Fri.Jan 20, 2023

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FDA rejects Lilly Alzheimer’s drug, citing insufficient data

Bio Pharma Dive

The drugmaker had sought an accelerated approval based on promising data from a small mid-stage trial. Results from a larger study are due in the second quarter

Trials 264
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The impact of climate change on the pharma supply chain

Pharmaceutical Technology

Pharmaceutical supply chains are extremely vulnerable to the effects of climate change and face many challenges from sourcing to distribution.

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Why Wall Street shrugged at Lilly’s Alzheimer’s setback

Bio Pharma Dive

Analysts argue the FDA’s choice to decline accelerated approval for donanemab, while surprising, is not the main factor that will determine whether it eventually becomes a commercial success

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Moderna takes aim at global expansion plans with manufacturing ramp-up

Pharmaceutical Technology

This week, at the World Economic Forum Annual Meeting, Moderna CEO Stéphane Bancel, said the company plans to build on its exponential growth through the pandemic by expanding its operations globally over the next few years.

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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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FDA lifts hold on Astellas gene therapy for Pompe disease

Bio Pharma Dive

The regulator’s decision ends a seven-month study pause that followed a report of one participant experiencing mild symptoms of peripheral neuropathy

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Overcoming challenges with scalability in biopharma manufacturing

Pharmaceutical Technology

The demand for mAbs is increasing as they offer patients targeted treatments for a wide range of serious health conditions and diseases.

More Trending

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BeiGene’s Brukinsa receives UK marketing authorisations to treat cancers

Pharmaceutical Technology

BeiGene has received marketing authorisations for Brukinsa (zanubrutinib) in Great Britain from the Medicines and Healthcare products Regulatory Agency (MHRA) to treat chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL).

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NICE recommends PTC Therapeutics’ Translarna reimbursement

Pharma Times

The NICE recommendation followed data from clinical trials and real-world evidence

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Study finds potential association between ROBO2 and anthracycline-related cardiomyopathy

Pharmaceutical Technology

A genome-wide association study (GWAS) published in the Journal of Clinical Oncology has identified a potential association between a genetic variant and anthracycline-related cardiomyopathy in childhood cancer survivors.

Genetics 130
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Ipsen's Onivyde proves its worth in aggressive pancreatic cancer

Fierce Pharma

Ipsen's Onivyde proves its worth in aggressive pancreatic cancer zbecker Fri, 01/20/2023 - 10:48

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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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NICE recommends Takeda’s Ninlaro triplet regimen

Pharma Times

Therapy involves patients living with relapsed or refractory multiple myeloma

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Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban

Fierce Pharma

Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban fkansteiner Fri, 01/20/2023 - 15:34

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FDA lifts hold on Astellas’ Pompe gene therapy

Pharma Phorum

The FDA has delivered some good news to Astellas’ troubled gene therapy unit, lifting a clinical hold on its Pompe disease candidate AT845 and clearing the way for dosing of patients to resume.

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AbbVie jacks up Humira price by 8%, joining many other companies with January hikes: report

Fierce Pharma

AbbVie jacks up Humira price by 8%, joining many other companies with January hikes: report kdunleavy Fri, 01/20/2023 - 10:06

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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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How Design of Experiments enriches life sciences’ findings

Pharma Phorum

Design of Experiments (DOE) is a methodology misunderstood by many, understood by some, and actively used by even fewer than that.

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JPM23: Pfizer, Moderna and more look to combine COVID and flu vaccine markets

Fierce Pharma

JPM23: Pfizer, Moderna and more look to combine COVID and flu vaccine markets zbecker Fri, 01/20/2023 - 14:48

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Crossed wires? Mixed messages on medicines

Pharma Phorum

Leela Barham argues that the latest operational guidance for the NHS in England continues to illustrate a disconnect between the messages in big-ticket policy documents from the central government and the messages from the NHS in England on medicines.

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New patent for Lundbeck Pharms drug CARNEXIV

Drug Patent Watch

Annual Drug Patent Expirations for CARNEXIV Carnexiv is a drug marketed by Lundbeck Pharms Llc and is included in one NDA. It is available from one supplier. There are six… The post New patent for Lundbeck Pharms drug CARNEXIV appeared first on DrugPatentWatch - Make Better Decisions. Patent Added

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Pfizer Purchases Production Site from Abzena

Pharmaceutical Commerce

North Carolina facility to manufacture Pfizer’s pipeline products us

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FDA blocks early nod for Lilly’s Alzheimer’s drug donanemab

Pharma Phorum

Eli Lilly has been unable to secure an accelerated FDA approval for its anti-amyloid Alzheimer’s disease therapy donanemab based on mid-stage clinical results, but says it remains on track to file a traditional submission around the middle of this year.

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Which pharmaceutical drugs have the most drug patents in Serbia?

Drug Patent Watch

This chart shows the drugs with the most patents in Serbia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Serbia?

Drugs 52
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How Syneos Health and VBI Vaccines delivered a new kind of partnership model

Pharma Phorum

For millions of people around the world living with infectious disease and cancer, the arrival of a new prophylactic or therapeutic vaccine on the market can be life changing. But in order for a treatment to reach patients, it needs to be launched.

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Harnessing Data to Improve Patient Access and Optimize Gross-to-Net

Drug Channels

Today’s blog post comes from Andrew Duncan, Vice President of Business Operations and Analytics at PHIL. Andrew discusses how manufacturers can use data-driven strategy to understand utilization, increase patient access and adherence, and optimize gross-to-net.

Drugs 52
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Unmedicated nation: COVID cuts heart drug use in GB

Pharma Phorum

Hundreds of thousands of people in Great Britain have missed out on receiving medication that could protect them from serious cardiovascular disease (CVD) as a result of the COVID-19 pandemic, says a new study.

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Accelerated approval for Seagen’s TUKYSA for colorectal cancer

Pharma Phorum

The US Food and Drug Administration (FDA) has granted Seagen Inc.