Trending Articles

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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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Opinion: Balancing hope and reality: The promise and peril of blood-based colorectal cancer screening

STAT

As a gastroenterologist and cancer researcher, my mission is to help my patients live longer, healthier, and cancer-free lives. A rise in the number of younger Americans diagnosed with colorectal cancer worries me — early-age onset colorectal cancer is expected to surge by more than 140% by 2030. But because colorectal cancer is preventable with early screening and detection, it’s possible to reduce the number of Americans diagnosed with this disease in the prime of their lives.

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FDA Grants Breakthrough Device Designation to Assay Supporting Earlier Diagnosis of Alzheimer Disease

Pharmacy Times

If approved, the test could provide more timely and accurate diagnosis, hopefully mitigating the impact of Alzheimer disease (AD) on individuals and the community.

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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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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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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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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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Optical Sensor Shows Promise in Non-Invasive Continuous Glucose Monitoring

Pharmacy Times

Optical glucose sensing techniques have been reported, but they require complex optical instrumentations found in laboratories, so feasibility for patient use has been challenging.

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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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Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus

Fierce Pharma

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

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Online chatter points to broad layoffs at Optum—but the full extent is unclear

Fierce Healthcare

UnitedHealth Group subsidiary Optum appears to have laid off a significant percentage of its workforce, Fierce Healthcare has learned, though the full extent of those job cuts remains unclear. | UnitedHealth Group subsidiary Optum appears to have laid off a significant percentage of its workforce, Fierce Healthcare has learned, though the full extent of those job cuts remains unclear.

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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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Scott Soefje, PharmD: Take a Site-Specific Approach to Optimize Care Delivery, Finances

Drug Topics

According to Scott Soefje, PharmD, understanding nuances across sites of care can help health care providers optimize patient care delivery while ensuring financial viability across all settings.

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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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USDA releases H5N1 bird flu genetic data eagerly awaited by scientists

STAT

The U.S. Department of Agriculture, which has been under pressure from scientists both at home and abroad to share more data on the H5N1 bird flu outbreaks in dairy cows, uploaded a large number of genetic sequences of the pathogen late Sunday. Access to the 239 genetic sequences will help scientists assess whether the dangerous virus has acquired mutations that might make it easier for it to spread to and among mammals, and whether additional changes have been seen as it moves from cow to cow a

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Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir

Fierce Pharma

Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.

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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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Headspace expands to direct-to-consumer mental health market

Fierce Healthcare

Headspace has launched direct-to-consumer text-based mental health coaching to expand its reach beyond employer customers and capture the cash-pay healthcare market. | Headspace is entering the direct-to-consumer mental health coaching market, broadening its reach beyond its model of contracting with health plans and employers.

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On the Front Lines: Pharmacists' Role in Combating America's Opioid Epidemic

Drug Topics

The ongoing opioid crisis in the United States shows no signs of slowing down. As trusted community health care professionals, pharmacists must play a key role in fighting it.

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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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STAT+: In a scientific first, researchers use CRISPR base editing to treat liver disease in fetal monkeys

STAT

The ambitious idea of using CRISPR to cure genetic diseases before birth is one step closer to reality. Scientists reported on Monday that they used a form of the technology known as “ base editing ” to alter the DNA of laboratory monkeys in the womb, substantially reducing the levels of a toxic protein that causes a fatal liver disease before the animals had even been born.

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What pharma stands to gain from technological innovation

pharmaphorum

Pharmaceutical companies stand to gain significant benefits from technological innovation in the form of improved data analytics, streamlined healthcare processes, and enhanced patient outcomes. Explore the potential advantages for the pharma industry.

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Simple HealthKit partners with Amazon to increase access to at-home diagnostics and chronic care

Fierce Healthcare

Simple HealthKit is bringing chronic condition diagnostics to front porches across the country via a new partnership with Amazon. | Consumers can now buy Simple HealthKit’s at-home tests for diabetes (HbA1c), respiratory wellness and sexual wellness and have it shipped to their door through Amazon.

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Peer Recovery Support May Benefit Patients in Emergency Departments for Opioid Overdose

Drug Topics

Patients in ED being treated for an opioid overdose were more likely to initiate medication for opioid use disorder after discharge when they received peer recovery support services.

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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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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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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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Biden admin finalizing industry-opposed staffing requirements for nursing homes

Fierce Healthcare

The Biden administration will finalize a controversial nursing home staffing rule today that includes the more stringent requirements floated in last September’s proposal, Vice President Kamala Har | Later today the federal government will finalize the more stringent version of the Nursing Home Minimum Staffing rule floated last year, Vice President Kamala Harris' office said Monday morning.

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Pharmacies Should Adopt Proactive Health, Wellness to Help Patients

Drug Topics

Kathy Campbell, PharmD, discusses why she believes wellness and proactive health are the future of pharmacy and the unique value they offer compared to traditional models.

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Practical Considerations of T-Cell Engagers in the Management of Relapsed/Refractory Multiple Myeloma

Pharmacy Times

Integration of these agents requires supportive care considerations for cytokine release syndrome, neurotoxicity, infection, and antigen-specific toxicities to ensure optimal care of patients with multiple myeloma receiving T-cell–engaging therapies.

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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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With $75m cash injection, SynOx plans ph3 rare tumour trial

pharmaphorum

Ireland’s SynOx Therapeutics has completed a second-round financing, raising $75 million, as it prepares to take its drug for tenosynovial giant cell tumour (TGCT) into phase 3 trials. TGCT is a rare disease affecting the joints and tendons caused by overproduction of the protein CSF-1, which stimulates the proliferation of various cell types, inflammation, and destruction of the matrix of the joint.

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UnitedHealth offers update on cyberattack data analysis, systems restoration

Fierce Healthcare

UnitedHealth Group provided an update late Monday on its analysis of the data accessed in the cyberattack on Change Healthcare, and said it identified files that contain personal and health informa | UnitedHealth Group provided an update late Monday on its analysis of the data accessed in the cyberattack on Change Healthcare, and said it identified files that contain personal and health information.

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CVS Pharmacists in Rhode Island Petition to Unionize

Drug Topics

Nine pharmacists from 2 corporate locations in Wakefield and Westerly are seeking to join the Pharmacy Guild in an attempt to improve working conditions.

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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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Hospitals largely keep quiet on maternal care since Dobbs, STAT survey finds

STAT

The Supreme Court decision to overturn Roe v. Wade has transformed not just abortion access but maternal health care across the United States, causing physicians in states with restrictive laws to shift treatment of conditions including ectopic pregnancy and miscarriage. The full scale of the impact, though, has been obscured in a polarized political climate where physicians are often afraid to speak out, or are blocked by their hospitals from talking about their experiences post-Dobbs.

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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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