Sat.Aug 14, 2021 - Fri.Aug 20, 2021

US to offer coronavirus boosters to all Americans in aggressive plan to counter delta's spread

Bio Pharma Dive

The Biden administration's call comes ahead of FDA authorization for additional doses in people who aren't immunocompromised, although agency head Janet Woodcock joined other officials in supporting the plan

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Small versus big digital agencies for pharma

World of DTC Marketing

SUMMARY: You should never choose an agency based on size. It should be because they are a good fit with your brand team and can take your digital marketing to the next level while ensuring that everything they do is best in class. Debra called me up in a bit of a panic.

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Developmental and Reproductive Toxicology (DART) Studies: What Are They, and How Do They Fit into Your Program?

Camargo

Development and Reproductive Toxicology studies, or DART studies, are required for most non-oncology programs between IND and NDA filings.

SAVE THE DATE: PMN Fall 2021 Summit: Pharma-Marketing Innovations & Trends of 2021 – Sep. 16th

Pharma Marketing Network

SAVE THE DATE – PMN Fall 2021 Summit: Pharma-Marketing Innovations & Trends of 2021 | SEP. 16th, 12:00PM – 1:30PM EST. SAVE YOUR SEAT TODAY. Telehealth: Is It Here to Stay?

FDA clears Rocket to resume testing gene therapy for a rare heart disease

Bio Pharma Dive

The decision from the regulator ends a three-month study pause that had stalled Rocket's development of of the Danon disease treatment

COVID Booster shots: Experts say it’s a mistake

World of DTC Marketing

SUMMARY: Not only do booster shots risk depriving millions throughout the world of the vaccine, but there is also is no evidence that additional shots meaningfully reduce death or hospitalization from covid-19 for healthy Americans. William F.

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F.D.A. Aims for Full Approval of Pfizer Covid Vaccine on Monday

NY Times

Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates. Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals

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Merck wins approval for cancer drug acquired in 2019 biotech buyout

Bio Pharma Dive

The FDA cleared Welireg, which Merck picked up in its $1 billion takeover of Peloton Therapeutics, to treat certain tumors associated with a rare genetic disease

How pharma can attract and keep talented, employees

World of DTC Marketing

SUMMARY: I believe the biggest challenge facing pharma companies doesn’t come from legislation or R&D. It comes from being able to recruit and hold onto people who have a passion for the industry and get discouraged by a culture of endless meetings and matrix decision making.

Beckley Psytech raises $80m for psychedelic meds development

Pharma Phorum

UK psychedelic medicine specialist Beckley Psytech has raised an impressive £58 million (around $80 million) in an oversubscribed second-round financing that will help fund clinical development of its psilocybin-based therapies.

Although Rare, New Data Suggests Higher Rate of Myocarditis with Moderna Shot

BioSpace

As governments and now even businesses push citizens to get vaccinated against COVID-19, anti-vaxxers are loading up more ammo for their argument with this week's report

Lilly, preparing Alzheimer's drug plans, forms new neuroscience unit in company restructure

Bio Pharma Dive

Lilly Bio-Medicines will be split into separate neuroscience and immunology groups, while the Loxo cancer research division will merge with Lilly Oncology

Oscillometry: An underutilized yet conclusive tool

ERT

As a leader in digital data solutions, ERT recognizes the importance of continuous learning and innovation within the industry to serve our customers best. As such, we regularly host webinar sessions led by experts in various therapeutic areas to educate stakeholders in the clinical trial industry.

Merck kicks off oral COVID-19 antiviral filing in Canada

Pharma Phorum

Health Canada has started a rolling review of Merck & Co’s molnupiravir, an oral antiviral therapy treatment for COVID-19 partnered with Ridgeback Biotherapeutics.

Canada Gaining in the Global War for Biotech Talent

BioSpace

Toronto saw the biggest growth in technology jobs of any North American city between 2015 and 2020, while Vancouver, British Columbia also made the top five

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Biden said to rule out Woodcock as permanent FDA chief

Bio Pharma Dive

A published report indicated the agency's longtime drug reviewer is no longer in consideration for the role, leaving the FDA's top job in flux as key decisions near on coronavirus booster shots and vaccinations for children

Covid Vaccines Produced in Africa Are Being Exported to Europe

NY Times

Johnson & Johnson is sending shots from South Africa to other parts of the world. African countries are waiting for most of the doses they’ve ordered.

NICE says yes to Novartis’ Rydapt for rare blood disorder

Pharma Phorum

Novartis’ Rydapt has become the first and only licensed treatment for rare and life-threatening blood disorder systemic mastocytosis (SM) to be cleared for routine NHS use, after getting a green light from NICE.

E-Protein Channel Blockers May Lead the Next Fight Against COVID-19

BioSpace

Research emerging from Israel identified eight already-approved compounds that inhibit the activity of the E-protein channels in the virus’s membrane

J&J chief Alex Gorsky to step down early next year

Bio Pharma Dive

Citing family health reasons, Gorsky will transition to the role of executive chairman and pass his torch to Joaquin Duato, currently vice chairman of J&J's executive committee

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NICE’s health technology assessment methods and processes to be evaluated

Pharma Times

Public consultation launches on proposed changes aiming to provide earlier access to new treatments

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Global regulators seek permanent working group on AI

Pharma Phorum

Rapid advances in the use of artificial intelligence (AI) in healthcare and medicines development are at risk of outstripping current regulatory frameworks, according to a new report.

Researchers Discover On/Off Switch for Inflammatory Pain

BioSpace

a preclinical study published in PNAS, scientists from Feinstein Institutes for Medical Research presented a new approach to treating diseases that involve inflammation and pain, like arthritis

Cell, gene therapy company funding reaches new heights, despite setbacks

Bio Pharma Dive

Developers of the complex treatments raised $14 billion between January and June, nearly three-quarters of last year's record-setting total, according to numbers compiled by the Alliance for Regenerative Medicine

Upcoming workshop on generic portfolio management

Drug Patent Watch

I’ll be leading a workshop on generic portfolio management, and also giving a talk, at the 14th annual Marcus Evans event on Portfolio Planning and Partnerships for Generics. The event….

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Health Innovators: PureTech Health’s Daphne Zohar

Pharma Phorum

In latest episode of our Health Innovators video interview series, Dr Paul Tunnah speaks to Daphne Zohar, the co-founder and CEO of PureTech Health.

COVID-19 Boosters Get Official Guidance, Critics Sound Dissent

BioSpace

The decision is largely based on three studies

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Lilly's new eczema drug scores in late-stage studies

Bio Pharma Dive

Positive results help validate the $1 billion acquisition that gave Lilly access to lebrikizumab. Even so, the company could face tough competition from Regeneron and Sanofi's Dupixent

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Accenture survey reflects changing patient experiences

Outsourcing Pharma

The check-in with nearly 1,800 US healthcare consumers reflects how COVID-19 and other factors have impacted patient access, equity, experience and trust. Patient centricity

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Organicell on regenerative medicine: the pharmaphorum podcast

Pharma Phorum

In the latest episode of the podcast Dominic Tyer speaks with Dr Maria Ines ‘Mari’ Mitrani, chief science officer at the clinical-stage biopharmaceutical company Organicell Regenerative Medicine. They looked at the development of regenerative medicine and where Organicell hopes to add to that field.

Diagnostic Face Mask Detects SARS-CoV-2 Quickly, with PCR-Like Accuracy

BioSpace

The prototype offers PCR-like precision without a power-source, and is stable at room temperature for many months

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FDA approves Lilly, Boehringer diabetes drug for heart failure

Bio Pharma Dive

The expanded clearance in heart failure with reduced ejection fraction is expected to boost sales of the drug, called Jardiance

UK approves monoclonal antibody treatment for COVID-19

Pharma Times

Regeneron/Roche's drug found to reduce hospitalisation

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Does draft RCT guide set the scene for future trials?

Pharma Phorum

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based.

Could Aspirin be Key in Unlocking Triple-Negative Breast Cancer?

BioSpace

?Scientists from The Christie NHS Foundation Trust have begun human trials on the use of aspirin and avelumab in treating patients diagnosed with triple-negative breast cancer

Coherus, known for biosimilars, nears an immunotherapy battle with big pharma

Bio Pharma Dive

New lung cancer results could make Coherus the next entrant in an ultra-competitive market dominated by pricey drugs like Merck's Keytruda

NICE recommends Novartis’ Rydapt for AdvSM treatment

Pharma Times

Treatment provides therapeutic benefits to adults with the disease

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