COVID-19: FDA Approves, Grants EUA to Moderna, Pfizer 2024-2025 Vaccine Formulations
Drug Topics
AUGUST 22, 2024
Novavax is still awaiting FDA authorization for their protein-based COVID-19 vaccine.
Thu.Aug 22, 2024
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FDA approves updated Covid-19 vaccines, shots should be available in days
STAT
AUGUST 22, 2024
WASHINGTON — U.S. regulators approved updated Covid-19 vaccines on Thursday, shots designed to more closely target recent virus strains — and hopefully whatever variants cause trouble this winter, too. With the Food and Drug Administration’s clearance, Pfizer and Moderna are set to begin shipping millions of doses. A third U.S. manufacturer, Novavax, expects its updated vaccine version to be available a little later.
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Disparities Hinder HPV Vaccine Goals in USAPI Jurisdictions
Drug Topics
AUGUST 22, 2024
Access inequities are preventing the US-affiliated Pacific Island (USAPI) jurisdictions from meeting the WHO 2030 goal of 90% human papillomavirus (HPV) vaccination series completion coverage.
Columbia medical school gets $400 million gift to fund long-shot basic research
STAT
AUGUST 22, 2024
Columbia University announced Thursday that its medical school has received $400 million to fund a new institute for basic biomedical research to fuel future discoveries that could improve human health and lead to new drug discoveries. The gift, from Columbia alumni Roy and Diana Vagelos, is the largest single donation given to the school and brings to $900 million the total given to Columbia by the couple since 2010.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Q&A: Social Drivers, Access to Care Limit Reach of Pharmacy-Based Diabetes Programs
Drug Topics
AUGUST 22, 2024
Addressing the external factors that can have an impact on patient health can make clinical interventions more effective when administered.
STAT+: Tome Biosciences, once a high-flying gene-editing startup, is floundering
STAT
AUGUST 22, 2024
Buzzy gene-editing startup Tome Biosciences is floundering, just nine months after launching with $213 million in funding, according to several sources with direct knowledge of the matter. One person with knowledge of the situation told STAT that Tome is winding down operations altogether and seeking a buyer by Nov. 1. Another source reported that there are still options on the table to keep the biotech running.
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STAT+: U.K.’s cost-effectiveness agency gives negative review of Alzheimer’s drug Leqembi
STAT
AUGUST 22, 2024
LONDON — Leqembi, the Alzheimer’s treatment from Eisai and Biogen, has hit another roadblock reaching patients in Europe. In draft guidance, the U.K.’s cost-effectiveness watchdog on Thursday said that the limited benefits of the drug, also called lecanemab , do not justify its costs, citing not just the price of the treatment but the related expenses of administering it and monitoring for side effects.
Q&A: As Scope of Practice Expands, Technology Must Catch Up
Drug Topics
AUGUST 22, 2024
Pharmacists can fill a role for patients, but without technology supporting workflows and reimbursement efforts, challenges will remain.
STAT+: Gene therapy pioneer Jim Wilson believes he can commercialize rare-disease drugs in a tough climate
STAT
AUGUST 22, 2024
If you’d told Jim Wilson three years ago that he’d be stepping down as director of the University of Pennsylvania’s storied Gene Therapy Program, he wouldn’t have believed you. And yet he’s now doing exactly that. Wilson, a gene therapy pioneer who has spent decades devising ways to deliver functional copies of missing or defective genes to patients, recently announced that he’s leaving Penn to found a pair of companies focused on developing gene therapi
Slideshow: Diabetes and Mental Health, Diet and Exercise for Prevention of T2D
Drug Topics
AUGUST 22, 2024
Recent research on diabetes has examined its bidirectional relationship with mental health, the significant increase in prevalence over the last decade, and how both diet and exercise can help prevent type 2 diabetes.
Position Your Pharmacy for Expansion
Speaker: Chris Antypas and Josh Halladay
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
Employers embracing direct contracting and bypassing insurers: survey
Fierce Healthcare
AUGUST 22, 2024
Employers are actively seeking out alternatives to curb rising health benefit costs by sidestepping traditional carriers, a new report from Brighton Health Plan Solutions shows. | A new report highlights a business opportunity for providers and health systems to engage in direct contracting.
Community Pharmacists Can Impact Disparities in Care Delivery, Access
Drug Topics
AUGUST 22, 2024
The tools that can be used to reduce health disparities exist, but they must be widely disseminated to populations across the US.
STAT+: Digital therapeutics pioneer Pear’s treatments get a second life, a year after bankruptcy
STAT
AUGUST 22, 2024
Over a year after Pear Therapeutics filed for bankruptcy and shut down, its smartphone apps for people with substance use disorder and opioid use disorder are again available to patients. After acquiring Pear’s Food and Drug Administration-cleared apps, called reSET and reSET-O,in December 2023 , virtual addiction treatment company PursueCare this month began offering them to its patients.
BioMarin taps Amgen, Roche vets in executive reshuffle
PharmaVoice
AUGUST 22, 2024
Greg Friberg and James Sabry will take over, respectively, as heads of R&D and business development, less than a year after BioMarin named a new CEO.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
UnitedHealth, Trinity Health of New England settle network dispute
Fierce Healthcare
AUGUST 22, 2024
UnitedHealthcare and Trinity Health of New England have agreed to a new, multiyear contract, retroactive July 1, putting to bed a public dispute between the two organizations. | UnitedHealthcare and Trinity Health of New England have finally resolved their breakdown in provider network contract negotiations.
Will the IRA squash new drugs? Those worries are likely exaggerated, studies say.
PharmaVoice
AUGUST 22, 2024
There’s no link between revenue and R&D from smaller biotechs, and that’s where most innovation comes from, according to new studies.
Steward Health Care must hold off on issuing closure notice for PA hospital, bankruptcy judge rules
Fierce Healthcare
AUGUST 22, 2024
A Thursday afternoon sale hearing scheduled for several Steward Health Care hospitals was shelved in favor of an amended bankruptcy court itinerary hashing out multiple disputes related to the comp | A busy day in bankruptcy court brought new updates on Steward Health Care's bids and closure plans for hospitals in Florida, Pennsylvania and Massachusetts.
Opinion: In drug development, diversity must be extended to preclinical research
STAT
AUGUST 22, 2024
The pharmaceutical industry has long operated on a one-size-fits-all model, developing drugs primarily tested on, and thus best suited for, people of European descent. This approach ignores — and potentially harms — the billions of people of color on the planet. Lack of diversity occurs at all levels of the pharmaceutical ecosystem, from the makeup of C-suite and research staffs to participation in clinical trials.
5 Reasons to Upgrade Your Pharmacy Management Software
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Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.
FDA Accepts Biologics License Application For Nivolumab Plus Ipilimumab to Treat Hepatocellular Carcinoma
Pharmacy Times
AUGUST 22, 2024
The FDA assigned the combination a Prescription Drug User Fee Act goal date of April 21, 2025.
Santa Clara County buying 258-bed HCA hospital for $175M to preserve trauma services
Fierce Healthcare
AUGUST 22, 2024
California’s Santa Clara County has cut a $175 million deal with HCA Healthcare to purchase a 258-bed hospital, a move the county says will restore critical care services for its residents. | HCA Healthcare had recently downgraded trauma and other services at Regional Medical Center, triggering a spike in volumes at the county's other Level 1 trauma center.
Updated COVID-19 Vaccines Approved by FDA to Defend Against Circulating Variants
Pharmacy Times
AUGUST 22, 2024
The acceptance will lead to vaccines that provide better protection against the KP.2 strain of SARS-CoV-2.
The fall and rise of digital therapeutics
pharmaphorum
AUGUST 22, 2024
Discover how digital therapeutics (DTx) have evolved in the wake of COVID-19, and how they are changing the landscape of healthcare. Explore the fall and rise of DTx and their potential impact on patient care.
UK health regulator rejects lecanemab as treatment for Alzheimer’s
The Guardian - Pharmaceutical Industry
AUGUST 22, 2024
Decision by Nice to rule out drug being available on NHS comes despite medicines licensing body giving green light The UK’s health regulator has rejected a drug that can slow the progression of Alzheimer’s disease, saying its benefits are too small to justify the costs of the therapy and close monitoring of patients for signs of “serious side-effects”.
BioMarin revamps leadership with ex-Roche, Amgen execs
pharmaphorum
AUGUST 22, 2024
BioMarin names Amgen's Greg Friberg to lead its R&D and former Roche exec James Sabry as its chief dealmaker amid a strategy change
Listen: BioMarin’s executive shakeup, a GLP-1 lowers diabetes risk, and a deep look at Recursion’s AI bona fides
STAT
AUGUST 22, 2024
What does the hiring of a well-known industry dealmaker mean for the future of BioMarin Pharmaceuticals? Can Eli Lilly’s blockbuster obesity medicine lower the risk of diabetes? And will Recursion Pharma, the AI drug developer, live up to all the hype? We discuss all that and more on this week’s episode of “The Readout LOUD.
H1 Connect links doctors to global humanitarian missions
Outsourcing Pharma
AUGUST 22, 2024
H1's decision to partner with GRM for this critical initiative in Ukraine was driven by a strong commitment to harness the power of global healthcare networks to provide humanitarian aid in regions that need it most.
FDA weighs limiting PD-1 drugs in stomach cancer, calls on experts to discuss Merck, BMS and BeiGene meds
Fierce Pharma
AUGUST 22, 2024
The FDA is once again gathering external experts to scrutinize PD-1 inhibitors as a group. | The FDA will hold an advisory committee meeting on Sept. 26 to consider whether approvals for checkpoint inhibitors in advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma—as well as in esophageal squamous cell carcinoma (ESCC)—should be restricted based on a tumor’s PD-L1 expression.
Breaking barriers in science: Thermo Fisher's Melanie Adams-Cioaba on innovation and inclusion
Outsourcing Pharma
AUGUST 22, 2024
In the rapidly evolving field of drug discovery, Melanie Adams-Cioaba stands at the forefront, leading transformative advancements in cryo-electron microscopy (cryo-EM) at Thermo Fisher Scientific.
STAT+: Pharmalittle: We’re reading about a negative U.K. review of Leqembi, Bavarian Nordic’s strong earnings, and more
STAT
AUGUST 22, 2024
Good morning, Pharmalittle fans! Adam Feuerstein here, filling in for Ed. I drink my morning coffee from a heavy, thick diner mug. I suggest you do the same. Here’s some news for your Thursday morning. … Eisai and Biogen secured approval in the U.K. for their Alzheimer’s treatment, Leqembi, but at the same time, the U.K.’s cost-effectiveness watchdog agency issued draft guidance that said the drug’s limited benefits do not justify its costs, STAT reports.
An Extra Layer of Transparency and Accountability
Pharmaceutical Commerce
AUGUST 22, 2024
In the final part of his Pharma Commerce video interview, Matt Hawkins, CaryHealth’s Chief Technology Officer, comments on the importance of mitigating security risks, along with ways to take action.
BMS eyes April FDA verdict on Opdivo/Yervoy in liver cancer
pharmaphorum
AUGUST 22, 2024
BMS looks ahead to April verdict from FDA on Opdivo/Yervoy combination as first-line treatment for unresectable hepatocellular carcinoma.
Fujifilm Opens Billingham Production Facility
Pharmaceutical Commerce
AUGUST 22, 2024
The unveiling of the microbial fermentation manufacturing plant is headlined by a $131 million financial commitment.
US insomniacs have a new prescription DTx option
pharmaphorum
AUGUST 22, 2024
US insomniacs have a new prescription DTx option Phil.
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