Tue.Aug 16, 2022

‘Treg’ cell therapy: bringing CAR-T to autoimmune disease

Bio Pharma Dive

At least seven companies, including five richly funded startups, are developing cell-based treatments for inflammatory conditions, making it one of biotech’s most competitive fields

Gilead to acquire global rights of Trodelvy from Everest

Pharmaceutical Technology

Gilead Sciences has entered an agreement with Everest Medicines to acquire complete rights to develop and market Trodelvy (sacituzumab govitecan) in Greater China, Singapore, South Korea, Philippines, Vietnam, Thailand, Indonesia, Mongolia and Malaysia.

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Amid market turbulence, a Flagship startup pushes off an IPO with a new fundraise

Bio Pharma Dive

Senda Biosciences decided to raise a $123 million Series C round rather than test public markets with an initial offering, its top executive said

FDA Inspections Back Up To Speed (Except Those Now Deemed Unnecessary)

The FDA Law Blog

By Douglas B. Farquhar — Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID.

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.

Gilead, with new results, doubles down on breast cancer drug

Bio Pharma Dive

The company has agreed to spend at least $280 million buying back rights to the drug, called Trodelvy, which were sold to Everest Medicines in 2019

Since Biden took over, Big Pharma has spent $205 million to protect drug price status quo, analysis finds

Fierce Pharma

Since Biden took over, Big Pharma has spent $205 million to protect drug price status quo, analysis finds. kdunleavy. Tue, 08/16/2022 - 11:31

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More Trending

Auransa, Polaris harness AI, quantum computing to discover cancer drugs

Outsourcing Pharma

The AI and QC specialists have joined to use AI and QC in order to discover biological pathways relevant to the treatment of triple-negative breast cancer. Preclinical Research

Drugs 100

Ventyx touts early data for potential rival to Bristol Myers psoriasis drug

Bio Pharma Dive

The biotech plans to start Phase 2 studies for a drug it believes may more effectively hit its target than Bristol Myers’ deucravacitinib, a skin disease treatment regulators could approve next month

Merck bags chance to test ADCs based on Starpharma delivery tech

Fierce Pharma

Merck bags chance to test ADCs based on Starpharma delivery tech. ntaylor. Tue, 08/16/2022 - 09:32

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Moderna’s next-gen COVID-19 booster becomes first authorized Omicron-specific bivalent vaccine

BioPharma Reporter

The first Omicron bivalent COVID-19 vaccine has been authorized: with the UKâs regulatory agency giving the green light to Modernaâs Spikevax Bivalent Original/Omicron booster shot. Markets & Regulations

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 grants swift review to Lynparza in first-line prostate cancer

Pharma Phorum

AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its use broadened if a new marketing application is approved by the FDA.

Injectable opportunities for CMOs despite internal capacity of big pharma sponsors

Pharmaceutical Technology

Even giant pharma companies with large internal production capabilities are leaning on outsourcing to meet market demand for huge numbers of injectables, including high-value biologics and Covid-19 vaccines, according to a GlobalData analysis.

In opening round of high-stakes Zantac litigation, GSK scores a decisive win

Fierce Pharma

In opening round of high-stakes Zantac litigation, GSK scores a decisive win. kdunleavy. Tue, 08/16/2022 - 16:36

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Parkinson’s monitoring tech advances in NICE approval process

Outsourcing Pharma

The National Institute for Health and Care Excellence is weighing the viability of PD Neurotechnologyâs PDMonitor system for Parkinsonâs disease patients. Markets & Regulations

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.

AstraZeneca heads to court to contest former exec's move to crosstown rival GSK: report

Fierce Pharma

AstraZeneca heads to court to contest former exec's move to crosstown rival GSK: report. fkansteiner. Tue, 08/16/2022 - 10:12

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UK Approves First Omicron-Targeting COVID-19 Booster

XTalks

Health regulators in the UK have become the first in the world to approve Moderna’s next generation COVID-19 vaccine booster that includes targeting of the Omicron variant.

After Trodelvy's approval in China, Gilead strikes $455M deal with Everest for Asian rights

Fierce Pharma

After Trodelvy's approval in China, Gilead strikes $455M deal with Everest for Asian rights. Tue, 08/16/2022 - 09:34

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Merck makes circular RNA play with $3.5bn Orna alliance

Pharma Phorum

Merck & Co has ramped up its involvement in the RNA category, partnering with US biotech Orna Therapeutics in a deal valued at up to $3.5 billion, including $150 million upfront.

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West takes stake in intradermal delivery startup Latch Medical

Fierce Pharma

West takes stake in intradermal delivery startup Latch Medical. ntaylor. Tue, 08/16/2022 - 09:35

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More big wins for the AstraZeneca-Daiichi Sankyo collaboration

Pharmaceutical Technology

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn.

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Lynparza in combination with abiraterone granted Priority Review in the US for patients with metastatic castration-resistant prostate cancer

The Pharma Data

First PARP asset to demonstrate clinical benefit in combination with a new hormonal agent irrespective of homologous recombination form( HRR) gene mutations.

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Q32 Bio and Horizon partner to develop autoimmune disease treatment

Pharmaceutical Technology

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials.

FDA accepts supplemental Biologics License Application for Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma

The Pharma Data

New Report Looks to the Supply Chains of the Future

Pharmaceutical Commerce

Three of the authors of a new EY study exploring the evolution of industry supply chain strategies and the long-term implications for healthcare delivery across three major trade regions discuss the report’s key findings and share their predictions as we move into Q3.

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FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

The Pharma Data

Today, the U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans.

Navigating Abortion Restrictions Post Dobbs: Considerations for Pharmacy Providers

Pharmaceutical Commerce

As a result of the United States Supreme Court’s overturning of Roe v. Wade and Planned Parenthood v. Casey, pharmacy providers are looking to state laws and other recently issued federal guidance in determining how they can compliantly meet patient needs and deliver medications.

Obesity: Is killing us all

World of DTC Marketing

The new Inflation Bill will not reduce healthcare costs in the U.S. An analysis predicts that by 2030, 48.9% of adults in the United States will be obese, and 24.2% will be severely obese.

Past the Podium: A New Tech Stack for Medical Affairs in the Future

Pharmaceutical Commerce

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UK advisors back Moderna’s bivalent shot for autumn COVID booster

Pharma Phorum

The UK’s Joint Committee on Vaccinations and Immunisations (JCVI) has said that Moderna’s bivalent COVID-19 vaccine should be used for the autumn booster campaign in adults.

New patent for Amicus Therap drug GALAFOLD

Drug Patent Watch

Annual Drug Patent Expirations for GALAFOLD Galafold is a drug marketed by Amicus Therap Us and is included in one NDA. There are forty-one patents protecting this drug. This drug…. The post New patent for Amicus Therap drug GALAFOLD appeared first on DrugPatentWatch - Make Better Decisions.

Roche eyes April FDA verdict on Polivy as first-line lymphoma therapy

Pharma Phorum

The FDA has started a review of Roche’s Polivy for people with previously untreated diffuse large B-cell lymphoma (DLBCL), as the drugmaker tries to move the drug further up the treatment pathway in the US.

Drug Patent Expirations for the Week of August 14, 2022

Drug Patent Watch

AFINITOR (everolimus) Novartis Patent: 8,778,962 Expiration: Aug 18, 2022 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit….

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Changing Pharma Social Media Ad Rules Discussed in AdWeek by EVERSANA INTOUCH Video Investment Director

Intouch Solutions

Interest-based marketing used to be one way to target Facebook ads – for example, a person’s interest in “World Diabetes Day” – but in an effort to protect Meta users’ privacy, the company has made it no longer possible for advertisers to do this.

New patent for Glaxosmithkline Llc drug LAMICTAL ODT

Drug Patent Watch

Annual Drug Patent Expirations for LAMICTAL+ODT Lamictal Odt is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from one supplier. There are three….