Mon.Aug 15, 2022

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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. However, some pharma companies are having problems filling open positions, and when they do, they often find it wasn’t a good fit. Here are some things to consider to ensure you’re hiring good people.

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Novartis bid to repurpose rare disease drug for cancer falls short in third trial

Bio Pharma Dive

A Phase 3 study testing Novartis’ canakinumab as an adjuvant lung cancer treatment missed its main goal, closing off an opportunity for an expanded approval.

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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. The updated, Omicron-containing bivalent vaccine that acts on two coronavirus variants is indicated as a booster dose for active immunisation for the prevention of Covid-19 in people of this age group.

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Pharma prepares to continue fight as drug pricing bill passes House

Bio Pharma Dive

Analysts have highlighted ways in which drugmakers might seek to sidestep the law, which President Biden is expected to sign this week after it passed the House on Friday.

Drugs 258
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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 Canadian life sciences hub that may not be on your FDI radar (but should be)

Pharmaceutical Technology

It is no secret that Canada boasts a strong and competitive life sciences sector. The country has a long history of leadership and innovation in this field, from the discovery of stem cells and insulin to the invention of the world’s first pacemaker and much more. Within Canada, one province has often stood out as the place to be for cutting-edge life sciences innovation.

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Despite failed trial, Brainstorm asks FDA to approve ALS drug

Bio Pharma Dive

The move comes less than a month after the agency agreed to review Biogen’s tofersen — another ALS drug with a questionable record in clinical testing.

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More Trending

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UK approves Moderna’s two-pronged COVID-19 booster

Bio Pharma Dive

Britain’s drug regulator is the first public health authority to clear a vaccine designed to fight omicron as well as the original strain of the virus.

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This group's wiped out $6.7 billion in medical debt, and it's just getting started

NPR Health - Shots

Nonprofit RIP Medical Debt buys up unpaid hospital bills plaguing low-income patients and frees them from having to pay.

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Messaging the right HCP at the right time via their electronic health record (EHR)

Bio Pharma Dive

HCPs spend 3x the time in their EHR each day as they do online. How should that affect your approach to reaching HCPs?

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Opinion: ‘Is an abortion medically necessary?’ is not a question for ethicists to answer

STAT News

Abortion raises many ethical questions. Determining whether an abortion is needed to save a pregnant person’s life or health is not among them. That’s a factual question requiring medical — not ethical — judgment. Yet in the struggle to provide medically necessary care in a post- Dobbs world, some clinicians and institutions have mistakenly turned to ethics consultants and committees to decide whether a patient’s pregnancy may be terminated.

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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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UK first to approve Moderna’s Omicron booster jab

pharmaphorum

The UK has become the first country in the world to authorise an updated COVID-19 booster vaccine directed at the Omicron variant, giving a green light to Moderna’s mRNA-1273.214 shot. The new vaccine is an updated version of Moderna’s widely-use Spikevax vaccine, which includes sequences from the original Wuhan strain of SARS-CoV-2, as well as from the Omicron BA.1 subvariant.

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Kraft Heinz recalls contaminated Wild Cherry flavored Capri Sun pouches

NPR Health - Shots

The company says diluted cleaning solution used to clean food processing equipment in its factories got into the Capri Sun pouches. (Image credit: Nam Y.

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‘What aren’t we facing?’: Immunization leader lays bare challenges to the monkeypox response

STAT News

In the United States, the circumstances around monkeypox vaccine are a good news, bad news kind of story. The good news is that there is a licensed vaccine. At the start of many outbreaks of new or rare diseases, there are no vaccines. But the bad news quickly overtakes the good. Demand outstrips supply, both domestically and internationally. In the U.S., the federal government has decided to use fractional doses — one-fifth of a normal dose, per person — to try to stretch supplies

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New patent for Pharmacyclics Inc drug IMBRUVICA

Drug Patent Watch

Annual Drug Patent Expirations for IMBRUVICA Imbruvica is a drug marketed by Pharmacyclics Inc and is included in two NDAs. It is available from one supplier. There are forty patents…. The post New patent for Pharmacyclics Inc drug IMBRUVICA appeared first on DrugPatentWatch - Make Better Decisions.

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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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STAT+: Bright Health Group heads toward insolvency as it rushes to raise more cash

STAT News

A little more than a year after going public, Bright Health Group is in danger of going under. Bright, a health insurance company that also owns physician offices, had $2 billion to fund operations as of June 30. Although executives are telling investors that Bright is “meaningfully closer to profitability in 2023,” the company admitted it could go belly-up by the end of the year if it doesn’t secure more cash.

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Nafis Sadik, a champion of women's health and rights around the world, dies at 92

NPR Health - Shots

Sadik became the architect of groundbreaking U.N. action that recognized for the first time that women have the right to control their reproductive and sexual health.

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STAT+: The private equity firms, like Blackstone and KKR, behind 8 of the biggest names in autism therapy

STAT News

Private equity investors are backing all of the major chains offering the country’s most popular form of autism therapy, known as applied behavior analysis, or ABA. Now, however, there are signs that those investors may be cooling on the industry. As part of its investigation into the ways that private equity’s profit fixation is short-changing kids with autism who rely on ABA therapy, STAT compiled a list of some of the biggest autism therapy chains in the country — and the

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OB-GYN residents want to quit in Indiana after state's abortion law, harassment

NPR Health - Shots

Medical residents in Indiana are rethinking their decision to practice medicine in the state after an almost total ban on abortion and harassment of an obstetrician.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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STAT+: A treatment for monkeypox was approved under the FDA’s ‘Animal Rule.’ Here’s what that means

STAT News

Take a look at the list of conditions that have treatments available thanks to what’s known as the “Animal Rule” and you’ll see a rogues’ gallery of plagues you hope never see the light of day. There’s smallpox, anthrax, and, well, the actual plague. The Animal Rule is a Food and Drug Administration policy that gives the agency the authority to approve treatments without efficacy data from human clinical trials in instances when those trials aren’

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Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

Pfizer

Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19. deliesschef. Mon, 08/15/2022 - 07:24. Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19. Monday, August 15, 2022 - 07:00am. NEW YORK, AUGUST 15, 2022 – Pfizer Inc. (NYSE: PFE) – I would like to inform the public that I have tested positive for COVID-19.

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Opinion: Report: More people should be tested for potential exposure to ‘forever chemicals’

STAT News

Nearly every American has been exposed at some point to a class of compounds known as perfluoroalkyl and polyfluoroalkyl substances, or PFAS for short. These substances, sometimes referred to as “forever chemicals” because they persist in many environments — including the human body — are present in a huge array of consumer products, from food packaging to stain-resistant couches; are in firefighting foam and used in many manufacturing processes; and have contaminated

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The 340B Program Climbed to $44 Billion in 2021—With Hospitals Grabbing Most of the Money

Drug Channels

Here’s a summer surprise for fans of the 340B Drug Pricing Program: Drug Channels has just obtained the 2021 figures from the Health Resources and Services Administration (HRSA)! Even better, my Freedom of Information Act (FOIA) request was able to pry out detailed purchases by covered entity type. The data tell a familiar story. For 2021, discounted purchases under the 340B program reached a record $43.9 billion —an astonishing $5.9 billion (+15.6%) higher than its 2020 counterpart.

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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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STAT+: Brainstorm to seek FDA approval for ALS stem-cell treatment, despite agency objections

STAT News

Last year, the Food and Drug Administration issued a rare public statement to inform the ALS community that a negative clinical trial involving an experimental stem-cell therapy from Brainstorm Cell Therapeutics did not support the filing of a marketing application. On Monday, Brainstorm announced its intention to seek approval from the FDA for its ALS treatment, called NurOwn, regardless of the agency’s past opposition.

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Predictive analytics could unlock precision medicine progress: AiCure

Outsourcing Pharma

An expert from the clinical insight specialist shares how predictive analytics could reveal info about medication adherence, disease progression, and more.

Medicine 100
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STAT+: Sales from controversial drug discount program rose to $44 billion last year

STAT News

Prescription medicines purchased in the U.S. under a controversial government discount program amounted to $44 billion in 2021, a nearly 16% increase from the previous year, according to the U.S. Health Resources & Service Administration, which oversees the program. The data marks a steady rise in sales under the 340B Drug Discount Program, which requires drugmakers to offer discounts that are typically estimated to be 25% to 50% — but could be higher — on all outpatient drugs

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MHRA authorises Moderna’s omicron-containing bivalent booster

Pharma Times

Study results show the candidate has demonstrated significantly higher antibodies against Omicron

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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Private equity’s latest fixation & the ACA subsidy spigot

STAT News

You’re reading the web edition of Health Care Inc., STAT’s weekly newsletter following the flow of money through the health care system.  Sign up here  to get it in your inbox. Private equity’s latest fixation: autism therapy. Private equity firms have latched on to almost every corner of health care. But a new, deeply reported story from Tara taught me something new: Private equity investments have engulfed a type of autism therapy called applied behavior analysis

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Santen launches Ducressa for post-cataract surgery

Pharma Times

Treatment involves a combination of levofloxacin and dexamethasone for use after cataract surgery

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Survival data firms up Trodelvy prospects in new breast cancer use

pharmaphorum

In the space of a couple of months, Gilead Sciences’ Trodelvy impact on overall survival (OS) in the TROPICs-02 trial in advanced breast cancer has gone from a trend to a statistically significant improvement, raising its chances of approval in a new indication. At this year’s ASCO congress, the Trop2-targeting antibody-drug conjugate (ADC) was found to improve progression-free survival significantly in in patients with hormone receptor-positive, HER2-negative metastatic breast cance

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UPS acquires multi-national healthcare logistics company Bomi

BioPharma Reporter

The purchase brings under the UPS Healthcare umbrella several temperature-controlled facilities in 14 countries situated throughout Europe and Latin America.

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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.