Thu.Aug 24, 2023

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Krystal Cascetta, Lindsay Clancy, and the impossibility of being a mom in American medicine

STAT

In Igbo-Nigerian culture, new moms receive exquisite care from their own mothers, mothers-in-law, or surrogate mothers for the first few months postpartum. After each of my daughters was born, I was blessed to participate in this tradition, called omugwo, which allowed me to be nurtured by the mothers who came before me. They cooked and cleaned. Massaged my belly and taught me how to breastfeed.

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‘Eris’ and other new COVID strains accelerate vaccine push from Pfizer, Moderna, Novavax

PharmaVoice

New variants drive a need for another round of shots, and biopharma companies are stepping up to the plate.

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STAT+: What past blockbusters can tell us about future of Wegovy and other weight loss medicines

STAT

The news that the weight loss drug Wegovy reduced the risk of heart attacks and strokes in overweight volunteers opens up the door to vastly expanded use of the drug and medicines like it, known as GLP-1 inhibitors. That could have a big, positive impact on public health, and it will very likely swell the coffers of the pharmaceutical companies that make these medicines, including Wegovy’s maker, Novo Nordisk, and Eli Lilly, now the most valuable drug company in history thanks largely to

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AstraZeneca’s Soliris approved in Japan for paediatric gMG patients

Pharma Times

The drug is the first to be approved in Japan to treat children and adolescents with& generalised myasthenia gravis - News - PharmaTimes

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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+: Mid-year drug price hikes are back despite Inflation Reduction Act

STAT

It’s almost a tradition. At the start and halfway points of each year, many pharmaceutical companies raise drug prices to bolster revenue and reportedly fund new research. “It’s not just all selling new drugs,” said Juliette Cubanski, deputy director of the Program on Medicare Policy at Kaiser Family Foundation. “It’s increasing prices on their existing portfolio.

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Fourteen HP&M Attorneys Recognized by Best Lawyers® in 2024 in America

FDA Law Blog: Biosimilars

Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.

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Early Signs of Heat Stroke (and how best to prevent it)

Community Pharmacy

This summer has been one of the hottest ever recorded and with these extreme temperatures comes serious risks like heat exhaustion—and its more serious and advanced form—heat stroke. A heat stroke occurs when the body can no longer regulate its internal temperature within safe limits. As a result, essential physical and mental faculties rapidly decline, and if left unchecked, a stroke can leave victims with loss of consciousness, seizures, and in particularly severe cases, death.

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Startup Cellares adds $255M as investors pour cash into cell therapy production

BioPharma Dive

Bristol Myers Squibb is among those backing the startup, which claims the manufacturing capacity at its New Jersey plant can surpass that of conventional CDMO facilities.

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GSK shingles vaccine achieves 100 percent efficacy in China trial

European Pharmaceutical Review

GSK’s Shingrix (Recombinant Zoster Vaccine or RZV) vaccine has been shown to offer 100 percent efficacy against shingles in adults 50 years old and over in China. The Phase IV trial (ZOSTER-076) is the first-ever efficacy trial of the shingles vaccine Shingrix in China. Almost 6,000 participants were enrolled in the trial, which was conducted between 2021 and 2023.

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CVS Health enters biosimilar fray with launch of new subsidiary

Pharmaceutical Technology

The newly-launched business, called Corvardis, is already targeting the Humira biosimilar landscape with Hyrimoz via a planned Sandoz-partnered launch in Q1 2024.

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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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CVS launches new venture in biosimilar drug experiment

BioPharma Dive

The subsidiary, called Cordavis, will work directly with manufacturers to market or co-produce low-cost biologic drugs, starting with Novartis’ Humira copy.

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Exclusive: £12m funding for independent prescribing pathfinder project

The Pharmacist

NHS England (NHSE) will allocate £12m in funding for the independent prescribing pathfinder programme, a portion of which will be available to pharmacies involved in the delivery of the programme, The Pharmacist has learned. The pilot, which was launched last week, will test how different models of pharmacist independent prescribing could work. And it will […] The post Exclusive: £12m funding for independent prescribing pathfinder project appeared first on The Pharmacist.

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Royalty Pharma buys into Ferring’s cancer treatment in first gene therapy deal

BioPharma Dive

The deal, worth up to $500 million, is a bet by the drug rights dealmaker on the uncertain commercial prospects of Ferring's gene therapy Adstiladrin.

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New Parkinson’s drug formulation “nearly doubles” exposure

European Pharmaceutical Review

A new drug formulation of a protein kinase inhibitor therapeutic designed to modify the course of Parkinson’s diseas e has been developed. The Abelson Tyrosine Kinase (c-Abl) inhibitor risvodetinib (IkT-148009), “nearly doubles” drug exposure, according to Inhibikase Therapeutics’ CEO. Dr Milton Werner, President & CEO of Inhibikase explained that the company “recently completed characterisation of a novel tablet formulation that mimics the oral drug formulation we used to evaluate eff

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Dizal receives approval in China for NSCLC therapy

Pharmaceutical Technology

Dizal has received approval from China’s NMPA for sunvozertinib to treat adult patients with locally advanced or metastatic NSCLC

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FDA grants ODD to Nexcella's multiple myeloma treatment

Pharma Times

The drug is currently being assessed in a phase 1b/2a clinical trial - News - PharmaTimes

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Japan grants patent for BioArctic’s Parkinson’s disease antibody

Pharmaceutical Technology

Japan has granted a new drug substance patent for BioArctic’s monoclonal antibody (mAb), BAN0805, to treat Parkinson’s disease.

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FORE Biotherapeutics closes $75M financing to accelerate development of plixorafenib

Outsourcing Pharma

FORE Biotherapeutics yesterday (August 23) announced the closing of its $75 million (Â59 million) series D financing, led by the SR One and co-led by Medicxi and joined by existing investors.

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Integrating the patient perspective for effective trial design and engagement customisation

pharmaphorum

Integrating the patient perspective for effective trial design and engagement customisation Mike.

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Oracle joins White House CancerX initiative to wage war on cancer

Outsourcing Pharma

Cloud services and life sciences company, Oracle, has been recognized as a founding member of The White House's public-private partnership CancerX.

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Researchers decode new antibiotic

World Pharma News

More and more bacterial pathogens are developing resistance. There is an increasing risk that common drugs will no longer be effective against infectious diseases. That is why scientists around the world are searching for new effective substances. Researchers from the University of Bonn, the German Center for Infection Research (DZIF), Utrecht University (Netherlands), Northeastern University in Boston (USA) and the company NovoBiotic Pharmaceuticals in Cambridge (USA) now have discovered and de

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Mahana Therapeutics and Bayer in multi-million dollar partnership to commercialize digital therapeutics

Outsourcing Pharma

Mahana Therapeutics announced last week (August 22) that it was entering into a multi-million dollar distribution and marketing partnership with the consumer health division of Bayer.

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New patent for Takeda Pharms drug TRINTELLIX

Drug Patent Watch

Annual Drug Patent Expirations for TRINTELLIX Trintellix is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from three suppliers. There are ten… The post New patent for Takeda Pharms drug TRINTELLIX appeared first on DrugPatentWatch - Make Better Decisions.

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Mahana Therapeutics and Bayer in multi-million dollar partnership to commercialize digital therapeutics

Outsourcing Pharma

Mahana Therapeutics announced last week (August 22) that it was entering into a multi-million dollar distribution and marketing partnership with the consumer health division of Bayer.

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New patent for Alkermes Inc drug LYBALVI

Drug Patent Watch

Annual Drug Patent Expirations for LYBALVI Lybalvi is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one supplier. There are ten patents… The post New patent for Alkermes Inc drug LYBALVI appeared first on DrugPatentWatch - Make Better Decisions.

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An Action Plan for Midmarket CPOs and CFOs To Make Faster and Better Buying Decisions

Pharma and Life Sciences Blog

An Action Plan for Midmarket CPOs and CFOs To Make Faster and Better Buying Decisions annmarie@AZglo… Thu, 08/24/2023 - 23:09 CPOs and CFOs need robust supply chain and procurement tools to monitor financial performance in real time and drive future growth. Midmarket enterprises, in particular, struggle with a lack of manpower, inadequate tools and inefficient processes.

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New patent expiration for Abbvie drug LATISSE

Drug Patent Watch

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

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Compounded Pain Medication: Customized Relief for Chronic Pain

Compounding Pharmacy of America

Chronic pain is debilitating for many. Rather than suffering, compounded solutions can be customized to provide relief. The post Compounded Pain Medication: Customized Relief for Chronic Pain appeared first on The Compounding Pharmacy of America.

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New patent for Gilead Sciences drug EPCLUSA

Drug Patent Watch

Annual Drug Patent Expirations for EPCLUSA Epclusa is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from two suppliers. There are fifteen… The post New patent for Gilead Sciences drug EPCLUSA appeared first on DrugPatentWatch - Make Better Decisions.

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Veterinary Telehealth: Optimizing Your Practice for Patient Care

epicur

When the pandemic hit in 2020, veterinary professionals, like so many others, had to quickly shift to alternate patient care models. Curbside visits and telemedicine became the norm. While the move toward digitization had long been underway in veterinary health, COVID-19 forced the timeline for many practices. Shifting to veterinary telehealth is not without its challenges – such as the patients not being able to speak – but embracing digital veterinary services alongside traditional practice mo

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NHC Briefing on IRA Implementation

Putting Patients First Blog

NHC Briefing on IRA Implementation Event Time: 3:00 - 4:00 p.m. ET Event Location: Virtual Home Register Schedule (Coming Soon) Speakers Event Policies CAE Credits On September 1 CMS will release the list of the first 10 drugs identified for price negotiation as part of IRA implementation. This release will officially start a 30 day clock for interested parties, including patient organizations, to submit data to the agency.

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How to Become a Sponsor of Choice

PharmExec

In this Q&A, Matt Smith, Vice President Research Site Development, Slope discusses the competition pharma companies and trial sponsors face when trying to become a sponsor of choice and build trust with sites and patients.

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Ensuring Aseptic Technique: Use of Isolators

Syner-G

By: Deb Quick, Ph.D. Senior Consultant Everyone knows that good aseptic technique is crucial when handling biological products, particularly in fill and finish operations. But for cellular therapies, good aseptic technique is essential throughout the entire process to prevent product contamination and to provide a safe product to the patient. These cellular therapies cannot be sterile-filtered, and thus the only way to prevent contamination is to ensure that all processing is performed aseptical

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AI returns voice to paralysed woman after 18 years

pharmaphorum

AI returns voice to paralysed woman after 18 years Nicole.

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Royalty Pharma Places $500 Million Bet on Ferring Gene Therapy

PharmaTech

Royalty Pharma agreed to spend up to $500 million for a 5.1 to 8% royalty on net sales of Ferring’s gene therapy adstiladrin (nadofaragene firadenovec-vcng).

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