STAT

OCTOBER 5, 2023

The Food and Drug Administration’s expert vaccine advisory panel on Thursday unanimously endorsed the idea of taking a strain of influenza viruses that no longer appears to circulate out of flu shots as quickly as possible, pressing the FDA and manufacturers to try to get the work done on an expedited timeline. While a representative of vaccine manufacturers warned it may not be possible to remove the influenza B/Yamagata component from the flu vaccines that will be made for the Northern

Vaccines 346

Vaccines 346

Pharmacy Is Right For Me

OCTOBER 5, 2023

The CVS Health Minority Scholarship for Pharmacy Students was awarded to five outstanding underrepresented minority (URM) student pharmacists who are currently pursuing their PharmD degree. Selected awardees demonstrated outstanding leadership, academic success, and a commitment to advancing the profession of pharmacy and patient care. This scholarship will support them in their goal of becoming pharmacists by reducing financial barriers.

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STAT

OCTOBER 5, 2023

Anyone picking up a prescription from their pharmacy is used to the reams of paper that typically accompany it: information on safety, storing, and how to use the drug. What if that information also included your medicine’s carbon footprint? Some scientists are trying to calculate those footprints, as part of a growing effort to understand biotech and pharmaceutical companies’ contributions to climate change.

Pharmaceutical Companies 298

Pharmaceutical Companies Pharmaceutical Companies Drug Development 298

Pharmaceutical Commerce

OCTOBER 5, 2023

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US highlights her “DSCSA—Final Checks to Have Before Deadlines.

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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

OCTOBER 5, 2023

SAN DIEGO — It was spring 2020, and Histogen, a small biotech with big ambitions to regenerate tissues throughout the body and turn a profit in the process, had just gone public. The company’s leadership believed they were poised for success — until everything slowly and irreversibly fell apart. Three years later, Histogen no longer develops therapies.

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Drug Development 282

Pharma Times

OCTOBER 5, 2023

The research approach will help small- to mid-sized organisations to advance their clinical studies - News - PharmaTimes

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Pharma Times

OCTOBER 5, 2023

It will be the company’s first platform to be installed in an external scientific setting - News - PharmaTimes

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STAT

OCTOBER 5, 2023

The shortage of cancer drugs is not going away, but it may be easing slightly, a new national survey suggests. Based on questions posed to 29 of its 33 member hospitals, the National Comprehensive Cancer Network said Thursday that 86% of those cancer centers are experiencing a shortage of at least one type of generic chemotherapy drug, down from 90% in May.

Chemotherapy 262

Chemotherapy Hospitals 262

BioPharma Dive

OCTOBER 5, 2023

Kyowa will pay nearly $400 million to acquire Orchard, which sells the gene therapy Libmeldy in Europe but has struggled to find paths to market for other experimental treatments.

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STAT

OCTOBER 5, 2023

LONDON — The Japanese firm Kyowa Kirin is acquiring gene therapy maker Orchard Therapeutics in a $400 million deal, the companies said Thursday. Kyowa Kirin is paying $16 per share — a nearly 100% premium on Orchard’s Wednesday closing price — in cash, amounting to roughly $390 million. Orchard shareholders stand to earn another $90 million if Orchard’s gene therapy, Libmeldy, wins U.S. approval.

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Pharmacy Management

The Pharmacist

OCTOBER 5, 2023

The sector has made fresh calls on the government to invest in community pharmacy following comments made by Prime Minister Rishi Sunak and health secretary Steve Barclay at the Conservative Party Conference this week. The Prime Minister announced a new plan for phasing out smoking and an emphasis on preventative healthcare, while Mr Barclay announced […] The post Back language with investment, sector tells Tory leaders appeared first on The Pharmacist.

Community Pharmacies 101

Community Pharmacies 101

STAT

OCTOBER 5, 2023

Will we ever get an HIV vaccine? And is the oft-criticized institution that awards the Nobel Prize each year showing signs of evolution? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. It’s Nobel week on the podcast, and reporter Megan Molteni details the unique story of this year’s winners for medicine, Katalin Karikó and Drew Weissman.

Vaccines 228

Vaccines 228

European Pharmaceutical Review

OCTOBER 5, 2023

Maja Pedersen has been appointed as Chief Quality Officer (CQO), to lead FUJIFILM Diosynth Biotechnologies’ global quality team. Pedersen’s new role is effective immediately. As a member of the executive leadership team, she will report to President and CEO Lars Petersen, who was appointed in June this year. With 20 years of leadership experience in the life sciences and biopharma sector, Pedersen has previously had senior leadership positions in quality assurance (QA) and quality control ( QC )

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STAT

OCTOBER 5, 2023

It should be obvious that medical school and clinical experience, in themselves, can’t fully prepare someone for the C-suite, any more than an MBA and corporate leadership experience equip someone to be a doctor. But all too many health care organizations promote their best physicians to chief medical officer (CMO) on the assumption that they can pick up the new skills they need on the fly.

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Medical Schools Hospitals 227

Express Pharma

OCTOBER 5, 2023

The Indian Pharmaceutical Alliance (IPA) recently organised 8th Advanced Good Manufacturing Practices Workshop with 20+ subject matter experts, industry leaders and global regulators from USFDA, MHRA, CDSCO. The workshop aimed to facilitate sharing of knowledge and the development of capabilities among Indian pharma companies, enabling them to embrace globally acknowledged manufacturing practices.

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STAT

OCTOBER 5, 2023

As the temperatures cool, the season of colds, flu, and now Covid-19 is heating up. If you’re like many people, you’ve probably stocked up on over-the-counter cold medicine to help thwart the cough and runny nose circulating this time of year. But you might be questioning your arsenal right now. An FDA advisory panel just concluded that a very common decongestant called phenylephrine is not effective when taken orally.

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European Pharmaceutical Review

OCTOBER 5, 2023

Longeveron’s Phase IIa trial of its stem-cell therapy for mild Alzheimer’s has revealed in top-line results, that certain doses enabled numerical slowing/prevention of disease worsening relative to placebo. According to Longeveron who developed the treatment, Lomecel-B is a living cell product made from mesenchymal stromal cells (MSCs) isolated from the bone marrow donors.

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STAT

OCTOBER 5, 2023

You’re reading the web edition of D.C. Diagnosis.  Sign up here  to receive this newsletter in your inbox on Tuesdays and Thursdays. Another committee could join the drug shortage bandwagon The Senate Finance Committee is testing the waters for action to address drug shortages, my colleague John Wilkerson and I scooped yesterday afternoon.

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Express Pharma

OCTOBER 5, 2023

Ashoka University has been selected as one of the five awardees of the Vivli AMR Surveillance Open Data Re-use Data Challenge. Their contribution, titled “ Novel Approach to Antibiogram Analysis: Looking at the Composite Resistance Phenotype, ” holds promise in advancing the comprehension of antimicrobial resistance (AMR). AMR represents a critical threat to humanity, with the World Health Organization (WHO) identifying it as one of the top 10 global public health challenges.

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STAT

OCTOBER 5, 2023

The clearance of a first-of-its-kind cancer treatment made by Amgen is on shakier ground following a Food and Drug Administration advisory committee meeting Thursday. Regulatory advisers voted 10-2 that the data on the company’s drug Lumakras, a treatment for lung cancer, could not be properly assessed. Lumakras targets a specific mutation to a protein called KRAS , which is one of the most common genetic mutations in cancer.

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European Pharmaceutical Review

OCTOBER 5, 2023

Ahead of her presentation on the future of biomanufacturing at CPHI Barcelona, Sheila Ann Mikhail, the co-founder and former CEO of AskBio, engages in a conversation about gene therapy, artificial intelligence, and the importance of being a well-informed innovator when selecting a manufacturing partner. What are the key topics you plan to cover during your session at CPHI Barcelona?

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Immunity Immunization 86

STAT

OCTOBER 5, 2023

Rise and shine, another busy day is on the way. We can tell because the official mascots got an early start chasing down cats, squirrels, and other creatures darting about the Pharmalot campus. And then there is the noisy clamor of drills and saws and the like up and down the street. As for us, we are firing up the trusty coffee kettle to brew another cup of stimulation.

Dosage 202

Dosage Packaging Diabetes Hospitals 202

Express Pharma

OCTOBER 5, 2023

Sun Pharmaceutical Industries announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2, for the treatment of adults with moderate to severe alopecia areata. In the NDA, Sun Pharma has submitted 8 mg twice daily regimen of deuruxolitinib for FDA review.

Immunity 86

Immunity Immunization 86

STAT

OCTOBER 5, 2023

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how tech is transforming the life sciences. Sign up to get it  delivered in your inbox every Tuesday and Thursday.  FDA approves device to save limbs of vascular disease patients An innocuous slip while cutting her toenails created a wound on Cynthia Elford’s right foot that wouldn’t heal.

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Pharmaceutical Technology

OCTOBER 5, 2023

Lumicell co-founder, Moungi Bawendi, has been awarded the accolade alongside two others for his research into quantum dots.

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World Pharma News

OCTOBER 5, 2023

Bayer AG has entered into an antibody discovery, option, and license agreement with Twist Bioscience Corporation, a company offering high-quality synthetic DNA using its silicon platform. The company's "Library of Libraries", a collection of synthetic antibody libraries that harness innovative structural and developability features to cover a wide range of antibody drug targets, is tailored to address specific challenges in antibody discovery.

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BioPharma Dive

OCTOBER 5, 2023

The company says Syfovre prescriptions accelerated again in August after a rocky summer of side effect probes.

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PharmaTech

OCTOBER 5, 2023

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

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Communication 98

Drug Channels

OCTOBER 5, 2023

This week, I’m rerunning some popular posts while I put the finishing touches on DCI's new 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. One important update on copay accumulators since my original post from August 2023 : U.S. District Court, District of Columbia struck down U.S. Department of Health and Human Services rule allowing non-grandfathered individual and group plans to exclude manufacturers' copay assistance from deductibles. ( Details and industry

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Diabetes 75

Pharmaceutical Commerce

OCTOBER 5, 2023

LogiPharma session reminds attendees of what to review, as far as DSCSA compliance is concerned.

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Outsourcing Pharma

OCTOBER 5, 2023

A female leadership program has been launched in Denmark by WiLD (Women in Life Science Denmark) for those working in life sciences in Denmark.

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Pharmaceutical Commerce

OCTOBER 5, 2023

Panel discusses how digital transformation can best impact supply chains.

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pharmaphorum

OCTOBER 5, 2023

How AI and omnichannel are transforming pharma marketing Mike.

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Outsourcing Pharma

OCTOBER 5, 2023

Clinical trial platform company, Lokavant, has received an $8 million strategic investment from global trading and investment giant, Mitsui & Co. Ltd.

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pharmaphorum

OCTOBER 5, 2023

Roche app relieves diabetes distress in clinical trial Phil.

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Diabetes 111