August, 2022

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

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.

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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.

Pharma Distribution: Carving New Ground

Pharmaceutical Commerce

Pharmaceutical distribution today is anything but monolithic.

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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.

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.

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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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.

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.

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.

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.

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.

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.

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

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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.

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.

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.

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.

Regen BioPharma files patent on mRNA cancer immunotherapy vaccine

BioPharma Reporter

San Diego headquartered, Regen BioPharma, has filed a provisional patent application filing covering utilization of dendritic cell technologies to augment efficacy of its patented survivin mRNA cancer immunotherapeutic vaccine. Markets & Regulations

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.

Biotech startup Ocean pivots from IPO to SPAC merger

Bio Pharma Dive

The blank-check deal gives Ocean another route to public markets after it struggled to price an initial public offering it revealed back in June 2021

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.

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.

European Commission grants marketing authorization for Ranivisio?®* (ranibizumab), a biosimilar to Lucentis®**, for age-related macular degeneration (AMD) 

The Pharma Data

Teva Pharmaceuticals to commercialize the product in Europe. Age-related macular degeneration (AMD) affects around 67 million people in Europe and is a leading cause of blindness for working age adults with uncontrolled diabetes 1 and the most common cause of blindness in developed countries 2.

Biden Administration Facing Renewed Pressure to Legalize Cannabis

FDA Law Blog

By Larry K. Houck — At least one public interest group and several members of Congress remain frustrated with the Biden Administration’s failure to take action to legalize cannabis.

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).

Pfizer follows GSK with positive Phase 3 results for RSV vaccine

Bio Pharma Dive

In a pre-planned interim data analysis, Pfizer said its shot was strongly protective against severe disease and plans to submit the results to regulators this fall

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.

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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The UK won't purchase AstraZeneca's Evusheld, citing 'insufficient data'

Fierce Pharma

The UK won't purchase AstraZeneca's Evusheld, citing 'insufficient data'. kdunleavy. Mon, 08/15/2022 - 11:05

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Dismay as UK ‘drags its heels’ on AZ’s COVID antibody Evusheld

Pharma Phorum

Half a million people in the UK with conditions like blood cancer that prevents them being protected from COVID-19 vaccines are facing another winter shielding, because the government has shelved plans to offer treatment with AstraZeneca’s antibody therapy Evusheld.

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.

Atlas Venture’s Bruce Booth on testing the IPO waters and putting the ‘tech’ in biotech

Bio Pharma Dive

In a wide-ranging conversation with BioPharma Dive, Booth, a prolific builder of new biotechs, said he’s starting to see positive signs for startups considering an IPO or private financing

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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.

Gilead’s Sunlenca receives EC approval to treat HIV

Pharmaceutical Technology

Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection.

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After billions in legal costs, Johnson & Johnson plans to halt talc sales worldwide

Fierce Pharma

After billions in legal costs, Johnson & Johnson plans to halt talc sales worldwide. kdunleavy. Fri, 08/12/2022 - 09:14

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Digital health app linked to better outcomes in heart failure

Pharma Phorum

A study of a mobile health app used to support patients hospitalised with heart failure has concluded that it provided a modest improvement in quality-of-life scores, as well as better clinical outcomes.