Wed.Feb 21, 2024

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Novavax dodges COVID vaccine refund by settling Gavi arbitration for up to $400M

Fierce Pharma

On the heels of a turbulent 2023 in which Novavax’s very existence was at stake, the beleaguered vaccine maker has new reason to be optimistic about the future. | Novavax has reached a settlement with Gavi, the Vaccine Alliance ending arbitration tied to a 2021 advance purchase agreement around its prototype COVID-19 vaccine NVX-CoV2373. Had Novavax lost the arbitration, the company might have had to refund nearly $700 million.

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Long-Acting Injectable Cabenuva Found More Effective Than Daily ART at Suppressing HIV in Patients With Adherence Challenges

Pharmaceutical Commerce

Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.

Patients 111
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Novo Nordisk, Eli Lilly lead industrywide sales surge in Q4

Fierce Pharma

In a year that started with more than two-thirds of biopharma companies posting | While Novo Nordisk and Eli Lilly continued to be the biopharma industry growth leaders in the fourth quarter of 2023, many other drugmakers also delivered big gains, including Daiichi Sankyo, Amgen, Teva, GSK and Novartis.

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HealthSnap Snags $25M to Help Providers Launch & Scale RPM Programs

MedCity News

HealthSnap closed a $25 million Series B funding round led by Sands Capital. The Miami-based company seeks to help providers better care for a rapidly aging and chronically ill population through its remote patient monitoring platform.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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Novo, Novartis, BMS and J&J win judge's blessing to combine arguments in upcoming IRA hearing

Fierce Pharma

Four major drugmakers are joining forces as they prepare to battle certain aspects of the Inflation Reduction Act (IRA) in court next month. | A federal judge in New Jersey agreed to let Bristol Myers Squibb, Novo Nordisk, Novartis and J&J present oral arguments together in their bid to challenge the government's new Medicare negotiations framework.

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EGFR inhibitor could provide major advance in lung cancer

European Pharmaceutical Review

Small molecule treatment TAGRISSO ® (osimertinib) demonstrated a “statistically significant and highly clinically meaningful improvement” in progression-free survival (PFS) for Stage III lung cancer patients, AstraZeneca has confirmed. This was established from positive high-level results seen in the LAURA Phase III trial. The data was based on observations from patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemor

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Medication Management Technology Puts Patient Safety at the Center of Care

MedCity News

In the same way that airbags were a natural evolution of vehicle safety technology, seamless, RFID-based systems are the next evolution of medication management technology.

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Joseph Papa, after leaving Bausch, begins another turnaround project as CEO of Emergent BioSolutions

Fierce Pharma

Joseph Papa has reemerged nearly a year after stepping down as head honcho of Bausch + Lomb. | Joseph Papa has re-emerged nearly a year after stepping down as head honcho of Bausch + Lomb. The former Valeant helmsman is now tasked with turning around Emergent BioSolutions as its new CEO.

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At ViVE 2024, Get a Glimpse of the State of Cybersecurity in Healthcare [Sponsored]

MedCity News

Mari Savickis, Vice President of Public Policy with CHIME, will be moderating a panel discussion as part of the Cybersecurity Pavilion at the ViVE 2024 event in Los Angeles, scheduled for February 25-28. She said her organization anticipates several developments addressing cybersecurity this year.

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United Therapeutics challenges FDA on application process for rival drug from Liquidia

Fierce Pharma

Two months ago, when a federal appeals court rejected United Therapeutics’ attempt t | When a federal appeals court rejected United Therapeutics’ attempt to revive an invalidated patent on its aging pulmonary arterial hypertension drug Tyvaso, it cleared one hurdle for the FDA to approve a rival treatment from the North Carolina-based Liquidia Corporation.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Mobile ADHD awareness game launches in Germany

pharmaphorum

Attention-deficit hyperactivity disorder (ADHD) in adults is not well understood and highly underdiagnosed, but the developers of a mobile game designed to raise awareness hope to shine a light on the struggles of people struggling with the condition.

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Sanofi's planned consumer health spinoff picks up interest from multiple firms: Bloomberg

Fierce Pharma

As Sanofi continues to plot its planned separation from its consumer healthcare division, the business has reportedly attracted interest from multiple private equity firms. | Top buyout firms, including Advent International and Blackstone, have their eye on Sanofi's consumer health business, according to the news service. Sanofi previously announced plans to split during this year's fourth quarter "at the earliest.

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UK manufacturing output expected to improve despite challenges

European Pharmaceutical Review

Based on data from the Confederation of British Industry (CBI)’s latest monthly Industrial Trends Survey on UK manufacturing, expectations for future selling price inflation rose in February, to their strongest since July 2023. Despite this, the survey noted that selling price expectations remained well below the multi-decade high observed in 2022 (+80 percent in March 2022).

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340B Program Preserves, Improves Access to Rural Health Care

MedCity News

To ensure that rural hospitals like ours can continue delivering high-quality, comprehensive health care, the federal government must support and protect the 340B Drug Pricing Program that enables us to do what we do best.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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Behind the breakthrough cancer therapy that just won a historic FDA nod

PharmaVoice

The first-of-its-kind TIL therapy for solid tumors developed by Iovance Biotherapeutics won FDA approval last week.

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Bavarian Nordic Hones Infectious Disease Focus by Dropping Cancer Vaccine R&D

MedCity News

Bavarian Nordic will concentrate on its portfolio and pipeline of infectious diseases vaccines, including top seller Jynneos, approved for mpox and smallpox. The company only had one clinical-stage cancer vaccine program.

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United sues FDA to try to block rival’s drug application

pharmaphorum

United sues FDA for allowing a marketing application for a competitor to its top-seller Tyvaso, filed by Liquidia, that sidesteps established procedures

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Menopause Startup Raises $3.3M in Funding Led By UPMC

MedCity News

Elektra Health, a virtual provider for menopause care, has secured $3.3 million in financing. With the funding, the company is focused on two areas: partnering with more payers and expanding its footprint to provide clinical care to more patients.

Patients 101
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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US, EU regulators start swift reviews of Servier glioma drug

pharmaphorum

FDA and EMA start speedy reviews of Servier’s vorasidenib for IDH-mutated low-grade glioma, hoping to end decades of stagnation in therapies for the brain cancer.

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Will smart tech revolutionise drug delivery for ulcerative colitis patients?

Pharmaceutical Technology

Biora’s new smart pill represents a new treatment modality that may increase the efficacy of therapeutics for ulcerative colitis

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RAPT hit by FDA clinical hold on eczema, asthma drug

pharmaphorum

RAPT Therapeutics shares fell sharply after the FDA placed a clinical hold on oral CCR4 antagonist zelnecirnon in atopic dermatitis and asthma.

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4 biotechs to watch in 2024

PharmaVoice

A splashy IPO, first-in-class treatments and upcoming approval dates are a few reasons we’ve got our eyes on these biotechs this year.

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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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Digital health firms DarioHealth and Twill merge

pharmaphorum

DarioHealth has bought fellow digital health company Twill in a move that combines their chronic disease and mental health platforms.

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FDA Grants Priority Review to Novel Bispecific Antibody for Multiple Myeloma

Pharmaceutical Commerce

Regeneron Pharmaceuticals’ linvoseltamab is currently in clinical development to treat adult patients with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies.

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Elicio’s vaccine shows promise as potential cancer treatment in phase 1 trial

PharmaTimes

Results showed robust responses in patients with pancreatic and colorectal cancer

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Advancing Lipid-Based Formulations and Softgels in Drug Development (Feb 2024)

PharmaTech

Lipid-based formulations (LBFs) are complex mixtures of lipid, surfactant and solvent excipient, where the composition determines the potential impact of dispersion and digestion on drug solubilization. By carefully selecting fill formulations during the early stages of drug development, it is possible to meet the specific requirements for bioavailability and stability for clinical trial and supply.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Researchers launch global iSPY network to research Strep A infections

PharmaTimes

A streptococcal bacterial infections are estimated to affect around 50 million people worldwide

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Calculating the Cost-Effectiveness of Empagliflozin in Patients Experiencing Heart Failure

Pharmaceutical Commerce

A trial set out to determine whether empagliflozin can help prevent hospitalizations and extend life for patients with heart failure, while not hurting the US payers’ pockets.

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Sparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope 

Legacy MEDSearch

Sparrow BioAcoustics recently unveiled its Stethophone TM software, which transforms smartphones into medical-grade stethoscopes. This innovative tool enables users to capture, analyze, and share crucial heart health data with medical professionals from any location. In June 2023, Sparrow received FDA clearance for the downloadable application, making it the first FDA-cleared smartphone stethoscope software-as-a-medical-device (SaMD).

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Regeneron's Linvoseltamab Granted FDA Priority Review for Relapsed/Refractory Multiple Myeloma

PharmExec

The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024.

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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