Thu.Jun 13, 2024

article thumbnail

With phase 3 miss, Pfizer's DMD candidate is no threat to Sarepta's Elevidys ahead of key label expansion: analysts

Fierce Pharma

With a phase 3 miss following a fatality in a related study and marking what analysts are calling the “final nail” in Pfizer’s Duchenne muscular dystrophy (DMD) gene therapy coffin, Sarepta Therape | With a phase 3 miss and severe safety signals, Pfizer's Duchenne muscular dystrophy gene therapy candidate is no competition to Sarepta's established Elevidys, according to analysts.

article thumbnail

Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

Tell us about Ocugen’s lead programme, OCU400. What’s the latest and what’s next? OCU400 is a modifier gene therapy aimed at treating retinitis pigmentosa and Leber congenital amaurosis (LCA). In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Pfizer expects 8 blockbuster cancer drugs to come from each of 4 focus areas: exec

Fierce Pharma

Pfizer's oncology division plans to have eight blockbusters by 2030, with contributions from each of its four focused therapeutic areas.

267
267
article thumbnail

Pfizer & Sarepta Gene Therapies Both Failed Phase 3, But Analysts Expect Sarepta Will Win Approval

MedCity News

A Pfizer gene therapy for Duchenne muscular dystrophy failed its Phase 3 clinical trial. But analysts draw distinctions between that therapy and Sarepta Therapeutics’ Elevidys, which awaits an FDA decision that could grant it full regulatory approval. The post Pfizer & Sarepta Gene Therapies Both Failed Phase 3, But Analysts Expect Sarepta Will Win Approval appeared first on MedCity News.

FDA 117
article thumbnail

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.

article thumbnail

Talc plaintiffs file for restraining order to block Johnson & Johnson's 3rd bankruptcy attempt

Fierce Pharma

As Johnson & Johnson has tried to resolve talcum powder lawsuits that have been consolidated in a multidistrict litigation in New Jersey, the company has had to deal with two groups of plaintif | J&J has had to deal with two groups of plaintiffs in its talc lawsuits—one that wants to accept a settlement and the other that doesn’t. Now, the latter group has asked a New Jersey federal court to issue a restraining order to block a J&J subsidiary from filing for bankruptcy.

201
201
article thumbnail

The Potential for AI in Drug Design

MedCity News

Despite misconceptions about its use, artificial intelligence (AI), through modalities such as machine learning models, is poised to enable companies to expedite the drug design process. The post The Potential for AI in Drug Design appeared first on MedCity News.

More Trending

article thumbnail

Being an Ally Isn’t Just for Pride Month

ALULA

Every June, companies plaster rainbow flags across their logos in a show of LGBTQIA+ "allyship" for Pride Month. But true allyship isn't just a celebration - it's an ongoing commitment to supporting LGBTQIA+ individuals every day.

98
article thumbnail

Investment firm Great Point Partners scoops up German CDMO Lyocontract

Fierce Pharma

On a mission to debut life science companies on the global stage, healthcare investment firm Great Point Partners is making a play for private German contract development and manufacturing organiza | On a mission to debut life science companies on the global stage, healthcare investment firm Great Point Partners is making a play for private German contract development and manufacturing organization Lyocontract.

article thumbnail

Haemophilia drug could reduce treated bleeding episodes

European Pharmaceutical Review

A next-generation FVIIIa mimetic bispecific antibody has demonstrated statistically significant and superior reduction of treated bleeding episodes in haemophilia A, new headline data from a pivotal Phase IIIa trial show. Mim8 was evaluated in participants aged 12 years or older as both a once-weekly and once-monthly treatment versus no prophylaxis treatment and prior coagulation factor prophylaxis treatment.

Safety 98
article thumbnail

Mahana’s DTx for IBS gets permanent reimbursement in Germany

pharmaphorum

Mahana Therapeutics has granted permanent reimbursement in Germany for its Cara Care digital therapeutic for irritable bowel syndrome

116
116
article thumbnail

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

article thumbnail

FDA approves AstraZeneca’s Farxiga for paediatric T2D patients

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's Farxiga for paediatric patients aged 10 years and above with type-2 diabetes.

FDA 105
article thumbnail

Flagship, ProFound set off on obesity drug hunt for Pfizer

pharmaphorum

Pfizer has had some setbacks in its efforts to develop drugs for the lucrative obesity market, but could see its pipeline swell thanks to its $7 billion partnership with venture capital firm Flagship Pioneering. Flagship has just announced that it will work with biotech startup ProFound Therapeutics to find first-in-class protein therapeutics with potential in obesity, confirming this is the first programme in the alliance with Pfizer signed last July.

Marketing 105
article thumbnail

AmeriHealth Caritas Exec: Worst Thing Insurers Can Do Is Be Paralyzed by AI Challenges

MedCity News

Payers face numerous challenges when it comes to AI, but that doesn’t mean they shouldn’t use the technology, according to Neil Gomes, senior vice president and chief digital officer of AmeriHealth Caritas. The post AmeriHealth Caritas Exec: Worst Thing Insurers Can Do Is Be Paralyzed by AI Challenges appeared first on MedCity News.

article thumbnail

Alzheon secures $100m to advance Alzheimer’s disease treatment

Pharmaceutical Technology

Alzheon has secured $100m in a Series E funding round to develop and commercialise ALZ-801 for Alzheimer's disease (AD).

98
article thumbnail

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

article thumbnail

WuXi buoyed as BIOSECURE Act is left out of US spending bill

pharmaphorum

Shares in WuXi Biologics and WuXi AppTec rose after the BIOSECURE Act was omitted from legislation due to be followed up in congress.

111
111
article thumbnail

LifeArc funds new projects to address and prevent global threat of dengue fever

PharmaTimes

The mosquito-borne viral disease is responsible for an estimated 390 million cases globally

101
101
article thumbnail

Future of Pfizer’s Duchenne gene therapy in doubt

pharmaphorum

Pfizer is “evaluating next steps” for its Duchenne muscular dystrophy (DMD) gene candidate after it failed a phase 3 trial

115
115
article thumbnail

Streamlining Aseptic Processes through Automation

PharmaTech

Leveraging automation advancements can help improve efficiency in aseptic processing and speed up commercialization of critical drug products.

69
article thumbnail

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

article thumbnail

Global medicines and the future outlook

pharmaphorum

In a conversation held earlier in the year as the four-year anniversary of the pandemic approached, the pharmaphorum podcast had as guest Murray Aitken, executive director of the IQVIA Institute for Human Data Science, to discuss the state of global medicines and the future outlook when it comes to research and development, and usage and spending appetites.

article thumbnail

How Covered Entities and Pharma Companies Can Better Collaborate on Drug Discount Programs

MedCity News

Three things drug manufacturers and CEs can do to build trust and enable effective collaboration The post How Covered Entities and Pharma Companies Can Better Collaborate on Drug Discount Programs appeared first on MedCity News.

Pharma 59
article thumbnail

Sysmex receives Longitude Prize on AMR for antimicrobial testing system

PharmaTimes

AMR is designated as one of the top ten global public health threats facing humanity by WHO

81
article thumbnail

How to increase specialist engagement in accountable care organizations

Clarify Health

Medicare is a pioneer in advancing value-based care, specifically its use of Accountable Care Organization (ACO) frameworks. Alternative Payment Models (APMs) are payment approaches that incentivize quality and value in healthcare delivery by rewarding providers for cost-efficient care and improved patient outcomes. Progressive APMs incentivize ACOs to deliver the best possible care, especially for patients with complex conditions that require multiple costly treatments—which describes the major

article thumbnail

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.

article thumbnail

Revamp your MLR review with these 7 data-driven strategies

Vodori

In today's fast-paced marketing landscape, ensuring the efficiency and effectiveness of promotional materials is more crucial than ever. The Medical, Legal, and Regulatory (MLR) review process plays a vital role in this, acting as the gatekeeper for compliance and quality.

Medical 52
article thumbnail

AbbVie Presents New Data from Antibody-Drug Conjugates Across Multiple Indications at ASCO 2024

PharmExec

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses data presented at ASCO from ABBV-400 and ABBV-706 in multiple studies.

52
article thumbnail

How to improve MLR team collaboration amidst changes

Vodori

In the dynamic world of medical, legal, and regulatory (MLR) reviews, change is a constant. Teams frequently evolve, with new members joining, processes being updated, and goals shifting to align with the latest regulatory requirements and market demands. In such a fluid environment, effective collaboration becomes more critical than ever. Ensuring that your MLR team can adapt seamlessly to these changes is essential for maintaining efficiency, compliance, and high-quality outputs.

Medical 52
article thumbnail

Craig Tooman: Silencing the Distractions

PharmExec

Craig Tooman, CEO of Silence Therapeutics, on steering through the rough biotech funding and investment waters post-pandemic—and how a retooled organizational approach has the company in a stronger position today in the growing field of gene silencing through siRNA drugs.

52
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Despite detractors, Lilly’s adcomm win shows amyloid and tau will likely dominate Alzheimer’s — for now

PharmaVoice

Lilly is the latest to approach the coveted Alzheimer’s approval, but a slate of drugmakers are lining up clinical trials in amyloid and tau to take a shot at improving patient outcomes.

article thumbnail

Biopharma Leadership in Times of Transition

PharmExec

How pharma and biotech leaders can navigate today’s challenging landscape—focusing on revamped approaches in business operations, talent strategy and development, and more to meet the evolving demands.

article thumbnail

Regenxbio CEO to step down after 15 years

PharmaVoice

Kenneth Mills will become chair of the gene therapy developer's board while Curran Simpson, the current chief operating officer, will take his place as company head.

52
article thumbnail

FDA Approves Farxiga to Improve Glycemic Control in Pediatric Patients with Type 2 Diabetes

PharmExec

AstraZeneca’s Farxiga has previously been approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, in addition to indications for heart failure.

FDA 52
article thumbnail

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