Sat.Aug 12, 2023 - Fri.Aug 18, 2023

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New appointments: Who are the movers and shakers in pharma?

Outsourcing Pharma

BioPharma Reporter and Outsourcing Pharma presents its latest round-up of the movers and shakers in the pharma industry. From Karuna Therapeutics to IO Biotech, we break down the key changes on the pharmaceutical job ladder.

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Why so few get screened for lung cancer, the deadliest cancer in the U.S.

STAT

It was Thanksgiving 2021, and Michael Young was at Target buying a turkey baster. “I’m in the parking lot, and my chest starts to feel like somebody’s sitting on me,” Young recounted. But he didn’t think too much of it and waited until February to tell the doctor about these on-and-off chest pains. “8:30 a.m.

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How an AstraZeneca exec is leading the charge in the next immuno-oncology era

PharmaVoice

The pharma giant’s head of immuno-oncology is now charging toward the next step in the cancer fight with long-term survival and precision.

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SAEM Clinical Images Series: A Man with Blurry Vision

ALiEM - Pharm Pearls

A middle-aged man with a past medical history of hypertension and tobacco use disorder presented to the Emergency Department after evaluation by an ophthalmologist. He complained of ten days of a right-sided headache and three days of diplopia. He denied eye pain, pain with eye movements, photophobia, and vision loss. Physical Exam Vitals : Temp 98.4 °F (36.9 °C); BP 122/72; Pulse 90; Resp 16; SpO2 100% Neuro : Ptosis, “down and out” deviation and pupil dilation of the right eye were noted.

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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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Blue Shield of California drops CVS Caremark in pharmacy benefit overhaul

BioPharma Dive

BSCA has kicked CVS Caremark, the largest pharmacy benefit manager in the country, to the curb and is electing to carve out various pharmacy functions with companies like Amazon instead.

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STAT+: Health care CEOs hauled in $4 billion last year as inflation pinched workers, analysis shows

STAT

The health care industry didn’t just provide a safe haven for jittery stock investors in 2022, a year defined by inflation and higher interest rates. It also provided a stable stream of wealth for top executives, who collectively pocketed billions of dollars in what was otherwise a rough patch for the economy. By almost every measure, 2022 was a bad year for the stock market.

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New patent for Bracco drug LUMASON

Drug Patent Watch

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

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Radiopharmaceuticals for cancer: Making radiation precise

BioPharma Dive

More than a dozen startups have joined a few publicly traded biotechs and larger pharmaceutical firms in what’s become one of the most competitive areas in drug research.

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New definition of a human embryo proposed amid rapid scientific advances

STAT

When someone says the word embryo, what do you think of? Probably that picture you’ve seen a thousand times on a thousand different news articles: a translucent orb swelling with cytoplasm being prodded by a microinjection needle under the light of a microscope. The mainstreaming of IVF, or in vitro fertilization, has familiarized new generations of people with what the earliest stages of human development entails.

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Demand for weight loss drugs soars to nearly half of Americans

PharmaVoice

Drugs like the buzzy Ozempic are high on consumers’ radar — but lofty barriers to access remain.

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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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New patent for United Therap drug REMODULIN

Drug Patent Watch

Annual Drug Patent Expirations for REMODULIN Remodulin is a drug marketed by United Therap and is included in two NDAs. It is available from one supplier. There are nine patents… The post New patent for United Therap drug REMODULIN appeared first on DrugPatentWatch - Make Better Decisions.

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Gilead antibody drug shows signs of potential in early lung cancer

BioPharma Dive

A combination of Trodelvy and Merck’s Keytruda appears active against lung tumors, but has a high bar to clear and faces competition from AstraZeneca and Daiichi Sankyo.

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STAT+: South Africa ordered to disclose contracts with Pfizer, J&J, and other Covid-19 vaccine suppliers

STAT

A South African court ruled the government must disclose contracts signed with pharmaceutical companies for Covid-19 vaccines, a victory for advocates who alleged that authorities may have overpaid for the shots and that the lack of transparency masked pharmaceutical profits at the public’s expense. At issue are contracts signed by the South African government with several companies — including Johnson & Johnson and Pfizer — that provided millions of Covid-19 vaccines du

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Behind Flagship Pioneering’s triumphs and tribulations

PharmaVoice

With Flagship and Pfizer’s newly announced partnership to find the next big blockbuster, we’re examining some of the VC fund’s biggest successes and failures to date.

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Episode 844: Why A Pharmacist Should Learn to Predict the Need for Intubation

Pharmacy Joe

In this episode, I’ll discuss the pharmacist’s role in predicting the need for intubation. Episode 844: Why A Pharmacist Should Learn to Predict the Need for Intubation Subscribe on iTunes , Android , or Stitcher Because of how drug delivery systems are set up in most US hospitals with medications stored in automated dispensing cabinets, there can be a considerable delay between the time a physician makes a decision to intubate a patient until the time the team is ready with medications to

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FDA Grants Accelerated Approval to Pfizer’s Multiple Myeloma Treatment

PharmaTech

FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

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Opinion: The CDC faces $1.5 billion in budget cuts. Layoffs will almost certainly follow

STAT

The nation’s health faces a dual threat — one anticipated, the other, self-inflicted. Covid-19 has not gone away; the Centers for Disease Control and Prevention reports that infections are showing signs of a late summer wave. The new strain, EG.5 , spreads easily and is more resistant to neutralizing antibodies but does not, to date, seem to be more virulent.

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Chancellor and former health secretary protests local pharmacy closure

The Pharmacist

The Chancellor of the Exchequer, Jeremy Hunt, has joined local Surrey residents in protesting the potential closure of a local Boots pharmacy. Mr Hunt, who was the Secretary of State for Health and Social Care between 2012 and 2018, has added his name to two local petitions against the potential closure of a Boots pharmacy […] The post Chancellor and former health secretary protests local pharmacy closure appeared first on The Pharmacist.

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FDA approves bispecific drug from Pfizer for multiple myeloma

BioPharma Dive

Elrexfio is the third bispecific antibody cleared to treat the blood cancer, and will compete with other therapies that target the “BCMA” protein on myeloma cells.

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Unsuccessful Regulatory Filings for Biosimilar Approval: A Comprehensive Review

Drug Patent Watch

A recent paper in Expert Opinion on Biological Therapy studies failed fillings for biosimilar drugs. Over the past three decades, biotherapeutics have revolutionized healthcare by providing effective treatments for complex diseases… The post Unsuccessful Regulatory Filings for Biosimilar Approval: A Comprehensive Review appeared first on DrugPatentWatch - Make Better Decisions.

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Radiation, a mainstay of cancer treatment, begins a fade-out

STAT

Every year, doctors get better tools to fight cancer. Engineered cancer-killing cells, immunotherapies, targeted drugs, and more are helping clinicians cure more patients. Increasingly, though, oncologists are trying to use less radiation, long one of the main pillars of cancer therapy. In some cases, they are even keeping certain patients with low-risk tumors off radiation entirely.

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Successful Drug Launches in a Digital-Forward Market: Q&A with Bridget Seay, Executive Director of Customer Experience & Commercial Consulting, epocrates

PharmExec

Bridget Seay of epocrates delves into drug launches in a digital-forward market, exploring how pharmaceutical companies can navigate complex patient journeys, strike a balance between traditional and digital marketing tactics, and ethically engage with healthcare professionals and empowered patients amidst ever-changing regulations.

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Mankind Pharma, NOTTO organise organ donation drive, garner 21,000 pledges

Express Pharma

Mankind Pharma organised an organ donation drive in collaboration with the National Organ and Tissue Transplant Organisation (NOTTO) and prominent medical experts. The event featured a live panel discussion between Dr Sandeep Guleria, Senior Consultant and Transplant Surgeon at Indraprastha Hospital and Apollo Hospital; Dr Subhash Gupta, Chairman of the Centre for Liver & Biliary Sciences, specialising in Liver Transplant and Biliary Sciences, along with Robotic Surgery at Max Super Special

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FDA won’t hold advisory meeting for Bluebird’s sickle cell gene therapy

BioPharma Dive

The decision stands in contrast to the agency’s plans for a would-be rival gene editing treatment from Vertex Pharmaceuticals and CRISPR Therapeutics that is also under a regulatory review.

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STAT+: BMS, looking to build a market for a heart drug, turns to a Viz.ai algorithm to detect disease

STAT

As Bristol Myers Squibb works to build its treatment for a heart condition that can cause difficulty breathing into a blockbuster drug, it’s propped up an algorithm designed to help find more people who are affected. The algorithm, called Viz HCM and developed by Viz.ai, earlier this month received clearance from the Food and Drug Administration.

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Decoding “NMC Regulations” For Pharma Industry

PharmaState Academy

???????????: To be awarded with 3CPhE (Continuing Pharma Education) points. Registrations Open Limited Seats Interest Form For Next Batch We limit the number of participants in a batch so that high-quality interactive learning can happen. In case you have missed this batch, you can fill out the Interest form for the next batch. We will send you the information, once the registrations open for the next batch.

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GMP Update: CDER Official Explains, Advises, and Predicts

FDA Law Blog: Biosimilars

By Douglas B. Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference. He talked about regulatory discretion being exercised for drug manufacturing facilities with serious compliance problems, about how firms should respond to FDA inspectional observations, and about an upcoming guidance that will be of

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Why high-tech solutions require high-touch service to create value in today’s complex drug development landscape

BioPharma Dive

Stephen Apps discusses how technology can help improve the speed and quality of clinical research and why a dedicated, cross-functional approach is needed to maximize its value for smaller biotechs.

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STAT+: What’s behind the recent surge in Apellis’ stock price? Growing confidence in the safety of its eye treatment

STAT

Shares of Apellis Pharmaceuticals are rebounding, driven by a growing belief among some investors that the serious safety issue that has derailed Syfovre, the company’s eye disease treatment, is receding. Declaring the crisis over is premature, but that could change with more uneventful weeks. Apellis has been a takeout target before, and may be again, at an acquisition price nearly twice its current market value.

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6 tips to beat the afternoon slump

FADIC

6 Tips to beat the afternoon slump Follow Japan’s 80% Rule: Most people lose 2-3 hours daily to the afternoon slump. But it doesn’t have to be that way. Imagine you reclaiming 14+ hours weekly of high energy. You could: • Boost productivity • Deepen relationships • Get in the best shape of your life 6 tips to beat the afternoon slump: 1) Follow Japan’s 80% Rule “Eat until you’re only 80% full.” Overeating makes the body divert blood &

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New training for pharmacy technicians to launch in September

The Pharmacist

Places are available for up to 840 pharmacy technicians to apply for new fully funded training launching in September. The training aims to enable community pharmacy technicians to take on responsibility while more pharmacists train as independent prescribers. Pharmacy technicians will be trained in consultation skills, therapeutics, clinical decision making and assessment skills as well […] The post New training for pharmacy technicians to launch in September appeared first on The Pharmac

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Lupin gets US FDA approval for Doxycycline Hyclate Delayed-Release Tablets USP

Express Pharma

Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Doxycycline Hyclate Delayed-Release Tablets USP, 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, to market a generic equivalent of Doryx Delayed-Release Tablets, 50 mg, 75 mg, 80 mg, 100 mg, 150 mg, and 200 mg and Doryx MPC Delayed Release Tablets, 60 mg and 120 mg, of Mayne Pharma International.

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Patient advocates warn FDA proposal on salt intake could do fatal harm to people with kidney disease

STAT

WASHINGTON — Patient advocates are warning that a recent proposal from the Food and Drug Administration meant to reduce consumers’ salt intake could inadvertently kill those with kidney disease, particularly Black Americans. The proposal at issue, which is still in draft form , was unveiled by the FDA in April. It would allow the use of salt substitutes in foods that have so-called standards of identity, regulations governing what ingredients must go in popular foods, like ketchup,

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Sandoz to file for approval of aflibercept biosimilar

European Pharmaceutical Review

Sandoz has announced positive results from the MYLIGHT Phase III study for its biosimilar aflibercept, for patients living with wet macular degeneration. The confirmatory efficacy and safety study ( NCT04864834 ) demonstrated therapeutic equivalence between the biosimilar aflibercept and the reference biologic, Eylea®. The study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar a

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NICE gives go ahead to digital platforms for weight loss services

The Pharmacist

NICE has recommended four digital platforms to be used by NHS weight management services to help assess patients and prescribe weight-loss medication for obesity. Draft guidance has proposed the use of platforms that can help clinicians support patients psychologically, provide monitoring, and even allow prescription. The platforms put forward – Liva, Oviva, Roczen, and Second Nature […] The post NICE gives go ahead to digital platforms for weight loss services appeared first on The Pharma

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