard of Care Docetaxel Chemotherapy, in KRAS G12C-Mutated Non-Small Cell Lung Cancer. Detailed Data to be Presented at an Upcoming Medical Congress.

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Alnylam drug succeeds in key heart disease study, boosting company

Bio Pharma Dive

The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on a planned approval application

Trials 285
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Our abysmal health care system

World of DTC Marketing

According to a 2021 study , 1.1 million deaths—including one in two of those under 65, thanks in large part to our abysmal health care system—”would have been averted if the U.S. had the mortality rates of other wealthy nations.

Marketing 219
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The potential of virtual reality-based therapy for serious mental disorders

Pharmaceutical Technology

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.

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Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

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How to Start a Pharma Company with a Low Budget in India?

Fossil Remedies

Do you think that India is a great place to launch a pharma business? Yes, indeed it is. In the past few decades, the Indian economy has done remarkably well. Many sectors have performed well, and the pharma sector is one of them. And the journey of growth has not ended yet.

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FDA Inspections Back Up To Speed (Except Those Now Deemed Unnecessary)

The FDA Law Blog

By Douglas B. Farquhar — Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID.

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Efficacy, cash and more will increase booster shot acceptance

The Pharma Data

The more effective the COVID- 19 supporter, the more likely people are to get it, according to new Cornell exploration. And they’re more likely to accept the supporter shot with cash impulses and if it’s made by Moderna or Pfizer.

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Roche digs into off-the-shelf cell therapy with Poseida deal

Bio Pharma Dive

The pharma has now signed two alliances with allogeneic drug developers since September, signalling its interest in CAR-T treatment alternatives

Drugs 279
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PhRMA lies to protect pharma profits

World of DTC Marketing

PhRMA is lying to protect its profits, and the lies have reached a new height as the Senate moved to adopt modest drug pricing negotiation measures in the Inflation Reduction Act.

Marketing 213
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UK health data collaboration paves the way to study long Covid symptoms

Pharmaceutical Technology

If the last two years have taught us anything, it’s that healthcare challenges transcend nations.

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It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTs

FDA Law Blog

By Jeffrey N. Gibbs & Allyson B. Mullen — Happy Birthday Laboratory Developed Tests (LDTs). Thirty years ago today, FDA announced that it had the authority to regulate you.

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Landmark Drug Pricing Bill Set to Become Law; HP&M Releases Summary Slide Deck

The FDA Law Blog

By Alan M. Kirschenbaum & Michelle L. Butler & Faraz Siddiqui — The Inflation Reduction Act of 2022 (“IRA”) has now passed both the Senate (on August 7) and the House (on August 12), and is headed to President Biden for signature.

Insulin 83
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Pfizer and BioNTech Granted FDA Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster for Ages 12 Years and Older

The Pharma Data

Authorization based on clinical, pre-clinical and manufacturing data for Omicron-adapted bivalent vaccines Pfizer-BioNTech Omicron BA.4/BA.5

Protein 83
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How a small UK biotech ended up in Gilead’s hands

Bio Pharma Dive

MiroBio, which was spun out of the University of Oxford three years ago, drew Gilead’s interest with its autoimmune disease research

Research 278
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Why DTC isn’t, and is, marketing

World of DTC Marketing

CPG marketers are trying to maintain market share amid price increases and smaller product sizes, leading to a more significant jump in consumerism. But, in pharma marketing, the changes affect every product category.

Marketing 211
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Cybersecurity hiring levels in the pharmaceutical industry rose in July 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for cybersecurity related positions rose in July 2022 compared with the equivalent month last year, with 42.3% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 39.5%

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Environmental Sustainability: An Imperative for the Life Sciences Sector

Pharmaceutical Commerce

Recognizing the sustainability issue is an important step, but the biopharmaceutical sector encompasses a complex set of networks and supply chains, so it is not straightforward to shift towards net zero across all operations.

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COVID At-Home Antigen Tests: If at First You Don’t Succeed Try, Try and Try Again

The FDA Law Blog

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Richard A.

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Evusheld long- acting antibody combination approved for forestallment and treatment of COVID- 19 in Japan

The Pharma Data

First global blessing for Evusheld as a COVID- 19 treatment. PROVENT Phase III forestallment trial showed reduced threat of developing characteristic COVID- 19. paraphernalia Phase III treatment trial showed reduced threat of severe COVID- 19 or death in high- threat cases.

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A biotech startup gives Merck its next shot at Alzheimer’s

Bio Pharma Dive

Boston-based Cerevance uses samples of healthy and diseased human brain tissue to find new targets for central nervous system diseases

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What should DTC do?

World of DTC Marketing

Consumers would ask their doctor about an advertised prescription drug in a perfect world. In our REAL world, that isn’t the way it happens. Is there a disconnect between what DTC marketers think will happen and what happens with DTC? The research was straightforward.

Marketing 205
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How close are we to getting a male contraceptive?

Pharmaceutical Technology

With advances in clinical studies evaluating male contraceptives, and laws restricting abortion access after Roe v. Wade was overturned in the US, male contraception has been getting increased attention from the public.

Hormones 247
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Jazz Pharmaceuticals’ epilepsy drug advances into phase 3 trial

Pharma Times

Epidiolex may ease symptoms associated with Doose syndrome, a rarer type of childhood-onset epilepsy

Trials 116
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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

The FDA Law Blog

By Sophia R. Gaulkin & Alan M. Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS).