Wed.Feb 16, 2022

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AZ’s lupus drug Saphnelo cleared in EU, challenging GSK’s Benlysta

pharmaphorum

AstraZeneca’s Saphnelo has become the first new drug to be approved to treat the autoimmune disease systemic lupus erythematosus (SLE) in the EU for more than 10 years. The European Commission has cleared the type I interferon receptor antagonist antibody as an add-on therapy to standard treatment for adults with moderate to severe SLE, four years after a miss in a phase 3 trial put the future of the drug in doubt.

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The history of pharmaceutical microbiology

Pharmig

Everyone wants to know where they come from, and microbiologists are no different. But were we grown in a petri dish. The post The history of pharmaceutical microbiology appeared first on Pharmig.

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Stem cell therapy ‘cures’ first woman with HIV, say researchers

pharmaphorum

A woman with HIV who received a stem cell transplant to treat acute myeloid leukaemia (AML) appears to have been cured of the infection according to US researchers. The case study described at the Conference on Retroviruses and Opportunistic Infections (CROI) this week involved a mixed-race woman who had been on antiretroviral therapy (ART) for four years before being diagnosed with AML.

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Putting user-needs at the heart of a multi-agency advisory service for artificial intelligence and data-driven technologies

NICE

NICE is working in partnership with the Care Quality Commission, Health Research Authority and Medicines and Healthcare products Regulatory Agency to deliver a multi-agency advisory service (MAAS) for developers and adopters of data-driven technologies, such as artificial intelligence (AI). This innovative new cross-regulatory service will provide support on the regulation and evaluation of AI technologies in health and care.

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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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Navigating Psychedelics and Psychotropics

The Spirit Pharmacist

Bridging the Gap: Navigating Psychotropics and Psychedelics. As psychedelics therapies rapidly emerge as treatments for mental health conditions, many are interested in use. However, some psychotropic medications can interfere with benefits or increase risks. Sometimes these interactions are significant enough to warrant taper and discontinuation, whereas sometimes they aren't.

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Equillium triples clinical pipeline with $329m Bioniz takeover

pharmaphorum

Equillium has announced another bolt-on deal to expand its pipeline tripling the size of its clinical pipeline to three drug candidates via a $329 million agreement to acquire Bioniz Therapeutics. The La Jolla, California-based biotech licensed its first drug – itolizumab for graft-versus-host disease (GvHD), asthma and lupus nephritis – from Indian drugmaker Biocon in 2017.

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Performance-io hires Lonneke Feskens to lead Europe

pharmaphorum

As the pharma market sharpens its online performance competencies the ‘go to’ agency performance-io expands its Global offices and hires Lonneke Feskens to lead Europe: London, 11th Jan 2022 : performance-io (PIO), Pharma’s first specialist online performance marketing and digital benchmarking agency has appointed Lonneke Feskens as its VP Global Client Relations & Head of Europe, a role that will see her lead the agency’s expansion of European offices.

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New medicine for patients with systemic lupus erythematosus

Pharma Times

Saphnelo is the first therapy in over a decade for patients with moderate to severe systemic lupus erythematosus

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Four ways emerging pharma companies can launch and scale content faster

pharmaphorum

An unexpected benefit of healthcare professional (HCP) engagement going digital in 2020 is that sales teams have more opportunities to spend quality time with doctors. Compared to traditional, face-to-face meetings, virtual meetings extended the amount of time HCPs were able to spend meeting with reps from an average of three minutes to 19 minutes. While the chance to engage in more meaningful conversations with doctors is a positive step for sales teams, marketers are under significant pressure

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Alexion and UK patient advocacy groups launch video campaign

Pharma Times

Rare Disease Day has inspired a pioneering video to support patients living with rare conditions

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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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Shift in the trend of Container closure integrity testing

Roots Analysis

In earlier times, container closure integrity testing was not regarded as an essential step in the process of manufacturing. The company developing drug product through such an intense process, use to consider container closure system only for packaging of the product. [1] However, gradually it was realized that container closure integrity is a key factor that maintains product stability and sterility throughout its shelf life.

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Thread, Eversana join forces on real-world data platform

pharmaphorum

Eversana’s expansion into real-world data (RWD) handling has gathered pace via an alliance with Thread, a specialist in decentralised clinical trials and electronic clinical outcome assessments (eCOAs). The two companies have collaborated to launch a new digital platform that promises to make clinical studies “more efficient, comprehensive and inclusive” – building in RWD from the ground up – and provide researchers “with a totality of evidence to inform their research,&#

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How do UK market access prospects look in 2022?

pharmaphorum

Leela Barham and Neil Grubert look back at what was expected for market access in 2021 and look ahead at what 2022 could hold. Will all the efforts to speed up market access and ensure that the UK remains attractive to the life sciences industry post-Brexit pay off in 2022? MHRA gave first Project Orbis approvals in 2021 followed by mixed success for access deals.