Thu.Feb 02, 2023

article thumbnail

Amid mainstream hype, Eli Lilly takes a hard line marketing its buzzy diabetes med Mounjaro

Fierce Pharma

Amid mainstream hype, Eli Lilly takes a hard line marketing its buzzy diabetes med Mounjaro fkansteiner Thu, 02/02/2023 - 11:20

Marketing 246
article thumbnail

Report: Nurse Understaffing Is Becoming More Deadly for Patients

MedCity News

More than 90% of nurses in Michigan believe that understaffing is negatively affecting the quality of care they’re able to provide, according to a new report. The percentage of respondents who know of a patient death being caused by nurses being assigned too many patients nearly doubled in the past seven years — from 22% in 2016 to 42% in 2023.

Patients 118
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

Fierce Pharma Asia—J&J, Legend's CAR-T win; Sanofi's India job cuts; BeiGene, Novartis' PD-1 delay

Fierce Pharma

Fierce Pharma Asia—J&J, Legend's CAR-T win; Sanofi's India job cuts; BeiGene, Novartis' PD-1 delay aliu Thu, 02/02/2023 - 15:58

Pharma 213
article thumbnail

NY Innovation Report Shows Funding Plummet for Women’s Health; Biotech Startups Gain Interest

MedCity News

New York healthcare startups received $3.9 billion of funding in 2022, compared to $9 billion in 2021, according to a new DHNY report. Biotech startups represented 22% of total funding in 2022, a stark difference from women’s health only representing 2%.

article thumbnail

Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

article thumbnail

Novo's Rybelsus comes into its own as Wegovy shakes off supply constraints

Fierce Pharma

Novo's Rybelsus comes into its own as Wegovy shakes off supply constraints fkansteiner Thu, 02/02/2023 - 08:57

212
212
article thumbnail

‘A Proactive and Necessary Step:’ NFPRHA Applauds Proposed Rule on Birth Control Coverage

MedCity News

Under the proposed new rule, employers are no longer able to be exempt from covering contraception due to moral convictions, but religious exemptions still remain. It’s an important move from the government during the reproductive health crisis, one advocate said.

More Trending

article thumbnail

MA Plans Rejected 2M Prior Authorization Requests in 2021

MedCity News

There were more than 35 million prior authorization requests submitted to MA plans in 2021, and 2 million were denied, according to KFF. Of those denied, just 11% were appealed. However, most of those appeals led to the denial being overturned.

112
112
article thumbnail

Merck's recent Keytruda label expansion in NSCLC is more of a 'long-term' opportunity, CEO says

Fierce Pharma

Merck's recent Keytruda label expansion in NSCLC is more of a 'long-term' opportunity, CEO says kdunleavy Thu, 02/02/2023 - 10:43

130
130
article thumbnail

GSK Gets FDA Nod for Drug Treating Anemia From Chronic Kidney Disease

MedCity News

The FDA approved GSK drug Jesduvroq for treating anemia in patients with chronic kidney disease. The once-daily pill is the first oral medicine to pass FDA muster in this indication, giving patients a more convenient alternative to injectable anemia therapies.

FDA 109
article thumbnail

Bristol Myers holds on to blockbuster Sotyktu hopes, plays down Otelza threat

Fierce Pharma

Bristol Myers holds on to blockbuster Sotyktu hopes, plays down Otelza threat zbecker Thu, 02/02/2023 - 13:22

150
150
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

What A Nobel Prize-Winner’s Research Means for Cancer Treatment

MedCity News

Drs. Carolyn Bertozzi, Barry Sharpless, and Morten Meldal shared the 2022 Nobel Prize in Chemistry for greatly simplifying the synthesis of complicated molecules. Dr. Bertozzi’s protégé writes why her research is so important.

Biopharma 107
article thumbnail

How AbCellera helps partners propel their antibody therapies to the clinic

Fierce Pharma

How AbCellera helps partners propel their antibody therapies to the clinic jpiatt Thu, 02/02/2023 - 10:34

130
130
article thumbnail

US FDA approves GSK’s Jesduvroq to treat anaemia of CKD

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It is claimed to be the only HIF-PHI approved in the country that offers a new oral treatment option for adult patients on dialysis with anaemia of CKD.

article thumbnail

Expanding Telehealth Access Not Reducing it Will Continue Saving Lives, Mitigating Costs of the Opioid Crisis

MedCity News

Protectionism against (and fear of) telehealth on display from companies like Walmart and states like Alabama threaten the only effective and scalable solution to America’s opioid epidemic.

article thumbnail

Roles and Responsibilities of Specialized Clinical Supply Experts

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.

article thumbnail

Magazine: CRISPR gene therapies cut through in 2023

Pharmaceutical Technology

If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. Having made significant advances in a relatively short period of time, CRISPR research is now edging closer to reaching the clinic , and this month’s cover story takes a look at the major players in this field and the big events that could break through this year.

article thumbnail

Why Lawmakers Are Trying to Nix VA’s $50B+ Dollar Oracle Cerner EHR Rollout

MedCity News

Two Congresspeople recently introduced a bill seeking to terminate the VA’s Oracle Cerner EHR rollout. The legislation said that the project is too flawed and costly to carry on — the lawmakers called for VA facilities to revert back to the department’s internally developed EHR.

article thumbnail

Tyber Medical LLC Acquires ADSM-Synchro Medical

Legacy MEDSearch

Tyber Medical LLC has acquired 100 percent of the capital of ADSM-Synchro Medical, a French orthopedic medical device company, specializing in the development and distribution of implants dedicated to treating surgical forefoot pathologies. Founded in 2010, ADSM has become a market leader in the European medical device industry with products like the ToeGrip Classic, the first hammer toe implant of its kind developed with PEEK material.

Medical 98
article thumbnail

Karuna Picks Up Kidney Drugs for Chance to Challenge Boehringer Ingelheim in the Brain

MedCity News

Karuna Therapeutics has licensed two small molecules that shuttering Goldfinch Bio had developed for kidney disorders. These compounds target a pathway that could also treat neurological disorders, giving clinical-stage Karuna the opportunity to compete against a drug candidate from Boehringer Ingelheim.

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

Capture Videos of HCPs at ASCO

Storyvine

ASCO is a great opportunity to reconnect with colleagues, show off your brand and discover what’s new in cutting edge oncology research. Storyvine wants to help you make the most of it. We all know how busy doctors can be, and here's your chance to not only meet them in person, but to film them talking about their expertise, and the latest research and learnings.

Doctors 94
article thumbnail

Mankind Pharma Limited- Openings for AGL/ GL -API Technology Transfer -Apply Now

Pharma Pathway

Mankind Pharma Limited- Openings for AGL/ GL -API Technology Transfer -Apply Now Job Description Openings for AGL/ GL -API Technology Transfer Department @ Mankind Pharma Limited Department: AGL/ GL -API Technology Transfer Qualification : B.Tech/ B.E/ M.Tech (Chemical Engg) Experience: 08 to 10+ years Role: Process Engineer Job Location: Visakhapatnam, Behror JD: Technology transfer of new molecules from R&D to R&D to Pants (in -house as well as outsourced locations) through kilo lab

Pharma 84
article thumbnail

First biosimilar to HUMIRA® available in US

European Pharmaceutical Review

AMJEVITA (adalimumab-atto), a biosimilar to Humira ® (adalimumab), is now available in the US. Amgen’s AMJEVITA was the first biosimilar to Humira approved by the US Food and Drug Administration (FDA), in 2016. The active ingredient in the anti-TNF-α monoclonal antibody has the same amino acid sequence as Humira. The Humira biosimilar will be available in prefilled syringe and autoinjector presentations to support dosing in each of the approved indications.

article thumbnail

Hetero Labs Limited-Walk-In Interviews for Freshers in Quality Control/ Quality Assurance/ Production On 5th Feb’ 2023

Pharma Pathway

Hetero Labs Limited-Walk-In Interviews for Freshers in Quality Control/ Quality Assurance/ Production On 5th Feb’ 2023 Job Description Hetero Labs Limited is one of India’s generic pharmaceutical companies and the “world’s largest producer of anti- retroviral drugs”. Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics.

article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

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.

article thumbnail

The Punctuated Evolution of Computer Software Validation

PharmaTech

Shifting guidance and the growing prominence of computer software assurance exemplify the state of computer software validation.

96
article thumbnail

Aurobindo Pharma-Walk-In Interviews for Packing Department On 4th Feb’ 2023

Pharma Pathway

Aurobindo Pharma-Walk-In Interviews for Packing Department On 4th Feb’ 2023 Job Description Company Profile: Aurobindo Pharma Ltd’ (APL). APL is a growing India multinational pharmaceutical manufacturing firm with turnover of over US$2.8 Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations.

Pharma 78
article thumbnail

Pharmapack Europe Awards 2023 winners announced

European Pharmaceutical Review

The winners of Pharmapack Europe’s 2023 awards have been announced, presented across a range of innovative recyclable packaging, drug delivery solutions, and reusable connected devices. Three categories were available for entry in the Exhibitor Innovations section. The winning products were: Drug delivery innovation: UniSafe ® reusable connected auto-injector by Owen Mumford Pharmaceutical Services Packaging innovation: PACKSYS GmbH for ampoule dispenser Sustainability initiative: Körber P

Pharma 77
article thumbnail

Hy-Gro Chemicals Pharmtek Pvt. Ltd.-Walk-In Interviews for R&D On 4th Feb’ 2023

Pharma Pathway

Hy-Gro Chemicals Pharmtek Pvt. Ltd.-Walk-In Interviews for R&D On 4th Feb’ 2023 Job Description Hy-Gro Chemical Pharmtek Pvt. Ltd is a leading Bulk Drugs & APIs Manufacturer, Approved by USFDA & KFDA, looking for suitable candidates for (R&D API/ Synthetic) Department at our Bollaram facility. Department: (R&D API/ Synthetic) Position: Chemist- Executive Experience: 02 to 08 years Qualification: M.Sc Chemistry Work Location: Bollaram, Hyderabad Date: 4th Feb’ 2023

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

Considerations for Method Validation

PharmaTech

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating analytical methods.

article thumbnail

Endevica Bio and Orbit Discovery unite to boost cachexia therapeutics

PharmaTimes

The central focus of the agreement is to establish peptide hits from selected library populations

93
article thumbnail

MHRA approves first oral advanced therapy for Crohn’s disease

European Pharmaceutical Review

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved RINVOQ ® ▼ (upadacitinib), the first oral advanced therapy for adults with moderately to severely active Crohn’s disease (CD). This approval for Great Britain marks the first marketing authorisation globally for the use of upadacitinib in CD. Treating Crohn’s disease “There have been limited new treatment options approved for Crohn’s disease in recent years and many people struggle to stay in remission, demonstrati

Safety 66
article thumbnail

Antitrust watchdogs have pharma in their sights, and the landscape is getting thornier

PharmaVoice

The FTC and DOJ are heightening antitrust enforcement, and pharma deals are a prime target.

Pharma 95
article thumbnail

The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.