STAT
APRIL 27, 2023
In public, hospitals rave about artificial intelligence. They trumpet the technology in press releases, plaster its use on billboards, and sprinkle AI into speeches touting its ability to detect diseases earlier and make health care faster, better, and cheaper. But on the front lines, the hype is smashing into a starkly different reality.
PharmaVoice
APRIL 27, 2023
From the "father" of the IL-23 pathway at Janssen to a big acquisition by Merck, the ultra-competitive immunology space is still growing with the pace of innovation.
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STAT
APRIL 27, 2023
Eleni Tsigas likens her first experience with preeclampsia to a plane crash. She was in the midst of what she thought was a healthy first pregnancy, with low risk for complications. But at 29 weeks, she was rushed to the emergency room with what she now knows are classic signs of preeclampsia: very high blood pressure, a pounding headache, nausea, blurred vision.
PharmaVoice
APRIL 27, 2023
Events over the last year, including Pfizer’s Seagen buy and AstraZeneca’s CinCor deal, have foreshadowed the comeback of biopharma M&A.
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
APRIL 27, 2023
Despite decades of advancements in genomics, we still don’t know what most of our DNA does. But an ambitious international research collaboration is providing new answers about how genetics shapes human health and disease, with help from an unlikely source — a menagerie of mammals. The findings , reported in a set of 11 studies published on Thursday in the journal Science, come out of the Zoonomia Project, which compared the genomes of 240 mammalian species.
EMCrit Project
APRIL 27, 2023
The precise utilization of ABG, VBG, and pulse oximetry remains controversial. Unfortunately, there is little high-level evidence investigating whether these interventions affect patient outcomes (for example, there is precious little evidence to support most of the target values that we're chasing after). This chapter attempts to explore the strengths, weaknesses, and indications for various techniques. […] EMCrit Project by Josh Farkas.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
BioPharma Dive
APRIL 27, 2023
Trial participants lost up to 15% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.
STAT
APRIL 27, 2023
WASHINGTON — The Biden administration on Thursday rolled out proposals to set national standards for care in Medicaid and children’s health care plans, amid upheaval for millions of Americans’ coverage in both programs. A pair of draft rules released by federal health officials Thursday would require Medicaid plans to book enrollees for appointments within two weeks.
Pharmaceutical Technology
APRIL 27, 2023
The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Described as the largest reform in over 20 years, the proposed revision touches on multiple topics ranging from unequal access to innovative medicines across the EU to new environmental protections.
STAT
APRIL 27, 2023
The Food and Drug Administration warned health care providers Thursday that a security vulnerability in DNA sequencers made by Illumina could allow unauthorized users to access or alter potentially important medical data. The news is an embarrassing development at a time when Illumina’s management team, including CEO Francis deSouza, is trying to fight off a proxy battle by Carl Icahn.
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BioPharma Dive
APRIL 27, 2023
The cell and gene therapy developer will also cut back on manufacturing and certain research in California as it redirects resources to three priority programs.
STAT
APRIL 27, 2023
You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday.
European Pharmaceutical Review
APRIL 27, 2023
Immunotherapy treatment blinatumomab will now become standard treatment worldwide for babies with acute lymphoblastic leukaemia (ALL). This decision is based on new results from an international trial published in the New England Journal of Medicine. Blinatumomab significantly improved survival, with the rate increasing from 66 percent to 93 percent, compared to individuals just given prior chemotherapy.
STAT
APRIL 27, 2023
Is a specter haunting Europe? Will Eli Lilly usurp Johnson & Johnson? And what does “Vowst” call to mind? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Andrew Joseph, STAT’s Europe correspondent, joins us to explain the EU’s sweeping proposal to overhaul how new drugs are regulated on the continent — and why the pharmaceutical industry is fighting it.
Pharmaceutical Business Review
APRIL 27, 2023
Opfolda will be used as an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in LOPD (acid α glucosidase [GAA] deficiency) adult patients. The European Commission (EC) is expected to take decision on miglustat’s authorisation in the third quarter of this year. Pombiliti (cipaglucosidase alfa), the biologic component of the two-component therapy, received EC approval last month.
The Pharmacist
APRIL 27, 2023
Just 456 out of 11,827 community pharmacies in England signed up for the new Pharmacy Contraception Service within the first two days of the option being available to contractors. According to the NHS Business Services Authority (NHSBSA), the figures – which represent less than 4% of community pharmacies in England – were correct as of […] The post EXCLUSIVE: Less than 4% of pharmacies sign up for contraception service in two days appeared first on The Pharmacist.
Pharmaceutical Technology
APRIL 27, 2023
Seres Therapeutics and Nestlé Health Science have received approval from the US Food and Drug Administration (FDA) for Vowst (faecal microbiota spores, live-brpk) for preventing the recurrence of C difficile infection (CDI) in adults. Vowst is an orally administered microbiota-based therapeutic, previously known as SER-109, and is indicated for the prevention of recurrence of CDI in people aged 18 years and above following an antibacterial treatment for recurrent CDI (rCDI).
The Pharmacist
APRIL 27, 2023
The Prime Minister has been pressed to take ‘urgent action’ to prevent more pharmacy closures and to commission an appropriately funded Pharmacy First service. During yesterday’s Prime Minister’s Questions in the House of Commons, Rishi Sunak was reminded of the important role community pharmacies could play in helping to deal with minor illnesses. Labour MP […] The post Prime Minister urged to act on closures and Pharmacy First appeared first on The Pharmacist.
BioPharma Dive
APRIL 27, 2023
Partner Regeneron said the data, which showed substantial reduction of a key protein, suggests hope for the “bold dream” of silencing genes in the brain.
The Pharmacist
APRIL 27, 2023
The average pharmacy makes an overall loss of £45,000 each year, an online meeting held to draw attention to the state of ‘crisis’ in community pharmacy has heard. Michael Niblock, finance director of Pharmacy Care Plus, shared the figures at a webinar organised by the Association of Independent Multiple Pharmacies (AIMp) on Tuesday evening. Ongoing […] The post Average pharmacy makes £45k loss each year, claims finance director appeared first on The Pharmacist.
Pulses
APRIL 27, 2023
By: Ryan Masak, Pharm D candidate, Lauren Pamulapati, PharmD, BCACP and Lauren Caldas, PharmD, BCACP Why assume near-peer teaching is unidirectional? In the Layered Learning Practice Model, an “attending” or more senior individual instructs multiple levels of students who then each teach students who are often near-peers. 1 Pharmacy education embraces this model using a modified “near-peer” teaching strategy, in which more senior students participate in teaching junior students.
European Pharmaceutical Review
APRIL 27, 2023
Through pre-clinical and clinical trial success, adeno-associated viral vectors (AAVs) have consistently demonstrated their effectiveness as a tool for gene delivery to treat a variety of human diseases. As we stand at the precipice of an era that truly embraces gene therapies, there are clearly still a number of challenges to overcome to fully realise the potential of innovative AAVs.
PharmaTech
APRIL 27, 2023
Yaakov Nahmias, founder and chief scientific officer of Tissue Dynamics, discusses the barriers in implementing organ on a chip technology.
Pharma Times
APRIL 27, 2023
Duo will collaborate to develop pluripotent stem cell-based microfluidic cultures for pain research
European Pharmaceutical Review
APRIL 27, 2023
In recent years, the biopharmaceutical industry has found itself at a crossroads – being able to offer advanced and truly innovative treatments, such as gene therapies, but facing the complex challenge of creating manufacturing standards for the biotechnology sector from the ground up. Solving this issue will improve industry best practice, increase public confidence and create a more efficient pathway to patients; but it necessitates enhanced collaboration between companies.
Pharma Times
APRIL 27, 2023
Therapy is being used during pivotal phase 1 study into patients with pancreatic cancer
European Pharmaceutical Review
APRIL 27, 2023
[the CHMP’s recommendation of Cosentyx] brings us one step closer to offering the first new hidradenitis suppurativa (HS) treatment in nearly a decade” The Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for biologic Cosentyx ® (secukinumab). The recommendation for a marketing authorisation “brings us one step closer to offering the first new hidradenitis suppurativa (HS) treatment in nearly a decade,” commented Marie-France Tschudin, President of Novartis I
PharmExec
APRIL 27, 2023
While ESG is still in the early stages for pharma, many companies are moving forward with a need for compliance.
World Pharma News
APRIL 27, 2023
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20®(20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained
European Pharmaceutical Review
APRIL 27, 2023
Christopher Boerner, PhD, Executive Vice President (EVP), Chief Commercialization Officer of Bristol Myers Squibb will become the company’s new CEO on November 1 2023. Effective immediately, Boerner has been named its EVP, Chief Operating Officer. The pharma company’s current CEO and Chairman of the Board Dr Giovanni Caforio will retire on November 1 2023.
BioPharma Dive
APRIL 27, 2023
Therini Bio is developing drugs that target fibrin, a protein involved in wound healing that the company thinks could also play a role in certain neurological and eye diseases.
Pharmaceutical Commerce
APRIL 27, 2023
From logistics lessons learned, how pharma can navigate new opportunities surfacing in ocean shipping.
Express Pharma
APRIL 27, 2023
Cipla holds a prominent position in the top five therapy areas in India, except for the anti-diabetes and gastrointestinal segment. Against this backdrop, the Indian pharma major is constantly partnering with multinational companies to get access to an innovative portfolio with a focus on diabetes, says GlobalData. Cardiology, anti-diabetes, respiratory, anti-infective and gastrointestinal are the top five therapy areas in India, accounting for 76 per cent of sales in 2022.
Outsourcing Pharma
APRIL 27, 2023
Greenphire, a company that finds solutions for companies wanting to run clinical trials has launched a new patient-facing digital platform.
Big Molecule Watch
APRIL 27, 2023
FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. Pursuant to a law enacted in late 2020, a reference product sponsor must provide patent information to FDA for listing in the Purple Book once it has provided a patent list to a biosimilar applicant pursuant to Section 3(A) of the patent dance provisions of the BPCIA.
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