Sat.Apr 16, 2022 - Fri.Apr 22, 2022

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A promising cancer drug leads Regeneron to reconsider its aversion to M&A

Bio Pharma Dive

Regeneron has agreed to purchase Checkmate Pharmaceuticals for $250 million, the first acquisition of a publicly traded company in the biotech's nearly 35-year history.

Drugs 333
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DTC marketers addicted to TV

World of DTC Marketing

TV creates awareness quickly when you have a big audience, but TV is a waste of money when your audience is small. I can get better results using digital laser targeting and targeted print ads, but DTC marketers are like TV because it makes them feel important within their company. Tepezza has been running many ads on TV, but it’s a waste of money. The money could have been better spent to learn all they can about their audience and take the message to where they are, either in print or online.

Marketing 227
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US study finds high rates of unneeded antibiotic prescribing

pharmaphorum

A study has found that there is still a very high level of inappropriate antibiotic prescribing to patients in the US, particularly to older and Black patients. Sifting through data from around seven billion outpatient visits to doctor’s offices, hospital clinics and emergency departments over a seven-year period, the researchers found that almost three-quarters (74%) of antibiotics prescribed to patients aged 65 years or older, and two thirds (64%) to Black patients, were unnecessary.

Scientist 122
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DNA analysis uncovers new cancer treatment clues

Pharma Times

Researchers were able to detect specific combinations of genetic alterations which may hold key to the growth of cancers

DNA 133
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Imara to reduce staff by 83% amid biotech shakeout

Bio Pharma Dive

The planned job cuts were announced days after Imara — one of three spinouts from the drug accelerator Cydan Development, stopped development of its top medicine.

Medicine 315
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HCPs sound off on pharma marketing

World of DTC Marketing

We just finished talking to over 200 hundred HCPs about pharma marketing and salespeople to measure any differences since before the pandemic. Attitudes are indeed changing, but one need remains clear: access to data obtained during clinical and ongoing trials. We’ve all heard that digital is the way to reach HCPs, and we found out that’s still mostly true, but not all digital tactics are created equal.

Marketing 218

More Trending

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New study reveals emotional and psychological impact of infertility

Pharma Times

Infertility is estimated to affect one in seven couples across the UK and can have a profound effect on mental health

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GSK to test FDA's tough stance on anemia pills

Bio Pharma Dive

Unlike treatments from Akebia and FibroGen, GSK's drug hasn't been tied to a higher risk of heart problems, potentially easing the agency's concerns.

Drugs 313
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DTC Marketing strategy must be fluid

World of DTC Marketing

Before most drugs are launched, much time and effort are spent developing marketing plans and getting approval. However, given the rapid changes in the market and the realization that too many tactics are more hype than reality, fixed marketing plans are a waste of time. There are three essential elements of any good marketing plan: brand objective, Strategy, and tactics.

Marketing 192
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Ampio slumps as FDA delivers knee osteoarthritis shock

pharmaphorum

Ampio Pharma’s candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review. Shares in the US biotech have fallen sharply after it revealed that the regulator did not accept changes to a phase 3 trial of the drug – called Ampion – that the company put forward in order to make it serve as a confirmatory pivotal study.

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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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RoboBurger: America’s First Burger Vending Machine

XTalks

Newark, New Jersey-based RoboBurger claims to have created America’s first burger vending machine and is now looking to expand. The startup aims to bring its burger vending machines to the Philadelphia area within the year after launching its first outpost at the Newport Centre Mall in North Jersey last month. So, how does the unusual vending machine work?

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Bristol Myers scraps $2B Nektar partnership after trial failures

Bio Pharma Dive

The companies have halted testing in kidney and bladder cancer, one month after ending a skin cancer study. Nektar executives are now preparing plans to conserve cash.

Trials 300
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Moderna’s bivalent COVID-19 booster offers improved protection against Omicron

BioPharma Reporter

Modernaâs bivalent COVID-19 booster vaccine candidate, mRNA-1273.211, demonstrated superior neutralizing titers compared to the original mRNA-1273 booster dose against all variants of concern, including Omicron, according to data released by the company this week.

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The largest pharma company in Europe calls for interoperability

pharmaphorum

Ehab Youssef, area head of Europe North at Roche Pharmaceuticals, tells us why European countries need interoperability to ensure a more effective overall European healthcare system. COVID spotlighted the vulnerability of the healthcare system and the need for structural and technological change to help manage such as crisis. Though some regions have started to make the necessary changes, Youssef says Europe is lagging. “In general, there is a good progression in almost every country.

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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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BioNTech Partners with Matinas BioPharma to Develop New Delivery Technology for mRNA Vaccines

XTalks

Top COVID-19 mRNA vaccine maker BioNTech is setting out to explore new and improved delivery technologies for mRNA vaccines, recently announcing a collaboration with New Jersey-based lipid nanocrystal developer Matinas BioPharma. The $2.75 million deal will allow BioNTech to tap into Matinas’ Lipid Nanocrystal (LNC) Delivery Platform Technology to develop novel vaccine formulations, including a potential oral solution.

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Troubling data leads a biotech to pull its prized drug from market and FDA review

Bio Pharma Dive

Early analysis of a key clinical trial showed a potentially increased risk of death in cancer patients who received a combination treatment that included TG Therapeutics' approved medicine, Ukoniq.

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Clinical trial evolution, innovation center of Oracle Health Sciences event

Outsourcing Pharma

The two-day Oracle Health Sciences Connect will gather an array of research experts to discuss how to make the most of emerging technologies and practices.

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Astellas takes $170m charge as it drops DMD gene therapies

pharmaphorum

Astellas has said it will book a $170 million impairment charge in its fourth quarter results as a result of a decision to halt the development of three gene therapy candidates for Duchenne muscular dystrophy in preclinical development. The write-down comes in the wake of problems affecting the Japanese drugmaker’s AT132 gene therapy candidate for rare disease X-linked myotubular myopathy (XLMTM), which was placed on clinical hold by the FDA last year after four patient deaths liked to pos

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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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New coalition formed to raise awareness of sight loss

Pharma Times

‘The Eyes Have It’ partnership will highlight the importance of eye health

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Gilead gets cell therapy boost with FDA clearance of Maryland factory

Bio Pharma Dive

The new site in Frederick, Maryland will be used to produce Yescarta, which this month won an expanded approval that substantially widens its market.

Marketing 300
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These Fast-Food Companies are Serving Up Food NFTs

XTalks

From vintage Coca-Cola coolers to non-edible Pringles, consumers are developing an appetite for non-fungible tokens (NFTs). The burgeoning technology allows people to secure unique ownership of artwork, videos, photos and other digital content on the blockchain. Now, food NFT adoption is picking up steam across the food and beverage industry, with many fast-food chains displaying interest in them.

Branding 101
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FDA starts speedy review of Enhertu in lung cancer

pharmaphorum

AstraZeneca and Daiichi Sankyo should only have to wait for six months to hear from the FDA if it will approve their HER2 drug Enhertu for non-small cell lung cancer (NSCLC) and add to its current uses in breast and gastric cancer. The US regulator has kicked off a priority review of Enhertu (trastuzumab deruxtecan) as a treatment for NSCLC with HER2 mutations after prior systemic therapy, setting up a decision in the third quarter of this year.

Sales 105
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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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NICE releases revised guidelines on antidepressants

Pharma Times

The new guidelines focus on key areas of prescription, management of withdrawal and severity of withdrawal symptoms

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Satellite Bio launches with new approach to bioengineering tissues

Bio Pharma Dive

Backed by $110 million in venture funding, Satellite is led by Dave Lennon, formerly head of Novartis Gene Therapies.

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Awake Prone Positioning in Hospitalized Adults With COVID-19

JAMA Internal Medicine

This nonrandomized controlled trial uses a modified World Health Organization ordinal scale to assess whether awake prone positioning was associated with improved clinical outcomes among patients with COVID-19–related hypoxemia who require supplemental oxygen but have not received invasive mechanical ventilation.

Trials 98
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Digital therapy for osteoarthritis tops other methods, says study

pharmaphorum

A meta-analysis of published studies looking at web- app- or telehealth-based therapy for osteoarthritis has concluded that they outperform standard approaches to care. The study – published in the journal Osteoarthritis and Cartilage – focused on patients with osteoarthritis of the hip or knee, and compared the digitally-delivered exercises to standard approaches such as in-person physiotherapy, other forms of care, waitlisting and patient education.

Research 105
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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.

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Oncomatryx announces 15m euros funding to conduct clinical trials

Pharma Times

Company at the forefront of developing personalised treatments against invasive cancer has raised 15m euros to conduct clinical trials

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Drug price hikes moderate as rebates rise, report finds

Bio Pharma Dive

List prices for branded medicines rose by nearly 5% last year, according to IQVIA, a figure that fell to 1% after accounting for rebates and discounts.

Branding 265
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BUBLUV: The Ready-to-Drink, Healthier Bubble Tea Alternative

XTalks

New York-based startup BUBLUV, Inc. recently launched its first product: a better-for-you, ready-to-drink bottled bubble tea. BUBLUV claims to be the first of its kind on the market and is available exclusively on the company’s direct-to-consumer (DTC) website. So, how does the brand differ from other bubble teas? While many bubble teas often lack nutritional value, BUBLUV boasts no added sugar, no artificial ingredients and contains less than 50 calories per bottle.

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Sarepta DMD rival PepGen files $115m IPO

pharmaphorum

Just days after dosing its first patient in a Duchenne muscular dystrophy trial, US biotech PepGen has pushed the button on an initial public offering (IPO). The Boston-based company has filed with the US Securities and Exchange Commission to raise up to $115 million from the IPO, according to a Renaissance Capital report. The funding will be used to continue the clinical development of lead oligonucleotide PGN-EDO51 for DMD, as well as two other oligo drugs PGN-EDODM1 for myotonic dystrophy ty

Protein 105
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.