Fierce Pharma

APRIL 6, 2023

Gilead caused injuries while waiting to develop safer HIV drugs, lawsuit claims zbecker Thu, 04/06/2023 - 11:40

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MedCity News

APRIL 6, 2023

As a first step to move toward greater hospital price transparency and lower costs, CMS can immediately issue $2 million fines on the 30% of American hospitals it concludes are noncompliant. If CMS takes enforcement seriously, the hospital industry will respond by quickly coming into compliance.

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Fierce Pharma

APRIL 6, 2023

Pfizer escapes proposed class action lawsuit over patient copay assistance esagonowsky Thu, 04/06/2023 - 11:03

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Patients 254

MedCity News

APRIL 6, 2023

By investing in the value chain of IVF with the right AI solutions, investors can solve the access problem growing in the IVF space, help more people build their families, and achieve significant ROI.

Healthcare 109

Healthcare Healthcare 109

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Fierce Pharma

APRIL 6, 2023

Fierce Pharma Asia—BioNTech's ADC deal; Sanofi's potential consumer cut; Takeda's latest celiac play aliu Thu, 04/06/2023 - 15:39

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Pharma 198

Pharmaceutical Technology

APRIL 6, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease. The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

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Safety Healthcare Healthcare Manufacturing 105

MedCity News

APRIL 6, 2023

FDA withdrawal of Makena from the market comes four years after the drug, granted accelerated approval in 2011, failed a post-marketing study to confirm the drug’s benefit. The FDA decision also affects generic versions of the drug.

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FDA Marketing Biopharma Pharma 103

Fierce Pharma

APRIL 6, 2023

AstraZeneca to face tough FDA scrutiny with Imfinzi-Lynparza combo in ovarian cancer: analyst aliu Thu, 04/06/2023 - 10:24

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FDA 154

MedCity News

APRIL 6, 2023

Oxos Medical recently raised $23 million in Series A funding. The company’s handheld X-ray devices are meant to replace C-arms, which are the leading medical imaging technology. The devices are portable are require little training to use, which is key considering the massive dearth of radiologists entering the field.

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Medical Training Leads 98

Fierce Pharma

APRIL 6, 2023

FDA snatches back accelerated approval for Covis' controversial preterm birth drug Makena zbecker Thu, 04/06/2023 - 16:47

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FDA 130

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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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InCrowd

APRIL 6, 2023

A well-known, established blockbuster brand at a top-10 pharma company needed a better solution for tracking its highly competitive market. Their traditional, data-heavy, time-consuming, and expensive ATU wasn’t meeting their needs. Learn how Essentials, InCrowd’s syndicated tracking solution, helped them collect competitive intelligence, save budgetary dollars, and eliminate their large ATU, allowing for more time and attention to the market events.

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Fierce Pharma

APRIL 6, 2023

Enoxaparin – New Reliable Supply from Trusted Source jpiatt Thu, 04/06/2023 - 14:34

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Legacy MEDSearch

APRIL 6, 2023

Icentia Inc., announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. “This approval marks a key milestone for our company. The FDA clearance opens the door to the world’s largest medical device market. With the cost effectiveness and demonstrated ability of our cardiac monitoring solution to provide effective patient care and outcomes, we have no doubts that CardioSTAT will

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Food and Drug Administration Food FDA Recruitment 98

MedCity News

APRIL 6, 2023

As a primary care physician and cancer survivor, I’ve seen and experienced the physical and […]

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Physicians 129

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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PharmaVoice

APRIL 6, 2023

Pharming just landed an FDA approval for a treatment targeting an ultra-rare immunodeficiency disorder discovered only a decade ago — and it’s already in the hands of patients.

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FDA Patients 96

European Pharmaceutical Review

APRIL 6, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for EPYSQLI , a biosimilar referencing Soliris (eculizumab), also known as SB12. EPYSQLI [has become]… our first biosimilar in haematology to be recommended for approval in Europe” EPYSQLI has been recommended for approval in patients with paroxysmal nocturnal hemoglobinuria (PNH).

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Medicine Patients Pharmaceutical Marketing 89

Copyright Clearance Center

APRIL 6, 2023

The post Improving Data Quality Through PIDs: How Scholarly Publishers Use Ringgold Solutions appeared first on Copyright Clearance Center.

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European Pharmaceutical Review

APRIL 6, 2023

A “groundbreaking deal” between AstraZeneca and NHS England has enabled the National Institute for Health and Care Excellence (NICE) to recommend olaparib for adults with early breast cancer and metastatic prostate cancer in final draft guidance. For breast cancer patients, the treatment is approved for those who have inherited faults in their BRCA1 or BRCA2 genes, after surgery and chemotherapy and are HER2-negative and at high-risk.

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Side effects Medicine Patients Pharmaceutical 82

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Safety

PharmaTimes

APRIL 6, 2023

Vital AstraZeneca therapy may transform lives of people with certain breast and prostate cancers

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Scott’s Directories

APRIL 6, 2023

The world we live in is full of technology, innovations, and advancements. Thanks to medical devices, healthcare providers can provide more accurate diagnoses and better treatment to patients. Medical device companies are dedicated to providing the latest and greatest equipment to medical professionals. However, finding the right physician to buy your products can be challenging.

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Physicians Medical Sales Healthcare Provider 52

eMediWrite

APRIL 6, 2023

Different types of video media are used in video marketing to advertise and market the goods and services offered by healthcare companies. An astounding 86% of healthcare companies use video marketing as a marketing strategy. The effectiveness of video as a marketing tool is also attributed to its extremely shareable nature. It tries to draw in and educate audiences, hold their attention, and turn them into customers.

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Marketing Healthcare Healthcare Media 52

Pharmaceutical Technology

APRIL 6, 2023

The UK’s National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending AstraZeneca’s olaparib to treat early breast cancer and metastatic prostate cancer. The latest development comes following commercial deals negotiated by NHS England and AstraZeneca for the anti-cancer medicine olaparib. These deals enabled NICE to recommend the medicine as a clinically and cost-effective option to treat HER2-negative, high-risk early breast cancer and previously tre

Medicine 52

Medicine Patients 52

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Specialization

PharmExec

APRIL 6, 2023

How to build a modular content system to optimize content creation and delivery, Using Al-powered engines that know your HCP's viewing behavior, using discomfort as an advantage and much more.

Engineering 52

Engineering Pharma 52

Pharmaceutical Technology

APRIL 6, 2023

Mirum Pharmaceuticals has submitted a marketing authorisation variation application to the European Medicines Agency (EMA) for expanding the use of LIVMARLI (maralixibat) to treat progressive familial intrahepatic cholestasis (PFIC) patients aged two months and above. EMA has already approved the oral solution for treating cholestatic pruritus in patients of this age group diagnosed with Alagille syndrome (ALGS).

Patients 52

Patients Pharmaceutical Medicine Marketing 52

Impetus Digital

APRIL 6, 2023

Something many of us are used to by now is attending virtual meetings. For most of us, this is due to working at home throughout the pandemic, but Natalie Yeadon, co-founder and CEO of Impetus Digital, recognized the benefits of implementing virtual technology into corporate meetings and events long before it became our reality. Yeadon sits down with host Greg Muzzillo from the Million Dollar Podcast to share how she took a leap of faith by founding a virtual-based company in 2008, and has since

Pharmaceutical 52

Pharmaceutical Professional Services Healthcare Provider Consulting 52

Pharmaceutical Technology

APRIL 6, 2023

Ginkgo Bioworks has strengthened its end-to-end R&D capabilities in gene therapy with the purchase of adeno-associated virus (AAV) capsid discovery and engineering assets from StrideBio, for an undisclosed sum. The acquisition of the assets was announced with a secondary close scheduled, following the transfer of further in-licence agreements to Ginkgo.

Engineering 52

Engineering Safety Manufacturing Leads 52

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Leads

PharmaTimes

APRIL 6, 2023

Data demonstrates a sound safety and tolerability profile for therapy during phase 1 clinical trial

Safety 68

Safety 68

Pharmaceutical Technology

APRIL 6, 2023

US-based biotechnology company ImmunoGen has signed a term loan financing facility worth up to $175m with the entities of Pharmakon Advisors. ImmunoGen will use the proceeds from the agreement to support its growth trajectory and bolster its balance sheet. The company will receive the loan facility in two tranches. The first tranche of $75m will be available to the company once the agreement has been executed.

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Sales Management Patients 52

PharmaVoice

APRIL 6, 2023

Although Janssen bowed out of the RSV vaccine race, several pharmas are quickly closing in on the finish line in a disease with decades of unmet need.

Pharma 52

Pharma 52

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Accord BioPharma is the US specialty division of Intas Pharmaceuticals. HLX02 is intended for adjuvant treatment of HER2-overexpressing breast cancer. It has also been developed to treat HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma and metastatic breast cancer.

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Food and Drug Administration FDA Biopharma Food 52

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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