Sat.Mar 04, 2023 - Fri.Mar 10, 2023

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Dawn of a new indication: how to study drugs for aging 

Pharmaceutical Technology

For a long time, aging biology and research have been enigmatic areas that biotechs hoped to capitalise on due to their market potential.

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J&J-backed startup launches with $100M to build better brain drugs

Bio Pharma Dive

Rapport Therapeutics aims to find new so-called receptor-associated proteins that could serve as targets for neurological disease medicines. Its most advanced drug is already in early-stage human testing

Protein 362
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QMSR Harmonization Curiously Missing from Spring 2023 Regulatory Agenda

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert — A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. Part 820 with a newly named Quality Management System Regulation (QMSR) (see here ).

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Moderna opts for Oxfordshire in quest for innovation

Pharma Times

Vaccines developed at the facility will cover a wide range of respiratory diseases

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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

This webinar will go over the FDA's guidance on pharmacological and toxicological considerations for optimizing doses for prescription drugs.

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New facility boosts UK’s cell and gene therapy manufacturing capacity

Pharmaceutical Technology

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies.

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GPCR-targeting drugs: A renewed focus on a ubiquitous group of proteins

Bio Pharma Dive

As many as a third of FDA-approved drugs target GPCRs in some fashion, with uses ranging from treating cancer to pain. But biotech startups say there is still room to develop more

Protein 360

More Trending

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New laboratory space for MSD at The Francis Crick Institute

Pharma Times

Move represents the latest phase of preparation for the opening of MSD’s new UK Discovery Centre

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Eli Lilly places price cap of $35 on out-of-pocket insulin cost

Pharmaceutical Technology

Eli Lilly has announced that it will reduce the price of its most commonly used insulin, Humalog, in the US, by 70% and cap the out-of-pocket cost for those on commercial insurance at $35.

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Lilly reaches end of the road with long-studied Alzheimer’s drug

Bio Pharma Dive

Prior trial failures hadn’t halted testing of solanezumab, once Lilly’s top Alzheimer’s drug candidate. But its final study defeat may help scientists better understand how to target the brain disease

Scientist 303
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FDA calls expert hearing for Intercept’s high-profile NASH application for Ocaliva

Fierce Pharma

FDA calls expert hearing for Intercept’s high-profile NASH application for Ocaliva aliu Fri, 03/10/2023 - 10:49

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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.

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Protalix and Chiesi gain positive opinion for pegunigalsidase alfa

Pharma Times

The therapy becomes the first pegylated enzyme for the treatment of adult patients with Fabry disease

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Teijin Pharma and Novartis sign licence deal for kidney disease candidate

Pharmaceutical Technology

Teijin Pharma and Novartis have signed an exclusive global licence agreement for an investigational preclinical small molecule candidate for proteinuric kidney diseases.

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AstraZeneca builds on study successes in early lung cancer

Bio Pharma Dive

The pharma’s drug Tagrisso extended survival in a trial that stirred debate at ASCO three years ago, while its immunotherapy Imfinzi reduced the risk of relapse in a different study

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Bucking FDA, independent panel backs Roche's lucrative lymphoma expansion bid for Polivy

Fierce Pharma

Bucking FDA, independent panel backs Roche's lucrative lymphoma expansion bid for Polivy aliu Thu, 03/09/2023 - 17:22

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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.

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AstraZeneca’s IMFINZI improves lung cancer survival

Pharma Times

Positive results emerge from AEGEAN phase 3 trial for patients with resectable non-small cell lung cancer

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Incannex partners with Catalent to manufacture psilocybin

Pharmaceutical Technology

Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use.

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Merck drug data suggest ‘new direction’ for rare blood vessel disease

Bio Pharma Dive

Treatment with Merck’s sotatercept helped improve the exercise capacity of patients with pulmonary arterial hypertension, anticipated results from a Phase 3 study showed

Drugs 297
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Moderna Eyes Accelerated Approval for mRNA Cancer Vaccine

BioSpace

Moderna Eyes Accelerated Approval for mRNA Cancer Vaccine 3/7/2023

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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.

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FlyPharma Europe, Vienna – 2023 conference officially launched

Pharma Times

FlyPharma Europe chose Vienna for its latest conference due to the growing presence of Austrian biotechnology and pharmaceutical manufacturing

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US FDA approves Pfizer’s migraine nasal spray Zavzpret

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Pfizer ’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura.

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Adaptimmune acquires struggling cell therapy rival following layoffs

Bio Pharma Dive

The planned merger between Adaptimmune and TCR2 will extend their cash runway by two years, as a biotech downturn continues to pressure companies

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Will the FDA investigate GSK over Zantac? DeLauro wants to know

Fierce Pharma

Will the FDA investigate GSK over Zantac? DeLauro wants to know kdunleavy Tue, 03/07/2023 - 14:54

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Cancer Research UK reach agreement with UCB

Pharma Times

The partnership will concentrate on the development of two investigational antibodies

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Cell One and CBM partner for cell and gene therapies

Pharmaceutical Technology

Cell One Partners has announced a strategic collaboration with the Center for Breakthrough Medicines (CBM) to expedite the development and commercialisation of cell and gene therapies.

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Controversial drug for preterm birth to be withdrawn, maker says

Bio Pharma Dive

The decision by Covis Pharma closes a yearslong battle over continued use of Makena, the only treatment available for prevention of early labor

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'The Top Line': Why pharma needs to ramp up its use of AI and machine learning, plus this week's headlines

Fierce Pharma

The Top Line': Why pharma needs to ramp up its use of AI and machine learning, plus this week's headlines tcarey Thu, 03/09/2023 - 15:25

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Novo Nordisk weight-loss drug available across NHS

Pharma Times

NICE has recommended the use of semaglutide alongside a reduced-calorie diet and exercise

Drugs 105
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CNM-Au8 could address vision problems in multiple sclerosis

Pharmaceutical Technology

Clene has presented updated trial results for its Visionary MS Phase II clinical trial for its lead pipeline candidate, CNM-Au8. The trial is investigating CNM-Au8 as a treatment for patients with relapsing forms of multiple sclerosis (MS) with chronic optic neuropathy.

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Voyager licenses gene therapy tools to Novartis

Bio Pharma Dive

The Swiss drugmaker's decision is the latest in a string of partnership announcements for the gene therapy maker, which aims to bounce back from past research failures

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Acadia Awaits Potential Approval of First Rett Syndrome Medicine

BioSpace

Acadia Awaits Potential Approval of First Rett Syndrome Medicine 3/10/2023

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SkinBioTherapeutics’ AxisBiotix-Ps gains approval

Pharma Times

Company’s skin health product poised for vital European market launch following success in the UK

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Danaher and University of Pennsylvania partner for cell therapies

Pharmaceutical Technology

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake.

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BioMarin, as expected, sees delay to FDA review of hemophilia gene therapy

Bio Pharma Dive

The agency is considering three-year follow-up data in its review of Roctavian, pushing back the potential U.S. arrival of BioMarin’s drug once again