FDA advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children
Bio Pharma Dive
JUNE 15, 2022
Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision
2022
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Digital health is overrated but there is a future
World of DTC Marketing
JUNE 3, 2022
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
JUNE 16, 2022
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
JUNE 16, 2022
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
Advertiser: FourKites
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
JUNE 9, 2022
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
APRIL 14, 2022
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
MAY 13, 2022
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
APRIL 14, 2022
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
MAY 31, 2022
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
JUNE 6, 2022
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
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
JANUARY 12, 2022
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
JANUARY 28, 2022
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
MARCH 24, 2022
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
MAY 24, 2022
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
Advertiser: Aggregage
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
JUNE 2, 2022
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
MARCH 18, 2022
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
MAY 26, 2022
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
J&J, Legend cell therapy approved by FDA for multiple myeloma
Bio Pharma Dive
FEBRUARY 28, 2022
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
Bristol Myers' autoimmune drug shows potential in lupus
Bio Pharma Dive
JUNE 1, 2022
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
Scientists home in on cause of Duchenne gene therapy side effect
Bio Pharma Dive
MAY 17, 2022
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
JUNE 22, 2022
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
'The music stopped': Biotech rout leaves drug startups grounded as demand slumps for IPOs
Bio Pharma Dive
FEBRUARY 6, 2022
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
JANUARY 14, 2022
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
MAY 31, 2022
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
MAY 3, 2022
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
JUNE 29, 2022
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.
Simons Foundation gives $4 million to CUNY Graduate Center to diversify astrophysics education
Scienmag
FEBRUARY 9, 2022
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.
GSK loses R&D chief Barron to high-powered startup amid investor pressure
Bio Pharma Dive
JANUARY 19, 2022
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
JANUARY 12, 2022
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
JANUARY 10, 2022
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
JANUARY 2, 2022
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
JUNE 15, 2022
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
MAY 11, 2022
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
MARCH 5, 2022
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.
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