STAT

JUNE 13, 2024

LONDON — Seth Berkley, a longtime and widely respected global health leader , said Thursday that it has been “shocking to watch the ineptitude” of the U.S. response to the avian influenza outbreak among dairy cattle , adding his voice to a chorus of critics. In a presentation in London about vaccine development, Berkley, the former CEO of Gavi, the Vaccine Alliance, raised the issue of H5N1 bird flu when discussing whether the world was ready for another pandemic following i

Vaccines 364

Vaccines 364

PharmaVoice

JUNE 13, 2024

Lilly is the latest to approach the coveted Alzheimer’s approval, but a slate of drugmakers are lining up clinical trials in amyloid and tau to take a shot at improving patient outcomes.

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STAT

JUNE 13, 2024

The U.S. Department of Agriculture released two reports Thursday that lay out what has been learned about how H5N1 bird flu is moving among dairy cow herds in the United States. The reports do not shed much new light on the situation. Instead, they sum up what is known: that the outbreak was probably the result of a single “spillover” of the virus from wild birds into a dairy herd, likely late last year, and that movement of cows, farmworkers, and shared equipment appears to be res

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PharmaVoice

JUNE 13, 2024

Kenneth Mills will become chair of the gene therapy developer's board while Curran Simpson, the current chief operating officer, will take his place as company head.

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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

Communication

STAT

JUNE 13, 2024

Early in her pregnancy in 2015, Nicole Hashemi wanted to know how much caffeine was safe for her to consume. “I was actually advised not to drink a lot of caffeine,” Hashemi, an associate professor of mechanical engineering at Iowa State University, told STAT. The American College of Obstetrics and Gynecologists, for instance, advises that pregnant people consume no more than 200 milligrams per day  to reduce the risk of miscarriage or preterm birth.

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European Pharmaceutical Review

JUNE 13, 2024

Tell us about Ocugen’s lead programme, OCU400. What’s the latest and what’s next? OCU400 is a modifier gene therapy aimed at treating retinitis pigmentosa and Leber congenital amaurosis (LCA). In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa.

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Immunity Immunization Vaccines 145

EMCrit Project

JUNE 13, 2024

the PREOXI trial validates what I have been saying for 15 years about preoxygenation for the critically ill patient EMCrit Project by Scott Weingart, MD FCCM.

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STAT

JUNE 13, 2024

LONDON — A major shakeup in how the benefits of medicines are assessed in Europe is looming, and developers of treatments like gene therapies are already arguing that what they see as flaws in the new system could entrench the issues they’ve had getting their products to patients. Starting next year, there will be a new, continent-level review of a drug’s effectiveness compared to what else is on the market.

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FDA Law Blog: Biosimilars

JUNE 13, 2024

By Sara W. Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared on talk shows, and filed amicus briefs all in the span of the last 8 months. It seems like all that work is paying off.

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Dosage 113

STAT

JUNE 13, 2024

The day an FDA advisory committee met to weigh the merits of an experimental treatment for amyotrophic lateral sclerosis was one of the worst of Mitze Klingenberg’s life.  Her son Matt had benefited, she said, from an ALS treatment under review for approval by the Food and Drug Administration. However, the expert panel voted against the therapy on that day, Sept. 27, 2023.

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Drug Development 327

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pharmaphorum

JUNE 13, 2024

Explore the key moments of truth in launch excellence for MSLs and commercial teams in this informative white paper. Gain valuable insights and strategies for successful launches.

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STAT

JUNE 13, 2024

“In Sweeping War on Obesity, Chile slays Tony the Tiger.” So read the headline of a front-page story in The New York Times in 2018 on a dramatic step Chile was taking to fight obesity. With some of the highest obesity levels in South America, the country had begun enforcing strict regulations on Frosted Flakes and other foods that exceeded set thresholds for sugar, calories, salt, or saturated fat in 2016.

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Pharmafile

JUNE 13, 2024

Pfizer has announced an update from its phase 3 randomised, multicentre, double-blind, placebo-controlled CIFFREO trial, which assessed the investigational mini-dystrophin gene therapy, gordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD). The post Pfizer shares update on DMD gene therapy clinical trial appeared first on Pharmafile.

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STAT

JUNE 13, 2024

On this week’s episode of “The Readout LOUD,” our STAT colleague Nicholas Florko joins us to explain what it means to be a reporter who writes about the commercial determinants of health. Hint: Florko’s most recent stories focused on weed, vapes and raw milk. And instead of being chained to a desk, he often drives around to convenience stores and buy bad stuff — all in the name of good journalism.

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Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

European Pharmaceutical Review

JUNE 13, 2024

A next-generation FVIIIa mimetic bispecific antibody has demonstrated statistically significant and superior reduction of treated bleeding episodes in haemophilia A, new headline data from a pivotal Phase IIIa trial show. Mim8 was evaluated in participants aged 12 years or older as both a once-weekly and once-monthly treatment versus no prophylaxis treatment and prior coagulation factor prophylaxis treatment.

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STAT

JUNE 13, 2024

This is the online edition of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here  to get it delivered every Thursday to their inbox. I’m back from my ASCO-Chicago detour. I missed you all! This week, let’s argue over Geron’s future and consider Candel Therapeutics to illustrate why survival claims from non-randomized studies are too often red flags.

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pharmaphorum

JUNE 13, 2024

Pfizer has had some setbacks in its efforts to develop drugs for the lucrative obesity market, but could see its pipeline swell thanks to its $7 billion partnership with venture capital firm Flagship Pioneering. Flagship has just announced that it will work with biotech startup ProFound Therapeutics to find first-in-class protein therapeutics with potential in obesity, confirming this is the first programme in the alliance with Pfizer signed last July.

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STAT

JUNE 13, 2024

Rise and shine, everyone, another busy day is on the way. We can tell because the pace of motor vehicles passing by our window is picking up and the official mascots are busy foraging for snacks on the campus grounds. As for us, we are engaged in the usual ritual of brewing cups of stimulation. Our choice today is strawberry cream. As always, you are invited to join us.

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Vaccines 240

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pharmaphorum

JUNE 13, 2024

Mahana Therapeutics has granted permanent reimbursement in Germany for its Cara Care digital therapeutic for irritable bowel syndrome

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STAT

JUNE 13, 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, it’s Meghana today! Some gene therapy talk: Pfizer’s gene therapy for Duchenne muscular dystrophy failed in Phase 3, and gene therapy developers say Europe’s looming regulatory changes may endanger such treatments.

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Drug Pricing Drug Development 232

pharmaphorum

JUNE 13, 2024

Learn valuable marketing lessons for B2B pharma companies by examining successful strategies used in the B2C prescription market, including over-the-counter (OTC) products and interactions with healthcare professionals (HCPs).

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Express Pharma

JUNE 13, 2024

China-based Innovent Biologics recently presented Phase I study results of its first-in-class anti-CLDN18.2/CD3 bispecific antibody (IBI389) for the treatment of advanced pancreatic cancer at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Preliminary results from the Phase I study (NCT05164458) of IBI389 demonstrated promising efficacy in pancreatic ductal adenocarcinoma (PDAC) and the bispecific antibody is expected to evolve as a promising therapeutic option for PDAC in

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Chemotherapy 104

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.

Outsourcing Pharma

JUNE 13, 2024

To guide sponsors, investigators, CROs, and other parties in clinical research, the European Medicines Agency (EMA) has consolidated the contemporary requirements for using computerized systems and electronic data in clinical trials.

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Express Pharma

JUNE 13, 2024

Suven Pharmaceuticals has entered into a definitive agreement for a strategic controlling investment in Sapala Organics, subject to regulatory approvals and conditions. Sapala is a Hyderabad-based CDMO focused on Oligo drugs and nucleic acid building blocks including specialised/modified Amidites and Nucleosides, drug delivery compounds (including GalNAc), Pseudouridine, amongst others.

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Compounding 104

pharmaphorum

JUNE 13, 2024

Last weekend, editor-in-chief Jonah Comstock attended the annual conference of the American Society of Clinical Oncologists in Chicago, an event renowned for announcing significant advancements in cancer treatment.

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Express Pharma

JUNE 13, 2024

Pfizer announced that CIFFREO, a Phase 3 global, multicentre, randomised, double-blind, placebo-controlled study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD) did not meet its primary endpoint of improvement in motor function among boys 4 to 7 years of age treated with the gene therapy compared to placebo.

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Clinic Management 104

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Pharmacy Management

Pharma Times

JUNE 13, 2024

The mosquito-borne viral disease is responsible for an estimated 390 million cases globally

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BioPharma Dive

JUNE 13, 2024

The failure of another trial adds to uncertainty around the benefits of the gene-based treatments, though industry analysts still expect Sarepta’s Elevidys’ to be unaffected.

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Pharmaceutical Technology

JUNE 13, 2024

The US FDA has granted approval for AstraZeneca's Farxiga for paediatric patients aged 10 years and above with type-2 diabetes.

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Diabetes 105

pharmaphorum

JUNE 13, 2024

Shares in WuXi Biologics and WuXi AppTec rose after the BIOSECURE Act was omitted from legislation due to be followed up in congress.

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Pharmaceutical Technology

JUNE 13, 2024

Alzheon has secured $100m in a Series E funding round to develop and commercialise ALZ-801 for Alzheimer's disease (AD).

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