Wed.Oct 04, 2023

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FDA calls for treatments for meth and cocaine addiction

STAT

No medication is approved to treat addiction to either methamphetamine or cocaine. But the Food and Drug Administration is taking steps to fill that glaring gap in addiction medicine.  The agency on Wednesday issued draft guidance that encourages drug manufacturers to develop new treatments that could help treat addiction to meth, cocaine, or prescription stimulants.

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FDA’s ‘ivory tower thinking’ ignores promising biomarkers, says a rare disease CEO

PharmaVoice

The FDA wouldn’t review a drug that was 90% effective. In rare diseases, this is too common, said the UltraGenyx CEO and a leading rare disease researcher.

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STAT+: Consumer watchdog sues diagnostic firm EpicGenetics, alleging misleading claims about fibromyalgia test

STAT

The consumer watchdog group the Center for Science in the Public Interest filed a lawsuit against a diagnostics company called EpicGenetics on Wednesday, alleging that the company is making false and misleading claims in marketing its blood tests for fibromyalgia and other diseases. The lawsuit focuses on two tests marketed by EpicGenetics — the FM/a Test and the 100Sure Test — which the company describes using nearly identical language.

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Drugmakers face uphill battle in Medicare negotiation suits

PharmaVoice

Judges have found fault with drug manufacturers’ First and Fifth Amendment arguments against the IRA’s drug pricing measures.

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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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2023 Nobel Prize in chemistry: Trio win for quantum dots discoveries that revolutionized nanotechnology

STAT

LONDON — The 2023 Nobel Prize in chemistry was awarded Wednesday to three scientists for the discovery and synthesis of quantum dots, tiny particles that have fueled innovations in nanotechnology from televisions to mapping different tissues in the body.   The prize went to Moungi Bawendi of MIT, Louis Brus of Columbia University, and Alexei Ekimov, formerly the chief scientist at Nanocrystals Technology in New York.

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The PharmaVoice 100: Brand and commercialization pros

PharmaVoice

Leaders decoding the complex language of drug development to push treatments past the finish line and into patients’ hands.

More Trending

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The PharmaVoice 100: Patient heroes

PharmaVoice

Leaders innovating new ways to incorporate patient voices in drug development and decrease barriers to access.

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STAT+: Was Amgen less than forthcoming about FDA’s concerns on its cancer drug?

STAT

Amid the stunning rebuke Amgen suffered at the hands of the U.S. Food and Drug Administration this week lurk numerous questions. And one of them may be whether the company was fully forthcoming about a pricey lung cancer drug that is supposed to generate key revenue growth. At issue is a trial that Amgen is relying upon to win final approval for Lumakras, which the FDA approved on a conditional basis in 2021.

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Cipla Foundation, NIMHANS partner to set up neuro-palliative care unit

Express Pharma

Cipla Foundation in partnership with National Institute of Mental Health and Neuro-Sciences (NIMHANS) has set up a neuro-palliative care unit in Bengaluru. The company informed that this unit has provided support to over 2,000 individuals with neurological conditions such as Alzheimer’s, Dementia, and Parkinson’s, through in-patient, out-patient, home care, and has offered teleconsultation services to patients as well as their families and caregivers. it also informed that at this ne

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Say goodbye to the Covid-19 vaccination card. The CDC has stopped printing them

STAT

It’s the end of an era for a once-critical pandemic document: The ubiquitous white Covid-19 vaccination cards are being phased out. Now that Covid-19 vaccines are not being distributed by the federal government, the Centers for Disease Control and Prevention has stopped printing new cards.

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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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Less than half of practice pharmacists have positive inductions, suggests survey

The Pharmacist

Pharmacists working in general practice have raised concerns about inadequate inductions and a lack of ongoing training and support from practices in a recent UK-wide survey by the Pharmacists’ Defence Association (PDA). Meanwhile, 35% of the 1,378 respondents said they do not feel they are regarded or treated as a full member of the practice […] The post Less than half of practice pharmacists have positive inductions, suggests survey appeared first on The Pharmacist.

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STAT+: To prevent amputation in patients with severe vascular disease, a device turns veins into arteries

STAT

An innocuous slip while cutting her toenails created a wound on Cynthia Elford’s right foot that wouldn’t heal. The Hermitage, Pennsylvania resident has vasculitis, a genetic disease that inflames the blood vessels and stops blood from flowing to the legs. She had already lost her left leg below the knee after a sunburn on the tip of her toe got progressively worse.

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2024 BCPS Exam – What’s Changing?

Med Ed 101

It’s hard to believe that I have been following pharmacist board certifications and helping pharmacists pass the BCPS exam for over 10 years since I first passed it in 2013! Each year in updating and creating our study materials, I review the content outline and any possible changes in the BCPS exam. There are definitely […] The post 2024 BCPS Exam – What’s Changing?

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Esketamine tops quetiapine for treatment-resistant depression in head-to-head trial

STAT

Nasal esketamine spray is more effective than an extended-release antipsychotic, when both are taken in combination with SSRIs and SNRIs, in patients with depressive episodes that didn’t respond to two or more consecutive treatments, according to a study published Wednesday in the New England Journal of Medicine. Research dating back to the early 2000s has shown that ketamine and esketamine — which is derived from ketamine — are effective in cases of so-called treatment-resi

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First pharmacists complete e-portfolio advanced pathway

The Pharmacist

The first cohort of seven pharmacists have completed the advanced pharmacist e-portfolio pathway jointly delivered by the Royal Pharmaceutical Society (RPS), NHS England (NHSE) Workforce, Training and Education Centre for Advancing Practice and the Centre for Pharmacy Post Graduate Education (CPPE). They are now eligible for the NHSE Centre of Advancing Practice’s ‘Advanced’ digital badge, […] The post First pharmacists complete e-portfolio advanced pathway appeared first on The Pharmacist

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STAT+: Pharmalittle: FDA finds ‘potential systemic bias’ in Amgen cancer drug trial; drugmakers organize to push back on antitrust reviews

STAT

Hello, everyone, and how are you this fine, sunny morning? The middle of the week has arrived, as you may know, so why not celebrate with a delicious cup of stimulation? After all, you made it this far, which is a likely sign of surviving another few days. And of course, no prescription is required, which is a good thing. Our choice today is butter pecan.

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Kate Therapeutics and Capsida Biotherapeutics collaborate on gene therapies

Pharma Times

The companies aim to bring gene therapies to patients sooner than traditional approaches - News - PharmaTimes

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STAT+: Key Senate panel eyes action on drug shortages

STAT

WASHINGTON — One of the top health care committees in the Senate is assembling ideas for bipartisan legislation to address drug shortages, three Senate aides and three lobbyists told STAT. The talks, led by Senate Finance Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) are in the early days, but they could move the debate over drug shortage reforms into a new phase.

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What Pharma Fears Most About AI

PharmExec

In this Q&A with Pharmaceutical Executive®, Andrew Hopkins, founder and CEO of Exscientia, reveals how artificial intelligence (AI) is currently being utilized in the pharma industry, predictions for where AI can be implemented in the future, and what pharma fears most about AI.

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The major biotech news updates you need to read today

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning, everyone. Damian here with the precarious case of gene therapy in Europe, a long-awaited coup for Novavax, and the unwinding of Amgen’s success story.

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Views sought on increasing practice pharmacist training placements in Wales

The Pharmacist

A consultation in Wales is seeking views on a primary care workforce plan for the country that includes increasing the number of pre-registration training placements for practice pharmacists. Health Education and Improvement Wales (HEIW) and the Strategic Programme for Primary Care (SPPC) have outlined ‘key actions’ contained within the Strategic Workforce Plan for Primary Care […] The post Views sought on increasing practice pharmacist training placements in Wales appeared first on The Ph

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STAT+: Federal bill would keep addiction medication from triggering a child abuse investigation

STAT

When Keri McCallum‘s doctor prescribed her Suboxone, she was told it was the “safest thing for me.” It would aid her in her recovery from fentanyl addiction. It would, like it has for others, help change her life, McCallum said. But, being pregnant with her second child, the Upton resident   also experienced another impact of her prescription: It required she be reported to the state for potential child abuse or neglect.

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Increased funding for practice pharmacist salaries should land this month

The Pharmacist

An increase in the general practice global sum, intended for funding practice staff pay rises, should be paid to surgeries from this month, the British Medical Association (BMA) has said. But the decision to pass on the uplift will be at the discretion of each employer, and will not apply to Additional Roles Reimbursement Scheme […] The post Increased funding for practice pharmacist salaries should land this month appeared first on The Pharmacist.

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WHO recommends second malaria vaccine

European Pharmaceutical Review

The World Health Organization ( WHO ) has recommended a new vaccine, R21/Matrix-M, to prevent malaria in children. The R21 vaccine is the second malaria vaccine recommended by WHO. This follows the WHO’s recommendation of the RTS,S/AS01 vaccine for the disease in 2021. Novavax’s President and Chief Executive Officer, John Jacobs, declared that the company is “proud” of the role of its saponin-based Matrix-M adjuvant plays in the R21/Matrix-M malaria vaccine.

Vaccines 101
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Novavax gets green light for updated COVID vaccine

pharmaphorum

Novavax has been given the go-ahead by regulators in the US for an updated version of its COVID-19 vaccine that targets the XBB.1.5 variant of the coronavirus. The FDA has signed off on the new protein-based shot, which joins two XBB.1.5-directed mRNA-based vaccines from Pfizer/BioNTech and Moderna as options for the upcoming immunisation campaign in the US.

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Lilly agrees $1.4 billion radiopharma acquisition

European Pharmaceutical Review

Eli Lilly and Company has agreed to acquire the radiopharmaceutical firm POINT Biopharma Global for $1.4 billion. According to Eli Lilly, it will action a tender offer to acquire all outstanding shares of POINT for total purchase price of approximately $1.4 billion. This will be payable once the deal has completed. What radioligand therapies will be developed under the acquisition agreement?

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King Faisal Specialist and Research Centre achieves world-first fully robotic liver transplant

Pharma Times

The approach reduces recovery times and lowers rates of complications - News - PharmaTimes

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Novartis completes Sandoz spin-off

European Pharmaceutical Review

Sandoz, a former division of Novartis, is now a standalone company. Going forward, the company will continue to focus on developing generic and biosimilar medicines for the European medicines market, with focus on sustainable access. The pharmaceutical firm originally announced the proposed departure from Novartis in August 2022. To prepare for the separation, Sandoz stated in June that its headquarters would transfer to Basel, Switzerland.

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Moderna claims positive results in early study for combo COVID, flu shot

BioPharma Dive

The company is planning to start a Phase 3 trial of the vaccine this year, and is targeting a regulatory approval in 2025.

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2023 Nobel Prize in Medicine Awarded for Development of mRNA Vaccines Against COVID-19

PharmaTech

The prize was awarded jointly to Katalin Karikó and Drew Weissman for their groundbreaking discovery regarding modification of the bases in mRNA.

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Alembic Pharma gets six USFDA approvals in Q2FY24

Express Pharma

Alembic Pharmaceuticals has received US Food & Drug Administration (USFDA) approvals on six of its Abbreviated New Drug Application (ANDA) during Q2FY24. The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, Brimonidine Tartrate Ophthalmic Solution, 0.1%, Guanfacine Extended-Release Tablets USP, 1 mg, 2 mg, 3 mg, and 4 mg, Erythromycin Tablets USP, 250 mg and 500 mg, Brimonidine Tartrate and Timolol Malea

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Gross-to-Net Bubble Update: 2022 Pricing Realities at 10 Top Drugmakers (rerun)

Drug Channels

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. Click here to see the original post from June 2023. Time for Drug Channels ’ annual update on pricing at the largest pharmaceutical manufacturers. This year’s review includes the following 10 companies: Eli Lilly and Company, Genentech, GlaxoSmithKline, Janssen, Merck, Novartis, Novo Nordisk, Sanofi, Takeda, and UCB.

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India Pharma Inc in M&A mode once again

Express Pharma

Glenmark Pharma’s 75 per cent stake sale in its API arm to Nirma, and the possibility of the biggest shake up in pharma rankings, as Cipla’s promoters mull a sell out, kept the pharma sector in simmer mode all through September. Both deals are symptomatic of India Pharma Inc today. The exit of Cipla’s Hamied family from the driver’s seat will mark the end of an era.

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Navigating EAPs: Clinical trials and the path to investigational drugs

pharmaphorum

Navigating EAPs: Clinical trials and the path to investigational drugs Mike.

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Strides Pharma gets FDA greenlight to market HIV treatment

Pharmaceutical Technology

Strides earned market approval in the US as part of a larger government endeavor to address HIV worldwide.

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