STAT

NOVEMBER 22, 2022

A viral hurricane is making landfall on health care systems battered by three pandemic years. With the official start of winter still weeks away, pediatric hospitals are facing crushing caseloads of children sick with RSV and other viral illnesses. Schools that promised a “return to normal” now report widespread absences and even closures from RSV and flu in many parts of the country , contributing to parents missing work in record numbers.

Hospitals 364

Hospitals 364

PharmaVoice

NOVEMBER 22, 2022

How Boston became the biotech capital of the U.S., and is now preparing for the next era of life sciences growth.

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Pharmaceutical Technology

NOVEMBER 25, 2022

Artificial intelligence (AI) was seen as one of the top current investment priorities and was thought to continue to attract investment in the healthcare sector in the upcoming two years, according to GlobalData's latest report ‘Digital Transformation and Emerging Technology in the Healthcare Industry - 2022 Edition’. In this survey-based report tracker, digital media was prioritised as a top current investment target, with 53% of surveyed respondents confirming that their companies are currentl

Pharmaceutical Companies 145

Pharmaceutical Companies Pharmaceutical Companies 145

European Pharmaceutical Review

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes. Standard treatment for the condition involves replacing the missing or deficient clotting factor to improve the body’s ability to stop bleeding and promot

Adverse Reactions 127

Adverse Reactions 127

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 22, 2022

The updated Covid-19 boosters increase people’s protection against symptomatic infection from the coronavirus, according to some of the first estimates of how the shot is performing in the real world and in people, not just in lab experiments. What’s more, that protection was even stronger when people waited a longer period of time since their last dose of the original shot.

Vaccines 345

Vaccines 345

PharmaVoice

NOVEMBER 22, 2022

Evelina Vågesjö, co-founder and CEO of the immunotherapy company Ilya Pharma, is working on a new modality to speed wound healing.

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European Pharmaceutical Review

NOVEMBER 21, 2022

The first-in-human gene therapy trial for heart failure patients with preserved ejection fraction (HFpEF) has been approved by the US Food & Drug Administration (FDA). SRD-001, the adenovirus associated virus (AAV)-based gene therapy is delivered to cardiac ventricular muscle cells via an intracoronary infusion system (produced by Sardocor, a clinical-stage gene therapy subsidiary of Medera), to increase the protein expression and functional activity of sarcoplasmic reticulum calcium ATPase

Labelling 126

Labelling 126

STAT

NOVEMBER 22, 2022

The Food and Drug Administration on Tuesday approved the first gene therapy to treat people with hemophilia B, an inherited bleeding disorder. The one-time treatment, called Hemgenix, was developed by the Dutch biotech company UniQure and will be marketed by CSL Behring, an Australian pharmaceutical company.

Pharmaceutical Companies 333

Pharmaceutical Companies Pharmaceutical Companies 333

PharmaVoice

NOVEMBER 21, 2022

Biopharma IPOs have puttered in 2022, particularly compared to the record-breaking previous year, but they might be set to rebound.

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pharmaphorum

NOVEMBER 25, 2022

There are approximately 7,000 different types of rare disease and researchers estimate that there are more than 300 million people worldwide living with such a condition, according to the National Institutes of Health (NIH). However, only 5% of rare diseases are estimated to have at least one approved treatment, known as “orphan” therapies. A rare disease is any disease that affects a small percentage of the population.

Immunity 117

Immunity Immunization Hospitals 117

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Pharmacy Management

Pharmaceutical Technology

NOVEMBER 25, 2022

In recent months, Wegovy (semaglutide), indicated for obesity, has been subjected to widespread supply shortages due to high demand, in addition to manufacturer production problems, with Novo Nordisk intending to relaunch Wegovy by the end of 2022. In the meantime, however, Novo Nordisk’s Ozempic, another version of semaglutide indicated particularly for patients with type 2 diabetes, has picked up the slack by being used off-label for obesity patients.

Diabetes 111

Diabetes Labelling 111

STAT

NOVEMBER 24, 2022

An experimental influenza vaccine developed using messenger RNA technology appears capable of inducing what should be a protective immune response against all known subtypes of flu, at least in animals. If the work is translated into humans it could turn out to be a version of a long-sought universal vaccine. This would not be a vaccine that would block all flu infections, nor would it replace the need for an annual flu shot.

Vaccines 332

Vaccines Immunity Immunization Hospitals 332

PharmaVoice

NOVEMBER 21, 2022

The company hopes its drugs can “take over where other available treatments fail” in multiple types of cancer.

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pharmaphorum

NOVEMBER 21, 2022

Provention Bio has priced its new type 1 diabetes (T1D) prevention therapy Tzield at $13,850 per vial – equivalent to almost $194,000 for its 14-day course – a higher level than had been predicted by industry observers. The company argues that the cost is justified as Tzield (teplizumab) is the first drug that can delay the onset of type 1 diabetes, fending off the time when they become highly reliant on insulins and at risk of the serious complications that can accompany advanced T1D.

Diabetes 113

Diabetes Drug Pricing 113

Pharmaceutical Technology

NOVEMBER 20, 2022

The UK's National Institute for Health and Care Excellence (NICE) has published a draft guidance that does not recommend the use of five major Covid-19 therapies. This news came as many organisations and patient advocacy groups have been campaigning for the adoption of some of the rejected drugs for several months, amidst concerns about access to medicines in the UK.

Hospitals 111

Hospitals Drug Development 111

STAT

NOVEMBER 22, 2022

Flu season is underway. RSV is putting record numbers of children in hospitals. And health professionals are gearing up for another Covid winter. With so many potential viruses in play, it would be helpful if Americans had a way to distinguish between different ailments at home. And when it comes to the flu in particular, at-home testing could help telehealth doctors decide when it makes sense to prescribe treatments like Paxlovid and Tamiflu, which need to be administered within a specific time

Hospitals 295

Hospitals 295

PharmaVoice

NOVEMBER 23, 2022

Empowered by her own cancer journey, Nicole Lambert is using her platform as chief operating officer of the genetic testing powerhouse to change the trajectory of care for millions of women.

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pharmaphorum

NOVEMBER 20, 2022

Elizabeth Holmes, the founder and former chief executive of blood testing biotech Theranos, has been sentenced after being convicted of defrauding investors in the company earlier this year, receiving a prison sentence of more than 11 years in a California court. That’s shorter than the 15 years sought by prosecutors, but considerably longer than the 18 months’ house arrest that Holmes’ defense attorneys had pushed for, and there is likely to be an appeal against the sentence,

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Pharmaceutical Technology

NOVEMBER 22, 2022

Umoja Biopharma has signed a research agreement with IASO Biotherapeutics (IASO Bio) to develop off-the-shelf therapies for haematological malignancies. Under the alliance, the companies will assess the induced cytotoxic innate lymphocytes (iCIL) platform of Umoja with chimeric antigen receptors (CARs) of IASO to develop the next generation of widely accessible, easily available cell therapies.

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STAT

NOVEMBER 21, 2022

The world is fast approaching the third anniversary of those days when we got our first inkling that a new disease was spreading in China. In the months that followed, normal life was suspended, then upended. At this point, everyone is well and truly sick of Covid-19 and the accommodations we have had to make to co-exist with it. So sick of it, in fact, that many people appear to have given up trying to avoid the SARS-CoV-2 virus.

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PharmaVoice

NOVEMBER 23, 2022

With their latest personnel moves, these life sciences companies are preparing for major business shifts.

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pharmaphorum

NOVEMBER 23, 2022

Each person living with a rare disease has a unique experience of their condition, but all will have faced similar challenges. They have suffered from an overwhelming diagnosis experience that has left them feeling misunderstood, isolated, and desperate for someone to help them connect symptoms and make sense of the sheer volume of information. Many will also face barriers to care, where access to specialists is limited and often geographically out of reach.

Communication 107

Communication 107

European Pharmaceutical Review

NOVEMBER 24, 2022

Patients with refractory systemic lupus erythematosus (SLE) were able to go into remission within three months of one small dose of a personalised anti-CD19 CAR T-cell immunotherapy in a clinical study. The German study showed all five young adult patients with systemic lupus erythematosus went into remission, enabling them to stop taking their lupus medications within three months of just one small dose of the CAR T therapy , as it essentially removed their existing B cells.

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STAT

NOVEMBER 21, 2022

Northwest Biotherapeutics tried again, but its experimental treatment for brain cancer still falls short. Last Thursday in JAMA Oncology, Northwest Biotherapeutics and its scientific collaborators published the results of a large clinical trial showing its personalized cancer vaccine administered to patients with brain tumors reduced the risk of death by 20% compared to a group of patients taken from “external controls.

Vaccines 258

Vaccines 258

PharmaVoice

NOVEMBER 21, 2022

In the biopharmaceutical industry, phases of innovation and change are often driven by regulatory action.

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Pharmaceutical Technology

NOVEMBER 25, 2022

Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) to treat HER2-positive unresectable or recurrent breast cancer in adults. The treatment is indicated for usage in such patients following previous chemotherapy, comprising trastuzumab and a taxane. The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy a

Adverse Reactions 105

Adverse Reactions Chemotherapy Labelling 105

European Pharmaceutical Review

NOVEMBER 22, 2022

Triastek, Inc. a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs. T21 is Triastek’s third FDA IND clearance for a 3D-printed medicine.

Dosage 105

Dosage 105

STAT

NOVEMBER 22, 2022

Early one afternoon in 2000, Monique Shields, just a few weeks shy of her 30th birthday, left her busy day as an executive assistant at Starbucks’ corporate headquarters to go to her routine prenatal checkup. Feeling healthy, as she had throughout her 34 weeks of pregnancy, she stopped by her home outside of Seattle, changed into her flip-flops, and drove the five minutes to the appointment at her obstetrician’s office.

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PhRMA

NOVEMBER 21, 2022

Research has shown that 340B hospitals are more likely to prescribe more expensive medicines and significantly mark up the price of medicines. For example, 340B hospitals received nearly five times what they paid, on average, to acquire oncology medicines through 340B. These practices have implications for what patients pay out of pocket — and new research adds to the evidence.

Biosimilars 105

Biosimilars Hospitals 105

pharmaphorum

NOVEMBER 25, 2022

Scientists in the US say they have developed an mRNA-based vaccine that encompasses all 20 known subtypes of influenza that could form the basis of a future universal jab. While the shot is still in preclinical development, if it works in human trials it could raise the prospect of eventually sidestepping the annual scramble to guess the most likely strains to be circulating in the following flu season, and protect against future flu pandemics.

Vaccines 104

Vaccines Immunity Immunization 104

European Pharmaceutical Review

NOVEMBER 22, 2022

A paper, published in Molecules , has developed validated the use of ultra-performance liquid chromatography with triple quadrupole mass spectrometry, or UHPLC-MS/MS, for identification and detection of the ?-lactams cephapirin and ceftiofur in cleaning solutions of the production reactors. Trace detection of ?-lactam antibiotics in cleaning rinse solutions and manufacturing aids in pharmaceutical facilities is crucial and regulated.

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Compounding 105

STAT

NOVEMBER 21, 2022

This story has been adapted from the STAT Report “The future of messenger RNA: Covid-19 vaccines are just the beginning.” The unprecedented success of messenger RNA vaccines against the coronavirus is raising hopes that the technology could lead to new and better vaccines against a much older public health scourge: cancer.

Vaccines 251

Vaccines 251

PharmExec

NOVEMBER 22, 2022

The Digital Medicine Society (DiMe) CEO Jennifer Goldsack and Takeda’s Head of Digital Health Sciences, Data Sciences Institute Shoibal Datta describe the current landscape of digitized clinical trials and the decisions needed to fully utilize their potential.

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pharmaphorum

NOVEMBER 22, 2022

GSK confirmed this morning that the disappointing readout from the DREAMM-3 trial of multiple myeloma therapy Blenrep reported earlier this month means that it will take the drug off the US market. The company said it has started the processing for withdrawing the marketing authorisation for Blenrep (belantamab mafodotin) at the request of the FDA. Some patients will be able to continue to receive the drug via a compassionate use programme.

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Pharma Times

NOVEMBER 23, 2022

Research showed that prescribing based solely on levels of proteins present is unlikely to be suitable

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