STAT

NOVEMBER 7, 2023

More than two dozen attorneys general are urging Food and Drug Administration officials to take urgent action to address disparities in how well pulse oximeters, the fingertip devices used to monitor a person’s oxygen levels, work on people with darker skin. In a Nov. 1 letter, the AGs noted that it had been a year since the FDA convened a public meeting of experts , who called for clearer labeling and more rigorous testing of the devices, and that no action had been taken.

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Labelling 359

PharmaVoice

NOVEMBER 7, 2023

23andMe always had bigger aims than at-home genetics testing. In this in-depth interview, the company’s founder explains its foray into pharma, drug R&D, solving cold cases and more.

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STAT

NOVEMBER 7, 2023

The number of babies born with congenital syphilis in the United States has soared over the last decade, leading to an increase in stillbirths, infant deaths, and life-altering birth defects, the Centers for Disease Control and Prevention reported Tuesday. The number of cases of congenital syphilis in 2022 was more than 10 times the number recorded in 2012, the agency said, noting that most of the 3,761 cases reported in 2022 could have been averted, if the babies’ mothers had been adequa

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The Guardian - Pharmaceutical Industry

NOVEMBER 7, 2023

Cure any ailment! Never known to fail! Early medicine adverts made grand claims but they look alarming today The confusion with patent medicines starts with the name, since they were rarely ever patented; manufacturers just thought it sounded cool. Bamboozling was always part of the package: from the 17th century, concoctions of water, alcohol and herbs were sold with wild claims and exotic origin stories.

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Packaging 116

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

NOVEMBER 7, 2023

Longtime cancer doctor Monica Bertagnolli is finally heading to the National Institutes of Health director’s office after a nearly two-year effort to install a permanent leader atop the $48 billion science agency. The Senate voted 62-36 Tuesday to confirm her nomination, giving the White House clearance to officially name Bertagnolli the institute’s director, the second woman ever to fill the role.

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PharmExec

NOVEMBER 7, 2023

Due to a higher than anticipated demand, Sanofi is carefully managing distribution of 50 mg doses of Beyfortus in the private market to fulfill existing orders and provide equitable access to remaining doses for the vaccine that protects infants against respiratory syncytial virus.

Vaccines 111

Vaccines 111

pharmaphorum

NOVEMBER 7, 2023

Frontiers Health 23 - Day 1 from the marvellous Auditorium della Tecnica in Rome, where we are set to bring you the biggest news stories, trends, and industry insights

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STAT

NOVEMBER 7, 2023

You’re reading the web edition of D.C. Diagnosis.  Sign up here  to receive this newsletter in your inbox on Tuesdays and Thursdays. On the hot seat, feeling the Bern Drug executives will soon have the chance to tell Congress why they’re suing Medicare over price negotiations when their companies sell drugs to all the other governments that negotiate prices, my colleague John Wilkerson reports.

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Drug Pricing 318

BioPharma Dive

NOVEMBER 7, 2023

Startup OrsoBio raised $60 million in a Series A round co-led by Longitude Capital and Enavate Sciences, and joined by the pharma’s venture arm.

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STAT

NOVEMBER 7, 2023

WASHINGTON — The pandemic showed how fragile the supply chain can be, and to fix it, the United States needs to treat health care like a national security issue, said experts at a health conference here on Monday. Rep. Debbie Dingell (D-Mich.), speaking on a panel at the Milken Institute’s Future of Health Summit, warned that if the country had another pandemic or faced a bacterial biowarfare threat, “and we don’t have the capability to produce antibiotics in our coun

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Drug Pricing 296

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Pharmacy Management

pharmaphorum

NOVEMBER 7, 2023

In this week’s episode of the pharmaphorum podcast, web editor Nicole Raleigh speaks with Raquel Izumi, chief operating officer and co-founder of Vincerx Pharma, who is on a mission to improve antibody drug conjugate (or ADC) drug development, aiming to conquer cancer with safe, well-tolerated, and paradigm-shifting therapeutics.

Drug Development 101

Drug Development 101

STAT

NOVEMBER 7, 2023

During the pandemic, in search of tools to keep patients healthy and virus-free, doctors turned to a new technology for help: remote patient monitoring. In 2020, home use of tools like connected blood pressure cuffs, continuous glucose monitors, and weight scales shot up, with billing for the devices and their associated care more than quadrupling. As use of remote patient monitoring has continued to grow — albeit at a slower rate than during the early-pandemic surge — data on its

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BioPharma Dive

NOVEMBER 7, 2023

The price is below what some analysts had predicted and significantly less than $34,000 Sage initially set for its earlier postpartum infusion, Zulresso.

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STAT

NOVEMBER 7, 2023

After years of trying, the Food and Drug Administration is again seeking to withdraw approval of an antibiotic that is widely used by farmers to control diarrhea in their pigs, but has generated controversy over links to cancer. At issue is carbadox , which, since the 1970s, has been added to livestock feed to combat diarrhea in young pigs after they are weaned from their mothers, as well as to promote growth.

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Express Pharma

NOVEMBER 7, 2023

The type 2 diabetes (T2D) landscape has historically been dominated by insulin receptor (IR) targeting drugs. However, driven by the success of recent glucagon-like peptide 1 receptor (GLP1R)-targeting drugs, there has been a surge in the number of active pipeline drugs addressing this target. This indicates a shift from the conventional IR to the GLP1R as the primary target for pioneering T2D treatments, says GlobalData.

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Diabetes 98

STAT

NOVEMBER 7, 2023

Kindbody, a fast-growing fertility chain, knowingly exposed countless eggs and embryos to unsafe conditions and suffered repeated embryo mix-ups, according to a months-long Bloomberg investigation published recently. Here we go again.

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PharmaTech

NOVEMBER 7, 2023

Matthew Lauber, senior director—Cell and Gene Therapy, Consumables & Lab Automation, at Waters Corporation discusses the analytical and downstream purification challenges of oligonucleotides.

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STAT

NOVEMBER 7, 2023

WASHINGTON — Current and former government officials proffered a clear-eyed, and often depressing, take Tuesday on the state of clinical trials, the pharmaceutical industry, and biotech investors coming out of the Covid-19 pandemic. The officials, including the Food and Drug Administration’s second-in-command Janet Woodcock, acknowledged the drug industry’s persistent lack of interest in collaborating on clinical trials, the ways hypercompetition pervades academic research a

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Vaccines 251

World Pharma News

NOVEMBER 7, 2023

Bayer AG today announced the global expansion of its life science incubator network, Bayer Co.Lab, to Shanghai, China, and Kobe, Japan. This move establishes new sites for the Bayer Co.Lab program at the hotspots of innovation in China as well as in Japan.

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STAT

NOVEMBER 7, 2023

WASHINGTON (AP) — As U.S. doctors scale back their use of  opioid painkillers , a new option for hard-to-treat pain is taking root: ketamine, the decades-old surgical drug that is now a  trendy psychedelic therapy. Prescriptions for ketamine have soared in recent years, driven by for-profit clinics and telehealth services offering the medication as a treatment for pain, depression, anxiety and other conditions.

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European Pharmaceutical Review

NOVEMBER 7, 2023

Positive results for a combination treatment using the first Fc-silent investigational monoclonal antibody in pivotal clinical trials that is designed to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), have been announced. The treatment is being evaluated in patients with upper GI adenocarcinomas. Domvanalimab plus the antibody zimberelimab and chemotherapy showed encouraging overall response rate and six-month progression-free survival (PFS) rate results in a preli

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Chemotherapy 94

STAT

NOVEMBER 7, 2023

Making good on a recent threat, the Federal Trade Commission is challenging more than 100 patents on brand-name medicines that were improperly or inaccurately listed by some of the world’s biggest drug companies in a key government registry. The agency notified 10 companies that listings for dozens of patents on such medicines as asthma inhalers and epinephrine autoinjectors are being disputed.

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Generic Medicine 236

Outsourcing Pharma

NOVEMBER 7, 2023

A breast cancer drug that has been used for many years to treat the disease, has been licensed today (November 7) as a preventative measure.

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STAT

NOVEMBER 7, 2023

COLUMBUS — Ohio voters approved a constitutional amendment on Tuesday that ensures access to abortion and other forms of reproductive health care, the latest victory for abortion rights supporters since the U.S. Supreme Court overturned Roe v. Wade last year. Ohio became the seventh state where voters decided to protect abortion access after the landmark ruling and was the only state to consider a statewide abortion rights question this year.

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Pharmaceutical Commerce

NOVEMBER 7, 2023

Conference session discusses the drivers, practical considerations, success factors, and landscape for next-generation pharmacy innovation.

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STAT

NOVEMBER 7, 2023

In August 2013, the FDA made news when it issued cybersecurity guidance for medical devices. But several years earlier, government officials recognized the risk: Soon after the FDA made its announcement, former Vice President Dick Cheney revealed in a “60 Minutes” interview that when his pacemaker was replaced in 2007, his doctors took precautions to make it hack-proof.

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PharmExec

NOVEMBER 7, 2023

Exagamglogene autotemcel (Exa-Cel) was assigned a Prescription Drug User Fee Act action date of December 8, 2023, for the treatment of sickle cell disease.

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STAT

NOVEMBER 7, 2023

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 a CRISPR delay, some curious biotech language, and the derailment of a promising startup.

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Drug Pricing Drug Development 180

pharmaphorum

NOVEMBER 7, 2023

Søren Møller, managing partner for seed investments at Novo Holdings, has successfully supported numerous healthcare startups through strategic investments.

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STAT

NOVEMBER 7, 2023

Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say, “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us.

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Communication 177

BioPharma Dive

NOVEMBER 7, 2023

The biotech company creator hopes its new office will help its portfolio companies grow and strike partnerships in the region.

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STAT

NOVEMBER 7, 2023

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday.  The  Federal Trade Commission chair Lina Khan dropped by the hallowed startup incubator last week, part of what she said was an effort to hear directly from smaller players who don’t have the lobbying clout of tech giants.

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The Pharmacist

NOVEMBER 7, 2023

The government has been urged by the Royal Pharmaceutical Society (RPS) to pass legislation prohibiting multi-buy deals on pain relief medicine. According to the RPS, multi-buy offers on paracetamol and ibuprofen such as ‘buy one, get one free’ encourage people to buy more than they need, leading to excess packs being stored at home and […] The post Ban multi-buy deals on pain relief medicine, government urged appeared first on The Pharmacist.

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Pharmaceutical Commerce

NOVEMBER 7, 2023

Bill Roth provides insight as to how where chief commercial officers and access leaders can plan for a profitable product lifecycle.

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Outsourcing Pharma

NOVEMBER 7, 2023

People with Alcohol Use Disorder (AUD) could benefit from taking a daily tablet that could see their intake reduced by half in just three months.

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