Pharmafile
APRIL 5, 2023
The FDA has announced that it will require opioid analgesic manufacturers to provide prepaid mail-back envelopes in outpatient pharmacies and dispensers as an additional disposal option for patients.
PharmaVoice
APRIL 6, 2023
Pharming just landed an FDA approval for a treatment targeting an ultra-rare immunodeficiency disorder discovered only a decade ago — and it’s already in the hands of patients.
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Pharmafile
APRIL 4, 2023
The FDA has published a report revealing that Global Pharma’s plant in India’s Chennai city failed to achieve safety norms throughout multiple observations. In February 2023, the eye drops, under the brand names EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, were recalled after a recommendation from the FDA, which then stopped the import of the products to the US.
PhRMA
APRIL 6, 2023
Next week, the Medicare Payment Advisory Commission (MedPAC) will vote on a number of policy proposals for changing Medicare Part B. One of the proposals would recommend that Congress adjust the payment for Part B medicines with accelerated approval , including medicines for serious and life-threatening diseases like cancers, rare diseases and HIV. This could compromise patient access to medicines, which is the opposite of what accelerated approval is designed to do.
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.
Drug Topics
APRIL 3, 2023
The new feature automatically applies manufacturer-sponsored coupons directly to an eligible patient’s order. So far, only a few pharma companies have made their coupons available through Amazon.
STAT
APRIL 3, 2023
Every hospital in America promises to protect the privacy of its patients and the details of their medical care. And almost every one of them uses sophisticated data tools to track and share the personal information of visitors as soon as they start clicking on their websites. A new study found that 99% of U.S. hospitals employed online data trackers in 2021 that transmitted visitors’ information to a broad network of outside parties, including major technology companies, data brokers, an
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
PhRMA
APRIL 7, 2023
PhRMA president and CEO Stephen J. Ubl spoke recently at The Hill’ s event, “ Pathways to Patient Affordability.” He spotlighted patients’ affordability challenges, the unintended consequences we’re already seeing from the government price setting provisions in the Inflation Reduction Act (IRA) and how policymakers can address harmful pharmacy benefit manager (PBM) practices.
Drug Topics
APRIL 6, 2023
Data reveal 50% of meningitis vaccination appointments were delayed or canceled amid the COVID-19 pandemic, leading authors of a survey to highlight the need for “urgent action” to maintain routine vaccination levels among children.
STAT
APRIL 7, 2023
In a case that could reshape pregnancy in America, a federal judge on Friday sided with anti-abortion groups seeking a nationwide ban on abortion pills, ruling that the Food and Drug Administration acted improperly in approving mifepristone in 2000. The ruling will go into effect in seven days if a stay is not granted by an appeals court or by the Supreme Court.
Pharmacy Times
APRIL 7, 2023
Eye drops come in many forms and for many indications, such as redness, itchiness, dryness, allergies, dilating drops, glaucoma drops, lubricants, numbing agents, antibiotics, and to lower pressure.
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.
PhRMA
APRIL 4, 2023
This week marks a somber anniversary for patients with Alzheimer’s. Last year, the Centers for Medicare & Medicaid Services (CMS) finalized a national coverage determination (NCD) that, for the first time ever, uses a coverage with evidence development (CED) policy that forces Medicare patients into highly restrictive research studies to simply gain access to new Alzheimer’s medicines that have been approved by the U.S.
Drug Topics
APRIL 4, 2023
During a session at the 2023 HOPA Annual Conference, Rebecca Champion, PharmD, BCOP, highlighted new therapies in the market for hematologic malignancies with a focus on bispecific antibodies and chimeric antigen receptor T-cell therapies.
STAT
APRIL 4, 2023
For the first time, Mark Cuban’s Cost Plus Drug Company is selling medicines made by a large drug manufacturer directly to consumers at a greatly reduced price, the latest sign that the billionaire is trying to make good on his vow to disrupt the opaque pharmaceutical supply chain. Until now, the company has focused on selling generic versions of brand-name medicines.
Fierce Healthcare
APRIL 4, 2023
6 megadeals made up 40% of digital health funding in Q1 as smaller startups face rough waters: Rock Health hlandi Tue, 04/04/2023 - 14:40
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PhRMA
APRIL 5, 2023
The United States will soon reach an important milestone in the COVID-19 pandemic: the official end of the federal public health emergency (PHE). According to the U.S. Department of Health and Human Services (HHS), the COVID-19 PHE will expire on May 11, 2023. This significant transition has been made possible, in part, by the biopharmaceutical industry’s continuing efforts to research, develop and manufacture safe, effective treatments and vaccines for COVID-19.
Drug Topics
APRIL 5, 2023
The biopharmaceutical company says it is “extremely disappointed” with the results of the COURAGE-ALS study, which failed to meet primary or secondary endpoints.
STAT
APRIL 3, 2023
One in six people across the globe face infertility at some point in their lifetime, according to the first new estimates from the World Health Organization in a decade. The prevalence is “staggering,” Pascale Allotey, director of sexual and reproductive health and research at WHO, said at a press conference Monday. The report estimates that 17.8% of adults in high-income countries and 16.5% in low- and middle-income countries experience infertility.
PharmExec
APRIL 7, 2023
Eli Lilly debuts its first Mounjaro TV commercial amid high demand for the diabetes injection, which also shows promise in weight loss applications and outperformed rivals Ozempic and Wegovy in clinical trials.
PhRMA
APRIL 4, 2023
Recently, Arkansas became the latest state to enact a law so that many patients aren’t paying more for their medicines than their insurance company or pharmacy benefit manager (PBM). The policy, commonly referred to as “share the savings,” requires insurers and the PBMs they work with to share the rebates, discounts, and other price concessions they receive from manufacturers directly with patients at the pharmacy counter.
Drug Topics
APRIL 6, 2023
The FDA has finally decided to withdraw approval of Makena and its generics after Covis Pharma volunteered to remove the drug from market in March.
STAT
APRIL 3, 2023
Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the second quarter: When is “mid-year”? This is not an existential question. Practically speaking, when a drugmaker, let’s say Bridge Bio , tells investors that an important readout of all-cause mortality data from a clinical trial of its heart drug acoramidis is coming “mid-2023,” does that mean the end of June or the beginning of July?
Pharmacy Times
APRIL 7, 2023
Discussions are led by a variety of experienced preceptors to provide insight, strategies, and resources for pharmacy residents.
Fierce Pharma
APRIL 3, 2023
After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits kdunleavy Mon, 04/03/2023 - 06:44
Drug Topics
APRIL 5, 2023
Members of the Senate Finance Committee are pushing PBMs to modernize the rules regarding out of pocket costs and competition.
STAT
APRIL 7, 2023
I care deeply about privacy, and as a professional researcher, I take meticulous notes. During my recent maternity leave, I spent most of my hands-free time trying to figure out why my doctors were trying to give my medical data away to advertisers — even after I opted out.
Pharmaceutical Technology
APRIL 3, 2023
The World Health Organisation (WHO) has revised its recommendations regarding the use of Covid-19 vaccines following a meeting of the agency’s Strategic Advisory Group of Experts on Immunisation (SAGE). The latest guidance applies to the current phase of the pandemic and reflects the impact of the Omicron variant, which has led to high levels of immunity in all age groups through both vaccination efforts and infections across the globe.
Fierce Healthcare
APRIL 4, 2023
From 'transformative' to 'tremendous fear': Takes on ChatGPT in healthcare at ViVE 2023 hlandi Tue, 04/04/2023 - 06:25
Drug Topics
APRIL 7, 2023
Both acute and chronic infection can increase the risk of cognitive decline and dementia in older adults.
STAT
APRIL 7, 2023
The road has run out for Pear Therapeutics: the pioneering digital therapeutics company filed for chapter 11 bankruptcy on Friday and will seek to sell off its assets to pay back its creditors. Pear will terminate 170 employees, or approximately 92% of its workforce, and will continue to operate in limited capacity with 15 employees as it seeks a buyer.
Pharmaceutical Technology
APRIL 7, 2023
Enanta Pharmaceuticals has secured the US Food and Drug Administration’s (FDA) fast track designation for EDP-323 to treat respiratory syncytial virus (RSV). In vitro data of EDP-323 showed a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B. Consistent potency was also observed across a range of RSV clinical isolates in several cell types.
Hospital Pharmacy Europe
APRIL 5, 2023
Dupilumab treatment produced the lowest incidence of asthma exacerbations and greatest improvements in FEV1 among three currently used mAbs Dupilumab treatment for 12 months gives rise to the lowest number of acute exacerbations and better improvements in FEV1 compared to two commonly used monoclonal antibodies (mAbs), omalizumab or mepolizumab, in adults with moderate to severe asthma, according to comparative analysis by US researchers.
Drug Topics
APRIL 7, 2023
Dupilumab monotherapy plus concomitant topical corticosteroids can improve signs, symptoms, and patient health-related quality of life.
STAT
APRIL 3, 2023
The first CRISPR treatment for sickle cell disease has been submitted to the Food and Drug Administration, beating a rival gene therapy that’s been delayed due to a manufacturing issue. On Monday, Vertex Pharmaceuticals and its partner CRISPR Therapeutics said they had met their previously announced goal of filing by the end of March a marketing application for their therapy known as exa-cel.
Pharmaceutical Technology
APRIL 6, 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease. The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).
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