UCB's bimekizumab finally back on the FDA's review list after May rejection
Fierce Pharma
DECEMBER 28, 2022
UCB's bimekizumab finally back on the FDA's review list after May rejection. zbecker. Wed, 12/28/2022 - 11:17.
Wed.Dec 28, 2022
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7 Strategies for Integrating Behavioral Health Into Primary Care
MedCity News
DECEMBER 28, 2022
As we collectively address this rising tide of behavioral health needs, we will need more payment reform, more innovation, and continued migration to more prospective payment models and treatment approaches that bring all stakeholders together to care for patients in a holistic manner.
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How to get acquisition ready – a seller’s guide to merger and acquisition in pharma
pharmaphorum
DECEMBER 28, 2022
This year, the predicted flurry of merger and acquisition (M&A) activity might not have materialised. However, as we near the end of the year, there were some big moves. M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline.
Career Advancement in Clinical Trials: How Developing New Skills Can Prevent Turnover
MedCity News
DECEMBER 28, 2022
The industry needs to more clearly define the different competencies and career paths within clinical research so all employees can lean into their strengths and build a career plan that brings them fulfillment.
Macleods Pharmaceuticals Ltd.-Openings for Engineering Services -Apply Now
Pharma Pathway
DECEMBER 28, 2022
Macleods Pharmaceuticals Ltd.-Openings for Engineering Services-Apply Now. Job Description. Macleods Pharmaceuticals, Indian’s fastest growing company was established in 1986. Ranked amongst the top 10 pharma companies with a strength of 20000 employees, operating in 140+ countries. Our bioequivalence centre was established in 2005 and is responsible for conducting studies for filing product registrations with various regulatory authorities.
Should Patients Have the Right to Own Their Clinical Trial Data?
MedCity News
DECEMBER 28, 2022
Putting data into the hands of participants is an important step in changing the traditional clinical trial paradigm. It fits in amongst the goal of running nimble and patient-centered studies. But, without legislation, it’s doubtful that pharma companies will give up ownership of participant data out of sheer goodwill.
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Carallel to Expand Caregiver Support Footprint With $8.2M Fundraise
MedCity News
DECEMBER 28, 2022
Carallel, a startup that provides digital tools to support family caregivers, recently raised $8.2 million in Series A funding. The Chicago-based company’s services are offered as a benefit by health plans and employers.
Aurobindo Pharma-Openings for M.Pharmacy Freshers -Apply Now
Pharma Pathway
DECEMBER 28, 2022
Aurobindo Pharma-Openings for M.Pharmacy Freshers -Apply Now. Job Description. Opportunity for M.Pharmacy Freshers. Aurobindo Research Centre 2 at Pashamaylaram, Hyderabad Location is providing an Opportunity for M.Pharmacy Freshers to gain the Industrial knowledge through its 9 months internship in the below R&D Areas. Formulations R&D (OSD): M.
One Simple Action Can Ease ‘Tripledemic’ Pressures: Paid Sick Leave
MedCity News
DECEMBER 28, 2022
Nearly a quarter of private sector employees don’t have any paid sick days, according to the National Partnership for Women & Families. Providing this benefit will save employers down the line, one expert argues.
FDA slaps partial hold on Biogen, InnoCare MS drug
pharmaphorum
DECEMBER 28, 2022
Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. The US regulator has placed oral BTK inhibitor orelabrutinib on partial clinical hold, meaning new patients cannot be enrolled into clinical trials and patients treated with the drug for 70 days or less must discontinue treatment.
How Machine Learning Drives Clinical Trial Efficiency
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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.
How Automation Can Cut Into the $500B of Administrative Waste
MedCity News
DECEMBER 28, 2022
Today, what’s required is an all-in-one, administration-specific data management platform (DMP). Purpose-built, integrated and fully connected across operations, these platforms can automate and facilitate compliance, licensing, credentialing, enrollment and more.
Exploring the Digital Therapeutics Landscape
Pharmaceutical Commerce
DECEMBER 28, 2022
Observations from recent digital health events and a glimpse of what’s ahead—from Milan to Boca Raton.
CMS: ACA Marketplace Enrollment Reaches 11.5M
MedCity News
DECEMBER 28, 2022
About 11.5 million people have selected a health plan through the ACA Marketplace as of December 15. This is 1.8 million people more than the same period last year, representing an 18% increase, CMS said.
How To Make A Successful Virtual Sales Pitch In Medical Sales?
Medical Sales Authority
DECEMBER 28, 2022
Virtual sales presentations have become commonplace since the Covid pandemic. Zoom, Microsoft Teams, WebEx, etc. There is a different dynamic to virtual meetings with healthcare customers. Meetings in this format can be very effective. But they need to be approached in a different manner. The ability to build rapport and engagement is different in the virtual environment.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Gilead Sciences to buy all rights of GS-1811 from Jounce
Pharmaceutical Technology
DECEMBER 28, 2022
Gilead Sciences and Jounce Therapeutics have amended their current license agreement for first-in-class immunotherapy, GS-1811 (formerly JTX-1811). The initial license agreement was signed in 2020. The amended agreement will allow Gilead Sciences to acquire all the remaining rights for GS-1811 from Jounce Therapeutics. Certain operational obligations of the companies that are related to GS-1811 have also been terminated as part of the transaction.
December OTC Product News
Pharmacy Times
DECEMBER 28, 2022
Products range from acne treatment to cough relief.
How medical device sales teams can embrace digital transformation
pharmaphorum
DECEMBER 28, 2022
Selling amid a global pandemic has changed the face of sales forever. This is nowhere more pronounced than for medical device sales teams, who typically schedule regular visits to hospitals and doctors’ offices to create a personal, ongoing connection that drives forward the sales process. Now, those field sales experts need to sell virtually – which can be increasingly difficult when healthcare professionals have a packed schedule and limited time away from patients and the practice.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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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.
Gilead grabs full rights to Jounce cancer immunotherapy
pharmaphorum
DECEMBER 28, 2022
Gilead Sciences must like what it has seen in a two-year-old partnership with Jounce Therapeutics for a CCR8-targeting cancer immunotherapy – it has just agreed to take full ownership of the programme. The drug in question – codenamed GS-1811 (formerly JTX-1811) – is an antibody drug designed to selectively deplete T regulatory cells in the tumour microenvironment that has been taken into phase 1 clinical testing as a monotherapy and in combination with PD-1 inhibitor zimberelimab for solid tumo
Congress delivers festive PIE to patients, speeding access to therapies
pharmaphorum
DECEMBER 28, 2022
After years of preparation, the US Congress passed the Pre-approval Information Exchange (PIE) Act just ahead of the Christmas break, legislation that will allow medical payers and the FDA to review new treatments concurrently. The act – which still needs to be signed into law by President Joe Biden – could shave months or even years off the time it takes for novel treatments to be available to patients, according to its sponsors.
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