2022

FDA advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children

Bio Pharma Dive

Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision

Digital health is overrated but there is a future

World of DTC Marketing

The continued emphasis on digital health is overrated but digital health will become an integral part of total patient care. To become a vital part of patient care, digital health providers need to provide the medical community with studies that show their value to patient outcomes.

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Pharma under the microscope as FTC considers new ways to review acquisitions

Bio Pharma Dive

At a two-day meeting, experts argued drug divestitures may not be enough to prevent market concentration. Economists and regulators also appeared worried by the effect of buyouts on innovation

Roche Alzheimer's study fails in another setback to a long-tested hypothesis

Bio Pharma Dive

The failure is an upset not only to Roche, but also a blow to the wider Alzheimer’s research field, which has for years kept focus on a protein called beta amyloid

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.

FDA panel backs Bluebird gene therapy despite safety risks

Bio Pharma Dive

Advisers to the agency voted 15-0 in support of the rare disease treatment eli-cel, which was linked to a bone marrow cancer in three study participants

Moving away from genetic continental ancestry categories in research and medicine

Scienmag

In a Policy Forum, Anna Lewis and colleagues argue that, for researchers and others who want to invoke genetic ancestry, there is a scientific and ethical imperative to move away from continental ancestry categories and to instead embrace a view of genetic ancestry that reflects continuous variation and historical depth.

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Lilly wins FDA approval of new kind of diabetes drug

Bio Pharma Dive

Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline

AbbVie, Genmab, with new data, prep FDA application for dual-acting cancer drug

Bio Pharma Dive

Fresh trial results intensify competition with Roche to deliver the first lymphoma drug that marries antibody technology with an immunotherapy pathway

BioMarin delays planned FDA filing for hemophilia gene therapy

Bio Pharma Dive

BioMarin now expects to resubmit its approval application to the FDA by the end of September, the latest regulatory setback for the company's closely watched treatment

ASCO 2022: Gilead's tough weekend, bispecific progress and 'gamma delta' cell therapy

Bio Pharma Dive

The biotech's highly anticipated breast cancer data were upstaged by a rival, while presentations from Roche, J&J and Adicet Bio highlighted emerging alternatives to CAR-T treatment

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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.

PDUFA VII: More Changes Coming in the Latest Reauthorization

Camargo

As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases.

Drug company profiteering

World of DTC Marketing

A cancer medication called Xtandi costs $189,800 per year and was developed with taxpayer dollars. The U.S. government has a responsibility for ending the exclusive patents that give them their profits.

As biotech retreats, gene therapy companies retrench and redraw plans

Bio Pharma Dive

At least nine biotechs working in cell or gene therapy have announced layoffs, cost cuts or restructured their research since December — restructurings that have coincided with a stock market downturn

Responding to outbreak, Moderna starts early work on monkeypox vaccine

Bio Pharma Dive

One day after the U.S. began releasing supplies of an approved Bavarian Nordic shot, Moderna said it's beginning development of its own vaccine against the virus

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.

Upstream Bio, a richly funded startup, reveals its lead drug and research plans

Bio Pharma Dive

Backed by $200 million in funding and led by biotech veteran Samantha Truex, Upstream is developing a clinical-stage inflammatory disease drug acquired from Astellas last year

Artificial intelligence paves the way to discovering new rare-earth compounds

Scienmag

Artificial intelligence advances how scientists explore materials. Researchers from Ames Laboratory and Texas A&M University trained a machine-learning (ML) model to assess the stability of rare-earth compounds.

Merck study results signal blood cancer potential for new type of immunotherapy

Bio Pharma Dive

Bristol Myers beat Merck to the first approval of a so-called LAG-3 inhibitor. But Merck is advancing its own and data to be presented at ASCO show it could help treat Hodgkin's lymphoma

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J&J, Legend cell therapy approved by FDA for multiple myeloma

Bio Pharma Dive

The CAR-T treatment is the second to be approved in the U.S. for the blood cancer, following Bristol Myers Squibb and 2Seventy bio's Abecma

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Bristol Myers' autoimmune drug shows potential in lupus

Bio Pharma Dive

Positive Phase 2 results could help boost company executives' arguments that the drug, called deucravacitinib and under FDA review in psoriasis, will become a top-seller

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Scientists home in on cause of Duchenne gene therapy side effect

Bio Pharma Dive

An unusual collaboration among gene therapy developers suggests certain mutations could be behind "peculiar" side effects experienced by several patients treated in clinical trials

Biogen, citing insurance challenges, shutters one of its Aduhelm studies

Bio Pharma Dive

The company says a recent coverage decision by Medicare has forced it to end an observational trial of the Alzheimer's drug after enrolling just 29 participants

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'The music stopped': Biotech rout leaves drug startups grounded as demand slumps for IPOs

Bio Pharma Dive

For the first time in years, biotechs no longer have an easy path onto Wall Street, a market reversal that could change what the next generation of young drugmakers looks like

Pharma’s outdated hiring practices

World of DTC Marketing

One of the reasons it’s a job-seekers market because candidates today want more from their employers. They want a good work-life balance and want to be valued as a contributor to the success of their company. We live in an instant gratification world.

GSK wagers $2.1B on Affinivax and its next-generation pneumonia vaccine

Bio Pharma Dive

The deal is the second acquisition for GSK since April and gives the company access to an experimental shot that’s meant to surpass new products from Pfizer and Merck & Co

Pfizer cleared to restart hemophilia gene therapy trial

Bio Pharma Dive

While a voluntary pause in dosing new patients will remain in place, the FDA's decision puts the study back on track to deliver data in 2023

AI hiring levels in the pharmaceutical industry rose in May 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for AI related positions kept relatively steady in May 2022 compared with the equivalent month last year, with 39.3% of the companies included in our analysis recruiting for at least one such position.

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Simons Foundation gives $4 million to CUNY Graduate Center to diversify astrophysics education

Scienmag

NEW YORK, February 9, 2022– Astrophysics is one of the most popular science fields, igniting the imaginations of many as they learn about it from television shows or news of space exploration. Like many other STEM fields, though, it lags in attracting students of color.

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GSK loses R&D chief Barron to high-powered startup amid investor pressure

Bio Pharma Dive

Hal Barron, a key figure in GSK's efforts to revitalize its drug research, will step down as its top scientist at a time when the company is feeling heat from investors to deliver faster growth

5 questions facing biotech M&A in 2022

Bio Pharma Dive

Analysts expect that deal engines are ready to start firing again following the recent quiet period. Still, uncertainty remains about how biopharma acquisitions could play out in the coming months

Pfizer expands into gene editing with Beam research deal

Bio Pharma Dive

Pfizer's work with mRNA vaccines led it explore other applications of the technology, resulting in a multi-year partnership with the high-profile biotech Beam Therapeutics on gene editing treatments for rare diseases

10 clinical trials to watch in the first half of 2022

Bio Pharma Dive

Biotech stocks ended 2021 in a slump. But positive results from eagerly anticipated studies in breast cancer, schizophrenia and Alzheimer's disease could help turn the sector's fortunes around

With biotech in retreat, Third Rock raises $1B for life sciences investing

Bio Pharma Dive

The fund, Third Rock’s sixth, comes amid a significant downturn in the biotech stock market, which has raised questions about the viability of young drug startups

In first, Verve gets clearance to test base editing inside the body

Bio Pharma Dive

Regulators in New Zealand have allowed human testing to proceed, another milestone for the gene editing technology. Verve plans to soon ask for approval to begin testing in the U.S. and U.K.,

The biggest challenge for healthcare

World of DTC Marketing

American healthcare is the most expensive globally, but it’s not close to being the best. Our healthcare system has become like a mass-market retailer, in the door to treat the problem and out the door with an Rx or other treatment recommendation.