Wed.Jul 06, 2022

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Ofatumumab Shows Long-Term Improvements in Multiple Sclerosis Disease Activity

Pharmacy Times

After 4 years of treatment with ofatumumab, 78.8% of patients with relapsing forms of multiple sclerosis who continuously received ofatumumab achieved NEDA-3 compared to 51.8% of those who switched from teriflunomide to ofatumumab.

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Is biotech facing a long bear market?

Pharmaceutical Technology

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7. Elsewhere, San Diego, California-based Heron Therapeutics announced restructuring and layoffs for 34% of its workforce.

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Daily Medication Pearl: Pravastatin Sodium (Pravachol)

Pharmacy Times

Pravastatin sodium (Pravachol) is indicated as an adjunctive therapy to diet to lower the risk of myocardial infarction, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident congenital heart disease.

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EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

Pharmaceutical Technology

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain. The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive recommendation in

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Sativex Does Not Meet Primary Endpoint on Measures of Spasticity for Multiple Sclerosis

Pharmacy Times

Jazz Pharmaceuticals announced top-line results from the phase 3 RELEASE MSS1 trial, evaluating nabiximols oromucosal spray in individuals with multiple sclerosis.

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FDA to decide on Roche’s lymphoma drug Lunsumio before year-end

pharmaphorum

The FDA has granted a priority review to Roche’s T-cell engager Lunsumio as a treatment for follicular lymphoma (FL), setting up a decision on the drug by 29 December. The first-in-class drug – which targets CD20 and CD3 – is being assessed by the regulator for relapsed or refractory FL, the most common slow-growing form of non-Hodgkin lymphoma (NHL), after two or more prior systemic therapies.

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Are timely access and robust safety mutually exclusive?

pharmaphorum

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety? Cancer patients in Europe wait an average of almost eight months longer for access to breakthrough medications than their American counterparts. A new cross-sectional study has found that the FDA green lit 95% of the 89 new oncology therapies approved between 2010 and 2019 before the EMA, with the Europeans trailing the Americans by a

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Europe is seeing a hiring boom in pharmaceutical industry data analytics roles

Pharmaceutical Technology

Europe was the fastest growing region for data analytics hiring among pharmaceutical industry companies in the three months ending May. The number of roles in Europe made up 11.8% of total data analytics jobs - up from 11.1% in the same quarter last year. That was followed by North America, which saw a -0.4 year-on-year percentage point change in data analytics roles.

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BioNTech bites back after CureVac patent challenge

pharmaphorum

BioNTech has responded to a patent infringement lawsuit filed by fellow German biotech CureVac over its COVID-19 vaccine, saying it will “vigorously” defend itself. CureVac revealed yesterday that had filed suit in the Düsseldorf Regional Court, claiming that mRNA technology used in BioNTech’s Comirnaty vaccine – partnered with Pfizer – infringes its intellectual property.

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FDA Grants Priority Review to Mosunetuzumab for Relapsed or Refractory Follicular Lymphoma

Pharmacy Times

Clinical trial results show durable responses with mosunetuzumab in advanced follicular lymphoma.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Woman of the Week: CinCor Pharmaceutical's Terry Coelho

PharmaVoice

From M&Ms to biotech, the chief financial officer's sweet tooth for taking risks is paying off.

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CureVac files patent lawsuit against BioNTech over mRNA technology

Pharmaceutical Technology

CureVac has filed a patent infringement lawsuit against BioNTech in Germany over intellectual property rights of messenger ribonucleic acid (mRNA) technology. The mRNA technology was used for the development of the Covid-19 vaccine. The lawsuit was filed against BioNTech and two of its subsidiaries in the German Regional Court in Düsseldorf. CureVac sought fair compensation for infringement of a portfolio of its intellectual property rights used to produce and sell BioNTech and Pfizer’s mRNA Cov

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Expert: The Great Migration of Hematology, Oncology Pharmacists Brings a Call to Action for the Field

Pharmacy Times

Zahra Mahmoudjafari, PharmD, BCOP, DPLA; Alison Gulbis, PharmD, BCOP; and Kamakshi Rao, PharmD, BCOP, FASHP, discuss research conducted looking to assess the hematology-oncology pharmacist “great migration” from the field.

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How Big Pharma is prepping for the late 2020s patent cliff

PharmaVoice

Ratings agency Moody’s lays out the risk exposure for industry leaders.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Implications of Legislation Passed in the House That Places Restrictions on FDA Accelerated Approval Pathway for Cancer, Rare Disease Drug Pipeline

Pharmacy Times

Ken Thorpe, PhD, professor of public health at Emory University and chairman of Partnership to Fight Chronic Disease, discusses legislation that the US House of Representatives recently passed to put greater restrictions on the FDA’s accelerated approval pathway.

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Covid-19 induced immune response may damage brain, NINDS study finds

Pharmaceutical Technology

Scientists at the National Institutes of Health (NIH) unit National Institute of Neurological Disorders and Stroke (NINDS) have found that Covid-19-induced immune response could damage the blood vessels of the brain and may lead to short and long-term neurological symptoms. . NINDS team analysed changes in the brain of nine individuals who died following Covid-19 infection.

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Gilead Resubmits NDA for Lenacapavir, Updates Based on FDA Complete Response Letter

Pharmacy Times

Lenacapavir is an investigational, long-acting HIV-1 capsid inhibitor that is not yet approved by any regulatory authority.

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Big data hiring levels in the pharmaceutical industry rose in June 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for big data related positions rose in June 2022 compared with the equivalent month last year, with 68.4% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 65.7% of companies who were hiring for big data related jobs a year ago and the same as the figure of 68.4% in May 2022.

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Evaluating Patients and Novel Agents for AML Maintenance Therapy

Pharmacy Times

Dr James McCloskey discusses patient selection for AML maintenance therapy, as well as novel agents that are being evaluated in this setting.

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Is biotech facing a long bear market?

Pharmaceutical Technology

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7. Elsewhere, San Diego, California-based Heron Therapeutics announced restructuring and layoffs for 34% of its workforce.

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Eli Lilly gets speedy NICE recommendation for breast cancer treatment

Outsourcing Pharma

England's cost-effectiveness watchdog has recommended Eli Lillyâs Verzenios treatment as an option for adjuvant treatment of certain forms of breast cancer.

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Boehringer takes on antimicrobial resistance with Evotec, bioMérieux JV

pharmaphorum

A Franco-German joint venture company – Aurobac Therapeutics – has been formed to try to tackle the rising threat of antimicrobial resistant (AMR) infections. The JV has been formed German pharma companies Boehringer Ingelheim and Evotec with in vitro diagnostics specialist bioMérieux, with the objective of developing new antimicrobial drugs backed by diagnostics to quickly identify pathogens and their resistance patterns and guide treatment.

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Manage Adverse Effects Associated With Navitoclax in Patients With Myelofibrosis

Pharmacy Times

Thrombocytopenia was the most common adverse effect, which was managed through dose reduction.

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Big three distributors claim win in $2.5bn WV opioid case

pharmaphorum

A court in West Virginia has ruled that US drug distributors McKesson, AmerisourceBergen and Cardinal Health are not responsible for fuelling the opioid crisis that has claimed thousands of lives in the state. District court judge David Faber rejected a call by prosecutors to force the distributors to pay $2.5 billion to fund an abatement plan to tackle an epidemic of deaths in Huntington and Cabell County – the hardest hit areas of the state – by shipping millions of opioid pills there.

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A Care Team’s Individual Roles When Treating AML

Pharmacy Times

The panel describes the various roles and responsibilities for each member of an AML management care team.

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Mental Effects of Stress: Learning to Relax in the Face of Everyday Stress

Compounding Pharmacy of America

Stress is a very normal part of everyday life, and in some respects, it is necessary for our survival. However, any life event that pushes you to experience worry, fear, or uncertainty for prolonged periods can have negative impacts on your mental and physical health. The post Mental Effects of Stress: Learning to Relax in the Face of Everyday Stress appeared first on The Compounding Pharmacy of America.

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Medical Solutions Acquires North Carolina-Based Matchwell

Aureus Medical Group

Omaha, Neb., July 6, 2022 — Medical Solutions, one of the nation’s largest providers of total workforce solutions serving the healthcare industry, today announced that it has acquired Durham, NC-based Matchwell. Terms of the deal were not disclosed. Launched in 2019, Matchwell’s AI enabled marketplace and SaaS solution efficiently matches licensed and certified staff with healthcare organizations across a variety of clinical settings ranging from hospitals to skilled and assisted living fa

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Analytics, A Game-Changer for Mid-Market Private Equity firms

Fuld

Private Equity (PE) firms primarily focus on these three parameters. First, to understand the target firm’s true worth through the due diligence process; second, to find sustainable systems to drive significant value creation post-investment; and third, to find the right time and suitable structure for an exit. A PE firm’s success can only be measured by the opportunities it uncovers and how it gets ahead of challenges in managing the firm.

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Business optimism improves in June 2022: Poll

Pharmaceutical Technology

Business optimism improved in June 2022 compared to May 2022, even amid concerns over rising costs and slowing demand, revealed an analysis of an ongoing poll by Verdict. Verdict has been conducting the poll to study the trends in business optimism during COVID-19 as reflected by the views of companies on their future growth prospects amid the pandemic.

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Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan

pharmaphorum

The FDA has started an accelerated review of Eisai and Biogen’s a new amyloid-targeting antibody lecanemab for Alzheimer’s disease, with a 6 January deadline that keep them ahead of closest rival Eli Lilly. The US regulator has been reviewing lecanemab as a treatment for patients with early-stage Alzheimer’s and amyloid plaques in the brain under a rolling biologics license application which completed in May.

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ParcelShield® Announces Agreement With Walmart Specialty Pharmacy to Expand Services

Pharmacy Times

Intelligent Parcel Tracking & Planning Solution and Ensure Patient Medications Arrive On-Time.

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Decentralized clinical trial transformations are ‘here to stay’: ICON

Outsourcing Pharma

In this first of a two-part series, an expert discusses various factors behind the DCT formatâs rapid rise and likely longevity in the drug development arena.

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Q&A With Chris Round, president, EMD Serono

PharmExec

Round discusses how he adjusted his leadership style and approach to patient care in the most effective way during the pandemic.

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Indiana University Health enlists LifeOmic platform for cancer research

Outsourcing Pharma

The academic research center has adopted the life science technology companyâs cloud-based platform for cancer research, drug discovery, and clinical trials.

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