Watch out, Amgen. Mirati kicks off KRAS showdown with FDA approval for Krazati
Fierce Pharma
DECEMBER 12, 2022
Watch out, Amgen. Mirati kicks off KRAS showdown with FDA approval for Krazati. aliu. Mon, 12/12/2022 - 18:14.
Mon.Dec 12, 2022
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Here’s How Skilled Nursing Facilities Can Use Virtual Reality Too
MedCity News
DECEMBER 12, 2022
It may take some time to introduce VR into your skilled nursing facility, but it will be worth it for the physical, mental, and social benefit of your residents.
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Buyout on Horizon: Amgen floats $28B offer for rare disease drug maker as Sanofi exits bidding war
Fierce Pharma
DECEMBER 12, 2022
Buyout on Horizon: Amgen floats $28B offer for rare disease drug maker as Sanofi exits bidding war. esagonowsky. Mon, 12/12/2022 - 08:18.
How L&D in Regulated Industries Can Move Beyond Just Compliance to Impact [Sponsored]
MedCity News
DECEMBER 12, 2022
The Covid-19 pandemic has forced life sciences companies to take a fresh look at how they do business. But as they reinvent their operations, companies often overlook a critical function: Their learning and development programs.
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
ASH: CSL, uniQure's gene therapy Hemgenix shows durable protection in hemophilia B
Fierce Pharma
DECEMBER 12, 2022
ASH: CSL, uniQure's gene therapy Hemgenix shows durable protection in hemophilia B. kdunleavy. Mon, 12/12/2022 - 14:25.
At the Crossroads of Hope and Truth
MedCity News
DECEMBER 12, 2022
Each of us gets one life, and every life contains its own death. Engage with that fuller picture, wield hope carefully, and then, from everything this hospice doctor has seen, you will be OK, made whole by the time death rolls around, rather than pulled apart by it.
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Amgen to Buy Horizon Therapeutics for $28B, Edging Out Sanofi in Bidding War
MedCity News
DECEMBER 12, 2022
Sanofi submitted the first unsolicited offer to acquire Horizon Therapeutics, but Amgen ultimately won what became a competitive bidding process. Amgen says Horizon’s drug lineup complements its own portfolio of autoimmune and inflammatory disorder products. .
ASH: Bristol's 3rd-line Abecma data didn't make the trip to New Orleans. Is it cause for concern?
Fierce Pharma
DECEMBER 12, 2022
ASH: Bristol's 3rd-line Abecma data didn't make the trip to New Orleans. Is it cause for concern? aliu. Mon, 12/12/2022 - 16:20.
5 Steps to Delivering Virtual First Care that Will Redefine the Healthcare Value Chain
MedCity News
DECEMBER 12, 2022
Virtual first care (V1C) – high-quality healthcare delivered virtually until it cannot be – will allow both new and incumbent providers to achieve success in the redefined value chain.
Sanofi started—and lost—$28B bidding war for Horizon. Is the company's M&A appetite still rumbling?
Fierce Pharma
DECEMBER 12, 2022
Sanofi started—and lost—$28B bidding war for Horizon. Is the company's M&A appetite still rumbling? fkansteiner. Mon, 12/12/2022 - 13:57.
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.
An Update on Gun Violence as a Public Health Issue
MedCity News
DECEMBER 12, 2022
Gun violence is a public health crisis, and lawmakers are taking small steps toward treating it that way, said Kris Brown, president of gun violence prevention nonprofit Brady United. But there is still a long road ahead in the fight to protect American communities against gun-related injuries and fatalities, she said.
In another leadership change at Roche, Anderson departs as pharma CEO
Fierce Pharma
DECEMBER 12, 2022
In another leadership change at Roche, Anderson departs as pharma CEO. kdunleavy. Mon, 12/12/2022 - 09:25.
Getlabs, Poplin Team Up To Bring Pre-pregnancy Wellness Testing to Couples’ Homes
MedCity News
DECEMBER 12, 2022
Poplin sells tests for couples looking to know more about their health before they start trying to get pregnant. After traditionally offering their tests in labs, Poplin is partnering with Getlabs to reach consumers in their homes.
GSK embraces hybrid work for the long haul at new London HQ
Fierce Pharma
DECEMBER 12, 2022
GSK embraces hybrid work for the long haul at new London HQ. fkansteiner. Mon, 12/12/2022 - 09:39.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Can Positive Patient Feedback Reduce Burnout? One Company Thinks So
MedCity News
DECEMBER 12, 2022
Software company Feedtrail recently launched a clinician retention workgroup designed to streamline the process of connecting employees to positive patient feedback. The first cohort involves four providers, including Cedars-Sinai in Los Angeles and Huntington Hospital in Pasadena.
Clovis Oncology finally throws in the towel, files for bankruptcy
Fierce Pharma
DECEMBER 12, 2022
Clovis Oncology finally throws in the towel, files for bankruptcy. zbecker. Mon, 12/12/2022 - 11:34.
Santa Clara Family Health Plan Taps Yes Health for Diabetes Prevention Program
MedCity News
DECEMBER 12, 2022
Yes Health provides concierge health coaching and services for weight loss and diabetes prevention, all through its app. After taking a short quiz, members will receive a personalized plan — created by the company’s dietitians, nutritionists, fitness experts and psychologists — to improve their health. The app also offers an AI-powered service where members can take pictures of their meals to receive guidance on how to make them healthier.
Amgen’s AMG-133 shows potential in competing with GLP-1RA obesity therapies
Pharmaceutical Technology
DECEMBER 12, 2022
Pipeline therapies within the cardiometabolic space have recently gathered interest following the 20th World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC) Hybrid Conference, which took place on 1–3 December. The spotlight was placed on many up-and-coming pharmacotherapies within the space, one of which was Amgen’s obesity therapy, AMG-133, following the company’s announcement of its Phase I therapy results last week, on 1 December.
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.
Utrogestan accepted as HRT in Scotland
European Pharmaceutical Review
DECEMBER 12, 2022
The Scottish Medicines Consortium (SMC) has accepted Utrogestan, the only adjunctive micronised progesterone available as hormone replacement therapy (HRT) for use alongside any oestrogen-only HRT for women with an intact uterus. Utrogestan 100mg, a product by Besins Healthcare UK, is a body-identical hormone, which means it has the same molecular structure as the hormone produced by the body.
Kite and Arcellx enter partnership for multiple myeloma therapy development
Pharmaceutical Technology
DECEMBER 12, 2022
Gilead company Kite has entered an international strategic partnership with Arcellx for the joint development and commercialisation of the latter’s T-cell therapy, CART-ddBCMA, to treat relapsed or refractory multiple myeloma patients. The alliance will utilise the capabilities of both firms, including international cell therapy leadership and manufacturing of Kite.
Dapagliflozin approved for heart failure across LVEFs
European Pharmaceutical Review
DECEMBER 12, 2022
The Medicines and Healthcare products Regulatory Agency ( MHRA ) has granted a licence extension for FORXIGA (dapagliflozin) in Great Britain for symptomatic chronic heart failure (HF) across the full spectrum of left ventricular ejection fraction (LVEF). The approval means potentially a further 250,000 patients across the full spectrum of LVEF >40 percent, including HF with reduced, mildly reduced, and preserved ejection fraction (HFrEF, HFmrEF, HFpEF) will be eligible for treatment in Engl
Pennsylvania-based Highmark Inc. Joins Theranica’s Coverage with Evidence Program for Nerivio® Drug-Free Migraine Treatment Device
Legacy MEDSearch
DECEMBER 12, 2022
Theranica , a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, announced that Highmark Inc. (Highmark), one of America’s leading health insurance organizations and an independent licensee of the Blue Cross Blue Shield Association, will conduct a targeted Coverage with Evidence program with the goal of providing its members with affordable treatment for episodic and chronic migraine.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
Utrogestan approved as HRT in Scotland
European Pharmaceutical Review
DECEMBER 12, 2022
The Scottish Medicines Consortium (SMC) has approved Utrogestan, the only adjunctive micronised progesterone available as hormone replacement therapy (HRT) for use alongside any oestrogen-only HRT for women with an intact uterus. Utrogestan 100mg, a product by Besins Healthcare UK, is a body-identical hormone, which means it has the same molecular structure as the hormone produced by the body.
Amgen agrees $26bn for Horizon following Sanofi withdrawal
pharmaphorum
DECEMBER 12, 2022
In a fresh update, Bloomberg has reported that US biotech Amgen Inc. has agreed to purchase Dublin-based Horizon Therapeutics Plc. for €24.7 billion ($26bn), in a deal which could yet see further delays or a breakdown in negotiations. Following Sanofi’s withdrawal from the running, stating that “transaction price expectations do not meet [their] value creation criteria” – for the purposes of Rule 2.12 of the Irish Takeover Rules in response to Horizon’s announcement under Rule 2.4 of the I
IRRAS Receives US FDA 510(k) Clearance for its Next Generation IRRAflow Control Unit
Legacy MEDSearch
DECEMBER 12, 2022
IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced that it received regulatory clearance from the United States Food, Drug, and Administration (FDA) to active all of the functionality on the next generation control unit for its flagship product, IRRAflow, the world’s first and only active fluid exchange system.
Dos and Don’ts for Medical Sales Rep Conduct
MedReps
DECEMBER 12, 2022
In order to be successful and meet those sales goals, medical sales representatives need to conduct themselves properly. Acting unprofessionally, among other things, can lead to complaints made against you, not to mention losing sales and reliable clients. If you want to stay on top of your game, you’ll need to do a number of things correctly, as well as avoid phrases and behaviors seen as unprofessional.
Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics
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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
SABCS: Pharmas show their working in HR+/HER2- breast cancer
pharmaphorum
DECEMBER 12, 2022
The San Antonio Breast Cancer Symposium (SABCS) has highlighted some of the most promising clinical research being undertaken by drugmakers in the category, with AstraZeneca leading the charge with a trio of major trial readouts. Along with data from its antibody-drug conjugates and oral selective oestrogen receptor degrader (SERD) camizestrant reported earlier, AZ presented results of the CAPItello trial of AKT inhibitor capivasertib in combination with injectable SERD Faslodex (fulvestrant) in
PI Industries Ltd- Walk-In Interview for B.Sc, M.Sc, Diploma in Chem. B.Tech, B.E On 20th Dec’ 2022
Pharma Pathway
DECEMBER 12, 2022
PI Industries Ltd- Walk-In Interview for B.Sc, M.Sc, Diploma in Chem. B.Tech, B.E On 20th Dec’ 2022. Job Description. PI Industries Limited (PI) is a fast growing agri-Sciences Company with a unique business model across the Agchem value chain from R&D. PI Industries, Founded in 1946, we work with a unique business model across the AgChem value chain from R&D to distribution providing innovative solutions by partnering with the best.
The pharma giants making the biggest strides with global drug access
PharmaVoice
DECEMBER 12, 2022
A recent report ranks the top 20 pharma companies by how well they’re boosting a critical component of health equity.
Granules India Limited- Walk-In Drive for ITI, Diploma, B.Sc, B.Com Freshers On 14th Dec’ 2022
Pharma Pathway
DECEMBER 12, 2022
Granules India Limited- Walk-In Drive for ITI, Diploma, B.Sc, B.Com Freshers On 14th Dec’ 2022. Job Description. Company Profile: Granules India Limited is an Indian pharmaceutical manufacturing company based in Hyderabad, Indian. Granules manufacturing several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the regulated and rest of the world markets.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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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.
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