Thoughts From the Streets: The Rise of Xylazine in Illicit Drug Use
Drug Topics
MARCH 16, 2023
Rates of xylazine use have skyrocketed in since 2010, leading to an increase in overdoses and death.
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FDA offers radio silence on question of spring Covid boosters, as other countries push ahead
STAT
MARCH 16, 2023
Are you six months out from your Covid-19 bivalent booster and wondering when you’ll be able to get another shot? If you live in the United Kingdom or Canada, you already have your answer. The Canadian and U.K. governments, acting on recommendations from expert committees, plan to offer spring booster shots for people at highest risk of getting severely sick from Covid.
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Combination of Two Drugs Effective In Treating Alopecia
Drug Topics
MARCH 16, 2023
The combination of prednisone and methotrexate provided nearly complete or complete hair regrowth in up to 31.2% of patients with alopecia areata.
Talem and Libera Bio partner for discovery of AI-driven antibodies
Pharmaceutical Technology
MARCH 16, 2023
Talem Therapeutics, a subsidiary of Immunoprecise Antibodies, has entered a multi-target artificial intelligence (AI)-driven antibody discovery collaboration with Libera Bio. The partnership will use nanotechnology, which was proven in vivo, for providing antibodies inside tumour cells and provides a potential solution to address the medical challenge.
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.
Large network of clinics offering ketamine for depression shuts down
STAT
MARCH 16, 2023
One of the largest operators of ketamine clinics in the country abruptly closed its facilities this week, leaving patients in the dark and out of treatment for depression and other chronic conditions. Ketamine Wellness Centers spanning nine states were shuttered, leaving laid-off employees and patients with more questions than answers. Interest in ketamine to treat depression and other conditions has grown in recent years.
Badass Staff Meetings: Here is the Formula
DiversifyRx
MARCH 16, 2023
Let’s talk about all things staff meetings We don’t have a choice. Running staff meetings is a necessity we can not ignore if we want to create a badass pharmacy team. Staff meetings are an opportunity to gain more team engagement, discuss new and upcoming initiatives, collaborate on ideas, learn what’s working and what’s not, and uncover any customer service issues that need attention.
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New Trends & Requirements from Digitalization, Annex 1, Continuous Manufacturing & High Potent Manufacturing
ISPE
MARCH 16, 2023
New Trends & Requirements from Digitalization, Annex 1, Continuous Manufacturing & High Potent Manufacturing Trudy Patterson Thu, 03/16/2023 - 08:00 iSpeak Blog iSpeak New Trends & Requirements from Digitalization, Annex 1, Continuous Manufacturing & High Potent Manufacturing Natalia Nikolaevna Vtyurina, PhD Dany SHAMI Richard Denk Amjad Wahbeh 16 March 2023 The pharmaceutical industry is rapidly evolving.
STAT+: Califf criticizes insurers for doing too little on drug research
STAT
MARCH 16, 2023
WASHINGTON — FDA Commissioner Robert Califf wants private insurers to chip in on doing post-approval clinical research on drugs. It’s a new request from the agency chief, who’s long pushed to find new ways to test drugs. “I’m not aware of a major effort by the insurance plans to help people get studies done,” he said at America’s Health Insurance Plans conference on Thursday.
Trofinetide approved for treatment of Rett Syndrome from two years of age
Hospital Pharmacy Europe
MARCH 16, 2023
Trofinetide is approved for treatment of the rare, neuro-developmental disorder Rett Syndrome in patients from two years of age Acadia Pharmaceuticals announced that the company has been given approval by the FDA for trofinetide to be used as a treatment for adult and paediatric patients with Rett Syndrome from two years of age. Rett syndrome is described as a neuro-developmental disorder characterised by typical early growth and development followed by a slowing of that development, loss of fun
STAT+: FDA to convene advisory panel for Sarepta’s gene therapy for Duchenne
STAT
MARCH 16, 2023
In a sudden about-face, the Food and Drug Administration will hold a meeting of outside experts to consider whether or not to approve Sarepta’s experimental gene therapy for Duchenne muscular dystrophy. The announcement Thursday comes just weeks after the company said the FDA had told it an advisory panel meeting to review the treatment, called SRP-9001, would not be necessary.
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.
DNA damage within oral cells similar among never smoking vapers and current smokers
Hospital Pharmacy Europe
MARCH 16, 2023
The DNA damage within oral epithelial cells induced by vaping in those who have never smoked is similar to that in current exclusive smokers The DNA damage that occurs to oral epithelial cells among electronic cigarette (i.e., vaping) users and who have never smoked, is broadly similar to that induced from current smoking and increases in a dose-dependent manner according to the findings of a study by a team from the Department of Population and Public Health Sciences, University of Southern Cal
STAT+: Sanofi becomes the third leading insulin maker to lower list prices, cutting Lantus price by 78%
STAT
MARCH 16, 2023
Following the lead of its rivals, Sanofi will cut the price of its most widely prescribed insulin in the U.S. by 78% and also place a $35 cap on out-of-pocket costs for commercially insured patients who take the treatment, which is called Lantus. The moves will go into effect on Jan. 1, 2024. The change comes after Eli Lilly and then Novo Nordisk announced plans this month to reduce list prices for some of their own insulin products by similar amounts.
Maesa launches luxury-inspired fragrance line, Fine’ry
Drug Store News
MARCH 16, 2023
Fine’ry, available exclusively at Target, is inspired by perfume icons in the industry and features a diverse range of fragrances that offer unique scent experiences.
STAT+: CRISPR? Nah. A new startup bets on an old approach to gene editing
STAT
MARCH 16, 2023
Before there was CRISPR, aspiring genome editors relied on an island of misfit, less elegantly named enzymes: Zinc-finger nucleases, TALENs, recombinases. Many of these once beloved tools were tossed aside when CRISPR came along, having helped few actual patients but driven plenty of graduate students to exhaustion. They were stubborn, inflexible enzymes, requiring endless engineering.
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.
Earlier Use Of Jakafi Leads To Improved Symptoms And Higher Survival In Myelofibrosis Patients
Drug Topics
MARCH 16, 2023
Treating myelofibrosis with Jakafi earlier has shown promise in improving both survival and symptom burden
STAT+: Momentum grows to subject medical devices to medicine’s gold standard — the placebo treatment
STAT
MARCH 16, 2023
It’s the gold standard in medicine: taking a treatment, and putting it head-to-head against a placebo to confidently declare whether it actually works. But for most medical devices, placebo trials have never been done. The most basic argument for this, put forth by medical device makers and regulators, is that mimicking an invasive procedure is far more difficult than handing patients a sugar pill.
UCB enters drug discovery collaboration with Aitia
Pharmaceutical Technology
MARCH 16, 2023
Global biopharmaceutical firm UCB has entered an early drug discovery collaboration with Aitia. The collaboration is aimed at discovering and validating new drug targets and drug candidates that are linked to clinical endpoints causally in Huntington’s disease, a debilitating genetic disorder. It will combine the use of new drug targets for Huntington’s disease from Aitia’s Gemini Digital Twins with the expertise of UCB in preclinical model systems and drug research in neurodeg
STAT+: Here’s why there aren’t many cheap, generic versions of pricey inhalers
STAT
MARCH 16, 2023
U.S. regulators approved dozens of inhalers to treat asthma and chronic obstructive pulmonary disease over a recent 15-year period, but a new study found that generic companies have only twice successfully pursued an established pathway to create lower-cost, rival products. The paltry outcome was largely blamed on steps that brand-name manufacturers take to forestall would-be competitors, as well as the high bar for regulatory approval.
AstraZeneca employees fight layoffs in India as drugmaker shifts 'strategic priorities'
Fierce Pharma
MARCH 16, 2023
AstraZeneca employees fight layoffs in India as drugmaker shifts 'strategic priorities' aliu Thu, 03/16/2023 - 09:54
U.S. pregnancy deaths dropped in 2022, after Covid spike
STAT
MARCH 16, 2023
NEW YORK — Deaths of pregnant women in the U.S. fell in 2022, dropping significantly from a six-decade high during the pandemic, new data suggests. More than 1,200 U.S. women died in 2021 during pregnancy or shortly after childbirth, according to a final tally released Thursday by the Centers for Disease Control and Prevention. In 2022, there were 733 maternal deaths, according to preliminary agency data, though the final number is likely to be higher.
FaceTory enters hair care scene with fermented masks
Drug Store News
MARCH 16, 2023
FaceTory’s new hair and scalp masks aims to strengthen and penetrate hair follicles for hydration and balance out oil production on the scalp, the company said.
STAT+: Pharmalittle: Alzheimer’s group starts lobbying for Medicare to cover new drug; U.S. judge seems sympathetic to abortion-pill challenge
STAT
MARCH 16, 2023
Good morning, everyone, and how are you today? Hazy skies are enveloping the frosty Pharmalot campus, where the official mascot is running about watering the weeds and the short person is sleeping in. As for us, we are busy firing up the trusty coffee kettle and brewing cups of stimulation. Our choice today is roasted coconut, for those who track this sort of thing.
Pennsylvania systems Penn Medicine, Crozer Health cut jobs amid reorganizations
Fierce Healthcare
MARCH 16, 2023
Pennsylvania systems Penn Medicine, Crozer Health cut jobs amid reorganizations dmuoio Thu, 03/16/2023 - 16:19
Listen: SVB’s long biotech shadow, pushy AI algorithms, & Icahn v. Illumina
STAT
MARCH 16, 2023
Is AI dictating patient care? What happens when your bank falls apart? And can Illumina endure some shareholder activism? We cover all that and more this week on the 250th episode of “The Readout LOUD,” STAT’s biotech podcast. STAT reporter Bob Herman joins us to explain how treatment algorithms powered by artificial intelligence are being used more frequently by Medicare Advantage plans to deny claims, even when continued treatment is medically justified.
Novo Nordisk hit with two-year suspension from UK pharma group after online marketing breaches
Fierce Pharma
MARCH 16, 2023
Novo Nordisk hit with two-year suspension from UK pharma group after online marketing breaches fkansteiner Thu, 03/16/2023 - 09:00
HRG’s five notable products from February 2023
Drug Store News
MARCH 16, 2023
HRG reviewed six products in the health category, 83 in the wellness sector and 106 items in the beauty aisle to see which ones stood out as Products to Watch.
HHS $25M grant program would expand mental health care services in schools
Fierce Healthcare
MARCH 16, 2023
HHS $25M grant program would expand mental health care services in schools fdiamond Thu, 03/16/2023 - 16:23
Pure Protein rolls out Popped Crisps snacking alternative
Drug Store News
MARCH 16, 2023
Available in hickory barbecue and sour cream and onion flavors, each portion-controlled serving contains 12 g of protein, the company said.
Dual cystic fibrosis modulator therapy shows efficacy in four-year study
European Pharmaceutical Review
MARCH 16, 2023
The combination modulator therapy tezacaftor (TEZ) and ivacaftor (IVA) for cystic fibrosis (CF) has demonstrated long-term safety and clinical benefit in a four-year trial. The two CF modulators were assessed in patients 12 years and older. The participants tolerated the combination regimen over the course of the 96-week extension study. These patients had previously participated in a 120-day trial of the same combination.
Access for all
Drug Store News
MARCH 16, 2023
DSN's editor-in-chief shares how retail pharmacies can provide health care access to people and communities who need it the most.
FDA's Califf calls on insurers to help providers participate in critical clinical drug trials
Fierce Healthcare
MARCH 16, 2023
FDA's Califf calls on insurers to help providers participate in critical clinical drug trials rking Thu, 03/16/2023 - 11:55
Pfizer's Paxlovid gets thumbs-up for full approval from FDA advisory committee
Fierce Pharma
MARCH 16, 2023
Pfizer's Paxlovid gets thumbs-up for full approval from FDA advisory committee kdunleavy Thu, 03/16/2023 - 16:46
True catastrophic coverage and shifting liability: Preparing for IRA changes
Fierce Healthcare
MARCH 16, 2023
True catastrophic coverage and shifting liability: Preparing for IRA changes mteefey Thu, 03/16/2023 - 15:34
First mixed race woman potentially cured of HIV
European Pharmaceutical Review
MARCH 16, 2023
Stem cells from cord blood have potentially cured the first mixed race female patient of HIV, scientists say. Using these stem cells rather than from compatible adult donors, as has been done previously, increases the potential to cure HIV via stem cell transplantation in people of all racial backgrounds.” The patient, who had leukaemia and HIV has been without HIV since 2017, because of a new method, transplanting HIV-resistant stem cells from umbilical cord blood.
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