Mon.Dec 18, 2023

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STAT+: New Jersey’s telehealth restrictions cut off access to lifesaving care, lawsuit alleges

STAT

Since states started rolling back pandemic-inspired flexibilities that allowed physicians to easily practice telehealth across state lines, virtual health care providers have criticized state-based medical licensure rules as unnecessarily burdensome, expensive, and detrimental to patient care. Now, two of them are arguing in a lawsuit that they can also be unconstitutional.

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Trends shaping the pharmaceutical industry in 2024

PharmaVoice

Advancements in cloud and AI technology will transform clinical trial efficiency and engagement.

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Trending Sources

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Opinion: Alzheimer’s drug approvals show we need a reevaluation of patient advocacy

STAT

When faced with a loved one’s progressive neurodegenerative disease, like Alzheimer’s, or your child’s rare respiratory disease, you question why researchers and resource-backed pharma cannot bring a drug to market quickly enough to help your loved ones. Many people faced with this horror get involved to fight for better treatments.

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SAEM Clinical Images Series: Rapidly Spreading Rash

ALiEM - Pharm Pearls

A 19-year-old female with a past medical history of epilepsy presented to the emergency department for evaluation of rash and fever. Two days prior to presentation she began to experience fevers with a Tmax of 103°F. One day before presentation she developed a rash that began on her face and slowly spread down her body, now involving her palms. The patient endorsed associated pruritus and cervical lymphadenopathy with the rash.

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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+: Biden administration asks judge to toss out Humana’s Medicare Advantage audit lawsuit

STAT

The Department of Justice has asked a federal judge to dismiss a lawsuit brought by Humana, which alleged the government’s new audits of Medicare Advantage plans are unlawful. And if the lawsuit isn’t thrown out, the DOJ said in a new legal filing, at a minimum, it should be moved to a different federal court in Texas — away from a judge that has a track record of striking down federal health care laws.

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Rise of the chief investment officer: Why the unique role works for Roivant

PharmaVoice

Dr. Mayukh Sukhatme, president and chief investment officer for Roivant, discusses the long game of partnering and business deals in biopharma.

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More Trending

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Babson gets one step closer to delivering on Theranos-like blood testing

PharmaVoice

A recent FDA clearance could pave the way to pin-prick blood tests at local pharmacies and potentially one day, clinical trials.

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STAT+: Wegovy may have another helpful trick: fighting inflammation via the brain, study finds

STAT

As more data emerges that obesity drugs like Wegovy can reduce complications from heart and kidney problems as well, scientists have been wondering whether these benefits are driven by weight loss alone or also by other mechanisms. A new study suggests that one possible contributor is the drugs’ ability to reduce inflammation independent of weight loss.

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To fight rare diseases, win the data battle first

pharmaphorum

To effectively combat rare diseases, it is essential to prioritise the collection and analysis of data. This article explores how pharmaceutical companies are leveraging AI and focusing on orphan drugs to tackle rare diseases.

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STAT+: Here are the best biopharma CEOs of 2023

STAT

It’s that time of the year again when I recognize the Best Biopharma CEO of the year. This year’s selection is so deservingly obvious that I won’t fabricate suspense by starting with an honor roll of runners-up. More on those high-achieving folks later. Let’s get right to the main course: David Ricks of Eli Lilly is the runaway, rock star, who-else-could-it-be Best Biopharma CEO of 2023.

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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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A Look Back: The Life Sciences Industry in 2023 and a View for 2024

PharmExec

In the coming year, efficiency and automation will take center stage to maximize constrained resources but balancing sensible financial management with strategic investments will be vital.

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STAT+: Structure Therapeutics GLP-1 pill cuts blood sugar, weight in early diabetes study

STAT

Structure Therapeutics said Monday that its experimental GLP-1 pill demonstrated a 1% lowering of blood glucose and slightly more than 3% weight loss relative to a placebo in a 12-week study involving participants with type 2 diabetes — results that are preliminary but don’t quite match a competing oral drug under development by Eli Lilly.

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Cognitive decline in early Alzheimer’s could stem from serotonin loss

Pharma Times

MCI patients had 25% lower levels of serotonin compared to healthy patients Researchers from Johns Hopkins Medicine have suggested that serotonin loss in parts of the brain may play a role in cognitive decline in the early stages of Alzheimer’s disease (AD). Published in the Journal of Alzheimer’s Disease , the study was supported by other contributing scientists from the Johns Hopkins University School of Medicine and the Johns Hopkins Bloomberg School of Public Health.

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STAT Virtual Event | Cancer’s Breakthrough Engine

STAT

Editor’s note: A livestream of the event will be embedded below at 1 p.m. ET. Since the development of Gleevec two decades ago, precision cancer medicines have become a driving force in biotech and a source of hope for cancer patients.

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Pharmacy contract reform could help integrate care, Lords report finds

The Pharmacist

Pharmacy contract reform is needed to ‘free up’ integration of primary and community care, a House of Lords select committee has been told. In a new report, the Integration of Primary and Community Care Committee has published evidence from various care professionals and academics in an inquiry into the obstacles to providing joined-up healthcare services. […] The post Pharmacy contract reform could help integrate care, Lords report finds appeared first on The Pharmacist.

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The legal pathway for experimental, ultra-rare disease treatments is rocky and expensive

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Today, we see a small biotech on the verge of ending a rare-disease program thanks to FDA difficulties  — and how that impacts patients. We fete the best of this year’s biopharma CEOs (hint: GLP-1s), and talk about post-doc and patient advocacy reform.

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New patent expiration for Glaxosmithkline drug VENTOLIN HFA

Drug Patent Watch

Annual Drug Patent Expirations for VENTOLIN+HFA Ventolin Hfa is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from nine suppliers. There are two patents… The post New patent expiration for Glaxosmithkline drug VENTOLIN HFA appeared first on DrugPatentWatch - Make Better Decisions.

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STAT+: Pharmalittle: Illumina will divest Grail after court finds deal was anti-competitive; FDA found problems at Moderna facility

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that familiar routine of online meetings and deadlines has predictably returned. But you knew this would happen, yes? To cope, we are firing up the coffee kettle and brewing another cup of stimulation. Our choice today is caramel brûlée.

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Cognitive decline in early Alzheimer’s could stem from serotonin loss

Pharma Times

MCI patients had 25% lower levels of serotonin compared to healthy patients - News - PharmaTimes

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Morning Rounds: Why some doctors plan to quit their jobs

STAT

Understand how science, health policy, and medicine shape the world everyday. Sign up for our Morning Rounds newsletter here. Good morning folks, we’re almost there! The shortest day of the year is this week. It’s also our last week of Morning Rounds before a break for the holidays, and the last Monday from me for 2023. See you next year!

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Digital health collaboration to trial AI-powered X-rays for lung cancer detection

Pharma Times

Earlier diagnosis could increase patient survival rates by five years or more - News - PharmaTimes

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CHMP backs Biogen’s Skyclarys for Friedreich’s ataxia

pharmaphorum

Biogen’s Skyclarys is on course to becoming the first approved medicine for the inherited neurological disease Friedreich’s ataxia (FA) in the EU after it was recommended by the EMA’s human medicines committee.

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Guide the pharma world with PHARMAP 2024

Express Pharma

Leaders of the whole pharma value chain meet at Pharmaceutical Manufacturing and Packaging Congress (PHARMAP) to find new connections and discuss trends of the industry. The Congress is held on April, 22-23, 2024 in Amsterdam, the Netherlands Pharmaceutical Manufacturing and Packaging Congress (PHARMAP) is an annual networking event, which has a closed-door format: there are no marketing presentations and only decision-makers, technical, supply chain and procurement specialists of key companies

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Menopause drug to treat hot flushes and night sweats gets MHRA approval

The Pharmacist

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the use of fezolinetant – manufactured under the brand name of Veoza – to treat hot flushes and night sweats associated with the menopause. Julian Beach, interim executive director of healthcare quality and access at the MHRA, said the organisation was pleased to approve the […] The post Menopause drug to treat hot flushes and night sweats gets MHRA approval appeared first on The Pharmacist.

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Shweta Rai appointed as new MD of Bayer Zydus Pharma

Express Pharma

Manoj Saxena will move out of his present role to take on the role of CDH for Bayer’s Pharmaceuticals Division and Senior Bayer Representative, Bayer Group for the Australia & New Zealand (ANZ) cluster, with effect from the same date Bayer has announced that Shweta Rai will take over as Managing Director of Bayer Zydus Pharma and Country Division Head (CDH) for Bayer’s Pharmaceuticals Business in South Asia effective, January 1, 2024.

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$260 million funding injection for Danish vaccines initiative

European Pharmaceutical Review

The Novo Nordisk Foundation has committed up to DKK 1.8 billion ($260 million) to establish a state-of-the-art research and vaccine development initiative in Denmark. Developed in partnership with the University of Copenhagen and Denmark’s Statens Serum Institut , the Foundation says this the first vaccines initiative globally to focus solely on understanding how to generate immunity in the airway itself.

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ACG joins list of WEF’s Global Lighthouse Network

Express Pharma

Capsule facility in Pithampur, Madhya Pradesh demonstrates excellence in technology enabled operations that transform value chains ACG, the world’s largest integrated supplier and service provider to pharma industry celebrated the inclusion of its capsule manufacturing facility in Pithampur, India, into the esteemed Global Lighthouse Network (GLN) by the World Economic Forum.

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The Price of Prescriptions: Getting it Right

PharmExec

Drug companies face new hurdles in a rapidly changing marketplace. How do they finance new drug development amid the uncertainty?

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Zydus receives USFDA approval to initiate Phase II clinical trial of ZYIL1 for Parkinson’s disease

Express Pharma

ZYIL1 is a novel oral small molecule NLRP3 inhibitor. Studies have demonstrated that ZYIL1 is highly potent and can suppress inflammation caused by NLRP3 inflammasome activation Zydus Lifesciences has announced that it has received permission from USFDA, to initiate the phase II clinical study of NLRP3 inhibitor “ZYIL1” in patients with Parkinson’s disease.

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Vertex secures CHMP nod for Casgevy approval in Europe

Pharmaceutical Technology

Following US and UK approvals, the EMA’s CHMP has recommended conditional approval for Casgevy, with a decision expected in Q1 2024.

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Biocon Biologics successfully integrates acquired biosimilars business across 120 countries

Express Pharma

Over 10 emerging markets along with Japan, Australia and New Zealand have transitioned in this final phase of the integration of the biosimilars business acquired from Viatris Biocon Biologics has successfully completed the transition of its acquired biosimilars business in ~120 countries across advanced and emerging markets, a year ahead of schedule.

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Eisai files biliary tract cancer drug tasurgratinib in Japan

pharmaphorum

Eisai files for approval in Japan for FGFR inhibitor tasurgratinib as a treatment for biliary tract cancers with FGFR2 gene fusions

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Innova Captab’s IPO to open on December 21, 2023

Express Pharma

Investors can bid for a minimum of 33 equity shares and in multiples of 33 equity shares thereafter Innova Captab has fixed the price band at Rs 426 to Rs 448 per equity share for its maiden Initial Public Offer (IPO). The IPO of the company will open on Thursday, December 21, 2023, for subscription and close on Tuesday, December 26, 2023. Investors can bid for a minimum of 33 equity shares and in multiples of 33 equity shares thereafter.

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UK approves treatment for hot flushes during the menopause

Outsourcing Pharma

Astellasâ drug fezolinetant (Veoza) has been approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the prevention of hot flashes during the menopause.

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As we look ahead to 2024, pharma sector is poised for sustained growth and innovation

Express Pharma

Anil Matai, Director General, Organisation of Pharmaceutical Producers of India (OPPI) shares that in 2024, we anticipate a continued partnership between the government and the pharma industry, driving advancements, fostering innovation, and ultimately contributing to a healthier and more resilient society In 2023, the pharma sector witnessed a dynamic landscape marked by robust government initiatives and a renewed industry focus on innovation, collaboration, and R&D.

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