Fierce Pharma

JUNE 13, 2024

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.

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Competition Safety 244

European Pharmaceutical Review

JUNE 13, 2024

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.

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Manufacturing Food and Drug Administration Engineering Safety 145

Fierce Pharma

JUNE 13, 2024

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

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MedCity News

JUNE 13, 2024

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.

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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.

Sales

Fierce Pharma

JUNE 13, 2024

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.

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MedCity News

JUNE 13, 2024

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.

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MedCity News

JUNE 13, 2024

The Supreme Court sided with the FDA and unanimously ruled to uphold access to abortion pill mifepristone. The decision quells worries about what it might look like if the Supreme Court sided with the physician group — many healthcare leaders feared that if the top court could overturn mifepristone’s FDA approval, the same could happen to other drugs.

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Fierce Pharma

JUNE 13, 2024

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.

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Manufacturing Healthcare Healthcare 195

ALULA

JUNE 13, 2024

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.

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European Pharmaceutical Review

JUNE 13, 2024

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.

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pharmaphorum

JUNE 13, 2024

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

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Pharmaceutical Technology

JUNE 13, 2024

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

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pharmaphorum

JUNE 13, 2024

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.

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MedCity News

JUNE 13, 2024

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.

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Insurance 93

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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

Sales

pharmaphorum

JUNE 13, 2024

SCOTUS rejects lawsuit challenging the FDA's regulation of abortion pill mifepristone, in a setback for the anti-abortion lobby

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FDA 102

Pharmaceutical Technology

JUNE 13, 2024

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

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pharmaphorum

JUNE 13, 2024

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

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PharmaTimes

JUNE 13, 2024

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

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pharmaphorum

JUNE 13, 2024

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

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PharmaTech

JUNE 13, 2024

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

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pharmaphorum

JUNE 13, 2024

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.

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Medicine 81

MedCity News

JUNE 13, 2024

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.

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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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Clarify Health

JUNE 13, 2024

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

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Physicians Patients Healthcare Healthcare 52

Vodori

JUNE 13, 2024

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.

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Medical Marketing 52

PharmExec

JUNE 13, 2024

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.

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Vodori

JUNE 13, 2024

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.

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Medical Marketing Management 52

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PharmExec

JUNE 13, 2024

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.

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PharmaVoice

JUNE 13, 2024

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.

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Patients 52

PharmExec

JUNE 13, 2024

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.

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Biopharma Pharma 52

PharmaTimes

JUNE 13, 2024

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

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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.

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