Tue.Jun 28, 2022

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New Clinical Data for Bivalent COVID-19 Booster Candidate Shows Potent Response Against Omicron Variant

Pharmacy Times

At 1 month, a 50-µg booster dose of mRNA-1273.214 had a potent neutralizing antibody response against the Omicron variants in all individuals, regardless of prior infection.

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Astellas and Sutro partner to develop immunostimulatory ADCs

Pharmaceutical Technology

Astellas Pharma and Sutro Biopharma have entered a global, strategic partnership and licencing agreement to discover and develop new immunostimulatory antibody-drug conjugates (iADCs). An iADC merges an antibody with a small molecule compound that elicits immunogenic cell death, and an immune-activating molecule. It can potentially enhance the anti-cancer effect.

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Research Continues Around COVID-19 Vaccinations and Pregnancy

Pharmacy Times

Infection in pregnancy increases the risk for preterm delivery and other adverse pregnancy outcomes, including stillbirth.

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Astellas pumps $90m into Sutro immuno-oncology alliance

pharmaphorum

Astellas has agreed a $1.36 billion partnership with US biotech Sutro Biopharma for a series of antibody-drug conjugates for cancer, focusing on applications in patients who don’t respond to current immunotherapies. The alliance includes an upfront payment of $90 million, backed by $422.5 million in possible milestone payments apiece for up to three development programmes based on Sutro’s immunostimulatory antibody-drug conjugate (iADC) technology.

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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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FDA Approves ANI’s Abbreviated New Drug Application for Generic Tranxene

Pharmacy Times

Clorazepate dipotassium tablets are for the management of anxiety disorders or for the short-term relief of symptoms.

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Overcoming Supply Chain Crises with Digitization

Pharmaceutical Commerce

Amy Shortman outlines some ways visibility technology is solving problems at a time when it’s needed most, and how digitization is the key to overcoming supply chain crises.

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Intelligent eCOA use enhances trials, amplifies patient voice: Medable

Outsourcing Pharma

An expert from the decentralized trial solutions company shares how eCOA and ePRO can be useful tools that improve the collection and quality of such data.

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Vyepti Shows Positive Results in the Treatment of Migraine

Pharmacy Times

Investigators studied the efficacy and safety of eptinezumab-jjmr in the 100 mg and 300 mg intravenous infusion dosages in individuals with 2 to 4 documented unsuccessful prior preventive treatment failures for migraine in the past 10 years.

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Continuous treatment with Kesimpta sees RMS patients achieving NEDA-3

European Pharmaceutical Review

New data reveals that more relapsing multiple sclerosis (RMS) patients continuously treated with Kesimpta ® (ofatumumab) had no evidence of disease activity (NEDA) versus switching from teriflunomide. 1. The Phase III Asclepios I/II trials and the Alithios open-label extension from Novartis , showed that earlier initiation with Kesimpta resulted in a more than three-fold increased likelihood of maintaining NEDA-3 throughout the study.

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Clincial Overview: Olopatadine Extra Strength for Treating Ocular Itching Due to Allergic Conjunctivitis

Pharmacy Times

Olopatadine stabilizes ocular mast cells to prevent histamine release by allergens.

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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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With abortion access restricted across the U.S., a new diagnostic aims to eliminate birth control's pain points

PharmaVoice

The hormonal and genetic test developed by Adyn is designed to predict and prevent adverse birth control side effects.

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Rx Product News: June 2022

Pharmacy Times

This month features Ozempic, Igalmi, and Triumeq PD.

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The challenge of handling highly potent API and ADCs in analytical chemistry

European Pharmaceutical Review

HIGHLY POTENT active pharmaceutical ingredients (HPAPIs) products are classified based on their toxicity through occupational exposure limits (OELs). These molecules are proven to be effective at much smaller dosage levels than traditional APIs. Some examples of HPAPIs are cytotoxic compounds and hormones such as oestrogen. What defines ‘high potency’?

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Key Comorbidity Considerations for Patients With MCL

Pharmacy Times

Ryan Haumschild, PharmD, MS, MBA, leads a discussion regarding the treatment of relapsed/refractory mantle cell lymphoma in the presence of comorbidities.

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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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Guide to Data Integrity

European Pharmaceutical Review

The post Guide to Data Integrity appeared first on European Pharmaceutical Review.

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Novartis offers $17.7m support in the fight for health equity

Outsourcing Pharma

The pharmaceutical company is expanding its alliance with historically Black medical schools to bolster the battle against systemic health disparities.

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EMA CHMP recommends AstraZeneca-Merck’s Lynparza for breast cancer

Pharmaceutical Technology

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting approval for AstraZeneca and Merck’s (MSD outside the US and Canada) Lynparza (olaparib) as adjuvant therapy for high-risk early breast cancer patients. The treatment is intended for breast cancer patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative who have previously received neoadjuvant or adjuvant chemotherapy.

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One of the Largest Specialty, Home Delivery Pharmacies Has New Look, Name

Pharmacy Times

Walgreens announced full ownership of AllianceRx Walgreens Prime in January, necessitating the name change to AllianceRx Walgreens Pharmacy.

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Rensselaer team receives NIAID grant to develop antiviral drug for Covid-19

Pharmaceutical Technology

Researchers at the Rensselaer Polytechnic Institute in the US have received a five-year, $3.5m grant from the National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) for developing a Covid-19 oral antiviral drug. The antiviral will be a low-dose drug which can be taken in the at-home setting. The latest research is part of the consortium of a new antiviral drug development centre named Center for Antiviral Medicines and Pandemic Preparedness (CAMPP)

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Addressing Unmet Needs in The Relapse/Refractory Setting

Pharmacy Times

Preetesh Jain, MBBS, MD, DM, PhD, offers perspective on unmet needs in treatment of patients with relapsed/refractory mantle cell lymphoma.

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The oncology market is surging despite a decline in routine screenings

PharmaVoice

A new report from IQVIA reveals the current challenges — and promise — in cancer drug R&D.

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Daily OTC Pearl: Nerve Pain Organic Plant Medicine

Pharmacy Times

Dual action for neuropathy and neuralgia pain relief as well as for use in diabetes-related nerve pain and shingles.

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Optimizing the digitization of tech transfer and scale-up for Pharma 4.0

Pharma Manufacturing

Advanced digital thread and technology transfer capabilities can help pharma reap the benefits of its processes

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Alex’s interview with Mike Koelzer from The Business of Pharmacy

The Happy PharmD

Focused During Adversity – Alex Barker, PharmD. Exposing my secret and overcoming my adversities over the last year. I’ve been keeping a secret from you over the past year as I’ve struggled with family members’ health and my own mental health. Listen to the full episode at the link below: [link]. In this interview with Mike Koelzer from The Business of Pharmacy , I finally talk about exactly what I’ve been going through.

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Filings buzz in pharmaceuticals: 22% decrease in robotics mentions in Q1 of 2022

Pharmaceutical Technology

Mentions of robotics within the filings of companies in the pharmaceutical industry fell 22% between the final quarter of 2021 and the first quarter of 2022. In total, the frequency of sentences related to robotics between April 2021 and March 2022 was as frequent as in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings.

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Basilea preps key US filing for MRSA antibiotic ceftobiprole

pharmaphorum

Basilea Pharmaceutica may finally be able to bring its antibiotic ceftobiprole to the US market – 13 years after its first attempt was turned down – thanks to a new phase 3 clinical trial. The intravenously-administered cephalosporin drug met its objectives in the ERADICATE study in adults with bacterial bloodstream infections caused by Staphylococcus aureus (SAB), setting up an FDA filing before the end of the year, said the Swiss pharma.

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Gates Foundation to fund pediatric brain research in low-income areas

Outsourcing Pharma

The Bill and Melinda Gates Foundation grant, awarded to data management platform Flywheel, will support pediatric brain development in impoverished areas.

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Celebrations for ASMD community as EU clears Sanofi’s Xenpozyme

pharmaphorum

Sanofi has claimed approval in the EU for Xenpozyme as a treatment for acid sphingomyelinase deficiency (ASMD) – which becomes the first and only treatment option for patients with the rare disease. The European Commission has cleared Xenpozyme (olipudase alfa) for non-central nervous system symptoms in children and adults with types A/B and B ASMD, which is also known as Niemann-Pick disease.

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Daily Medication Pearl: Levetiracetam (Keppra)

Pharmacy Times

Levetiracetam is an anticonvulsant used to treat epileptic seizures.

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Register for the Oligonucleotide Therapeutics and Delivery Conference

pharmaphorum

SAE Media Group is delighted to announce the 2nd Annual Conference Oligonucleotide Therapeutics & Delivery, taking place on the 21st and 22nd September 2022 in London, UK. The 2022 Conference theme is on the latest advances in oligonucleotide discovery and delivery. Chairs for the conference are industry expert Ekkehard Leberer, Senior Consultant, Elbiocon, and Jim Weterings, Principal Scientist, AstraZeneca.

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ACMA To Offer Board Certification Program for Biologics and Biosimilars

PharmExec

Board Certified Biologics and Biosimilars Specialist (BCBBS) program will launch in 2022.

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Preventing the next pandemic: Learning the lessons

pharmaphorum

In the first of a three part series, Ben Hargreaves looks at what the odds are of another pandemic arising in our lifetimes and what can be done to lower the risk of this happening again. The current pandemic is still very much underway. The question is, as one study was recently entitled , whether the current phase brings the world closer to the end of the pandemic or just to the end of the first phase?

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People Spotlight — June 2022

Pharmaceutical Commerce

The latest people news happenings over the past month.

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Sanofi extends Health2Sync digital diabetes partnership to Japan

pharmaphorum

Digital health company Health2Sync will work with Sanofi on digitising its range of insulin products in Japan, extending an earlier alliance in other markets. Health2Sync provides patient management software for doctors and mobile app for patients that is designed to help them improve blood glucose control by encouraging adherence – for example by logging insulin doses – and provides advice on managing symptoms and potential side effects of therapy.