February, 2023

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Current treatments for cramps aren’t cutting it. Why aren’t there better options?

STAT

One day last fall, Kiran’s period cramps became so painful they woke her up from a nap. The 19-year-old took some ibuprofen, but found little relief. “The pain was so bad, it felt like someone was punching me,” said Kiran, who asked to be referred to by only her first name for privacy. It felt “like I was giving birth.

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Brian Fox is bringing ‘fresh eyes’ to ad agency Klick

PharmaVoice

Why the recently appointed president of commercial solutions sees near limitless potential to expand Klick’s footprint across the life sciences — and how generative AI is playing a role.

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Virtual reality training in pharma: just a headset away?

European Pharmaceutical Review

The COVID-19 pandemic led to an unparalleled paradigm shift in the use of and the incorporation of new technologies into our workflows. This was particularly apparent in academia and the pharmaceutical industry, where we have seen words such as Teams and Zoom becoming part of our new lexicon of language for meetings. Now we reach for these types of online meetings without a second thought, due to the clear productivity benefits they provide over real in-person meetings. 1 However, notwithstandin

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Senate hearing to examine bipartisan reforms to rein in middlemen

PhRMA

Did you know that insurance companies use middlemen — known as pharmacy benefit managers (PBMs) — to decide what medicines people can get and what people pay out of pocket for those medicines?

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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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Scottish biotech aims to cure common cold

Pharmafile

Scottish biotech company ScotBio has announced that it has seen “promising initial results” from its attempts to extract a cure for the common cold from algae. The Livingston-based company is assessing how waste molecules from spirulina, an algae often consumed as a superfood, could be used as a cure for the common cold, COVID-19 and various other viruses.

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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

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Woman of the Week: KaliVir Immunotherapeutics’ Helena Chaye

PharmaVoice

The triple threat CEO — scientist, lawyer and biotech pro — thinks she’s discovered a key to curing a wide range of cancers.

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Medicinal cannabis: the route to good manufacturing practice registration

European Pharmaceutical Review

The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. After the substance became legal in the UK in 2018, pharmaceutical companies have faced numerous obstacles to attain a fairer position in the industry. Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabin

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Weight loss jabs to be sold via high street chemists in England

The Guardian - Pharmaceutical Industry

Appetite suppressant Wegovy, popular with celebrities, seen as breakthrough treatment but not permanent remedy Weekly weight-loss jabs that are popular with celebrities will soon be made available through high street chemists in England, despite controversy over their use. Many people struggle to tackle obesity through diet and exercise alone as they often find they regain the weight that they lose.

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Sun Pharma recalls at least 34,000 bottles of generic drug

Pharmafile

Mumbai-based pharma company, Sun Pharma, has announced that it is recalling over 34,000 bottles of a generic drug, Diltiazem Hydrochloride, from the US market. The drug is used for treating high blood pressure, angina and some types of irregular heartbeat. This recall follows the FDA’s Enforcement Report, which saw “failed impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA

Pharmaceutical Technology

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme. This collaboration is expected to help expedite the clinical manufacturing of RVM-V001 and future mRNA-based vaccines that target infectious diseases such as Clostriodioides difficile infection (CDI) and R

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STAT+: In about-face, Moderna vows Americans won’t have to pay for its Covid-19 vaccine

STAT

In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution. The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage.

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Pheast’s new CEO on how its ‘don’t eat me’ platform could deliver next-gen precision immunotherapies

PharmaVoice

Jacopo Leonardi’s latest venture is in the burgeoning field of macrophage inhibitors that could target a wide range of cancers.

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First successful CAR-T treatment for muscle inflammation

European Pharmaceutical Review

University Hospital Erlangen in Germany is the first in the world to use chimeric antigen receptor (CAR) T-cells to successfully treat a patient suffering from a severe case of muscle inflammation (myositis). The researchers noted that risk of developing a very severe form of the autoimmune inflammatory disease is high. The patient who received the CAR T treatment was diagnosed with anti-synthetase syndrome.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Holding pharmacy benefit managers accountable

PhRMA

State legislative sessions across the country are in full swing, and many state officials have made lowering the cost of medicine for patients a top priority. If policymakers are serious about addressing high out-of-pocket costs for patients, they should start by taking steps to finally hold pharmacy benefit managers (PBMs) accountable.

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Trio of COVID-19 treatments receive NICE nod

Pharma Times

Final draft guidance from NICE ensures people at highest risk will have access to COVID-19 therapies

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Is the microbiome therapy hype up for a reckoning?

Pharmaceutical Technology

In the last decade, the idea of tapping into the gut has attracted much interest from investors and the public, but recent years have showed that a lot more work needs to be done before such treatments enter the mainstream. This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times.

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Opinion: Disruptive science is leaping forward, not limping along

STAT

A recent study and accompanying news story in the preeminent journal Nature provocatively concludes that disruptive innovation in science has dramatically and mysteriously declined 90% since 1945. The study has prompted a wave of news coverage and tweets decrying the apparent languishing of modern science. We feel that the authors make interesting observations on publishing trends, but their conclusions seem to be quite disconnected from the valuable and transformative innovations that benefit h

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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As clinical trials face a hiring crunch, here’s how research organizations can pivot

PharmaVoice

Staffing shortages are causing inefficiencies in clinical trials, but one leading CRO is finding ways to adapt.

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Shining a light on Raman for microbiological analysis

European Pharmaceutical Review

Advances with microbiological methods are providing more accurate and sensitive datasets at a faster rate, relating to bacterial identity, numbers, responses to environments and so on. Recent years have seen progress with applying a long-established spectrophotometric phenomenon – Raman spectra – to advance our understanding of bacterial populations, including differentiating between living and dead cells and interpreting phenotypic variations to different environmental stressors.

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Celebrating 40 years of the Orphan Drug Act on Rare Disease Day

PhRMA

For over a decade, Rare Disease Day has been celebrated on February 28 to raise awareness and generate change for the more than 30 million patients in the U.S. living with a rare disease. This year’s Rare Disease Day is particularly special because this year also marks the 40 th anniversary of the Orphan Drug Act (ODA), allowing us to celebrate all the progress that’s come to patients because of it.

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Michael J. Fox Foundation funding boost for Newel Health’s Soturi

Pharma Times

Next phase of Newel Health’s digital therapeutics solution for Parkinson’s disease gains vital grant

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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How epilepsy researchers are moving the needle past anti-seizure treatments

Pharmaceutical Technology

While several therapeutics are available for treating symptoms associated with epilepsy, researchers and patients have strongly called out the need for more holistic treatments that would address the condition as a whole. Although recently approved drugs can treat seizures more safely, they do not treat the comorbidities that patients experience. Several biotech companies and researchers are now exploring medical devices and gene therapies to address not just common forms of epilepsy, but also r

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STAT Madness 2023

STAT

Welcome to STAT Madness, a bracket-style contest to find the best innovation in science and medicine. Click on each matchup for a short summary of each school’s pioneering research. Then pick your favorites. Help us crown a champ!

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Why the pharma industry is digging deep in rare disease

PharmaVoice

The rare disease market is set for major growth in the decade to come, and pharma companies are securing their footholds now.

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Five potential EU regulatory changes impacting the life sciences industry in 2023

European Pharmaceutical Review

A wave of important legislative changes is anticipated in the EU in 2023 making this year one of the biggest for the EU regulatory landscape governing the life sciences industry in recent times. Changes have been spurred by the COVID-19 pandemic, which emphasised the need to urgently modernise outdated EU pharmaceutical law and revise regulatory ambitions in the MedTech sector.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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AstraZeneca’s Forxiga approved in EU for chronic heart failure

Pharmafile

AstraZeneca has announced that its drug, Forxiga, has been approved in the EU for the treatment of symptomatic chronic heart failure. This follows an approval from the EMA’s Committee for Medicinal Products for Human Use in December. The drug is already approved in the EU for the treatment of type 2 diabetes as well as chronic kidney disease. It has also received regulatory approvals in Britain, Japan and Turkey, as well as the US and now the EU.

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Pfizer update Lyme disease vaccine candidate

Pharma Times

Research concerning candidate VLA15 has been discontinued across certain trial sites

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4D Molecular’s Fabry gene therapy program on FDA clinical hold

Pharmaceutical Technology

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310). 4DMT had paused enrollment of patients to two of its trials for 4D-310 last month following a significant adverse event where three patients experienced kidney issues; however, these were treated and resolved in a four-week period. 4DMT has stated that

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STAT+: How a depression test devised by a Zoloft marketer became a crutch for a failing mental health system

STAT

A bedrock of the U.S. mental health system — a nine-item questionnaire used to spot depression — began not with a doctor, but with a marketing man. Howard Kroplick, now 73 years old and living on Long Island, is obsessed with antique racing cars and, in his storied career in the pharmaceutical industry, crucially urged Pfizer to avoid the word “impotence” when promoting Viagra.

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Tapping into the molecular fountain of youth

PharmaVoice

Kristen Fortney, CEO of BioAge Labs, wants to improve the human life span by focusing on the human health span.

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