Bio Pharma Dive
NOVEMBER 26, 2021
Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday.
Bio Pharma Dive
OCTOBER 25, 2021
The barrier to knowledge can be eliminated when pharmaceutical companies use natural language processing to analyze unstructured content.
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pharmaphorum
DECEMBER 15, 2021
Words matter. In the pharma industry, “patient engagement” and “patient centricity” might seem like interchangeable bits of corporate jargon. But the difference between them is not like the choice between “agreeing” and “aligning” or “getting together later” and “taking this offline.” Going from the vital activity of patient engagement to the more encompassing state of patient centricity requires big steps in the evolution of new-drug discovery, development, and delivery.
BioSpace
SEPTEMBER 15, 2021
?The FDA's IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy.
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
NY Times
AUGUST 20, 2021
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.
BioPharma Reporter
FEBRUARY 22, 2021
Pfizer and BioNTech have dosed the first participants in a Phase 2/3 study for their COVID-19 vaccine in pregnant women; and plan to trial the vaccine in children later this year.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
JANUARY 8, 2021
The US Food and Drug Administration (FDA) released a statement this week about dosing schedules for COVID-19 vaccines, saying that any dose changes would be premature. In the statement , the FDA said that it wants to “remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.”.
Scienmag
MAY 28, 2021
Features of large systems yielded from tiny simulations with super-resolution techniques Credit: Tokyo Metropolitan University Tokyo, Japan – Researchers from Tokyo Metropolitan University have enhanced “super-resolution” machine learning techniques to study phase transitions. They identified key features of how large arrays of interacting “particles” behave at different temperatures by simulating tiny arrays before using a […].
Pharma Times
JULY 13, 2021
Researchers discover presence of 'autoantibodies' in people with persistent COVID-19 symptoms
Outsourcing Pharma
DECEMBER 13, 2021
The pharmaceutical company currently has several promising treatments in development for gastroenterological, dermatological, and cardiological conditions.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Bio Pharma Dive
AUGUST 31, 2021
Marion Gruber and Phil Krause, two veteran vaccine reviewers, are unexpectedly leaving the agency at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter.
Bio Pharma Dive
AUGUST 10, 2021
Deals were few and far between last quarter. But the recent history of biopharma M&A suggests they'll return. Keep track of them as as they happen with BioPharma Dive's new database.
Bio Pharma Dive
NOVEMBER 9, 2021
Encouraged by Moderna's success, Flagship Pioneering has been busy creating startups like Alltrna, which launched Tuesday. The biotech is researching how to make medicines from transfer RNA molecules.
Bio Pharma Dive
JUNE 26, 2021
Results published in The New England Journal of Medicine offer the first clinical evidence that CRISPR gene editing inside the body can be safe and effective, a culmination of years of scientific research.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Bio Pharma Dive
JULY 9, 2021
After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech.
Bio Pharma Dive
AUGUST 23, 2021
The acquisition reflects growing industry interest in the cancer-linked protein targeted by Trillium's drugs, most notably shown by Gilead's acquisition of Forty Seven last year.
Bio Pharma Dive
SEPTEMBER 7, 2021
On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice.
Bio Pharma Dive
MAY 28, 2021
For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Bio Pharma Dive
JUNE 15, 2021
Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors.
Bio Pharma Dive
FEBRUARY 5, 2021
Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors.
Bio Pharma Dive
MARCH 29, 2021
A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June.
Bio Pharma Dive
OCTOBER 31, 2021
Through high-stakes litigation, aggressive patenting practices and a bit of luck, Amgen will likely stretch Enbrel's monopoly until 2029, more than 30 years after it was approved.
Advertiser: Aggregage
New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!
Bio Pharma Dive
AUGUST 18, 2021
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.
Bio Pharma Dive
DECEMBER 23, 2021
The decision follows worrisome results in lab studies that indicated omicron can evade both drugs and leaves the U.S. with fewer treatments to respond to the variant's spread.
Bio Pharma Dive
SEPTEMBER 15, 2021
Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months.
Bio Pharma Dive
JULY 2, 2021
The agency is under pressure to grant full approvals to two coronavirus vaccines and faces important questions on how to handle the next Alzheimer's drugs after Aduhelm. A safety review of several arthritis medicines, meanwhile, is ongoing.
Bio Pharma Dive
JUNE 3, 2021
Study results disclosed ahead of ASCO could make Lynparza a standard "adjuvant" treatment for people with an inherited form of breast cancer — as long as they know they have it.
Bio Pharma Dive
MARCH 24, 2021
A group of drug companies, including Novartis, Takeda and Roche's Genentech, have agreed to collaborate with Vineti to usher in new identification standards for complex medicines.
Bio Pharma Dive
JANUARY 5, 2021
By March, the FDA expects to conclude reviews of key drugs for heart failure, Duchenne's and multiple myeloma, as well as decide on whether to clear Biogen's controversial Alzheimer's treatment.
Bio Pharma Dive
SEPTEMBER 17, 2021
In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19.
Bio Pharma Dive
OCTOBER 12, 2021
The gene editing company aims to expand its trial and add a second dose to improve effectiveness. However, safety worries have emerged since the FDA ordered CRISPR's rival Allogene to suspend clinical work.
Bio Pharma Dive
SEPTEMBER 23, 2021
Agency advisers supported giving a third Pfizer vaccine dose to older adults and those with medical conditions. But in a break with the FDA, they voted against recommending it for younger people in high-risk jobs.
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