Thu.Oct 14, 2021

FDA advisers unanimously back Moderna booster shot for many Americans

Bio Pharma Dive

But the committee members remain opposed to broad use of boosters in healthy young adults, for whom the benefits of an additional shot are less clear

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In the News: September 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Discusses Focus Areas for PDUFA VII During Public Meeting.

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Merck advantage grows as FDA approves Keytruda for first-line cervical cancer

Bio Pharma Dive

The company's immunotherapy is the only drug of its type cleared for advanced cervical cancer. Others are being tested, however

By 2500 earth could be alien to humans

Scienmag

To fully grasp and plan for climate impacts under any scenario, researchers and policymakers must look well beyond the 2100 benchmark.

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.

Regeneron Antibody Cocktail a Priority for FDA with April Action Date

BioSpace

?The FDA and Regeneron are reportedly in talks to set up an advisory committee meeting to discuss the BLA ahead of the target action date

Digital therapeutics world first for Big Health in Scotland

Pharma Phorum

UK-based Big Health has passed a digital health milestone after Scotland became the first country to make anxiety and insomnia digital therapeutics available on a national basis.

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More Trending

New Merck KGgA viral vector CDMO plant opens in California

BioPharma Reporter

Merck KGgA and subsidiary MilliporeSigma have completed work on their second Carlsbad, California-based facility. Upstream Processing

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New Biotech Company Emerges to Tackle Multifunctional Biotherapeutics

BioSpace

On Thursday, Tentarix Biotherapeutics announced that it earned $50 million in a Series A financing round, which was co-led by Versant Ventures and Samsara BioCapital

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PTC Therapeutics opens new gene therapy manufacturing facility

BioPharma Reporter

PTC Therapeutics is celebrating the opening of a new gene therapy manufacturing facility in Hopewell, N.J. Upstream Processing

Merck’s COVID-19 Pill Up for Panel Review as Scientists Voice Concerns

BioSpace

Merck is getting its chance at participating in the pandemic. The FDA has announced an outside expert panel will meet on November 30 to deliberate on Merck’s COVID-19 pill

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.

Innovate UK funded NA-ATTC adds three new industry partners

Pharma Times

The ATTC is coordinated as part of the Cell and Gene Therapy Catapult, and operates within the NHS framework

Illumina Makes First Imprint on GRAIL with New CEO

BioSpace

Genomics veteran Bob Ragusa is taking over GRAIL, a newly-acquired business unit of Illumina, Inc. He is taking over as CEO Hans Bishop steps down from his role

Molecular mixing creates super stable glass

Scienmag

Researchers at Chalmers University of Technology, Sweden, have succeeded in creating a new type of super-stable, durable glass with potential applications ranging from medicines, advanced digital screens, and solar cell technology.

Research Roundup: T-Cell Immune Response to COVID-19 Vaccines and More

BioSpace

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones

Fujifilm Diosynth in tie-up with US AAV gene therapy developer

BioPharma Reporter

LEXEO Therapeutics, a clinical-stage gene therapy company, is partnering with CDMO, Fujifilm Diosynth Biotechnologies (FDB), to support the development and manufacturing of its AAV-mediated gene therapies. Upstream Processing

Hope Alights at ECTIRMS 2021 as Companies Present New Data

BioSpace

The 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis ran from October 13 to 15, with companies globally presenting cutting-edge studies on MS

‘Progress does not happen overnight’: Sanofi on evolution of medicine

Outsourcing Pharma

A leader from the pharmaceutical firm talks about some of the most impactful technologies and shares a number of notable advancements made by the company. Clinical Development

New Hope in Liver Cancer as AstraZeneca Combo Improves Survival

BioSpace

They are calling the combination of tremelimumab and Imfinzi the STRIDE regimen for Single Tremelimumab Regular Interval Durvalumab

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FDA Lowers Sodium Guidelines to Reduce Salt Consumption

XTalks

The US Food and Drug Administration (FDA) announced new sodium guidelines on Wednesday that provide voluntary sodium reduction targets for a multitude of foods.

A New Pathway to Solving Chronic Neurological Diseases - Maybe Long COVID?

BioSpace

CT38 is being studied in myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS), as well as in fibromyalgia and chronic Lyme disease

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Avid Bioservices expands into viral vector development and manufacturing services for cell and gene therapy

BioPharma Reporter

Avid Bioservices, Inc. is expanding its CDMO service offering into the cell and gene therapy market: constructing a purpose-built 53,000 sq. viral vector development and CGMP manufacturing facility in Costa Mesa, CA. Upstream Processing

ICYMI: Biopharma News You Might Have Missed This Week

BioSpace

Read about TFF Pharmaceuticals and Augmenta Bioworks' dry powder COVID-19 antibody formula, the world's first gene editing clinical trial for PKU, Bayer's COVID-19 vaccine and other key developments in life sciences research

Life Sciences BC Announces Presenting Companies Pitching at Invest in BC Presented by Lumira Ventures

BioTech 365

New journal article examines vaccination misinformation on social media

Scienmag

Research conducted by Assistant Professor Jessie Chin’s Adaptive Cognition and Interaction Design Lab (ACTION) in the School of Information Sciences at the University of Illinois Urbana-Champaign provided the foundation for an article recently published in the Journal of Medical Internet Research.

Number of Shares and Voting Rights of Innate Pharma as of October 1, 2021

BioTech 365

Number of Shares and Voting Rights of Innate Pharma as of October 1, 2021 Number of Shares and Voting Rights of Innate Pharma as of October 1, 2021 MARSEILLE, France–(BUSINESS WIRE)–Regulatory News: Pursuant to the article L. 233-8 II of the … Continue reading → Business Wir

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Calling All Women!

My Local Study

Over 2,000 years ago, during an influenza outbreak, it was first noticed that women respond differently to disease than men. They also do not respond the same to treatments. Despite this, many current therapies have only been evaluated in men.

AirPhysio Asthma Breathing Device – Symptom/Mucus Management Product Relaunched

BioTech 365

AirPhysio Asthma Breathing Device – Symptom/Mucus Management Product Relaunched AirPhysio Asthma Breathing Device – Symptom/Mucus Management Product Relaunched Life Wellness Healthcare has relaunched the AirPhysio device on its online store to cater to the demand from those affected by asthma.

Vitamin D supplement may enhance dairy cows’ immune health

Scienmag

Philadelphia, October 14, 2021 – Known as a crucial component in the body’s ability to absorb and retain calcium, essential to processes such as the development and maintenance of healthy bones, vitamin D has also been found to play important roles in immune defense.

Sensient Technologies Announces Increased Quarterly Dividend

BioTech 365

Sensient Technologies Announces Increased Quarterly Dividend Sensient Technologies Announces Increased Quarterly Dividend MILWAUKEE–(BUSINESS WIRE)–The Board of Directors of Sensient Technologies Corporation (NYSE: SXT) has declared a regular quarterly cash dividend on its common stock of $0.41

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Electric sheep: Grazing in solar arrays supports economy, climate

Scienmag

ITHACA, N.Y. – As industrial-sized solar installations pop up throughout New York and New England states, residents fear the loss of agricultural land. One solution is simple: sheep. Credit: Lindsay France, Cornell University ITHACA, N.Y. –

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Mammogen and Brilliantly Combine Forces to Advance Community Efforts for Breast Cancer Previvors and Survivors

BioTech 365

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Concordia researchers develop a new model to assess for flood hazards

Scienmag

The widespread flooding that submerged parts of the province’s most densely populated regions in 2017 and 2019 exposed important gaps in Quebec’s flood preparedness regime.

Biote Recognized as 50-Fastest-Growing Women-Owned/Led Companies of 2021

BioTech 365

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New theories and materials aid the transition to clean energy

Scienmag

With each passing day, the dark side of our addiction to fossil fuels becomes more apparent. In addition to slashing emissions of carbon dioxide, society must find sustainable alternatives to power the modern world.

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Culture Biosciences Raises $80M Series B to Tackle Demand for Large-Scale Biomanufacturing

BioTech 365

Culture Biosciences Raises $80M Series B to Tackle Demand for Large-Scale Biomanufacturing Culture Biosciences Raises $80M Series B to Tackle Demand for Large-Scale Biomanufacturing Culture is closing the gap in manufacturing capacity with its large-scale cloud bioreactors to support a … Continue reading → Business Wire