Mon.Aug 12, 2024

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Ascendis scores hard-fought FDA nod for hormone replacement therapy Yorvipath

Fierce Pharma

Ascendis Pharma should be well prepared for the U.S. | After two delays, the FDA has finally signed off on Ascendis Pharma's hormone replacement therapy Yorvipath, also known as TransCon PTH, which is the first approved product for hypoparathyroidism in adults in the U.S.

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Report: A “Multifaceted Approach” Is Needed To Tackle the Obesity Epidemic

MedCity News

The obesity epidemic is due to factors like inadequate access to care, stigma and a lack of insurance coverage for effective treatments, according to a new report published in the American Journal of Managed Care. The post Report: A “Multifaceted Approach” Is Needed To Tackle the Obesity Epidemic appeared first on MedCity News.

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Pfizer, looking to expand RSV vaccine's reach, touts its benefits in immunocompromised adults

Fierce Pharma

Locked in a closely watched respiratory syncytial virus (RSV) vaccine competition, Pfizer aims to expand the reach of its offering Abrysvo. | Locked in a closely watched RSV vaccine competition, Pfizer aims to expand the reach of its offering Abrysvo. Monday, Pfizer said Abrysvo elicited a strong response in adults with compromised immune systems.

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Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency

MedCity News

FDA approval of Ascendis Pharma’s Yorvipath is just in time for patients with hypoparathyroidism as Takeda Pharmaceutical will soon stop making the only drug therapy for the rare disorder. But competition could come from others, including an AstraZeneca peptide in late-stage development. The post Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency appeared first on MedCity News.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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After icodec rejection, Novo Nordisk plots 2024 FDA filing for once-weekly insulin and semaglutide combo

Fierce Pharma

Despite hitting a roadblock on the path to approval for its once-weekly insulin icodec in the U.S., Novo Nordisk is continuing to move full speed ahead with a combo treatment pairing the drug with | Despite hitting a roadblock on the path to approval for its once-weekly insulin icodec in the United States, Novo Nordisk is continuing to move full speed ahead with a combo treatment pairing the drug with its unstoppable GLP-1 semaglutide.

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Merck Picks Up Novel Bispecific Antibody With Potential in Both Cancer & Autoimmune Disease

MedCity News

Merck is acquiring a Curon Biopharmaceuticals drug whose encouraging Phase 1 data were presented during the ASCO annual meeting. The pharmaceutical giant sees potential applications of the bispecific antibody in cancer and autoimmune disease. The post Merck Picks Up Novel Bispecific Antibody With Potential in Both Cancer & Autoimmune Disease appeared first on MedCity News.

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Maintaining a Specialty Medication Regimen

Pharmaceutical Commerce

In this part of his Pharma Commerce video interview, Josh Marsh, Vice President and General Manager of Cardinal Health Sonexus Access and Patient Support, discusses the impact technology has in relation to patients sticking to their medication plan.

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Ajinomoto will lay off 71 staffers in CA to streamline CDMO business following $620M Forge Biologics buy

Fierce Pharma

Following last year’s acquisition of viral vector and plasmid specialist Forge Biologics, Japan’s Ajinomoto Bio-Pharma Services is streamlining its business in San Diego. | Following last year’s acquisition of viral vector and plasmid specialist Forge Biologics, Japan’s Ajinomoto Bio-Pharma Services is streamlining its business in San Diego. As a result, 71 California-based staffers—or 13% of the company’s overall workforce—are set to lose their jobs, Ajinomoto said in a memo shared with Fierce

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This New Venture Firm Thinks Payers Will Be the Ones to Drive Change in the Healthcare Industry

MedCity News

Create Health Ventures announced the close of its inaugural $21 million fund, which is focused on technology for payers. This is because payers are “the lynchpin” for the types of change that the fund wants to see, such as better care access and improved population health outcomes, Managing Partner Amit Aysola said. The post This New Venture Firm Thinks Payers Will Be the Ones to Drive Change in the Healthcare Industry appeared first on MedCity News.

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Era of ADCs: Pharma companies innovate to stand out in a buzzing market

Pharmaceutical Technology

As antibody drug conjugate (ADC)-centred deals dominate the oncology space, biotechs are using newer targets and linkers to differentiate themselves.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Closing the Gap Between Lifespan and Health Span with Predictive Analytics

MedCity News

By establishing a standard method of gathering data and utilizing programs like STEADI, we can significantly advance our frailty and fall prevention efforts and improve delivery models for other conditions that impact the most vulnerable members of our population. The post Closing the Gap Between Lifespan and Health Span with Predictive Analytics appeared first on MedCity News.

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Digital Health Networks Announces Finalists of 2nd Annual CineHealth International Health & Wellness Film and Video Festival

PM360

Winners Across Five Categories to Be Awarded During Ceremony at Digital Pharma East in Philadelphia, PA on September 10th August 12, 2023 – LOS ANGELES, CA – Digital Health Networks, today announced the finalists in the first annual CineHealth International Health and Wellness Film and Video Festival. At the awards ceremony in Philadelphia, PA, winners will be honored on the evening of Tuesday, September 10 th during Digital Pharma East for their work in film, video and podcasting.

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NICE updates on controversial multiple myeloma decisions

pharmaphorum

Three controversial decisions by NICE on NHS use of new multiple myeloma therapies are heading for the end of comment and appeals processes.

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HHS’s Information Blocking Disincentives are a Necessary Step Toward Better Patient Care

MedCity News

These disincentives may seem harsh, but we must remember the real stakes involved — when medical records are not readily available at the point of care, patients suffer. The post HHS’s Information Blocking Disincentives are a Necessary Step Toward Better Patient Care appeared first on MedCity News.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

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Pharmacy Deserts are Becoming a National Problem

Pharmaceutical Commerce

A lack of access could shut out patients in need of maintenance drugs for complex conditions.

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MSD adds bispecific cancer antibody via $1.3bn Curon deal

pharmaphorum

MSD adds a bispecific antibody for blood cancers and autoimmune diseases to its pipeline via a $1.3bn licensing deal with Curon Biopharma.

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Study suggests COVID-19 vaccination lowers incidence of arterial thromboses

PharmaTimes

A second dose of the vaccine lowered the incidence of conditions such as heart attack or stroke

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FDA clears first anaphylaxis nasal spray at second attempt

pharmaphorum

ARS Pharma gets FDA approval for epinephrine nasal spray neffy, the first needle-free alternative to EpiPen-style autoinjectors for serious allergic reactions.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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UCL study reveals routine blood tests could improve early cancer diagnosis

PharmaTimes

Bowel cancer was the most common cancer to be identified in both men and women

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Article retractions muddy MDMA waters after FDA denial

pharmaphorum

Journal retracts three articles on MDMA-assisted psychotherapy, shortly after FDA blocks approval of @Lykos_PBC's therapy for PTSD

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MSD set to acquire novel antibody for B-cell malignancies

European Pharmaceutical Review

Merck (MSD outside of the US and Canada) has agreed to acquire a novel biologic for B-cell associated diseases, from the biotech Curon Biopharmaceutical. CN201 is a novel CD3xCD19-targeting T-cell-engager bispecific antibody. Through the agreement, Merck, through a subsidiary, will acquire worldwide rights, for a total of $700 million. Curon stated that it will be eligible for up to $600 million in milestone payments for CN201.

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Another AIM defection as BiVictriX plans to delist

pharmaphorum

BiVictriX is the latest UK biotech to say it wants to cancel its AIM-listed shares and go private in pursuit of better financing opportunities.

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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.

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Second Annual CINEHEALTH International Film and Video Festival Announces Panel Discussions at Digital Pharma East

PM360

CineHealth brings discussion about content and storytelling from key industry thought leaders to leading healthcare conference. August 12, 2024 – LOS ANGELES, CA – Digital Health Networks, a global leader in healthcare-focused original content production and OTT streaming, announces the first panel discussions in the festival’s history in conjunction with Questex’s Digital Pharma East.

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Evolving Global Medical Communications With a Digital-First Approach

Eversana Intouch

In the ever-evolving landscape of medical communications, a paradigm shift toward digital-first strategies is essential. Mary Manna Anderson, Managing Director and Head of Medical Communications, and Francis Namouk, SVP, Global Strategic Development, explore this transformation in a recent PM360 article , emphasizing the need for meaningful engagement across channels.

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Pharma Pulse 8/12/24: Balancing Profitability and Mission, Minority Groups Remain Underrepresented in Vitiligo Trials & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Ensuring Compatibility of Pre-filled Syringes

PharmaTech

There is not a syringe solution that fits all challenges. In this Podcast, Enrico Barichello, Product Manager for Syringe Platform in Stevanato Group, and Alan Xu, Product Manager for Analytical Services in Stevanato Group's Technology Excellence Centers, discuss the best strategies to select the right pre-filled syringe (PFS) based on the key needs of combination products and illustrate how introducing analytical services from an early stage can help customers reach the market faster by avoidin

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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

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AstraZeneca VP, Head of Medical Affairs, US Oncology, Discusses the Impact of PARP Inhibitors on Cancer Treatment

PharmExec

In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, Head of Medical Affairs, US Oncology Business Unit, AstraZeneca, talks PARP inhibitors in cancer treatment and the history of Lynparza.

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RSV Vaccine Shows Positive Results in Substudy of Phase III Trial of Immunocompromised Patients

PharmaTech

The virus, which is contagious and a common cause of respiratory illness, hospitalizes up to 160,000 people and is responsible for as many as 13,000 deaths in the United States every year.

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An Examination of Big Pharma Inventories

Pharmaceutical Commerce

A conversation with Matthew Bardell, managing director, nVentic, about a perhaps overlooked but useful strategic component of company performance and overall business benchmarks: inventory optimization.

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Leap Consulting launches practice to assist labs with FDA’s LDT ruling

Pharmaceutical Technology

Leap Consulting Group has launched a practice aimed at guiding Clinical Laboratory Improvement Amendments-certified labs (CLIA) in adhering to the US Food and Drug Administration’s (FDA) Final Rule over the classification of laboratory-developed tests (LDTs).

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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.