December, 2022

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Four ways Biogen is tackling digital innovation in neurological disease

Pharma Phorum

Digital transformation in pharma is not a singular endeavour. It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging.

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2022 in review: Regulation starts to catch up with AI in pharma

Pharmaceutical Technology

Artificial intelligence (AI) continued to stay in the news with several high-profile deals this year, as the pharmaceutical industry readily took to adopting AI models to improve drug discovery.

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Ferring wins FDA approval for bladder cancer gene therapy

Bio Pharma Dive

The OK caps a long development journey for the treatment, which was previously turned back by the agency. Ferring doesn’t expect it to be available until the second half of next year, however

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A New Dimension in New Drug Molecules Research with Nanome’s VR technology [Interview]

Pharma Mirror

The COVID-19 pandemic challenged researchers to discover life-saving treatments at an unprecedented pace. While these researchers rose to the occasion by discovering drugs faster than ever before, variants continue to challenge the world in addressing COVID-19.

Research 219
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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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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

The FDA Law Blog

By Mark A. Tobolowsky & James E.

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Boehringer Ingelheim announces appointments to Board of Managing Directors

The Pharma Data

Boehringer Ingelheim announces appointments to Board of Managing Directors. Boehringer Ingelheim today announces that the Shareholders have appointed Paola Casarosa and Shashank Deshpande to the Board of Managing Directors.

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Lilly and ProQR to expand genetic medicine development agreement

Pharmaceutical Technology

Eli Lilly and Company has expanded a licencing and partnership agreement with ProQR Therapeutics to discover, develop and market new genetic medicines. The companies entered the initial agreement in September last year.

Genetics 262
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FDA approves first microbiota-based treatment

Bio Pharma Dive

The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection

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CPHI Frankfurt returns to pre-pandemic strength as pharma industry booms again

Pharma Mirror

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Doctoring the Law: Congress May Let FDA Regulate the Practice of Medicine

The FDA Law Blog

By Jeffrey N. Gibbs & Sara W. Koblitz — Back in June, when Congress was negotiating the User Fee Acts, FDA asked Congress to add in some provisions reversing several lawsuits that it had just lost.

Doctors 93
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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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Sanofi and Innate Pharma expand collaboration for natural killer cell therapeutics in oncology

The Pharma Data

Sanofi and Innate Pharma expand collaboration for natural killer cell therapeutics in oncology.

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Get Set up for Success in the Account Incubator Program

Intouch Solutions

Finding an agency job after graduating college can feel overwhelming, but it doesn’t have to. Jumpstart your career at EVERSANA INTOUCH and be set up for success as part of our Account Incubator program where you can dip your toes into an Account Services role!

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Moderna and UK government sign deal to establish mRNA facility

Pharmaceutical Technology

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. The latest development comes after the parties announced an agreement in principle in June this year.

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Biotech veteran Jeff Jonas on leaving Sage, guiding new biotechs and his ‘personal odyssey’

Bio Pharma Dive

In an interview with BioPharma Dive, the longtime industry executive discussed becoming a biotech investor and his plans for Abio-X, a new incubator with $150 million to spend on startups

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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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Olympus to Join Government Project to Verify Dissemination of Endoscopic AI Diagnosis in Vietnam

Pharma Mirror

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Third Circuit Court of Appeals Upends “Intended Loss”

The FDA Law Blog

By Douglas B. Farquhar & John W.M.

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Astellas, Seagen and Merck Announce FDA Acceptance of sBLA for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

The Pharma Data

Astellas, Seagen and Merck Announce FDA Acceptance of sBLA for PADCEV ® (enfortumab vedotin-ejfv) with KEYTRUDA ® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer. Astellas Pharma Inc.

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The Value of ML in Customer Targeting

Pharmaceutical Commerce

How biopharma commercial teams can leverage machine learning techniques to improve targeting of HCPs and patients.

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The Mexico pharma market: growth factors and advantages for manufacturing

Pharmaceutical Technology

Mexico is Latin America’s second-largest pharmaceutical market and ranks in the top 15 on the global list of biggest pharma markets. By 2025, multiple growth factors are contributing to this figure rising to a projected $30.04bn, according to GlobalData analysis.

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Amgen to buy Horizon Therapeutics in year’s biggest biotech deal

Bio Pharma Dive

After outlasting rival suitors Sanofi and J&J in deal talks, Amgen agreed to a deal that values the Ireland-based maker of rare and inflammatory disease drugs at about $28 billion

Drugs 272
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Botanical Solution Inc. (BSI) & Croda Pharma Partnership Agreement to Accelerate Production for GMP QS-21  

Pharma Mirror

QS-21 in blockbuster Shingles vaccine, first vaccine approved for Malaria, promising RSV phase III candidate, and Covid-19 applications. Botanical Solution Inc.

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FDA Finalizes Guidance Re Enforcement Policy for Homeopathic Drugs

The FDA Law Blog

By Riëtte van Laack — On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015.

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Kite to Acquire Tmunity Therapeutics to Pursue Next Generation CAR T-Cell Therapy Advancements in Cancer

The Pharma Data

Kite to Acquire Tmunity Therapeutics to Pursue Next Generation CAR T-Cell Therapy Advancements in Cancer.

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UK digital health project aims to tackle dysfunctional breathing

Pharma Phorum

A collaboration between academic centres in the UK has won government funding for a digital approach to dysfunctional breathing or dyspnoea, a symptom that affects around 10% of the population.

Engineer 114
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Looking back at 2022: The top healthcare stories

Pharmaceutical Technology

The healthcare industry saw its share of ups and downs in 2022. Our response to the worldwide pandemic evolved over time, and so did the needs of the sector and the people relying on healthcare companies to deliver solutions.

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Dantari emerges with a new way to make cancer drug conjugates

Bio Pharma Dive

As the success of drugs like Enhertu catalyzes new investment in antibody-drug conjugates, the California startup is launching with plans to develop more potent versions of the targeted cancer medicines

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AstraZeneca focuses on breast cancer care transformation

Pharma Times

Data reinforces potential to deliver new standards across HER2-targetable breast cancer

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Pfizer, Sanofi settle first California Zantac case slated for trial: report

Fierce Pharma

Pfizer, Sanofi settle first California Zantac case slated for trial: report. zbecker. Thu, 12/22/2022 - 12:38

Trials 110
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Datopotamab deruxtecan showed promising responses as monotherapy and in combination with Imfinzi in patients with metastatic triple-negative breast cancer in two early trials

The Pharma Data

Datopotamab deruxtecan showed promising responses as monotherapy and in combination with Imfinzi in patients with metastatic triple-negative breast cancer in two early trials.

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Newly formed gene therapy company has genetic Parkinson’s disease in its sights

BioPharma Reporter

Replay, the genome writing company reprogramming biology by writing and delivering big DNA, has launched its third product company, Kaleibe, a HSV gene therapy company targeting genetic brain disorders. Bio Developments

DNA 106
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EMA CHMP recommends Moderna’s Covid-19 booster for children

Pharmaceutical Technology

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 mRNA-1273.214) booster for usage in children aged six to 11 years.

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Roche’s hemophilia gene therapy holds steady with longer-term data

Bio Pharma Dive

Roche’s subsidiary Spark has offered few updates on its hemophilia A treatment since being acquired in 2019. New data at ASH show the therapy can maintain levels of a key blood-clotting protein for years

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AlzeCure’s promising Alzheimer’s abstract accepted

Pharma Times

ACD856 has also been shown across preclinical studies to improve cognition and memory

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Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report

Fierce Pharma

Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report. aarmstrong. Thu, 12/29/2022 - 14:42

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