Drug Topics

AUGUST 12, 2024

Our congressional representatives have plenty of interaction with PBM lobbyists. It’s time they hear from patients as well.

PharmaVoice

AUGUST 12, 2024

Deals driven by obesity meds are fueling an M&A comeback.

Drug Topics

AUGUST 12, 2024

Ascendis Pharma said it is currently completing manufacturing of commercial product, which it anticipates will be available in the US in the first quarter of 2025.

FDA

STAT

AUGUST 12, 2024

If you twirl a bottle of alcohol and squint, you might see a text box with a warning. Usually in black and white, with letters two to three millimeters high, it reads: GOVERNMENT WARNING: (1) According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects. (2) Consumption of alcoholic beverages impairs your ability to drive a car or operate machinery, and may cause health problems.

Labelling

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

Drug Topics

AUGUST 12, 2024

Call Developed as Part of National Initiative with Stakeholder Input.

STAT

AUGUST 12, 2024

When the FDA learned that a testing facility in India had submitted fraudulent data for more than 400 drugs (most of them generics), the agency should have withdrawn them from the market. Instead, it has allowed these drugs to continue to be prescribed and distributed for at least a year as the pharmaceutical companies retest them for equivalency to the original brand-name drugs.

FDA

STAT

AUGUST 12, 2024

Pharmacy benefit managers have been in the crosshairs of late, as the focus of media scrutiny, government investigations and reports, and proposed federal legislation. A few recent examples make the point: A New York Times story in June 2024 bore the headline, “Pharmacy benefit managers are driving up drug costs for millions of people, employers and the government.

Patient Care

Pharmacy Times

AUGUST 12, 2024

The trial evaluated a fixed-dose combination of vibostolimab and pembrolizumab in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer.

Chemotherapy

Fierce Pharma

AUGUST 12, 2024

Ascendis Pharma should be well prepared for the U.S. | After two delays, the FDA has finally signed off on Ascendis Pharma's hormone replacement therapy Yorvipath, also known as TransCon PTH, which is the first approved product for hypoparathyroidism in adults in the U.S.

FDA

STAT

AUGUST 12, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning. A hard weekend for those backing MDMA-assisted psychotherapy: First, the FDA rejects a treatment from Lykos Therapeutics. Now a journal is retracting three MDMA papers, citing data integrity issues. Also, a nasal epinephrine spray gets an FDA approval, and more.

FDA

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.

Fierce Healthcare

AUGUST 12, 2024

A recent rule by the Centers for Medicare & Medicaid Services (CMS) extending health insurance to children of undocumented immigrants under the Deferred Action for Childhood Arrivals (DACA) pro | A coalition of right-leaning states are calling foul on a recent CMS rule that would expand health insurance for DACA recipients under the Affordable Care Act.

Insurance Coverage

STAT

AUGUST 12, 2024

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of phone calls, online meetings, and deadlines has predictably returned. But you knew this would happen, yes? After all, we can only move forward. So what better way to cope than with a refreshing cup or two of stimulation?

FDA

Fierce Healthcare

AUGUST 12, 2024

Prior authorization denials in Medicare Advantage jumped between 2021 and 2022, according to a new analysis from KFF.

STAT

AUGUST 12, 2024

Want to stay on top of health news?  Sign up  to get our Morning Rounds newsletter in your inbox. It’s Brittany subbing for Theresa this fine Monday. Thank you for all of the excellent song recommendations over the weekend. If you want to check out my road trip playlist, you can find it here.

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

Fierce Pharma

AUGUST 12, 2024

Following last year’s acquisition of viral vector and plasmid specialist Forge Biologics, Japan’s Ajinomoto Bio-Pharma Services is streamlining its business in San Diego. | Following last year’s acquisition of viral vector and plasmid specialist Forge Biologics, Japan’s Ajinomoto Bio-Pharma Services is streamlining its business in San Diego. As a result, 71 California-based staffers—or 13% of the company’s overall workforce—are set to lose their jobs, Ajinomoto said in a memo shared with Fierce

pharmaphorum

AUGUST 12, 2024

Explore how the recent and upcoming elections may impact the field of life sciences and medical technology. Stay informed about the intersection of politics and health advancements.

Fierce Pharma

AUGUST 12, 2024

Locked in a closely watched respiratory syncytial virus (RSV) vaccine competition, Pfizer aims to expand the reach of its offering Abrysvo. | Locked in a closely watched RSV vaccine competition, Pfizer aims to expand the reach of its offering Abrysvo. Monday, Pfizer said Abrysvo elicited a strong response in adults with compromised immune systems.

Vaccines

pharmaphorum

AUGUST 12, 2024

MSD adds a bispecific antibody for blood cancers and autoimmune diseases to its pipeline via a $1.3bn licensing deal with Curon Biopharma.

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Pharmacy Management Software

Fierce Pharma

AUGUST 12, 2024

Despite hitting a roadblock on the path to approval for its once-weekly insulin icodec in the U.S., Novo Nordisk is continuing to move full speed ahead with a combo treatment pairing the drug with | Despite hitting a roadblock on the path to approval for its once-weekly insulin icodec in the United States, Novo Nordisk is continuing to move full speed ahead with a combo treatment pairing the drug with its unstoppable GLP-1 semaglutide.

FDA

pharmaphorum

AUGUST 12, 2024

Journal retracts three articles on MDMA-assisted psychotherapy, shortly after FDA blocks approval of @Lykos_PBC's therapy for PTSD

FDA

Pharmacy Times

AUGUST 12, 2024

Risk of developing anxiety or depression is highest within the first year after cardiovascular hospitalization.

Hospitals

pharmaphorum

AUGUST 12, 2024

Three controversial decisions by NICE on NHS use of new multiple myeloma therapies are heading for the end of comment and appeals processes.

Pharmacy Times

AUGUST 12, 2024

Palopegteriparatide is a prodrug of parathyroid hormone designed to provide continuous exposure of the hormone over a 24-hour dosing period.

FDA

Fierce Pharma

AUGUST 12, 2024

After treading the commercial path alone for the past year and change, Revance Therapeutics, maker of the Botox rival Daxxify, has agreed to fly the Crown Laboratories flag. | Revance and Crown Laboratories—a privately held skin care company with multiple marketed products of its own—are merging, the companies said in a release Monday. Under the deal, which has won the unanimous blessing of Revance’s board of directors, Crown will enter a tender offer to acquire all outstanding Revance stock for

Pharmaceutical Technology

AUGUST 12, 2024

As antibody drug conjugate (ADC)-centred deals dominate the oncology space, biotechs are using newer targets and linkers to differentiate themselves.

Pharmaceutical Commerce

AUGUST 12, 2024

A lack of access could shut out patients in need of maintenance drugs for complex conditions.

The Checkup by Singlecare

AUGUST 12, 2024

There’s a new needle-free treatment option for people at risk for life-threatening allergic reactions. On August 9, the U.S. Food and Drug Administration (FDA) approved neffy, a nasal spray for the emergency treatment of anaphylaxis. It’s the first epinephrine product that does not have to be administered by injection. The approval comes more than three decades after epinephrine was first approved by the FDA for the treatment of anaphylaxis in 1987.

FDA

Pharmaceutical Commerce

AUGUST 12, 2024

The latest news for pharma industry insiders.

Pharmacy Times

AUGUST 12, 2024

The systematic review summarized all available evidence on the subject, finding that intravenous immunoglobulin could have a role in treatment.

Pharmaceutical Commerce

AUGUST 12, 2024

In this part of his Pharma Commerce video interview, Josh Marsh, Vice President and General Manager of Cardinal Health Sonexus Access and Patient Support, discusses the impact technology has in relation to patients sticking to their medication plan.

pharmaphorum

AUGUST 12, 2024

ARS Pharma gets FDA approval for epinephrine nasal spray neffy, the first needle-free alternative to EpiPen-style autoinjectors for serious allergic reactions.

FDA

The Checkup by Singlecare

AUGUST 12, 2024

Nearly half of U.S. adults want to lose weight , and many are looking for solutions that can aid them in their journey. Some are turning to Farxiga (dapagliflozin) , a Type 2 diabetes drug that can cause weight loss as a side effect. This medication improves blood glucose levels by removing excess sugar from the body. Farxiga also can reduce the risk of hospitalization from heart failure and slow down kidney disease progression in patients with chronic renal disease.

Labelling

pharmaphorum

AUGUST 12, 2024

BiVictriX is the latest UK biotech to say it wants to cancel its AIM-listed shares and go private in pursuit of better financing opportunities.