pharmaphorum

JUNE 14, 2022

Eli Lilly and Incyte’s Olumiant has secured the first FDA approval for a systemic drug to treat alopecia areata, an autoimmune condition causing patchy hair loss that affects more than 700,000 people in the US. The JAK1/2 inhibitor has been cleared for adults who are severely affected with the condition at a dose of 2mg once-daily, which can be stepped up to 4mg/day if needed, and according to the FDA will “help fulfil a significant unmet need for patients.” It is estimated tha

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Labelling FDA Insurance 98

Outsourcing Pharma

JUNE 14, 2022

During BIO International, US leaders shared lessons learned from COVID-19, and how government and industry are collaborating to avoid future supply chain crises.

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pharmaphorum

JUNE 14, 2022

An alliance between Spanish drugmaker Almirall and digital health company Happify has yielded its first fruit, with the launch of their Claro app designed to reduce anxiety and improve wellbeing in people with psoriasis. The web-based app is rolling out first in the UK, Spain and Italy and is aimed at the 20% to 30% of patients with moderate to severe psoriasis who also suffer from mental health issues, according to the partners.

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PharmExec

JUNE 14, 2022

Industry must continue research and development to combat the pandemic.

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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.

Outsourcing Pharma

JUNE 14, 2022

The company has completed its early-phase development and manufacturing facility in Bend, giving it 11 processing suites focused on first steps into the clinic.

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Viseven

JUNE 14, 2022

Once there’s an inquiry about how to improve pharmaceutical sales representatives’ performance, there’s a need to ask a simple question: “What does it mean to be a pharmaceutical representative? What is exactly a pharma rep’s responsibility zone?” Looking for the answer, you may find that the key role of a pharma representative is to deliver the pharma company’s ideas and messages to the health care reps in a most efficient, understandable, and intelligi

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JUNE 14, 2022

Four years after getting the first drug approved by the FDA to treat rare disease hereditary ATTR amyloidosis, Alnylam has got the go-ahead for a second – Amvuttra – which has a simpler, more patient-friendly dosing regimen. ATTR amyloidosis is an aggressive, rapidly progressing, debilitating and fatal disease, and the launch of Alnylam’s earlier Onpattro (patisiran) in 2018 for polyneuropathy associated with the disorder was a massive step forward for patients.

FDA 52

FDA 52

Outsourcing Pharma

JUNE 14, 2022

The newly launched CDMO plans to set up two new manufacturing lines, after expanding into a 5,000-square-meter manufacturing facility.

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PharmExec

JUNE 14, 2022

A roadmap for cohering patient perspectives.

Communication 72

Communication 72

Pharmaceutical Commerce

JUNE 14, 2022

Configurable applications address patient and healthcare-provider interfaces, and an analytics dashboard.

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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.

FDA

Pharma Times

JUNE 14, 2022

Funding will enable the development of Spirea’s pipeline of antibody drug conjugate therapeutics for the treatment of solid tumours

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Pharma Manufacturing

JUNE 14, 2022

Comprehensive strategies to save time and reduce cost in end-to-end clinical development

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Pharma Times

JUNE 14, 2022

The three-year project will focus on molecular representations and computational tools

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Pharmaceutical Commerce

JUNE 14, 2022

Expanded partnership revolves around hemophilia A therapeutics.

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pharmaphorum

JUNE 14, 2022

China’s emergence as an R&D powerhouse means that the country is quickly adding a number of drug candidates to the global pipeline. Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical trials, leading to the FDA rejecting certain treatments and clarifying what is required for approval.

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FDA Vaccines 96

pharmaphorum

JUNE 14, 2022

There’s a growing body of evidence that digital therapeutics (DTx) can complement other therapies for a wide range of health conditions, reducing costs and improving patient engagement, but the sector runs the risk of being held back by a lack of clinical, regulatory and reimbursement standards. A new partnership between the non-profit Digital Therapeutics Alliance (DTA) and digital health innovation organisation Healthware has now been formed to tackle that issue, aiming to bring together

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Patient Care 72