Mon.Oct 16, 2023

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Serotonin levels are depleted in long Covid patients, study says, pointing to a potential cause for ‘brain fog’

STAT

If you’ve been following the mystery of long Covid since it emerged in 2020, you’ll recall interferons and serotonin have been clues from the start as combatants in the body’s prolonged battles against the virus. Theories about why symptoms persist long after the acute infection has cleared often point to two suspects: viral reservoirs where SARS-CoV-2 lingers and inflammation sparked by the infection that doesn’t subside.

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Has the science of anti-aging caught up with the dream of a longer life?

PharmaVoice

Billionaire investors and a new crop of longevity biotechs are betting big money on a lifespan-altering tipping point.

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Is there a nursing shortage in the United States? Depends on who you ask

STAT

Hospitals are frustrated with a nationwide nursing shortage that’s only gotten worse since the pandemic. In 2022, the American Hospital Association quoted an estimate that half a million nurses would leave the field by the end of that year, bringing the total shortage to 1.1 million. At the same time, National Nurses United insists there isn’t a nurse shortage at all.

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The PharmaVoice 100: Rare disease warriors

PharmaVoice

Biopharma leaders pounding away at rare diseases so patients with few other options can have healthier lives.

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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+: White House moves closer to a ban on menthol cigarettes, amid intensifying opposition from tobacco companies

STAT

WASHINGTON — The White House is about to feel what it’s like to go up against the world’s most powerful tobacco companies. On Friday, the Food and Drug Administration requested White House clearance on a policy that would ultimately ban menthol cigarettes. The tobacco industry has already spent the last few months doing everything it can to drum up opposition, from drafting letters for members of Congress to rallying freedom-focused smokers, according to a review of advertis

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SAEM Clinical Images Series: A Serious Pain in the Neck

ALiEM - Pharm Pearls

An otherwise healthy 34-year-old male presented to the Emergency Department with two weeks of anterior neck pain. Symptoms began with several days of pain in his mandibular molars, progressing to pain and swelling in the neck. In the last several days, the patient developed warmth and redness in the chest wall associated with subjective fever and chills.

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More Trending

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The top biopharma conferences in 2024

PharmaVoice

A few key meetings remain this year, like ESMO and ASH, while next year’s events are already being planned. Here’s a list of conferences to keep in mind.

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STAT+: FDA’s warning to J&J’s Abiomed signals a crackdown on digital health tools

STAT

The Food and Drug Administration is following through on its promise to regulate more health software tools, starting with a public reprimand of Johnson & Johnson’s heart pump company, Abiomed. Abiomed, which was bought by Johnson & Johnson late last year for $16.6 billion, sells devices for heart failure patients as well as patient monitoring software.

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UCL study suggests changes to improve MRI scans for prostate cancer

Pharma Times

The research aims to make MRIs more available to men and improve treatment decisions - News - PharmaTimes

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Studies highlight risks of excluding people with obesity from drug trials

STAT

People with obesity often go underrepresented in drug development trials, a critical gap that researchers say leaves drugmakers and doctors unsure of efficacy or risks in that patient population. “Patients and providers are not aware of how some drugs may act differently in people with obesity,” said Christina Chow, the head of research at Emerald Lake Safety, an institution that conducts independent research to make pharmaceuticals safer.

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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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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law Blog: Biosimilars

By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?

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STAT+: Teva sues Colorado over ‘unconstitutional’ program to lower cost of epinephrine injectors

STAT

In the latest tussle over the cost of medicines, Teva Pharmaceuticals has filed a lawsuit alleging that a new Colorado program aimed at making epinephrine auto-injectors more affordable violates its constitutional rights. The lawsuit was filed in response to a state law that was passed in August and requires health insurers that provide coverage for these injectors to cap out-of-pocket costs to $60 for a package of two injectors.

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Influencers of Generic Drug Utilization

Drug Patent Watch

In a systematic review titled “Influencers of Generic Drug Utilization,” researchers aimed to shed light on the key factors influencing the use of generic prescription drugs in the United States.… The post Influencers of Generic Drug Utilization appeared first on DrugPatentWatch - Make Better Decisions.

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STAT+: Cell and gene therapy CEOs share survival strategies amid biotech slump

STAT

CARLSBAD, Calif. — Biotech CEOs leading cell and gene therapy companies spoke frankly at a conference here last week about the tough choices they’re making to preserve limited cash amid the industry’s ongoing slowdown. The company leaders said that they’ve felt added pressure to use smaller teams to work quickly on fewer projects, and at times to partner with outside firms that have specific manufacturing and research expertise.

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Inclusion of pharmacy technicians in New Medicine Service considered

The Pharmacist

Discussions have taken place over the inclusion of pharmacy technicians in the delivery of the NHS New Medicine Service, according to Hammaad Patel, national pharmacy integration lead at NHS England. Speaking at the Pharmacy Show at NEC Birmingham today, Mr Patel expressed the view that pharmacy technicians were ‘well placed’ in community pharmacies to provide […] The post Inclusion of pharmacy technicians in New Medicine Service considered appeared first on The Pharmacist.

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STAT+: Pharmalittle: Rite Aid files for bankruptcy; Alzheimer’s brain scans get broader Medicare coverage

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was sufficiently relaxing and invigorating, because that oh-so-familiar routine of online calls and deadlines has returned. After all, the world — such as it is — continues to spin. And to nudge it in a much-needed better direction, we are quaffing cups of stimulation.

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The top biopharma conferences in 2024

BioPharma Dive

A few key meetings remain this year, like ESMO and ASH, while next year’s events are already being planned. Here’s a list of conferences to keep in mind.

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Candor on gene therapy, Abiomed is warned, & BTK success in MS

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! Today, cell and gene therapy executives describe how they’re handling their sector’s contraction, we talk about how regulators are cracking down on clinical decision support software, and we look at some impressive BTK data in multiple sclerosis from Roche.

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Granules India, NIPER sign MoU to Dr Chigurupati Centre of Excellence in Innovative and Sustainable Pharmaceutical Development

Express Pharma

Granules India and the National Institute of Pharmaceutical Education and Research (NIPER) in Mohali Chandigarh, announced the signing of a Memorandum of Understanding (MoU), to establish Dr Chigurupati Centre of Excellence in Innovative and Sustainable Pharmaceutical Development (CCE-ISPD). This initiative aims to bring sustainability and innovation at the core of pharma research and development.

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Podcast: The British start-up taking psychedelic therapy mainstream

Outsourcing Pharma

In our first podcast interview of 2023, BioPharma Reporter spoke with Dr Sarah Bateup, therapy lead at Clerkenwell Health, about the potential of psychedelic medicine and her work within the psychedelic therapy training space.

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Synaffix partners with SOTIO Biotech in deal worth up to $740m

Pharma Times

SOTIO will gain access to Synaffix’s three ADC technologies - News - PharmaTimes

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Lonza to enhance commercial antibody-drug conjugate supply capacity

European Pharmaceutical Review

Lonza is planning to build a commercial-scale aseptic current good manufacturing practice (cGMP) filling line at its site in Stein, Switzerland. The new filling line will facilitate the aseptic filling of highly-potent antibody drug conjugates (ADCs) and lyophilisation under containment. The added capabilities will increase Lonza’s capacity to support clinical and commercial supply of bioconjugates.

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Nidlegy Phase III PIVOTAL trial shows postive results for patients with locally advanced fully resectable melanoma

Express Pharma

Philogen and Sun Pharmaceutical Industries announce positive results from the Phase III PIVOTAL trial in patients with locally advanced fully resectable melanoma (NCT02938299). The study compared neoadjuvant intratumoral Nidlegy (Daromun) followed by surgery (treatment arm) vs. surgery alone (control arm). Patients were allowed to receive approved adjuvant systemic therapies after surgery in both arms.

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Pfizer and BioNTech face 2023 revenue hits amid Covid product write-offs

Pharmaceutical Technology

Pfizer is launching a $3.5bn cost-saving programme and BioNTech expects 2023 revenues to decrease as demand for Covid treatments wanes.

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'Extremely important outcome for Alzheimer's patients' following Synaptogenix trial

Outsourcing Pharma

Patients with severe Alzheimer's Disease (AD) showed no cognitive decline throughout a ten-month trial while being treated with Bryostatin-1.

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CHMP recommends European authorisation for seven new drugs 

Pharmaceutical Technology

Pfizer’s Elrexfio and Astellas’ Veozah are among the seven drugs recommended for approval by the European regulatory committee.

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Targeting a coronavirus ion channel could yield new COVID-19 drugs

World Pharma News

The genome of the SARS-CoV-2 virus encodes 29 proteins, one of which is an ion channel called E. This channel, which transports protons and calcium ions, induces infected cells to launch an inflammatory response that damages tissues and contributes to the symptoms of COVID-19. MIT chemists have now discovered the structure of the “open” state of this channel, which allows ions to flow through.

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US FDA grants approval for BMS’ Opdivo for melanoma

Pharmaceutical Technology

The US FDA has granted approval for Bristol Myers Squibb’s (BMS) Opdivo to treat stage IIB or IIC melanoma patients.

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Exclusive: ‘No concerns’ about Pharmacy First implementation, says Steve Brine

The Pharmacist

Former pharmacy minister Steve Brine has no concerns around the implementation of the upcoming pharmacy common conditions service, despite pressures on the sector, he has told The Pharmacist at today’s Pharmacy Show. And in a keynote address to delegates, the Health and Social Care Committee chair promised to put pressure on ministers regarding the medicines […] The post Exclusive: ‘No concerns’ about Pharmacy First implementation, says Steve Brine appeared first on The Pharmacist.

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Patient Centricity to Integration: Enhancing Cancer Outcomes

pharmaphorum

Patient Centricity to Integration: Enhancing Cancer Outcomes Mike.

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Why is it now so hard to get my ADHD medication? | Tom Hawking

The Guardian - Pharmaceutical Industry

I moved to New York this year and am embroiled in a Kafkaesque ordeal trying to get my meds filled Back in 2019, I was diagnosed with ADHD at age 40, a process I described for the Guardian. The diagnosis came as a surprise to me, but not to anyone I knew: sure, I’d never been especially hyperactive (or even, y’know, active), but the chronic lateness, difficulty concentrating, lack of emotional self-regulation and decades-long struggle to locate my keys … these were all classic symptoms.

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Leucine's $7M series A funding to remedy 'not fit for purpose' compliance protocol processes

Outsourcing Pharma

AI start-up, Leucine, claims ânot fit for purposeâ compliance protocol processes are hindering the ability to deliver life-saving drugs faster.

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The UK market: A land of new opportunities for medical device manufacturers

pharmaphorum

The UK market: A land of new opportunities for medical device manufacturers Mike.

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New patent expiration for Aurinia drug LUPKYNIS

Drug Patent Watch

Annual Drug Patent Expirations for LUPKYNIS Lupkynis is a drug marketed by Aurinia and is included in one NDA. It is available from one supplier. There are three patents protecting… The post New patent expiration for Aurinia drug LUPKYNIS appeared first on DrugPatentWatch - Make Better Decisions.

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Bayer adds QR code to pack to help blind patients

pharmaphorum

Bayer adds QR code to pack to help blind patients Phil.

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