October, 2024

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CVS ousts Karen Lynch, taps Caremark head as new CEO

Fierce Healthcare

It's a tumultuous time at industry giant CVS Health, and on Friday the company revealed a shake-up at the top that now has David Joyner stepping in as CEO. | It's a tumultuous time at industry giant CVS Health, and on Friday the company revealed a shake-up at the top that now has David Joyner stepping in as CEO.

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Senators Call on FTC to Investigate PBM Co-Manufacturing Tactic

Drug Topics

Senators Ron Wyden and Sherrod Brown wrote a letter to the Federal Trade Commission calling to explore yet another PBM tactic impeding competition.

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STAT+: Teva fined $503 million for disparaging a rival and using patents to thwart competition

STAT

Teva Pharmaceutical, the world’s largest generic drugmaker, was fined $503 million by European antitrust regulators for delaying competition to a blockbuster multiple sclerosis medicine. The European Commission found the company had artificially extended the patent protection of Copaxone and systematically spread misleading information about a rival product.

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The 2024 PharmaVoice 100

PharmaVoice

This year’s PharmaVoice 100 encompasses the industry’s ongoing revolutions and leaders who are not only navigating these changes, but at times, forging new paths for others to follow.

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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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FDA removes Novo's Wegovy from shortage list, marking end of semaglutide supply rout in US

Fierce Pharma

Less than a month after the FDA removed Eli Lilly’s tirzepatide from its shortage list, the agency has done the same for Novo Nordisk’s rival GLP-1 semaglutide, potentially signaling the end of a d | The FDA this week revised its shortage list to note that the.25 mg starter dose of Novo’s semaglutide-based obesity med Wegovy is now available in the U.S.

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Humanizing Pharmacy: Shifting From Volume to Value for Improved Care and Reduced Pharmacist Burnout

Pharmacy Times

Retail pharmacies benefit from the shift from a volume-centric model to a value-centric approach that focuses on enhancing patient care, reducing pharmacist burnout, and leveraging technology to improve efficiency and expand the scope of pharmacy services.

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Palliative Care Pharmacist Discusses How Building Relationships with Patients Leads to Rewarding Career

Drug Topics

A discussion with Madison Irwin, PharmD, BCPS, clinical pharmacist specialist in palliative care at University of Michigan Health and clinical assistant professor at the University of Michigan College of Pharmacy.

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STAT+: Two generic drugmakers pay $49 million to settle price-fixing charges

STAT

Two generic drugmakers, Apotex and Heritage Pharmaceuticals, have agreed to pay a combined $49 million to settle allegations they fixed prices on numerous medicines, the first such agreements since state attorneys general began probing price-fixing in the generics industry a decade ago. In 2016, a number of states filed what eventually became the first in a trio of lawsuits against many of the largest generic companies for allegedly coordinating efforts to fix and maintain prices for dozens of m

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On the front lines of the superbug war, new treatments can’t arrive soon enough

PharmaVoice

As antimicrobial resistance rises, researchers are running out of time to fight each new wave of superbugs. And the funding isn’t enough.

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Novo Nordisk asks FDA to prevent compounders from making copycat versions of GLP-1 star semaglutide

Fierce Pharma

The war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patent | Novo Nordisk has asked the FDA to prevent compounders from manufacturing copycat versions of its juggernaut diabetes and obesity treatments Ozempic and Wegovy, claiming the drugs are too complex to safely replicate.

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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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FDA Recalls Over 7000 Bottles of Duloxetine Because of Chemical Presence

Pharmacy Times

The FDA announces a Class II recall for the lot #220128, which were reported to contain the presence of nitrosamine.

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Novartis pays $150m upfront for Monte Rosa degrader drug

pharmaphorum

The lengthening list of pharma alliances focused on molecular glue degraders has another entry after Novartis signed a deal with Monte Rosa Therapeutics worth up to $2.2 billion. The partnership – which has seen a $150 million upfront payment from Novartis alongside a pledge for up to $2.1 billion in milestones – gives the Swiss pharma group rights to Monte Rosa's VAV1-directed molecular glue degrader programme.

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Pharmacy-Based PrEP Program Can Increase HIV Prevention Services Among MSM

Drug Topics

Individuals living in rural areas can benefit from pharmacy-based pre-exposure prophylaxis programs.

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STAT+: Dreams of cancer vaccines are becoming more real. Here are 9 scientists making it happen 

STAT

Vaccines are the original immunotherapy, in the view of Ryan Sullivan, a cancer immunotherapy researcher and oncologist at Mass General Cancer Center. But many other modes of immunotherapy for cancer were approved first — checkpoint blockade drugs like Keytruda and engineered immune cell therapies like Yescarta. Shadowed by the successes of other therapies, the field of cancer vaccines was “seemingly dying,” Sullivan said.

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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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An Alzheimer’s drugmaker is accused of data ‘manipulation.’ Should its trials be stopped?

PharmaVoice

Cassava Sciences’ beleaguered investigational Alzheimer’s therapy is in two phase 3 studies.

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After prior rejection, Iterum nabs long-sought FDA nod for oral UTI drug Orlynvah

Fierce Pharma

Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem. | Iterum's Orlynvah was approved by the FDA Friday to treat certain uncomplicated urinary tract infections (uUTIs) in adult women who have limited or no alternative antibacterial treatment options.

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Op-Ed: Lower Prescription Drug Costs, Pass PBM Reform Legislation

Pharmacy Times

Lowering prescription drug costs for patients, saving taxpayers money, helping small businesses level an anti-competitive playing field: all of this is at stake.

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Thank You to the Massachusetts Association of Ambulatory Surgery Centers

OctariusRx

Speaking at the “2024 Northeast ASC Conference” is always a great time. A special thank you to MAASC President, Greg DeConciliis for the invitation to participate. My presentation focused on current topics in medication management, including patient safety, safe injection practices and controlled substances. As always, the most rewarding part of the conference was seeing old friends and meeting new ones.

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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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How Mark Cuban Cost Plus Drug Company Is Approaching Drug Pricing Transparency

Drug Topics

Erin Albert, vice president of pharmacy relations and chief privacy officer at Mark Cuban Cost Plus Drug Company, PBC, discussed drug pricing and what her company is doing to revolutionize transparency.

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STAT+: Novo Nordisk’s Ozempic and Wegovy, long in shortage, are now listed as available by FDA

STAT

All doses of Novo Nordisk’s blockbuster diabetes and obesity treatments are listed as available on the Food and Drug Administration’s drug shortage list as of Wednesday, raising the possibility that the medications could soon be taken off the list entirely, a development that could affect compounding pharmacies and patients relying on compounded drugs.

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Where Big Pharma’s campaign cash is flowing in this election

PharmaVoice

Big Pharma CEOs are hedging all bets by supporting both sides of the aisle in the 2024 election.

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UK's Labour Party unveils £520M innovative manufacturing fund as part of life-sci-heavy budget

Fierce Pharma

Biopharma production efforts are set to receive a big boost in the U.K. thanks to a new budget rolled out by the Labour Party following this summer’s general election. | As part of the new budget presented Wednesday by the U.K.’s Chancellor of the Exchequer, Rachel Reeves, the country is debuting a new capital grants vehicle known as the Life Sciences Innovative Manufacturing Fund.

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QSM Scans Indicate Brainstem Damage is Key to Long-Lasting Physical, Psychiatric Effects of Severe COVID-19

Pharmacy Times

High-resolution scans can provide a picture of a patient’s brain that typical MRIs cannot, allowing for more detailed insights into the neurological effects of COVID-19.

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Chiesi announces phase 3 results from enzyme-replacement study

Pharmafile

Chiesi Global Rare Diseases have announced the results from their BRIGHT trial, which evaluates the efficacy of enzyme-replacement therapy drug ELFABRIO at twice the approved dose in patients who have been treated with agalsidase alfa or beta. The current approved dose of pegunigalside alfa-iwxj (ELFABRIO) is 1miligramg (mg) per kilogram (kg) administered every two weeks. […] The post Chiesi announces phase 3 results from enzyme-replacement study appeared first on Pharmafile.

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Pharmacy Benefit Managers: The Silent Squeeze on Independent Pharmacies in America

Drug Topics

Industry experts gathered to discuss pharmacy benefit managers, their current grasp on the drug supply chain, and how it all impacts independent pharmacies.

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STAT+: Warren wants close FTC scrutiny of drug distributors buying cancer medical groups

STAT

Sen. Elizabeth Warren (D-Mass.) is urging the Federal Trade Commission to scrutinize recent deals from McKesson and Cardinal Health to buy oncology practices, saying those transactions pose “clear, anticompetitive risks.” McKesson, Cardinal Health, and Cencora are the three dominant wholesalers that distribute drugs and medical products.

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‘It’s been hard to watch.’ A noted epidemiologist talks H5N1 and the U.S.’s fragmented response

PharmaVoice

Katelyn Jetelina, well known for her newsletter “Your Local Epidemiologist,” digs into the H5N1 outbreak, the public health response and what’s next for vaccinations.

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Bristol Myers partner Zai Lab plots KarXT filing in China after trial win

Fierce Pharma

After the recent FDA approval for the promising schizophrenia drug Cobenfy (xanomeline and trospium chloride), Bristol Myers Squibb and its partners are moving fast to expand the global reach of th | In a phase 3 bridging study run by Zai Lab in China, Bristol Myers Squibb's KarXT helped schizophrenia patients chart a 9.2-point total-score reduction on the Positive and Negative Syndrome Scale versus placebo at week 5, teeing up a forthcoming regulatory filing.

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Clinicians, Pharmacists Should Work to Ensure Safety Compounded GLP-1 Medications

Pharmacy Times

Pharmacists can educate patients about how to recognize unsafe online sources of medications and ensure patients are properly educate on how to administer their medications.

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Weight-loss drug firm accused of prioritising profits after halting insulin pen production

The Guardian - Pharmaceutical Industry

Novo Nordisk’s decision will force people in developing countries to use outdated glass vials and syringes, warn campaigners The pharmaceutical company behind injectable weight-loss drugs has been accused of prioritising profits over the health of people in developing countries by halting production of its insulin pens. People living with type 1 diabetes who are reliant on the human insulin produced by Novo Nordisk, will instead be given glass vials and syringes – which they say are inconvenient

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Vaccination Key to Preventing COVID-19 Hospitalizations Among Children

Drug Topics

A study found that children aged 6 months or younger who are not eligible for vaccination were at the highest risk for hospitalization due to SARS-CoV-2.

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STAT+: Drug may make chemotherapies less effective in cancer patients with obesity — but many doctors are in the dark

STAT

A drug used to combat fungal infections in cancer patients comes with a big caveat — research shows the medicine can last twice as long as in people with obesity. This means chemotherapies may be less effective when interacting with the medicine, but some clinicians, and their patients, are unaware of that possibility. The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population.

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AlphaFold’s Nobel Prize is ‘the dawn of a new era’ in mapping drug development potential

PharmaVoice

A Nobel Prize in chemistry for Google’s DeepMind protein-structure mapping is the tip of the iceberg for advances in drug discovery and development.

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