Sat.Aug 13, 2022 - Fri.Aug 19, 2022

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.

Bluebird gene therapy approved by FDA for rare blood disease

Bio Pharma Dive

The regulator cleared the biotech’s medicine Zynteglo for transfusion-dependent beta thalassemia, giving patients a powerful new treatment option. But it will come at a very high cost of $2.8 million in the U.S.

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What to look for when hiring in pharma

World of DTC Marketing

The great resignation has not affected pharma because the jobs within the industry pay very well and most positions and employees like the benefit of having a steady job with good money.

Valneva’s Lyme disease vaccine faces final clinical test in a sparse landscape

Pharmaceutical Technology

On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality.

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.

Landmark Drug Pricing Bill Set to Become Law; HP&M Releases Summary Slide Deck

The FDA Law Blog

By Alan M. Kirschenbaum & Michelle L. Butler & Faraz Siddiqui — The Inflation Reduction Act of 2022 (“IRA”) has now passed both the Senate (on August 7) and the House (on August 12), and is headed to President Biden for signature.

‘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

More Trending

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.

The UK won't purchase AstraZeneca's Evusheld, citing 'insufficient data'

Fierce Pharma

The UK won't purchase AstraZeneca's Evusheld, citing 'insufficient data'. kdunleavy. Mon, 08/15/2022 - 11:05

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Schrödinger names longtime biotech analyst Porges its CFO and top dealmaker

Bio Pharma Dive

Geoffrey Porges, who has spent nearly two decades researching biotechs at SVB Securities and AllianceBernstein, will now oversee and seek to grow the drug discovery specialist's network of partnerships

Drugs 245

Millennium hits a home run with DTC

World of DTC Marketing

Millennium Pharma’s ad and website for ENTYVIO touch all the bases with targeted patients. It shows that the team understands what it’s like for patients with severe ulcerative colitis. This is the kind of DTC that can help patients seek treatment. Empathy.

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 approval for bluebird’s Zynteglo to treat beta-thalassemia

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for bluebird bio ’s Zynteglo (betibeglogene autotemcel, beti-cel) for the treatment of the underlying genetic cause of beta?thalassemia thalassemia in adult and paediatric patients.

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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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

Can we be serious about telehealth?

World of DTC Marketing

If you follow the hype around telehealth, you would think it will save healthcare. Telehealth does have a future as PART of healthcare, but it won’t replace the benefit of seeing a patient in person and being able to diagnose a health problem. There it is again.

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.

Atomwise and Sanofi partner for drug discovery using AI

Pharmaceutical Technology

Atomwise and Sanofi have entered a strategic and exclusive research partnership to use the former’s artificial intelligence (AI)-driven AtomNet platform to discover and research up to five drug targets computationally.

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

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

With FDA approval, Axsome touts Auvelity as a potential game-changing depression treatment

Fierce Pharma

With FDA approval, Axsome touts Auvelity as a potential game-changing depression treatment. kdunleavy. Fri, 08/19/2022 - 11:01

IN FOCUS: Northgate Technologies

Pharmaceutical Technology

RANKINGS 2022 Excellence Innovation Commended Excellence Product Launch Commended Excellence Safety Commended. The Verdict. Northgate Technologies Inc. NTI) is a Illinois based producer of medical devices and technologies for the healthcare sector, with a particular focus on surgical environments.

A Saga of 75 years journey of Indian Pharmaceutical Industry

Pharma Tutor

A Saga of 75 years journey of Indian Pharmaceutical Industry. Look back of growth drive for Indian pharmaceutical industry after 75 years of independence and future roadmap. admin. Sun, 08/14/2022 - 18:21. Pharmapedia. Articles.

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Merck pays startup Orna $150M as ‘circular RNA’ attracts industry interest

Bio Pharma Dive

The pharmaceutical company has formed an alliance with Orna and invested $100 million in its Series B round, hoping the young biotech’s approach could lead to multiple new vaccines and drugs

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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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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above.

Understanding the Patient Journey in Complex and Rare Diseases

Pharmaceutical Commerce

Optimizing the use of data and improving the patient experience go hand in hand.

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Axsome rebounds to win FDA approval of depression drug

Bio Pharma Dive

A year after finding flaws in the biotech’s application, the regulator cleared a treatment some analysts view as a blockbuster-to-be, sending shares up by as much as 40

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

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.

Predictive analytics could unlock precision medicine progress: AiCure

Outsourcing Pharma

An expert from the clinical insight specialist shares how predictive analytics could reveal info about medication adherence, disease progression, and more. Patient centricity

CSL says drug for rare swelling disorder succeeds in late-stage study

Bio Pharma Dive

The company plans to soon seek approval of a once-monthly preventive drug for hereditary angioedema, a disease other drugmakers are targeting with gene editing and RNA medicines

Eisai inaugurates new US HQ as closely watched FDA Alzheimer's decision draws near

Fierce Pharma

Eisai inaugurates new US HQ as closely watched FDA Alzheimer's decision draws near. Fri, 08/19/2022 - 11:03

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UK first to approve Moderna’s Omicron booster jab

Pharma Phorum

The UK has become the first country in the world to authorise an updated COVID-19 booster vaccine directed at the Omicron variant, giving a green light to Moderna’s mRNA-1273.214 shot.

‘A watershed moment for the field of gene therapy’: bluebird bio’s gene therapy Zynteglo receives FDA approval

BioPharma Reporter

The U.S.

US plans shift to private market sales of COVID-19 vaccines, drugs

Bio Pharma Dive

The federal government will begin the transition as early as this fall, clearing the way for drugmakers to control sales and distribution of their shots and therapeutics

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Eagle soars over Endo's patent claim, triggering more troubles for the recently bankrupt company

Fierce Pharma

Eagle soars over Endo's patent claim, triggering more troubles for the recently bankrupt company. zbecker. Fri, 08/19/2022 - 10:49

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