Tue.Apr 23, 2024

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FDA Issues CRL for Epidermolysis Bullosa Gene Therapy

Drug Topics

Abeona Therapeutics’ pz-cel is an investigational autologous, COL7A1 gene-corrected epidermal sheet therapy for the treatment of recessive dystrophic epidermolysis bullosa.

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FDA Approves Ankiva Plus Bacillus Calmette-Guérin For Non-Muscle Invasive Bladder Cancer

Pharmacy Times

The approval was based on the QUILT-3.032 study, which included 77 adults with carcinoma in situ with or without papillary tumors after a transurethral resection.

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Smell Loss Still Impacted Some Patients 1 Year After COVID-19 Diagnosis

Drug Topics

Collecting smell and taste scores from individuals with and without a history of COVID-19, researchers found significantly lower scores for smell in COVID-19-diagnosed individuals.

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H5N1 bird flu virus particles found in pasteurized milk but FDA says commercial milk supply appears safe

STAT

WASHINGTON — Testing conducted by the Food and Drug Administration on pasteurized commercially purchased milk has found genetic evidence of the H5N1 bird flu virus, the agency confirmed Tuesday. But the testing, done by polymerase chain reaction, or PCR, cannot distinguish between live virus or fragments of viruses that could have been killed by the pasteurization process.

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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

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Novartis nominates former Bristol Myers CEO Giovanni Caforio as its new chair. Will M&A deals follow?

Fierce Pharma

Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.

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Genetic analysis reveals H5N1 flu virus outbreak in cows likely started earlier than thought

STAT

The H5N1 bird flu outbreak in dairy cows in the United States has likely been going on for months longer than was previously realized, and has probably spread more widely across the country than the confirmed outbreaks would imply, according to an analysis of genetic sequences that were released Sunday by the U.S. Department of Agriculture. The genetic data point to a single spillover event that probably occurred in late 2023, Michael Worobey, an evolutionary virologist at the University of Ariz

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STAT+: FTC’s noncompete ban would force sweeping changes in health care, if it survives legal battle

STAT

The Federal Trade Commission approved a far-reaching noncompete ban Tuesday that could force sweeping changes across the health care industry. But those changes may not take effect for years — if they ever do — because the contentious rule will almost certainly be held up in litigation. Commissioners voted three to two in favor of approving the final rule banning noncompete agreements across all sectors of the economy, a change the agency says will lead to more new businesses and h

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FTC votes 3-2 on final rule to ban noncompete agreements, but legal challenges expected

Fierce Healthcare

The Federal Trade Commission (FTC) voted 3-2 Tuesday to issue a final rule striking new noncompete agreements for all workers and phasing out existing noncompetes for all but senior executives acro | The final rule, which does not apply to nonprofits, forbids noncompete contracts for all new hires and winds down existing noncompetes for all employees who are not senior executives.

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STAT+: The evidence grows: Prices spike after mergers between far-flung hospitals

STAT

The trend is clear: When hospitals in the same community merge, prices spike. The government has such an easy time blocking those deals, hospitals rarely propose them anymore. But a study released Tuesday adds to a growing body of evidence that prices still go up even if the merging hospitals are far apart. The Federal Trade Commission has never tried to block such cross-market mergers, but antitrust experts say these latest findings add to what could become a strong legal argument against the d

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FDA Approves Lutathera for Pediatric Patients With SSTR+ Gastroenteropancreatic Neuroendocrine Tumors

Pharmacy Times

This approval makes lutetium Lu177 the first therapy to be approved for the treatment of gastroenteropancreatic neuroendocrine tumors in pediatric patients.

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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.

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STAT+: Telehealth startups see an opportunity in long-ignored, complex chronic diseases

STAT

If her neurologist moved to China, Lauren Stiles says she’d follow him there. “There’s so few doctors who do this,” said the New York-based president of patient advocacy group Dysautonomia International. In her world, informed, experienced specialists — particularly in the autonomic nervous system — are extremely rare.

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Elevating Antimicrobial Stewardship: Insights From Pharmacist-Led Initiatives Combatting Health Care–Associated C diff

Pharmacy Times

Laura Gillespie, PharmD, discusses the impact of pharmacist-led initiatives on health care–associated C diff rates for health care systems.

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Orphan drug market to reach $270B by 2028, led by J&J, Vertex and Roche: Evaluate

Fierce Pharma

The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. | The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. But thanks to blockbuster meds across wider disease areas and other challenges, the lucrative market may soon slow down for the first time in years.

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Considerations When Treating Migraines in Gender Diverse Patients Receiving Gender-Affirming Hormone Therapy

Pharmacy Times

The AAN speaker highlights what health care providers need to know when treating migraines in populations on hormone therapy, as well as how hormones can influence migraines.

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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.

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STAT+: Day One drug for common childhood brain tumor approved by FDA

STAT

D ay One Biopharmaceuticals said Tuesday the Food and Drug Administration approved its pill for one of the most common forms of childhood brain tumors, called pediatric low-grade glioma. The authorization is particularly notable because industry has historically developed few drugs for children with cancer, focusing instead on adults and often only years later testing their molecules in younger patients.

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How do we unlock the potential of digital health?

pharmaphorum

Unlock the power of digital health through AI and clinical advancements. Learn how these technologies are shaping the future of healthcare and how to harness their potential.

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STAT+: NIH postdocs will get a raise next year — but not as much as they hoped

STAT

The National Institutes of Health will raise the minimum salary for postdoctoral researchers to $61,008 next year, the agency announced Tuesday, responding to growing calls from young life scientists to provide a living wage. The 8% pay bump is far short of the increase to $70,000 that was recommended by an NIH working group late last year. But the agency noted in a press release that it’s the largest year-over-year update for NIH-funded postdocs since 2017.

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FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt

pharmaphorum

After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product

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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.

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Opinion: Lessons to psychiatrists-in-training from the CIA’s mind-control projects

STAT

My chief resident gave me a strange look when I arrived for another day of work at the Mayo Clinic one morning. “Something you’re not telling us?” she asked, gesturing to the two letters on my desk from the Central Intelligence Agency. The jokes — about how I was secretly working for America’s international spy service — wrote themselves.

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Day One takes on Novartis with FDA nod for Ojemda in broader common childhood brain tumor use

Fierce Pharma

Another drug is in town for common pediatric brain tumors. Compared with an incumbent offering from Novartis, the newcomer boasts an FDA approval covering a broader patient population. | Another drug is in town for common pediatric brain tumors. Compared with an incumbent offering from Novartis, Day One's newcomer boasts an FDA approval covering a broader patient population.

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STAT+: Health care lobbying giants spent big as little got done in Congress

STAT

WASHINGTON — Congress did nothing this spring to rein in how pharmacy benefit managers operate, which is precisely the outcome the industry’s lobbyists wanted. And the PBM industry spent big to get that result, new disclosures show. The Pharmaceutical Care Management Association, the industry’s biggest trade group, spent a whopping 71% more on lobbying in the first three months of this year compared with 2023, increasing its spending from $2.8 million to $4.8 million.

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Blue Shield of California pleased with soft rollout of digital MSK pain treatment

Fierce Healthcare

More than 1,600 Blue Shield of California members have registered for a musculoskeletal (MSK) program through the payer's digital health platform since its launch in January. | Less than 2,000 members have registered for musculoskeletal health programs through the Blue Shield of California digital platform, but the insurer hopes to see growth ramp up soon.

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STAT+: Accreditation agencies take on telehealth with new virtual care standards

STAT

In the early days of the pandemic, as social distancing forced patients out of doctors’ offices, health care organizations scrambled to offer care online. In turn, health care accreditation organizations rushed to tweak their standards, filling a void in best practices for virtual visits. But as telehealth has matured, accreditation bodies — typically nonprofits that offer a seal of approval to organizations that pass their audits — are trying to address the nuance of digita

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CMS unveils managed care rule, refutes nursing home rule complaints

Fierce Healthcare

Medicaid managed care plans and the Children’s Health Insurance Program (CHIP) will be subject to new wait time standards and quality ratings requirements, the Centers for Medicare & Medicaid S | CMS defended implementing stronger rules over nursing home staffing as well as explained its thoughts behind Medicaid access and managed care rules.

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Encouraging early engagement to revitalise Europe’s pharmaceutical landscape

pharmaphorum

In an on-site interview at Reuters Pharma Europe in Barcelona, this week’s podcast saw Tommy Bramley, SVP of market access and healthcare consulting at Cencora, discuss revitalising Europe’s pharmaceutical landscape and leveraging legislation for health and competitiveness.

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Claims operation AI company Alaffia Health raises $10M in series A round

Fierce Healthcare

Alaffia Health, a health tech business that works with payers and third-party administrators to minimize fraud and help clinicians conduct reviews more efficiently, has raised $10 million in series | Alaffia Health's revenue has increased 4x in the last year. Here's how its AI tools help payer partners save money and be more efficient.

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FDA Grants Tovorafenib Approval to Treat Relapsed or Refractory Pediatric Low-Grade Glioma

Drug Topics

The approval for tovorafenib (Ojemda) was based on data from the phase 2 FIREFLY-1 trial, in which the therapy demonstrated an overall repose rate of 67%.

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Novartis names ex-BMS CEO Caforio as chair amid strong Q1

pharmaphorum

Novartis has proposed ex-BMS CEO Caforio as the successor to chair Joerg Reinhardt when he steps down next year, as it posts a strong set of Q1 results

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Striking Pharmacists Put Concern for Patients First

Drug Topics

The action taken by CVS staffers seems to be the only way to get the attention of corporate officials.

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Opinion: Bashing accelerated approval isn’t supported by the data

STAT

The Food and Drug Administration’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint” of overall survival (progression-free survival). Overall survival is usually considered the gold standard in oncology because people with cancer generally want to take medications that can help them live longer.

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Another delay for Abeona's topical gene therapy pz-cel as FDA sends out a rejection

Fierce Pharma

Dating to a 2019 clinical hold of a phase 3 trial, getting its gene therapy ra | Dating to a 2019 clinical hold, getting its gene therapy pz-cel across the FDA finish line has been a challenge for troubled Abeona Therapeutics. Now the wait continues as the FDA has rejected the treatment due to CMC issues.

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STAT+: Anticompetitive hospital mergers skate by due to FTC’s shallow resources

STAT

Over the past two decades, hundreds of hospital mergers have escaped federal antitrust scrutiny and led to both higher prices and less competition, a new study shows. But the study’s authors, and other researchers, believe the Federal Trade Commission’s hands often are tied. The agency simply doesn’t have enough money or people to crack down on all anticompetitive hospital deals, and some state laws shield hospital mergers from federal review completely.

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Eli Lilly inks deal to acquire Nexus manufacturing plant in WI as Mounjaro and Zepbound shortages drag on

Fierce Pharma

As doctors and patients in the U.S. | As doctors and patients in the U.S. grapple with widening shortages of the popular diabetes therapy Mounjaro and its obesity counterpart Zepbound, the maker of the tirzepatide drugs, Eli Lilly, is forging ahead on its quest to expand capacity for its injectable medicines.

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