Trending Articles

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AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

Fierce Pharma

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

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Telehealth Advocates Praise DEA’s 3rd Extension of Telemedicine Flexibilities, but Call for Further Action

MedCity News

The DEA recently announced the third extension of Covid-19 flexibilities for the virtual prescribing of controlled substances. Telehealth advocates applaud this move but remain hopeful for a more permanent solution in the future. The post Telehealth Advocates Praise DEA’s 3rd Extension of Telemedicine Flexibilities, but Call for Further Action appeared first on MedCity News.

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Taking its best shot at Roche, Merck scores in phase 3 trial of subcutaneous Keytruda

Fierce Pharma

Two months after Roche scored FDA approval for its subcutaneous ve | Two months after Roche scored FDA approval for its subcutaneous version of PD-LI inhibitor Tecentriq, Merck has achieved a key milestone in lining up its checkpoint inhibitor Keytruda to follow suit. On Tuesday, the company revealed that its subcutaneous formulation of Keytruda has aced a phase 3 trial, demonstrating non-inferiority to the immunotherapy’s intravenous version.

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Grifols linked to €7bn takeover offer from Brookfield

pharmaphorum

Private equity company Brookfield has reportedly moved closer to taking control of Grifols, after months of disruption at the Spanish pharma company.A report in Spanish newspaper El Confidencial suggests that Brookfield is preparing to make a bid to take a 65% controlling stake in the drugmaker for €10.50 per share, worth around €7 billion ($7.4 billion).

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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How Copyright Clearance Center’s Michael Healy Advocates for ‘Responsible AI‘

Copyright Clearance Center

In a rapidly evolving publishing landscape, the executive director of the CCC is taking the lead on addressing one of the industry’s most pressing concerns: the use of copyrighted material in artificial intelligence systems.

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What is a ‘cure,’ really? AbbVie’s Humira creator leaps into the next phase of medicine

PharmaVoice

AbbVie’s head of R&D cures has lofty ambitions to end diseases like HIV through a community of researchers that work as one.

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Ex-Invitae Spinoff Relaunches as Citizen Health, Picks Up $14.5M in Seed Funding

MedCity News

The Silicon Valley startup formerly known as Ciitizen relaunched as Citizen Health. The company seeks to empower patients with access to their complete health history — and it’s starting off by focusing on patients with rare diseases. The post Ex-Invitae Spinoff Relaunches as Citizen Health, Picks Up $14.5M in Seed Funding appeared first on MedCity News.

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GSK drug raises hopes for patients with PBC itch

pharmaphorum

GSK has reported promising phase 3 results with linerixibat in treating severe itching that plagues patients with primary biliary cholangitis

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BioNTech signs agreement to acquire Biotheus

Pharmaceutical Technology

BioNTech has signed a definitive agreement to acquire Biotheus to obtain complete worldwide rights to BNT327/PM8002, a programmed death-ligand 1 and vascular endothelial growth factor A-targeting bispecific antibody.

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Gilead data lends insight into transforming HIV prevention landscape

European Pharmaceutical Review

New clinical trial findings show that twice-yearly lenacapavir for HIV pre-exposure prophylaxis (PrEP) had high efficacy and safety in a diverse group of participants. This data provides the first in-depth insight into full results of Gilead Sciences pivotal Phase III PURPOSE 2 trial. In the oral PrEP study group, adherence to the small molecule injectable HIV-1 capsid inhibitor and placebo injections was 91.0 percent with on-time injections at week 26, the results showed.

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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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GSK Wagers $80M on a Tech Platform and Parkinson’s Drug from Flagship-Founded Vesalius

MedCity News

Vesalius Therapeutics’ AI-based technology finds novel targets and intervention points for subgroups of patients within a common disease. A small molecule that Vesalius has been developing for a novel Parkinson’s disease target is now headed to GSK, which has licensed global rights. The post GSK Wagers $80M on a Tech Platform and Parkinson’s Drug from Flagship-Founded Vesalius appeared first on MedCity News.

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Sanofi wins appeal in spat with NICE over Sarclisa

pharmaphorum

Sanofi has taken a small step towards potentially overturning a recent rejection by NICE for NHS use of Sarclisa as a treatment for relapsed and refractory multiple myeloma (RRMM).The drugmaker has won an appeal against NICE's recent final draft guidance on Sarclisa (isatuximab) as a regimen alongside Bristol-Myers Squibb/Celgene's Imnovid (pomalidomide) and dexamethasone (Isa-Pd) for relapsed RRMM.

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EMA’s CHMP recommends Sanofi’s Sarclisa approval for multiple myeloma

Pharmaceutical Technology

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi’s Sarclisa combined with Velcade, plus Revlimid, plus dexamethasone (VRd) for treating newly diagnosed multiple myeloma (MM).

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The Dodgers’ World Series run brought attention to a rare disease. Annexon is stepping up to the plate.

PharmaVoice

The company is looking to score an FDA nod for its investigational therapy that targets a molecule linked to Guillain-Barré syndrome and other autoimmune diseases.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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England's NICE turns down cancer drug Enhertu—again—amid pricing stalemate with AZ, Daiichi Sankyo

Fierce Pharma

Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s | Although AstraZeneca, Daiichi Sankyo and England’s drug cost watchdog have spent months trying to hash out a fair price for Enhertu, the trio’s best efforts—and even the intervention of the U.K.’s new health secretary—have failed to yield a solution.

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Market Trends to Watch for Health Systems and Their Specialty Pharmacies

MedCity News

The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. The post Market Trends to Watch for Health Systems and Their Specialty Pharmacies appeared first on MedCity News.

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Syndax gets FDA okay for first-in-class leukaemia drug

pharmaphorum

Shortly after a disappointing trial readout for Syndax's menin inhibitor Revuforj in one form of leukaemia, the company has claimed FDA approval in another

FDA 83
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Pfizer considers divestiture of hospital drugs business

Pharmaceutical Technology

Pfizer is currently assessing the potential divestiture of its hospital drugs unit, a division mainly focused on antibiotics and sterile injectables used in hospitals and clinics, Reuters reported.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Workplace Shortages? Attract Top Talent With 5 Healthcare Recruitment Marketing Strategies

Healthcare Success

You know about competitive compensation, life-enhancing benefits, a supportive company culture, and a healthy work-life balance. But, how do you ensure that your marketing efforts truly differentiate your organization, giving you a competitive edge? We’ve gathered our top recruitment marketing strategies to help position your organization as an employer of choice and attract high-caliber professionals. 5 Healthcare Recruitment Marketing Strategies to Combat Workforce Shortages 1.

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Rapid growth spurt for UCB's Bimzelx continues with hidradenitis suppurativa nod marking 5th FDA approval

Fierce Pharma

It was only last October that UCB’s up-and-coming immunology powerhouse Bimzelx first crossed the FDA finish line in psoriasis after an initial delay. | The latest nod positions Bimzelx to go head-to-head with Novartis' Cosentyx in the hidradenitis suppurativa market.

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Managing the Specialty Drug Cost Challenge: Is Your Pharmacy Benefits Strategy Ready for 2025?

MedCity News

What concrete strategies should employers pursue to control rising costs while ensuring the best member experience and clinical outcomes? The post Managing the Specialty Drug Cost Challenge: Is Your Pharmacy Benefits Strategy Ready for 2025? appeared first on MedCity News.

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NIH algorithm matches patients to clinical trials

pharmaphorum

Researchers from the National Institutes of Health (NIH) are applying artificial intelligence to the recruitment of volunteers into clinical trials, aiming to solve a major obstacle in clinical research.Patient recruitment remains a major challenge for trial sponsors and can lead to delays and increased costs, and traditional methods can be time-consuming and inefficient.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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AHA 2024: Plozasiran demonstrates promising Phase III results in FCS adults

Pharmaceutical Technology

During AHA 2024, data were presented from the Phase III trial of plozasiran targeting adults with genetically or clinically diagnosed FCS,

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Sanofi investment to enhance antibody bioproduction in France

European Pharmaceutical Review

Sanofi is investing over €40 million in its Lyon Gerland site, supporting antibody bioproduction in France. A portion of this, €25 million, will be directed toward production and development of Sanofi’s second generation of its polyclonal antibody Thymoglubulin. It is used for transplantation and is manufactured exclusively at the Lyon Gerland site, Sanofi stated.

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BMS, Merck, Amgen and more must look to M&A to offset looming patent lapses: Leerink

Fierce Pharma

As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term. | As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term, according to a new loss of exclusivity report from Leerink Partners.

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Don’t Erode Medical Device Trust with Right to Repair

MedCity News

Right to repair would undermine the FDA’s regulations and introduce unnecessary risk into the healthcare industry, threatening the high-quality care that doctors provide patients. The post Don’t Erode Medical Device Trust with Right to Repair appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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MSD joins PD-1/VEGF push in cancer with LaNova deal

pharmaphorum

There has been a lot of talk about drugs targeting both PD-1 and VEGF stealing the crown held by MSD's Keytruda in cancer immunotherapy. Now, the company has made a move to try to make sure it isn't left behind. Its solution is a licensing deal with Chinese biotech LaNova Medicines for LM-299, which consists of an anti-VEGF antibody joined to the functional parts of a pair of anti-PD-1 antibodies.

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AbbVie’s Elahere wins European approval for certain ovarian cancers

Pharmaceutical Technology

The decision in Europe follows an approval granted by the US Food and Drug Administration (FDA) in March this year.

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12 Essential Sales Challenges and How To Overcome Them

Integrity Solutions

The road to success in sales is filled with challenges, highs and lows. Many variables come into play. As we note in our book, Listen to Sell , “It can be easy to feel that given the right factors—the market, the product, the tools, the data, the competition, a natural sales ability—selling would be easier, and success would be inevitable.” But this is a passive and, ultimately, self-defeating way to view and approach the profession of sales.

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In boost to GSK's £3B plan for Blenrep, myeloma ADC shows survival edge over J&J's Darzalex

Fierce Pharma

GSK’s 3 billion pounds sterling peak sales goal for its multiple myeloma drug Blenrep appears increasingly attainable thanks to a key patient survival win.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A