Sat.Dec 23, 2023 - Fri.Dec 29, 2023

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STAT+: 3 issues to watch in pharma in 2024

STAT

As another year comes to an end and the world seems to hit the proverbial pause button, the temptation to look ahead is too great to ignore. After all, this is what journalists like to do as the calendar turns another page. So once again, we will take a whack at identifying some of the most noteworthy developments to watch. However, if these seem familiar, there is good reason.

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2023 In Review for The Digital Apothecary

The Digital Apothecary

So, 2023 is coming to a close, and 2024 is upon us soon. With that being the case, I thought I'd summarize what I have been up to and what I look forward to next year! 2023 Areas of Focus This year, my focus was largely on AI and digital health technologies (DHTs). My anticipation of the societal impact of AI, which I expressed last December, has proven accurate.

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Insulin Storage and Beyond Use Dates – Free Downloadable PDF

Med Ed 101

We’ve taken the time to create a new free PDF resource. In my practice, I always run into nursing staff and caregivers who are using expired insulin or who are not dating the insulins that are in use. Insulin Storage and Beyond Use Dates Free PDF should be a vital resource designed to help healthcare […] The post Insulin Storage and Beyond Use Dates – Free Downloadable PDF appeared first on Med Ed 101.

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Intas Pharma signs licensing pact with mAbxience for etanercept biosimilar

Express Pharma

Intas Pharmaceuticals has signed an exclusive licensing agreement with mAbxience ( a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma) for biosimilar for Etanercept. Etanercept is a dimeric fusion protein with tumor necrosis factor (TNF) blocking action, that was approved for use over 20 years ago, offering patients a valuable therapeutic option for treating various autoimmune diseases.

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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.

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STAT+: UnitedHealth used secret rules to restrict rehab care for seriously ill Medicare Advantage patients

STAT

Health insurance giant UnitedHealth Group used secret rules to restrict access to rehabilitation care requested by specific groups of seriously ill patients, including those who lived in nursing homes or suffered from cognitive impairment, according to internal documents obtained by STAT. The documents, which outline parameters for the clinicians who initially review referrals for rehab care, reveal that many patients enrolled in Medicare Advantage plans were routed for a quick denial based on c

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Navigating transplant networks: Ensuring equitable access and improving outcomes for highly sensitised kidney transplant patients

pharmaphorum

Navigating transplant networks: Ensuring equitable access and improving outcomes for highly sensitised kidney transplant patients Mike.

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Biocon academy conducts its 8th graduation day

Express Pharma

Five batches across four programs of Biocon Academy namely ‘Biocon KGI Certificate Program in Biosciences’, ‘Biocon JSS AHER Certificate Program in Global Regulatory Affairs’, ‘Biocon Ramaiah Certificate Program in Quality Control Analytical’, and ‘BITS Biocon Certificate Program in Applied Industrial Microbiology’, participated in the graduation ceremony Biocon Academy, a ‘Centre of Excellence for Advanced Learning in Applied Biosciences’ and a CSR initiative of Biocon held its eighth graduatio

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We wish we’d written that: STAT staffers share their favorite stories of 2023

STAT

It’s time to take stock of the year that was in health and science: the meteoric rise of weight loss drugs , the approval of the first CRISPR-based therapy , the continuing effects of abortion access restrictions after the Dobbs decision, and much more. Below is our annual list of stories that STAT staffers loved, and wish that they had written.

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Eisai working on wristband sensor for brain amyloid

pharmaphorum

Eisai and Oita University have developed a machine learning-powered wearable that can predict whether someone is at risk of developing Alzheimer’s disease

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FDA warns of rare hypersensitivity reaction due to antiseizure drugs

Pharmaceutical Technology

FDA warns that levetiracetam and clobazam can cause DRESS, a rare hypersensitivity reaction which can be life threatening.

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5 Reasons to Upgrade Your Pharmacy Management Software

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.

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Ractigen’s RAG-01 becomes second saRNA drug globally to advance to clinical stage: GlobalData

Express Pharma

Ractigen Therapeutics, headquartered in China, submitted a clinical trial application for RAG-01 in Australia. This application paves the way for Phase I trial of RAG-01 in patients with non-muscle-invasive bladder cancer (NMIBC) who have not responded to Bacillus Calmette-Guérin (BCG) therapy, making it globally the second saRNA drug to advance into the clinical stage, says GlobalData.

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Quitting alcohol — or even drinking less — reduces risk of oral cavity and esophageal cancer, per new analysis

STAT

Reducing or eliminating alcohol consumption reduces the risk of developing oral cavity and esophagus cancers, according to a special report from the International Agency for Research on Cancer. But more data are needed to conclude whether the same is true for several other cancer types, including colorectal, breast, and liver cancer. Even so, it is likely that reducing or ceasing to drink alcohol will lessen the risk of these cancers, said Farhad Islami, a cancer epidemiologist at the American C

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EMCrit 365 – Setting PEEP and Righting the Right Ventricle in ARDS with Matt Siuba

EMCrit Project

Setting PEEP and Righting the RV in ARDS with Matt Siuba EMCrit Project by Scott Weingart, MD FCCM.

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J&J jumps on ADC train, signs $1.7bn licensing deal with LegoChem

Pharmaceutical Technology

J&J has acquired a global license for South Korean LegoChem’s ADC for $100m upfront along with milestone-based payments and tiered royalties.

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Akums launches Doxylamine + Pyridoxine ER tablets

Express Pharma

Akums Drugs and Pharmaceuticals announced the launch of Doxylamine + Pyridoxine extended-release tablets, a therapy approved by the CSDCO, India and the USFDA. Doxylamine, a competitive histamine H1 receptor inhibitor with sedative and anticholinergic effects, is paired with Pyridoxine Hydrochloride (Vitamin B6), known for its anti-emetic properties and its role in haemoglobin production and neurotransmitter metabolism.

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STAT+: Complications spiked 25% in hospitals bought by private equity

STAT

There’s ample evidence that private equity buyouts in health care drive up costs. A new study shows quality declines, too. Hospitals acquired by private equity saw a 25% uptick in adverse events compared with controls, according to a new study released today in the Journal of the American Medical Association. The findings add to an accumulating body of literature underscoring the harm that occurs when financial investors take over health care providers — not only hospitals, but nur

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Leveraging innate cell engagers for lymphoma treatment

European Pharmaceutical Review

In this exclusive interview, Andreas Harstrick, the Chief Medical Officer of Affimed unveils the potential of innate cell engagers for treating lymphoma. As well as presenting recent findings from the pivotal AFM13-104 study, Andreas also reflects on the challenges encountered and conquered in developing Affimed’s innate cell engager, Acimtamig, which targets CD30 on lymphoma cells and CD16A on NK cells.

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Enveric’s EB-003 selected as lead candidate for mental health disorders

Pharmaceutical Technology

Enveric Biosciences has selected EB-003 as its lead drug candidate from its EVM301 series for difficult-to-treat mental health disorders.

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Menarini India signs pact with Pierre Fabre Laboratories

Express Pharma

A. Menarini India has signed an exclusive partnership with esteemed French pharma company – Pierre Fabre Laboratories. Under this strategic collaboration, Menarini India has obtained exclusive rights to market and distribute the dermo-cosmetic brands, EAU THERMALE AVÈNE and DUCRAY in India. EAU THERMALE A VÈNE, a Pierre Fabre dermo-cosmetic brand, is for sensitive, intolerant, and allergic skin with solutions cleansing, moisturising, sun care, anti-aging, anti-acne, and hyperpigmentation.

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Opinion: Remembering Betty Rollin, who told her breast surgeon that post-operative appearance mattered to her—and other women

STAT

Women who had undergone disfiguring surgery for breast cancer, according to one surgeon in the 1970s, needed to “stick an old sock in their bra and get on with their lives.” It was this climate that Betty Rollin, then a television correspondent for NBC, entered when she was diagnosed with the disease in 1975. Rollin, who died of voluntary assisted suicide in Switzerland in November at age 87, became a highly visible activist not only for women with breast cancer but also end-of-lif

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Ultragenyx Picks Andelyn Biosciences to Manufacture Novel Gene Therapy for Sanfilippo Syndrome

PharmaTech

Andelyn Biosciences has been selected by Ultragenyx to manufacture UX111, that company’s gene therapy for treating Sanfilippo Syndrome.

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AstraZeneca buys Chinese CAR-T biotech Gracell in a $1.2bn deal

Pharmaceutical Technology

The deal is worth approximately $1.2bn in combined upfront and potential contingent value payments and is expected to close in Q1 2024.

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Cell and gene therapy will be top industry trend for pharma in 2024: GlobalData

Express Pharma

Healthcare industry professionals scored cell and gene therapy (CGT) as the industry trend to have the greatest impact on the pharmaceutical industry in 2024, in a recent survey launched by GlobalData. The survey data presented in “The State of the Biopharmaceutical Industry 2024” report reveals that N=21 (18 per cent) of industry professionals were convinced that CGT will dominate as the most important trend in pharma next year.

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Opinion: Does food as medicine help patients with diabetes? Here’s what a new clinical trial says

STAT

Food-as-medicine programs that address food insecurity and diet-related chronic diseases have drawn widespread attention from policymakers , payers, and health care providers. But what is the evidence that such programs work as intended? Some research suggests that food as medicine can improve health and lower health care costs, but until now there has been little evidence from randomized clinical trials.

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BMS wagers $14bn on Karuna’s schizophrenia drug

pharmaphorum

BMS has reached a $14bn agreement to buy Karuna and its KarXT schizophrenia candidate, due for an FDA verdict next September

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BMS agrees to acquire Karuna Therapeutics for $14bn

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has signed a definitive agreement for the acquisition of Karuna Therapeutics for $14bn in cash.

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AstraZeneca to acquire Gracell Biotechnologies

Express Pharma

AstraZeneca has entered into a definitive agreement to acquire Gracell Biotechnologies, a global clinical-stage biopharma company developing innovative cell therapies for the treatment of cancer and autoimmune diseases. The proposed acquisition will add to AstraZeneca’s pipeline of cell therapies with GC012F, a novel, clinical-stage FasTCAR-enabled BCMA and CD19 dual-targeting autologous chimeric antigen receptor T-cell (CAR-T) therapy, a potential new treatment for multiple myeloma, as well as

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STAT+: Cytokinetics heart drug aficamten succeeds in pivotal study

STAT

An experimental medicine from Cytokinetics significantly improved exercise capacity for patients with a rare, progressive heart disease, the company said Wednesday — a result that compared favorably with a competing treatment from Bristol Myers Squibb. The study enrolled about 300 people with obstructive hypertrophic cardiomyopathy, or HCM, a hereditary disorder that restricts blood flow.

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BMS strikes again, with $4.1bn RayzeBio takeover bid

pharmaphorum

Bristol-Myers Squibb makes a foray into the radiopharmaceutical category with a $4.

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BMS bags UK advanced melanoma win for Opdualag

Pharmaceutical Technology

The MHRA gave Bristol Myers Squibb’s Opdualag marketing authorisation for advanced melanoma as part of Project Orbis.

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Masterclass with Dr Ajaz S Hussain, Pharma Expert | Regulatory Watch

Express Pharma

The world of pharma regulations is constantly evolving, presenting new challenges and opportunities. In this ever-changing environment, continuous learning is key. Therefore, Express Pharma is launching “Regulatory Watch” a series of Master Classes led by experts and thought leaders to empower you with the knowledge and insights needed to navigate the ever-changing regulatory landscape successfully.

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STAT+: 3 CRISPR advances to watch in 2024

STAT

Life in the CRISPR lane tends to move at lightning speed. This year saw the first-ever approval of a medicine based on the gene editing technology, barely more than a decade after publication of its first demonstration by Nobel laureates Jennifer Doudna and Emmanuelle Charpentier. The landmark decision paves the way for in vivo therapies, which edit cells inside the body, to reach patients, as well as treatments based on more efficient genome editors with fancier DNA-altering tricks up their sle

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Cancer test shows promise for bringing the benefits of immunotherapy to more patients

World Pharma News

Brigham researchers' findings from next-generation sequencing suggest that revising current cancer care guidelines could allow approximately 6,000 more patients in the U.S. to benefit from immunotherapy treatment each year. Immunotherapy is a highly effective treatment for patients whose cancers harbor mismatch repair deficiency, and a new study identifies more cancer patients who could benefit from this form of therapy.

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Cytokinetics rockets on positive heart drug trial

pharmaphorum

Cytokinetics rises on report that its aficamten drug improved symptoms in people with rare disease obstructive hypertrophic cardiomyopathy

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Informa Markets organises CPHI & PMEC India 2023 successfully at India Expo Centre

Express Pharma

Informa Markets in India recently organised the CPHI & PMEC India 2023 at the India Expo Centre in Greater Noida, Delhi-NCR. A statement from Informa markets informed, “As the largest and most exhaustive pharma industry gathering in South Asia, CPHI and PMEC India expo, drew an overwhelming positive response, attracting over 48,000 attendees from 120+ countries in a vast 100,000 sq m exhibition space.