FDA Officially Withdraws Approval of Makena After Lengthy Debate
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.
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MedPAC proposal threatens access to medicines in Part B
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.
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Half of All Meningococcal Vaccination Appointments Were Delayed or Canceled During COVID-19 Pandemic
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.
A drug just launched for a disease discovered only 10 years ago
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.
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
Padcev - Keytruda Combo Gets FDA Accelerated Approval
Drug Topics
APRIL 6, 2023
Approximately 8000 to 9000 U.S. patients would be eligible for this combination, intended for patients with locally advanced or metastatic urothelial cancer (la/mUC).
New bipartisan bill aims to tie doc pay to inflation amid industry concerns
Fierce Healthcare
APRIL 6, 2023
New bipartisan bill aims to tie doc pay to inflation amid industry concerns rking Thu, 04/06/2023 - 16:13
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HHS quietly trims inaugural list of price capped Medicare drugs from 27 to 20
Fierce Healthcare
APRIL 6, 2023
HHS quietly trims inaugural list of price capped Medicare drugs from 27 to 20 dmuoio Thu, 04/06/2023 - 15:23
Genentech review of Tessier-Lavigne paper finds no evidence of fraud — but hints at a different misconduct case
STAT
APRIL 6, 2023
South San Francisco biotech Genentech on Thursday announced that an internal review of misconduct allegations concerning a landmark 2009 paper co-authored by Marc Tessier-Lavigne, a former top executive at the company and Stanford University’s current president, did not find any evidence of fraud or intentional wrongdoing. But the review also points to another previously undisclosed case of scientific misconduct by a post-doctoral researcher in Tessier-Lavigne’s lab.
WTW expert: How employers can protect themselves against rising healthcare costs
Fierce Healthcare
APRIL 6, 2023
WTW expert: How employers can protect themselves against rising healthcare costs fdiamond Thu, 04/06/2023 - 14:39
Hairitage expands beyond hair care with bath, body collection
Drug Store News
APRIL 6, 2023
The new collection is made with clean formulas and naturally derived ingredients, including niacinamide, jojoba oil, aloe vera, and açaí fruit extract.
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.
MHRA fast tracks ADvantage’s immunomodulator for Alzheimer’s disease
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).
Meijer sets opening date for 11th supercenter
Drug Store News
APRIL 6, 2023
Meijer will open a new supercenter in Elkhart, Ind., on May 11, making it the 11th store in Northern Indiana.
Eculizumab biosimilar gets positive CHMP opinion
European Pharmaceutical Review
APRIL 6, 2023
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for EPYSQLI , a biosimilar referencing Soliris (eculizumab), also known as SB12. EPYSQLI [has become]… our first biosimilar in haematology to be recommended for approval in Europe” EPYSQLI has been recommended for approval in patients with paroxysmal nocturnal hemoglobinuria (PNH).
STAT+: Research misconduct allegations put Stanford’s president — and science — under an uncomfortable spotlight
STAT
APRIL 6, 2023
STANFORD, Calif. — It’s the one thing everyone knows. And it’s the last thing people want to talk about openly. But if you step away from Stanford University’s public spaces — its spacious courtyards surrounded by sandstone buildings and bike paths flanked by palm trees — a subject that almost feels too big to talk about emerges at last.
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.
Gilead caused injuries while waiting to develop safer HIV drugs, lawsuit claims
Fierce Pharma
APRIL 6, 2023
Gilead caused injuries while waiting to develop safer HIV drugs, lawsuit claims zbecker Thu, 04/06/2023 - 11:40
STAT+: FDA withdraws approval of controversial drug to prevent preterm births
STAT
APRIL 6, 2023
After a years-long controversy, the U.S. Food and Drug Administration ordered the immediate withdrawal of a drug that had been widely used to prevent premature births, even though clinical trial data indicated the medication failed to do so. The manufacturer, Covis Pharma, earlier this year agreed to withdraw the treatment, which is known as Makena.
How Essentials Research Supported Established Brand with Agile Syndicated Tracking
InCrowd
APRIL 6, 2023
A well-known, established blockbuster brand at a top-10 pharma company needed a better solution for tracking its highly competitive market. Their traditional, data-heavy, time-consuming, and expensive ATU wasn’t meeting their needs. Learn how Essentials, InCrowd’s syndicated tracking solution, helped them collect competitive intelligence, save budgetary dollars, and eliminate their large ATU, allowing for more time and attention to the market events.
STAT+: With weight loss drug ads, telehealth companies wade into a regulatory gray area
STAT
APRIL 6, 2023
They’ve swiftly caught the attention of subway goers: splashy ads plastered on train station walls and turnstiles across New York by telehealth companies promoting controversial weight loss medications like Wegovy by name. Companies including Ro and Calibrate have capitalized on the new drugs by launching telehealth services dedicated to prescribing Wegovy and Ozempic, which patients inject themselves to treat obesity.
5 Reasons to Upgrade Your Pharmacy Management Software
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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.
Eggo sweetens breakfast with new flavors
Drug Store News
APRIL 6, 2023
The new launches include Vanilla Bean Grab & Go Waffles, Chocolatey Chip Banana Waffles and Berry Blast Mini Toast Waffles.
STAT+: To make immunotherapy safe for brain tumors, researchers will have to tackle new risks
STAT
APRIL 6, 2023
The success of CAR-T immunotherapies against blood cancers has raised hope that CAR-T can bring breakthroughs to brain cancers, which haven’t had new treatments for decades. The initial clinical trials have yielded progress against brain tumors and new, potentially fatal, risks. Three years ago, Michelle Monje, a pediatric neuro-oncologist at Stanford University, and her colleagues began a trial testing a CAR-T therapy for diffuse midline glioma, a brain cancer that primarily affects pedi
Pfizer escapes proposed class action lawsuit over patient copay assistance
Fierce Pharma
APRIL 6, 2023
Pfizer escapes proposed class action lawsuit over patient copay assistance esagonowsky Thu, 04/06/2023 - 11:03
Abbott glucose monitor readers could catch fire, FDA warns in recall notice
STAT
APRIL 6, 2023
Health care giant Abbott issued a warning impacting four million readers for glucose monitors after reports that devices were overheating and catching fire when patients used non-Abbott charging cords. The company said that customers do not need to return the readers, but cautioned against using cords other than those provided by Abbott. In a notice posted Thursday, the Food and Drug Administration identified the problem as a Class 1 recall, which signals that use of a device might cause serious
Bayer's Astepro Allergy partners with Meghann Fahy
Drug Store News
APRIL 6, 2023
To further encourage consumers to relieve their allergies and live spontaneously this spring, the brand is hosting a Feel Sexy Fast Sweepstakes, where fans can win a limited-edition Astepro kit.
STAT+: Brazilian committee says a Vertex cystic fibrosis is not cost-effective and should not be reimbursed
STAT
APRIL 6, 2023
A Brazilian government advisory committee recommended that the health ministry not pay for a cystic fibrosis treatment made by Vertex Pharmaceuticals after deciding the drug is not cost effective, the latest clash over access to the expensive but groundbreaking medicine. The decision by the National Committee for Health Technology Incorporation, also known as Conitec, is not final, because a protracted public consultation will still occur over the drug, called Trikafta.
Avacta opens two US sites and doses first patient in sarcoma drug trial
Outsourcing Pharma
APRIL 6, 2023
TWO US clinical investigator sites have been opened for a phase 1 clinical trial for patients with soft tissue sarcoma and the first patient has been dosed.
STAT+: Pharmalittle: Weight-loss drug ads pose new oversight challenge; will the new Bayer CEO split the company?
STAT
APRIL 6, 2023
Rise and shine, another busy day is on the way. We can tell because the official mascot is noisily bounding about the grounds in search of wildlife and Mrs. Pharmalot is busy putting the finishing touches on yet another feast that marks the observance of ancient traditions this week. As for us, we’re quaffing cups of stimulation —cinnamon dolce is our choice today — and foraging for items of interest.
Chutes & Ladders—Providence health system names a medical director for national environmental stewardship
Fierce Healthcare
APRIL 6, 2023
Chutes & Ladders—Providence health system names a medical director for national environmental stewardship aburky Thu, 04/06/2023 - 15:04
Telehealth’s new weight loss drug pitch, a crackdown on AI to deny care, and Boston Scientific enters obesity treatment area
STAT
APRIL 6, 2023
You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday.
Moderna’s mRNA vaccine along with Keytruda obtains PRIME designation
Pharmaceutical Technology
APRIL 6, 2023
Moderna has announced that its cancer vaccine mRNA-4157/V940 along with Keytruda secured the European Medicines Agency (EMA) Priority Medicines (PRIME) scheme designation for the adjuvant treatment of high-risk stage III/IV melanoma patients after complete resection. mRNA-4157/V940 is Moderna’s investigational personalised messenger ribonucleic acid (mRNA) vaccine for cancer and Keytruda is Merck’s anti-PD-1 therapy.
Listen: Illumina’s boardroom intrigue, the next big Alzheimer’s readout, & J&J’s creative lawyers
STAT
APRIL 6, 2023
Is Illumina the Disney of biotech? Does the Texas two-step work after all? And can you ever really go home again? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Matthew Herper joins us for a deep dive into Illumina, explaining how the biggest company in genome sequencing lost the faith of shareholders and painted itself into a corner.
NICE guidance recommends olaparib for breast and prostate cancers
European Pharmaceutical Review
APRIL 6, 2023
A “groundbreaking deal” between AstraZeneca and NHS England has enabled the National Institute for Health and Care Excellence (NICE) to recommend olaparib for adults with early breast cancer and metastatic prostate cancer in final draft guidance. For breast cancer patients, the treatment is approved for those who have inherited faults in their BRCA1 or BRCA2 genes, after surgery and chemotherapy and are HER2-negative and at high-risk.
STAT+: With Apollo Endosurgery acquisition, Boston Scientific dives into the obesity treatment market
STAT
APRIL 6, 2023
The landscape of obesity treatment is quickly changing — and with its acquisition this week of Apollo Endosurgery, medical device maker Boston Scientific is again shaking up the space. “We’ve been calling it a measured entry into the bariatric space,” said Brian Dunkin, who oversees Boston Scientific’s endoscopy division.
Gillette Venus debuts dermaplaning skin care regimen
Drug Store News
APRIL 6, 2023
The Venus for Facial Hair & Skin Care with Olay collection consists of a cleansing primer, dermaplaning razor and hydrating serum.
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