STAT

JULY 21, 2023

Diagnostic errors — that is, overlooking a disease, or diagnosing it erroneously or late — are a known occurrence in health care, and one that can have tragic effects. Yet so far there have been few attempts to quantify misdiagnoses in terms of deaths and permanent disability, and the full scale of their impact has been underestimated by the medical community, according to a 2015 report by the National Academy of Medicine.

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BioPharma Dive

JULY 21, 2023

The offering is a financial lifeline for Turnstone and the fourth for the sector this month, the first time that’s happened in nearly a year and a half, according to BioPharma Dive data.

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STAT

JULY 21, 2023

WASHINGTON – The White House on Friday launched its pandemic preparedness office, half a year after Congress instructed the administration to set up a new arm in the wake of the coronavirus pandemic. The Office of Pandemic Preparedness and Response Policy is a now-permanent installment in Washington and will first be led by retired Major General Paul Friedrichs, a longtime biosecurity official.

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Packaging 244

Drug Patent Watch

JULY 21, 2023

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

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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.

STAT

JULY 21, 2023

Significant challenges remain before most American clinicians feel comfortable treating patients with buprenorphine , according to a new study. While the federal government’s recent moves to deregulate buprenorphine have led to a bump in new prescribers, it didn’t lead to a significant bump in overall prescribing volume. Many health care providers still see prescribing buprenorphine as difficult, or simply have little interest in using the medication, according to the study.

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European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year.

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Vaccines Pharmaceutical Manufacturing Communication Hospitals 95

European Pharmaceutical Review

JULY 21, 2023

A semi-quantitative limulus amebocyte lysate (LAL) gel clot test with a narrow dilution range can be valuable for relatively accurate estimation of endotoxin in biopharmaceutical products, research shows. The paper published in Vaccine Research demonstrated the compatibility and benefits of LAL gel clot tests in a semi-quantitative manner compared to the LAL chromogenic assay.

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Vaccines 94

STAT

JULY 21, 2023

Stanford President Marc Tessier-Lavigne , who will step down from his position Aug. 31, was initially accused of scientific misconduct, but that’s not why he lost his job. He lost it because he failed to adequately lead his labs, and because of the repercussions that failure had for his leadership of a premier research institution. In his own words, Tessier-Lavigne resigned because Stanford “needs a president whose leadership is not hampered” by discussions of problems with

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BioPharma Dive

JULY 21, 2023

The Swiss drugmaker now joins a lengthy list of biotechs that, amid a drawn-out market downturn, have turned to job cuts and research re-evaluations to save money.

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STAT

JULY 21, 2023

LONDON — European regulators on Friday recommended the approval of Pfizer’s RSV vaccine both for older adults and for use in pregnancy, which could extend protection against the common respiratory virus to newborns. The Pfizer vaccine, called Abrysvo, is already approved in the United States for people 60 and older. The Food and Drug Administration is scheduled to weigh in on its use for pregnant people next month.

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Vaccines 225

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European Pharmaceutical Review

JULY 21, 2023

To support future growth of its biosimilar pipeline, Sandoz is planning to build a Biosimilar Technical Development Center in Slovenia. The company intends to invest approximately $90 million at its site in Ljubljana, Slovenia, to establish a dedicated Sandoz Biopharma Development Center by 2026. With this financial boost, the Ljubljana site is set to become a key location for biosimilar product development at Sandoz. “The new Biosimilar Development Center in Ljubljana will …[help] Sandoz

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Biosimilars Drug Development 91

STAT

JULY 21, 2023

Pfizer says a tornado that ripped through a key manufacturing plant in North Carolina does not appear to have caused “any major damage” to areas that produce medicines. The company reported most damage from the storm occurred at a warehouse that stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance personnel.

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Packaging Hospitals 220

The Pharmacist

JULY 21, 2023

The community pharmacy sector in Scotland will receive a 6% increase on the global sum, in an offer agreed by Community Pharmacy Scotland and the Scottish Government yesterday (20 July). Scotland’s 1,256 community pharmacies will also receive a guaranteed minimum (retained margin) of £100m and £80m in ‘mapped money’, which is used to support the […] The post Scotland pharmacies given 6% increase on global sum appeared first on The Pharmacist.

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Community Pharmacies 90

STAT

JULY 21, 2023

In the latest melee over the safety of prescription medicines, the European Medicines Agency is reviewing studies conducted by Synapse Labs, a contract research organization, due to questions about its study data. The review comes in response to an inspection of Synapse facilities by Spanish regulators, who raised “serious concerns about the validity and reliability” of clinical trial data generated by the company.

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Generic Medicine 209

World Pharma News

JULY 21, 2023

Pfizer Inc. (NYSE: PFE) announced data from a Phase 2 study investigating its hexavalent capsular polysaccharide (CPS) conjugate Group B Streptococcus (GBS) vaccine candidate, GBS6, being developed for maternal administration to protect infants against invasive GBS disease. In stage two of the three-part study, which enrolled 360 healthy pregnant individuals, GBS6 generated robust maternal antibody responses against the six GBS CPS serotypes included in the vaccine, and these antibodies were eff

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Vaccines 89

STAT

JULY 21, 2023

As anxiety mounts over climate change, seven of the world’s largest drugmakers urged dozens of their suppliers to outline targets they expect them to reach over the next few years in order to reduce carbon footprints. In explaining their action, the companies — GSK, Sanofi, Roche, AstraZeneca, Novo Nordisk, Samsung Biologics, and Merck KGaA — noted that the health care sector contributes approximately 5% of global greenhouse gas emissions, with around half of this coming fro

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Pharma Times

JULY 21, 2023

The inhaler supports appropriate individuals presenting with asthma and chronic obstructive pulmonary disease - News - PharmaTimes

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STAT

JULY 21, 2023

A European regulatory panel has recommended against approval of a lung cancer drug made by Mirati Therapeutics, the company said Friday. Mirati said it will appeal the negative opinion of the drug, called Krazati, issued by a committee of the European Medicines Agency that met this week. But for now, the adverse decision is likely to be adopted by European regulators and prevent the company from marketing the pill in Europe.

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Pharmaceutical Commerce

JULY 21, 2023

The importance of industry, as it moves forward, in focusing on patient-centered care and prioritizing patient needs across the supply chain.

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STAT

JULY 21, 2023

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.   That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Drug Channels

JULY 21, 2023

Today’s guest post comes from Brent Clifton, Vice President of Product Management at CoverMyMeds. Brent discusses the challenges that patients, caregivers, and providers face when seeking access to medications requiring prior authorization. He explains how an electronic prior authorization solution can reduce delays and help patients start their therapies sooner—especially when patients and brands can play an active role in the process.

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STAT

JULY 21, 2023

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is shaping up quickly. We plan to promenade with the official mascots, manicure the grounds, attend some nuptials, and squeeze in a listening party, where the rotation will likely include this , this , this , and this.

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Vaccines Hospitals 181

Pharma Times

JULY 21, 2023

Data underlines the significance of the company’s anti-GDF-15 antibody candidate, visugromab - News - PharmaTimes

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STAT

JULY 21, 2023

WASHINGTON — A top Food and Drug Administration official wants Congress to dedicate full-time staff to emerging pathogens, after the FDA scrambled to find people for Covid-19 priorities like Operation Warp Speed. “Vaccines were a pretty heavy duty lift during the pandemic,” said Peter Marks, director of the Center for Biologics Evaluation and Research, at a Thursday Politico event.

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Vaccines 172

The Pharmacist

JULY 21, 2023

Better communication is needed around why medicine supply issues are happening and when pharmacists can expect them to be resolved, the executive director of the Healthcare Distribution Association (HDA UK) has told The Pharmacist. Martin Sawer, who leads the organisation representing the interests of large-scale wholesalers and distributers, also suggested that members of the supply […] The post Better communication would keep pharmacists ‘out of the dark’ on supply issues appeared first

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Communication 84

European Pharmaceutical Review

JULY 21, 2023

European Medicines Agency (EMA) has published a draft reflection paper on using artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. The US Food and Drug Administration (FDA) published its discussion paper on AI in drug development in May 2023, and now European regulators following a similar route to help chart a new course for this emerging technology.

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Drug Development Documentation 83

Pharmaceutical Technology

JULY 21, 2023

Hutchmed has secured breakthrough therapy designation from China’s NMPA for fruquintinib and sintilimab combination to treat EMC.

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The Pharmacist

JULY 21, 2023

Medicines supply issues were ranked as the most pressing financial issue for community pharmacy owners, in a recent ‘temperature check’ survey carried out by Community Pharmacy England (CPE). Workforce costs, inflation and utility bills and increasing rental rates were also leading causes of financial pressures, according to a poll of 850 contractors carried out by […] The post Medicines supply ‘most concerning’ financial issue for contractors appeared first on The Pharmacist.

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Community Pharmacies 80

Pharmaceutical Technology

JULY 21, 2023

While artificial intelligence (AI) in medical devices has regulatory boundaries, its use in a medicine’s life cycle is less clear.

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PharmExec

JULY 21, 2023

In this latest Harvard Business School Healthcare Alumni Association Q&A, JT Saunders, Chief Diversity Officer at global consulting firm Korn Ferry, discusses diversity in pharma, as well as what mentors and mentees should be considering in the workplace.

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pharmaphorum

JULY 21, 2023

Digital transformation in pharma: The importance of digitalisation Mike.

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Drug Patent Watch

JULY 21, 2023

Annual Drug Patent Expirations for TRIJARDY+XR Trijardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are fifteen… The post New patent for Boehringer Ingelheim drug TRIJARDY XR appeared first on DrugPatentWatch - Make Better Decisions.

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pharmaphorum

JULY 21, 2023

FDA okays Daiichi Sankyo’s Vanflyta for first-line AML Phil.

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Drug Patent Watch

JULY 21, 2023

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

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Pharma Marketing Network

JULY 21, 2023

Google Ads is a powerful platform that can help pharma companies reach their target audience and achieve their marketing goals. However, in order to get the most out of Google Ads, it’s important to optimize your campaigns. Here are some tips for optimizing your Google Ads campaigns for the pharma industry: Set clear goals: Before you start optimizing your campaigns, it’s important to set clear goals for what you want to achieve.

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