Thu.Sep 28, 2023

article thumbnail

Decades-long regulatory odyssey ends with FDA nod for Fabre-Kramer's depression med Exxua

Fierce Pharma

Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. | Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week. Its label doesn't include sexual dysfunction as an adverse reaction, which is rare among antidepressants.

FDA 304
article thumbnail

Amicus Therapeutics Rare Disease Combo Therapy Wins Long-Awaited FDA Nod

MedCity News

Sanofi dominates the market for therapies that treat Pompe disease, a rare enzyme deficiency. The FDA has approved an Amicus Therapeutics combination treatment for patients inadequately served by the Sanofi products.

FDA 120
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

After Amicus scores FDA nod for Pompe disease combo, it's game on with Sanofi

Fierce Pharma

Slated for an FDA decision last October, Amicus Therapeutics’ Pompe disease bid was foiled by COVID-related travel restrictions. | Slated for an FDA decision last October, Amicus Therapeutics’ Pompe disease bid was foiled by COVID-related travel restrictions. Nearly a year later, the Philadelphia company has gained its long-awaited green light.

FDA 278
article thumbnail

Customer Service Training: Empowering A Service Mindset

Integrity Solutions

It’s never been more important to understand your customers and what they value. It’s easy to say that we put the customer first, but what does that actually look like in practice? In the past, customer service centers were viewed as cost centers or expenses. Today, the organizations that are delivering a superior customer experience are proving just how outdated that perspective is.

Training 116
article thumbnail

Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.

article thumbnail

Novo Nordisk’s Ozempic gets FDA label update flagging risk of intestinal blockage disorder

Fierce Pharma

While GLP-1 drugs from Novo Nordisk and Eli Lilly are believed to be relatively free of serious side effects, a few problems have emerged as the treatments have gained wider and longer-term use.

article thumbnail

4 States Received Enhanced Medicaid Funding During Covid Despite Wrongly Terminating Coverage

MedCity News

New York, Florida, Texas and Minnesota terminated Medicaid coverage for some enrollees for “unallowable or potentially unallowable reasons” during the Covid-19 public health emergency, according to a recent Office of Inspector General report.

110
110

More Trending

article thumbnail

Generative AI-focused biotech startup Evozyne raises $81m

Pharmaceutical Technology

The company’s algorithms put proteins through millions of years of simulated evolution to identify potential functional candidates.

126
126
article thumbnail

J&J's Rybrevant combo bests AstraZeneca's established Tagrisso in key lung cancer study

Fierce Pharma

A highly anticipated head-to-head matchup between a Johnson & Johnson combination and AstraZeneca’s star Tagrisso as a first-line treatment in a subset of non-small cell lung cancer (NSCLC) has | With the trial win, Johnson & Johnson sees potential for its drug combination as the new standard of care in locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer.

236
236
article thumbnail

C-SNPs: Promoting Healthcare Focused on Chronic Conditions

MedCity News

C-SNPs are Medicare Advantage plans formulated to meet the desired needs of people living with chronic diseases. These plans are different from traditional Medicare plans because they’re only available to people who fit the special needs category that the plan serves.

article thumbnail

GSK dials up HIV sales projection to £7B by 2026, updates next-gen launch timelines

Fierce Pharma

Riding on the growth of long-acting antiretroviral therapy Cabenuva, GSK is laying out a more optimistic vision for its overall HIV business. | Riding on the growth of long-acting antiretroviral therapy Cabenuva, GSK is laying out a more optimistic vision for its overall HIV business.

Sales 216
article thumbnail

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.

article thumbnail

Driving Dosage Form Developments

PharmaTech

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

Patients 116
article thumbnail

Bluebird taps Lonza to boost manufacturing capacity for its gene therapies Zynteglo, Skysona

Fierce Pharma

As bluebird bio’s pricey gene therapy launches take flight, the company is boosting manufacturing capacity with Swiss CDMO Lonza. | Bluebird and Lonza recently amended their production contract for the second time since the deal was announced in summer of 2016. Under the updated deal, Lonza has agreed to increase manufacturing capacity for bluebird’s therapies Zynteglo and Skysona, according to a SEC filing published Wednesday.

article thumbnail

CCC Pilots AI-disambiguated Researcher and Institution Data in RightFind Navigate

Copyright Clearance Center

September 28, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, announces the availability of AI-disambiguated data and enriched metadata, for researchers and institutions, within RightFind Navigate through a pilot for its customers. CCC also announces several powerful new features of the RightFind Suite.

article thumbnail

'The Top Line': Exploring AstraZeneca's environmental pledges

Fierce Pharma

AstraZeneca has made several news headlines for its environmental sustainability pledges, including deals for renewable natural gas and a commitment to plant hundreds of millions of trees. | In this episode of "The Top Line," Fierce Pharma's Eric Sagonowksy talks with Pam Cheng, the AstraZeneca executive who is playing a key role in driving the company's sustainability ambitions.

Pharma 208
article thumbnail

Commercial Drug Sourcing for Clinical Trials

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors

article thumbnail

Ophelia, Vori Health Team Up To Support Patients with Opioid Addiction, MSK Pain

MedCity News

Through a new partnership, Vori Health will be able to refer its patients who report having an opioid addiction to Ophelia. On the flip side, Ophelia can refer its patients who report having MSK pain to Vori Health for non-opioid treatment.

article thumbnail

In second attempt, Takeda scores FDA nod for subcutaneous version of Entyvio

Fierce Pharma

The FDA has signed off on Takeda’s subcutaneous version of Entyvio to be used as a maintenance therapy for patients with ulcerative colitis.

FDA 215
article thumbnail

AstraZeneca and SAS link up on AI and analytics

PharmaTimes

Collaboration will enable teams across the organisation to increase clinical research innovation - News - PharmaTimes

114
114
article thumbnail

Fierce Pharma Asia—AZ, Daiichi's TROP2 readout; Padcev's bladder cancer win; AbbVie, I-Mab's CD47 breakup

Fierce Pharma

Dato-DXd, the TROP2-targeted antibody-drug conjugate in development by AstraZeneca and Daiichi Sankyo, has hits its goal in a breast cancer trial. | AstraZeneca and Daiichi Sankyo's TROP2-targeted antibody-drug conjugate has hits its goal in a breast cancer trial. The combination of Padcev and Keytruda also succeeded in a broad first-line bladder cancer setting.

Pharma 130
article thumbnail

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.

article thumbnail

Counterfeit Meds: Fighting the Forgers

Pharmaceutical Commerce

Questions and considerations for pharmaceutical companies in designing and executing strategies to curb the incidence of fake drugs.

article thumbnail

European PFAS restriction could jeopardise pharmaceutical manufacturing

European Pharmaceutical Review

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than 600 essential medicines are at risk if a proposed restriction on the use of fluorinated substances, per- and polyfluoroalkyl substances (PFAS) across pharmaceutical manufacturing in the EEA, is implemented. A total ban [of PFAS] would see medicines’ manufacturing in the EU grind to a halt in under three years” EFPIA stated that the EU chemical legislation under The Regulation on the regist

article thumbnail

Women in Life Science Denmark launches leadership drive

PharmaTimes

Initiative has been designed to support career advancement for women across the life sciences - News - PharmaTimes

108
108
article thumbnail

Pfizer CEO Albert Bourla led Big Pharma bonus payouts over 5 years — but he’s no Elon Musk

PharmaVoice

A recent report showed how pharma’s bonuses pale in comparison to other industries, but several execs still rake in hefty packages.

Pharma 95
article thumbnail

Making the Case for Case Management for Cell and Gene Therapies

As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. Deviations from the intended supply chain can delay timelines and affect these high value products, which can be detrimental to budgets, but more importantly can have dire effects on the patients whose lives depend on receiving these critical doses safely and on time.

article thumbnail

Reshaped Priorities Pave Cold Chain Path

Pharmaceutical Commerce

How recent advancements in practice and technology have ushered in a new era of pharmaceutical logistics.

article thumbnail

Takeda ulcerative colitis biologic receives FDA approval

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Takeda’s single-dose pre-filled pen for ENTYVIO ® (vedolizumab) as a treatment for the chronic inflammatory disease ulcerative colitis. Subcutaneous (SC) administration is authorised for US adults with moderate to severe active ulcerative colitis (UC) after induction therapy with ENTYVIO intravenous (IV).

FDA 76
article thumbnail

MedCity Moves Podcast: Recent Hires, Layoffs & an Interview with Chris Allen, CFO at Keck Medicine of USC

MedCity News

For the September episode, we discuss some recent executive appointments occurring in the healthcare sector, as well as layoffs affecting the industry. We also hear from Chris Allen, who recently became CFO at Keck Medicine of USC.

article thumbnail

Guaranteeing resilience in vaccine manufacturing

European Pharmaceutical Review

There has been a steady stream of developments in the vaccine manufacturing space throughout 2023. A notable milestone was Moderna’s announcement in April that it had, following finalisation of a ten-year strategic partnership with the UK Government, commenced construction of its mRNA vaccine manufacturing technology centre. Known as MITC, or the Moderna Innovation and Technology Centre, the facility is located in Harwell, Oxfordshire and is expected to become operational in 2025.

article thumbnail

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

article thumbnail

Finding New Value in Drugs: Q&A With Darius Lakdawalla, Chief Scientific Officer at EntityRisk

PharmExec

Lakdawalla speaks about how drugs aren’t being properly valued.

110
110
article thumbnail

How pharma marketers can reclaim the drug pricing narrative

PharmaVoice

As Medicare negotiations heat up, it’s more important than ever for pharma companies to communicate their value. Here’s how.

Pharma 72
article thumbnail

Meet Our Mentor: Grant Cox

MedTechVets

SEP 28th – We were proud to interview MedTechVet Academy Mentor, Grant Cox. Grant is currently the Vice President of Operations at Z Construction. He recently was going through the Fire Academy in Greenville, SC to become a Firefighter, but was medically released after having surgery on both of his hips.Grant is a huge believer in medicine and believes that better days are ahead of him. “With strong faith, a goal in mind and a purpose, you can get through anything.

Medical 59
article thumbnail

Healthcare Moves: A Monthly Summary of Hires and Layoffs

MedCity News

Here is a selection of recent executive hires, promotions and layoffs occurring across the healthcare industry.

article thumbnail

How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr