Thu.Aug 22, 2024

article thumbnail

FDA approves updated Covid-19 vaccines, shots should be available in days

STAT

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.

Vaccines 144
article thumbnail

Disparities Hinder HPV Vaccine Goals in USAPI Jurisdictions

Drug Topics

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.

Vaccines 112
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

STAT+: U.K.’s cost-effectiveness agency gives negative review of Alzheimer’s drug Leqembi

STAT

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  In draft guidance, the U.K.’s cost-effectiveness watchdog on Thursday said that the limited benefits of the drug, also called lecanemab , do not justify its costs, citing not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.

142
142
article thumbnail

Employers embracing direct contracting and bypassing insurers: survey

Fierce Healthcare

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.

Insurance 132
article thumbnail

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

article thumbnail

STAT+: Gene therapy pioneer Jim Wilson believes he can commercialize rare-disease drugs in a tough climate

STAT

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

140
140
article thumbnail

Santa Clara County buying 258-bed HCA hospital for $175M to preserve trauma services

Fierce Healthcare

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.

Hospitals 120

More Trending

article thumbnail

FDA weighs limiting PD-1 drugs in stomach cancer, calls on experts to discuss Merck, BMS and BeiGene meds

Fierce Pharma

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.

FDA 121
article thumbnail

Opinion: In drug development, diversity must be extended to preclinical research

STAT

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.

FDA 123
article thumbnail

COVID-19: FDA Approves, Grants EUA to Moderna, Pfizer 2024-2025 Vaccine Formulations

Drug Topics

Novavax is still awaiting FDA authorization for their protein-based COVID-19 vaccine.

Vaccines 154
article thumbnail

STAT+: Digital therapeutics pioneer Pear’s treatments get a second life, a year after bankruptcy

STAT

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.

Insurance 127
article thumbnail

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.

article thumbnail

The fall and rise of digital therapeutics

pharmaphorum

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.

article thumbnail

Q&A: How Phononic is Revolutionizing Heating and Cooling for Pharmaceuticals

Drug Topics

Dana Krug, Senior Vice President of Cold Chain Fulfillment at Phononic, discussed the role his company’s technology plays in the pharmaceutical industry.

98
article thumbnail

Steward Health Care must hold off on issuing closure notice for PA hospital, bankruptcy judge rules

Fierce Healthcare

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.

Hospitals 125
article thumbnail

H1 Connect links doctors to global humanitarian missions

Outsourcing Pharma

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.

110
110
article thumbnail

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.

article thumbnail

An Extra Layer of Transparency and Accountability

Pharmaceutical Commerce

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.

105
105
article thumbnail

Breaking barriers in science: Thermo Fisher's Melanie Adams-Cioaba on innovation and inclusion

Outsourcing Pharma

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.

113
113
article thumbnail

With 36% increase, Eli Lilly leads industrywide sales boom in Q2

Fierce Pharma

Once again, fueled by booming sales of their GLP-1 products, Eli Lilly and Novo Nordisk were the top performers in the biopharma industry in the second quarter. | The momentum the biopharma industry showed in the first quarter of 2024 continued into the second quarter as 21 of the industry's top 25 companies achieved year-over-year revenue increases.

106
106
article thumbnail

Five-Part Action Plan For Patients With Asthma, COPD Helps to Alleviate Wildfire-Related Health Risks

Pharmacy Times

Communities that are impacted by increased wildfires can experience increased health risks, particularly among those who have asthma or chronic obstructive pulmonary disease.

94
article thumbnail

5 Reasons to Upgrade Your Pharmacy Management Software

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.

article thumbnail

Despite looming BIOSECURE threat, pharma contracting giant WuXi Bio scoops up new projects

Fierce Pharma

Despite some Western drugmakers’ concerns around working with Chinese manufacturers in light of the looming BIOSECURE Act, WuXi Biologics continues to pick up a steady stream of new contracts. | Despite some Western drugmakers’ concerns around working with Chinese manufacturers in light of the looming BIOSECURE Act, WuXi Biologics continues to pick up a steady stream of new contracts, the company said.

102
102
article thumbnail

STAT+: Pharmalittle: We’re reading about a negative U.K. review of Leqembi, Bavarian Nordic’s strong earnings, and more

STAT

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.

Vaccines 104
article thumbnail

Q&A: Social Drivers, Access to Care Limit Reach of Pharmacy-Based Diabetes Programs

Drug Topics

Addressing the external factors that can have an impact on patient health can make clinical interventions more effective when administered.

131
131
article thumbnail

Listen: BioMarin’s executive shakeup, a GLP-1 lowers diabetes risk, and a deep look at Recursion’s AI bona fides

STAT

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.

105
105
article thumbnail

Slideshow: Diabetes and Mental Health, Diet and Exercise for Prevention of T2D

Drug Topics

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.

112
112
article thumbnail

BioMarin revamps leadership with ex-Roche, Amgen execs

pharmaphorum

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

109
109
article thumbnail

UK health regulator rejects lecanemab as treatment for Alzheimer’s

The Guardian - Pharmaceutical Industry

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”.

101
101
article thumbnail

UnitedHealth, Trinity Health of New England settle network dispute

Fierce Healthcare

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.

123
123
article thumbnail

Bavarian Nordic shares jump as it logs new vaccine order in global fight against mpox

Fierce Pharma

As a rise in new mpox cases garners international attention, Danish drugmaker Bavarian Nordic is stacking up orders for its Jynneos vaccine and simultaneously seeing its share price jump. | The company reported a new order of its smallpox and mpox vaccine, Jynneos, from an undisclosed European country. The procurement deal adds to a list of several recent orders for the company.

article thumbnail

FDA Accepts Biologics License Application For Nivolumab Plus Ipilimumab to Treat Hepatocellular Carcinoma

Pharmacy Times

The FDA assigned the combination a Prescription Drug User Fee Act goal date of April 21, 2025.

FDA 122
article thumbnail

Q&A: As Scope of Practice Expands, Technology Must Catch Up

Drug Topics

Pharmacists can fill a role for patients, but without technology supporting workflows and reimbursement efforts, challenges will remain.

123
123
article thumbnail

Updated COVID-19 Vaccines Approved by FDA to Defend Against Circulating Variants

Pharmacy Times

The acceptance will lead to vaccines that provide better protection against the KP.2 strain of SARS-CoV-2.

Vaccines 122
article thumbnail

BMS eyes April FDA verdict on Opdivo/Yervoy in liver cancer

pharmaphorum

BMS looks ahead to April verdict from FDA on Opdivo/Yervoy combination as first-line treatment for unresectable hepatocellular carcinoma.

FDA 104
article thumbnail

Secondary packaging for sterile injectables: Overcoming today’s design challenges

Pharmaceutical Technology

Packaging experts discuss emerging challenges in secondary packaging design for injectables that balance sustainability with end-user needs.

article thumbnail

Changing Faces – Digital and supplier hires from July 2024

pharmaphorum

Changing Faces explores the digital and supplier hires of July, including Biomedica, Signant Health, Arima Genomics, and more. Stay updated on this exciting industry.

90