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.

238

238

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.

Vaccines 186

Vaccines 186

STAT

APRIL 6, 2023

The wholly synthetic mRNA vaccines for Covid-19 saved nearly 20 million lives in just their first year of use, according to data published in 2022 by The Lancet. That success stands as the most prominent example of the power of synthetic biology, a field whose possibilities have excited me since I first heard the term more than 15 years ago. As scientists gain increasing dexterity in manipulating the basic elements of life, they are designing not only other synthetic vaccines, but also therapies

Vaccines 120

Vaccines 120

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.

FDA 187

FDA 187

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.

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.

Documentation 116

Documentation 116

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).

FDA 98

FDA 98

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.

107

107

DiversifyRx

APRIL 6, 2023

If you provide strip or multi-dose packaging, you were just handed a golden egg from CVS. SimpleDose is no more; now is the time to kick your pharmacy marketing into high gear! CVS suddenly announced the discontinuation of its strip packaging services. Patients were given zero warning and told to find another pharmacy after their current order. You can read their announcement HERE.

Packaging 98

Packaging HIPAA Independent Pharmacies Patient Care 98

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.

FDA 104

FDA 104

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.

98

98

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

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

FDA 98

FDA 98

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.

98

98

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.

Labelling 100

Labelling FDA 100

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.

105

105

Advertisement

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.

Pharmacy Management Software

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.

98

98

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

124

124

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

98

98

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.

FDA 92

FDA 92

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.

Packaging 97

Packaging Immunization 97

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.

97

97

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.

96

96

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

115

115

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.

94

94

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).

85

85

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.

91

91

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

98

98

Fierce Pharma

APRIL 6, 2023

Pfizer escapes proposed class action lawsuit over patient copay assistance esagonowsky Thu, 04/06/2023 - 11:03

109

109

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.

97

97

Fierce Pharma

APRIL 6, 2023

Gilead caused injuries while waiting to develop safer HIV drugs, lawsuit claims zbecker Thu, 04/06/2023 - 11:40

108

108

Fierce Healthcare

APRIL 6, 2023

Zocdoc expands search, appointment booking for federally qualified health centers as PHE expiration nears agliadkovskaya Thu, 04/06/2023 - 13:56

92

92

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.

98

98

Fierce Healthcare

APRIL 6, 2023

WTW expert: How employers can protect themselves against rising healthcare costs fdiamond Thu, 04/06/2023 - 14:39

105

105

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.

105

105

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.

Chemotherapy 78

Chemotherapy 78