Drug Topics

AUGUST 22, 2024

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

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Vaccines FDA 154

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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Vaccines FDA 143

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.

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Insurance 133

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

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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

Patient Care

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.

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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.

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Medical Schools 142

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.

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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.

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FDA 126

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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Pharmacy Times

AUGUST 22, 2024

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

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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.

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.

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FDA 123

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.

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Hospitals 122

Pharmacy Times

AUGUST 22, 2024

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

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Vaccines FDA 122

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.

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Insurance 118

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.

FDA

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.

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Patient Care 115

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.

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Vaccines 112

Fierce Pharma

AUGUST 22, 2024

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.

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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

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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”.

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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.

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Fierce Pharma

AUGUST 22, 2024

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.

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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.

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pharmaphorum

AUGUST 22, 2024

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

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FDA 105

Pharmaceutical Commerce

AUGUST 22, 2024

The unveiling of the microbial fermentation manufacturing plant is headlined by a $131 million financial commitment.

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pharmaphorum

AUGUST 22, 2024

US insomniacs have a new prescription DTx option Phil.

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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.

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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.

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Pharmaceutical Commerce

AUGUST 22, 2024

The latest news for pharma industry insiders.

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Drug Topics

AUGUST 22, 2024

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

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Pharmaceutical Technology

AUGUST 22, 2024

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

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Packaging 98

pharmaphorum

AUGUST 22, 2024

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

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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.

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Vaccines 97

Fierce Pharma

AUGUST 22, 2024

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.

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Vaccines 97