Sat.Sep 10, 2022 - Fri.Sep 16, 2022

Increasing trial participation for new cancer treatments

Elsevier

Thanks to new and innovative treatments, cancer survival rates continue to improve dramatically – and this will likely only accelerate in the future.

Bluebird wins FDA approval of gene therapy for rare brain disorder

Bio Pharma Dive

The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million

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Trending Sources

Is Apple that naive when it comes to compliance?

World of DTC Marketing

Apple’s Health app gets new capabilities with iOS 16. The Health app adds Medications, allowing users to conveniently build and manage a medications list, create schedules and reminders, and track their medications, vitamins, or supplements. Will it matter?

Novo Nordisk partners with Microsoft for AI-driven drug discovery

Pharmaceutical Technology

Novo Nordisk has signed a new strategic partnership with Microsoft to expedite the discovery and development of drugs leveraging big data and artificial intelligence (AI).

2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

The future of AI drug discovery & development in immunology and GPCR research

Pharma Phorum

Alphabet subsidiary and precision health company Verily recently announced a breakthrough in its AI drug discovery GPCR research collaboration with Sosei Heptares.

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FDA, NIH initiative aims to speed development of drugs for ALS, other brain diseases

Bio Pharma Dive

The public-private partnership plans to bring together scientific experts, private entities and patient groups to better understand certain neurodegenerative disorders and find new treatments

More Trending

Gilead’s Veklury receives WHO recommendation to treat severe Covid-19

Pharmaceutical Technology

Gilead Sciences has received expanded recommendation under the World Health Organization’s (WHO) Therapeutics and COVID-19: living guideline for the use of Veklury (remdesivir) to treat severe Covid-19 patients.

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Mucosal antibodies in the airways protect against omicron infection

The Pharma Data

High Situations of mucosal antibodies in the airways reduce the threat of being infected by omicron, but numerous don’t admit sensible antibodies in the airways despite three boluses of the SARS- CoV- 2 vaccine.

Third Harmonic boosts biotech with sector’s top IPO in four months

Bio Pharma Dive

The startup’s $185 million initial public offering is the largest for the sector since early May and potentially a sign of renewed investor interest in young biotechs

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Pfizer hit with racial discrimination lawsuit over minority fellowship program

Fierce Pharma

Pfizer hit with racial discrimination lawsuit over minority fellowship program. zbecker. Fri, 09/16/2022 - 11:21

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

FDA and NIH partner for neurodegenerative disease treatment development

Pharmaceutical Technology

The US Food and Drug Administration (FDA) and the US National Institutes of Health (NIH) have unveiled a public-private partnership (PPP) to understand and develop treatments for neurodegenerative diseases.

Novo Nordisk teams up with Microsoft for faster and scaled use of AI in drug discovery

BioPharma Reporter

Novo Nordisk and Microsoft have entered a new strategic collaboration to combine Microsoftâs computational services, cloud, and artificial intelligence (AI) with Novo Nordiskâs drug discovery, development, and data science capabilities. Bio Developments

Drugs 101

AstraZeneca claims positive results for its “add-on” drug for rare blood disease

Bio Pharma Dive

The drug, meant to complement other treatments for paroxysmal nocturnal hemoglobinuria, comes via Alexion, which had acquired it from Achillion in 2019

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AbbVie and BMS slash 360 jobs in California, the latest in a streak of biopharma layoffs

Fierce Pharma

AbbVie and BMS slash 360 jobs in California, the latest in a streak of biopharma layoffs. fkansteiner. Fri, 09/16/2022 - 13:34

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Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

Top biopharmaceutical Covid-19 vaccine companies boosted with over 80% revenue growth

Pharmaceutical Technology

Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines.

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WHO Expands Recommendation for Veklury® (Remdesivir) to Patients With Severe Disease in Latest Update to COVID-19 Guideline

The Pharma Data

— Veklury is Now Recommended by the WHO for Use in Both Non-Severe COVID-19 Patients at the Highest Risk of Hospitalization and Patients with Severe COVID-19 — Gilead lores,Inc.(

Alnylam, Regeneron to advance NASH drug after early signs of potential

Bio Pharma Dive

A gene discovery four years ago led to a partnership between the companies, which plan to start a Phase 2 study later this year after encouraging early data

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Sanofi, AZ's blockbuster hopeful RSV med nears first approval as showdown with Pfizer, GSK looms

Fierce Pharma

Sanofi, AZ's blockbuster hopeful RSV med nears first approval as showdown with Pfizer, GSK looms. fkansteiner. Fri, 09/16/2022 - 09:36

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ESMO 2022: the evolution of TIL therapy – a highly promising approach

Pharmaceutical Technology

Tumour-infiltrating lymphocyte (TIL) therapy has been investigated as a treatment modality for melanoma for almost 20 years.

Novartis probed by Swiss authorities over ‘unlawful’ patent use

Pharma Phorum

The competition authorities in Switzerland said this morning they have carried out a raid on a pharma company – now confirmed to be Novartis – as part of an investigation into a “possible unlawful use of a patent to reduce competitive pressure.”

Intellia offers first look at CRISPR drug for rare swelling disorder

Bio Pharma Dive

Preliminary study results show the biotech’s gene editing treatment could reduce markers and symptoms of hereditary angioedema, though the data come from few patients and follow-up remains limited

Gilead Foundation Awards $20 Million to Organizations Working to Advance Health Through Education Equity

The Pharma Data

Gilead lores,Inc.( Nasdaq GILD) moment blazoned that the Gilead Foundation’s Creating Possible Fund ™ will give a aggregate of$ 20 million to 13 initial succeeders.

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US FDA grants approval for BMS’ Sotyktu to treat plaque psoriasis

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb ’s (BMS) Sotyktu (deucravacitinib) to treat adult patients with moderate-to-severe plaque psoriasis. The oral treatment is indicated for such patients who are candidates for systemic therapy or phototherapy.

EU ignores information request in probe over massive Pfizer COVID-19 vaccine order

Fierce Pharma

EU ignores information request in probe over massive Pfizer COVID-19 vaccine order. fkansteiner. Wed, 09/14/2022 - 11:01

Acelyrin sets hopes high for arthritis drug with $300M fundraise

Bio Pharma Dive

The well-funded startup is planning Phase 3 trials for a drug it claims could be superior to top-selling medicines from Novartis and others

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Malaria booster vaccine shows durable high efficacy in African children, meeting WHO-specified 75% efficacy goal

The Pharma Data

Rare Disease Spotlight II – Tracking Orphan Drugs Across Therapy Areas

Pharmaceutical Technology

Rare diseases affect only a small percentage of the population, and since their pathophysiology has historically been poorly studied, there is an acute scarcity of available treatments.

Hemophilia gene therapies from BioMarin, CSL pick up an early ICER endorsement

Fierce Pharma

Hemophilia gene therapies from BioMarin, CSL pick up an early ICER endorsement. kdunleavy. Wed, 09/14/2022 - 11:07

Bristol Myers gets FDA approval for new type of psoriasis drug

Bio Pharma Dive

Sotyktu has been on the pharma’s top pipeline candidates and its clearance continues a string of positive regulatory news for the company

New ARASENS data reinforce strong tolerability profile of darolutamide plus ADT and docetaxel without compromising quality of life for patients with mHSPC

The Pharma Data

Consistent benefits were also seen in other patient-relevant endpoints, including all-cause and prostate cancer-related death and cumulative incidence of adverse events (AEs) of special interest.

President Biden Issues Executive Order to Boost Federal Investment in Domestic Biotechnology and Biomanufacturing

The FDA Law Blog

By Holly N. Brevig, Senior Regulatory Device and Biologics Exper — Earlier this week, President Biden signed Executive Order 14081, titled “ Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.”

Mallinckrodt scores long-awaited FDA nod to treat life-threatening liver condition

Fierce Pharma

Mallinckrodt scores long-awaited FDA nod to treat life-threatening liver condition. kdunleavy. Thu, 09/15/2022 - 09:39

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Pfizer brings mRNA flu vaccine into Phase 3 testing

Bio Pharma Dive

The trial, expected to enroll 25,000 adults, is the second late-stage test of an mRNA flu shot to begin this year, following the June start of a Moderna study

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Novo Nordisk and Microsoft collaborate to accelerate drug discovery and development using big data and artificial intelligence

The Pharma Data

Novo Nordisk and Microsoft unite to accelerate medicine discovery and development using big data and artificial intelligence.