STAT

MARCH 28, 2024

While an increasingly anxious world watched a new coronavirus spread across the globe in early 2020, veteran immunologist Rafi Ahmed quickly grasped that his field was about to experience something truly extraordinary. His former student Ali Ellebedy was gnawed by frustration as Covid shutdowns stalled his influenza research; it took until the summer, when mass vaccination planning hit his radar, before the same realization kicked in.

Immunity 363

Immunity Immunization Vaccines 363

PharmaVoice

MARCH 28, 2024

With Zola Therapeutics, Krieg plans to design and sell a series of cancer immunotherapies without the help of outside investors, he told BioPharma Dive.

130

130

STAT

MARCH 28, 2024

The staff of the Institute for Clinical and Economic Review, or ICER, are known as the nerds of the drug industry: bespectacled killjoys who emerge a few times a year to scold drugmakers for pricing their latest cancer or MS advance far beyond reason. But last year, its staff sat down and concluded a forthcoming treatment was worth up to $3.9 million — more than any medicine in history, more than a 45-year supply of Humira, the autoimmune drug often held up as an emblem of America’

Drug Pricing 352

Drug Pricing 352

PharmaVoice

MARCH 28, 2024

Novo Nordisk’s acquisition of Cardior Pharmaceuticals is a bet on new approaches to cardiovascular disease, says Cardior CEO Claudia Ulbrich.

130

130

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

MARCH 28, 2024

WASHINGTON — There’s a fight brewing over the future of decaf coffee. Consumer health advocates are petitioning the Food and Drug Administration to ban a key chemical, methylene chloride, used to decaffeinate coffee beans. While the chemical is almost entirely removed during the decaffeination process, advocates say that a little-known nearly 66-year-old federal law mandates the agency ban the additive because it has been proven to cause cancer in rodents.

349

349

BioPharma Dive

MARCH 28, 2024

Xilio will get just over $40 million from Gilead in return for a license to its experimental IL-12 immunotherapy. The biotech is also discontinuing other work and laying off staff.

112

112

The Pharmacist

MARCH 28, 2024

Pharmacy technicians will be enabled to supply medicines under patient group directions (PGDs), subject to parliamentary approval, the government has announced today. As a result, they may be able to provide Pharmacy First consultations or administer vaccinations, the Department of Health and Social Care (DHSC) has said. This follows a public consultation, which the government […] The post Pharmacy technicians to supply medicines under PGDs appeared first on The Pharmacist.

Pharmacy Technician 108

Pharmacy Technician Vaccines 108

STAT

MARCH 28, 2024

Diabetes and obesity GLP-1 drugs like Ozempic, which can delay stomach emptying, have introduced a predicament for patients undergoing surgeries and endoscopies — the patients in some cases may still have food in their stomach even if they’ve fasted, raising concerns that they could accidentally breathe food into their lungs during the procedures.

Diabetes 298

Diabetes 298

Pharma Times

MARCH 28, 2024

The self-replicating mRNA molecule could be used in cancer and potentially a broad range of other diseases

126

126

STAT

MARCH 28, 2024

Oprah Winfrey, true to form, is forcing America to yet again grapple with a complex topic: weight loss. Her full-throated endorsement on national television last week for using GLP-1 drugs like Ozempic and Wegovy to treat obesity has opened the door for an important conversation about the use of these drugs for people struggling with their weight. As a physician focused on obesity and metabolic disorders, I was troubled by Oprah’s support for these drugs.

279

279

Advertisement

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.

Pharmacy Management

Pulses

MARCH 28, 2024

By: Cherie Lucas, PhD, BPharm, Grad Cert Edu Stud (Higher Educ), MPS and Dr Arcelio Benetoli , BPharm, MSc, PhD How is Professionalism Defined? Professionalism is a complex and multifaceted construct. Many definitions in the literature embody what this entails. Values of professionalism in pharmacy include altruism and core norms, such as self-reflection, along with other attributes, behaviors, ethical conduct, and standards that pharmacists must epitomize daily. 1 This extends beyond the techni

Communication 98

Communication 98

STAT

MARCH 28, 2024

WASHINGTON — Supreme Court Justice Samuel Alito had a clear question at Tuesday’s arguments over the abortion pill mifepristone: If the doctors who brought that case can’t sue the FDA over a drug’s label, who can? And when? “Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful? And maybe what they did was perfectly lawful, but shouldn’t somebody be able to challenge that in court?

Labelling 275

Labelling Drug Development 275

BioPharma Dive

MARCH 28, 2024

The agency gave Akebia’s drug an OK after receiving more safety data, but imposed a strict boxed warning for its use that may limit uptake.

109

109

STAT

MARCH 28, 2024

The United Kingdom has released comprehensive data showing which institutions have failed to register their clinical trials, a move that was hailed by transparency advocates who say this marks the first time that a country has taken such a step. Last week, the Health Research Authority posted complete registration information for 1,545 trials, including the name of the study, the sponsor, and registration number for the trial.

257

257

Pharmaceutical Technology

MARCH 28, 2024

Nanoscope Therapeutics released promising top-line results for its RESTORE trial, which is studying the gene therapy MCO-010 in patients with retinitis pigmentosa (RP).

98

98

STAT

MARCH 28, 2024

Top of the morning to you and a fine one it is. Despite cloudy skies hovering over the Pharmalot campus, our spirits remain sunny. How so? We will trot out a bit of wisdom from the Morning Mayor, who taught us that “every new day should be unwrapped like a precious gift.” So while you tug on the ribbon, we will proceed by brewing another cup of stimulation.

Diabetes 244

Diabetes 244

Pharma Times

MARCH 28, 2024

Healthcare agencies can submit their entries free of charge with a deadline of 30 April

128

128

STAT

MARCH 28, 2024

Who gets to sue the FDA? Is pharma caught in a trade war? And what does “AF” stand for? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Sarah Owermohle joins us to explain the Supreme Court case that could have dramatic effects on access to medication abortion — and the development of new medicines.

242

242

Pharmaceutical Technology

MARCH 28, 2024

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

Documentation 113

Documentation Vaccines 113

STAT

MARCH 28, 2024

This is the inaugural edition of Adam’s Biotech Scorecard, a new subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered every Thursday to their inbox. Hello! Welcome to the premiere issue of Adam’s Biotech Scorecard. I’m excited to get started. Let’s do this! (By the way, the AF in the logo are my initials, not the “other” AF.

238

238

The Guardian - Pharmaceutical Industry

MARCH 28, 2024

Drug companies urged to ‘release stranglehold’ on medicines such as Ozempic and Trulicity, as millions are priced out of treatment Drug companies are pricing diabetes medicines at almost 400 times the level necessary to make a profit, according to a new study. Researchers said it would also be possible for modern insulin pens, which are safer and offer more accurate doses than vials and syringes, to be used even in low-income countries if pharmaceutical firms “put people before their astronomica

Diabetes 101

Diabetes 101

STAT

MARCH 28, 2024

Today is the inaugural publishing day for Adam’s Biotech Scorecard — a subscriber-only newsletter offering senior reporter Adam Feuerstein’s no-holds-barred perspective on the rapidly shifting world of biotech. Sign up to get it in your inbox here. Hello! It’s Meghana. Today, we’re reading about the world’s costliest drug, plus we learn about immune senescence and a potential cause for a kidney autoimmune disease.

Immunity 213

Immunity Immunization Drug Pricing Drug Development 213

pharmaphorum

MARCH 28, 2024

Scientists say a test for motor neuron disease, based on an aptamer for biomarker TDP-43 in brain tissue, could detect at-risk people before symptoms develop.

99

99

Pharma Times

MARCH 28, 2024

Set to open in 2032, the RUEDI facility is funded by the UKRI’s recent infrastructure fund worth £388m

114

114

Express Pharma

MARCH 28, 2024

Dr. Satish Wagh, Chairman & MD, Supriya Lifescience speaks to Express Pharma on the company’s strategy to achieve a turnover of INR 1000 crore within the next five years, and how PLI schemes are helping pharma manufacturers to backward integrate. India is now being seen as a focused pharma manufacturer, according to Dr Wagh and explains how these moves will ensure that the pharma sector will be a major contributor to India’s economy.

91

91

European Pharmaceutical Review

MARCH 28, 2024

A paper published in Applied Sciences has described a quality risk assessment methodology for application in sterile PET radiopharmaceutical production under Good Manufacturing Practice (GMP) regulations. According to research highlighted in the paper, applying quality standards such as GMP and ISO 9001 “guarantees the quality and safety of a radiopharmaceutical and contributes to optimising the performance and efficacy of the entire production process.

91

91

pharmaphorum

MARCH 28, 2024

New data for Beckley Psytech's psychedelic therapy for treatment-resistant depression builds anticipation for a phase 2b readout later this year

97

97

European Pharmaceutical Review

MARCH 28, 2024

The global pharmaceutical and biotechnology environmental monitoring market valued $24 billion in 2023, according to a report by Verified Market Research. This figure is projected to increase to $38.1 billion by 2030. Pharmaceutical and biotechnology environmental monitoring market Influencing factors The report also covered that due to the biotechnology industry requiring sterile conditions and products, expansion of this sector creates demand for extensive environmental monitoring.

83

83

pharmaphorum

MARCH 28, 2024

Explore the cutting-edge innovations featured at WIRED Health 2024, including insights on Alphafold, clean air technology, and Lingo. Stay informed about the latest disruptors shaping the future.

88

88

Drug Channels

MARCH 28, 2024

Today’s guest post comes from Bill Dupere, SVP of Product Development & Partnerships at Mercalis. Bill discusses specialty therapy access barriers, including payer utilization management techniques and “no coverage” policies. Contact Mercalis to learn about their Patient Support Services. Read on for Bill’s insights. Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company.

79

79

pharmaphorum

MARCH 28, 2024

Akebia’s Vafseo has been approved in the US as a treatment for anaemia caused by chronic kidney disease in dialysis patients, the first direct rival to GSK’s Jesduvroq.

86

86

The Pharmacist

MARCH 28, 2024

The provision of pharmacy services is currently balanced ‘in a different way’ amid community pharmacy closures and a rise in distance selling pharmacies (DSPs), NHS England’s director for primary care has suggested. Dr Amanda Doyle was speaking as part of the Health and Social Care Committee’s (HSCC’s) pharmacy inquiry this week when she said that […] The post NHSE: Different ‘balance’ in pharmacy provision amid closures and rise in DSPs appeared first on The Pharmacist.

Community Pharmacies 83

Community Pharmacies 83

Express Pharma

MARCH 28, 2024

Caplin Steriles, a subsidiary company of Caplin Point Laboratories has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ketorolac tromethamine Ophthalmic Solution 0.5% (eye drops), a generic therapeutic equivalent version of (RLD), ACULAR Ophthalmic Solution of Allergan Inc.

76

76

pharmaphorum

MARCH 28, 2024

Moderna’s development of mRNA vaccines for influenza will be backed by up to $750m in funding from Blackstone in a risk-sharing deal

Vaccines 89

Vaccines 89

World Pharma News

MARCH 28, 2024

A transformative study published in Health Data Science, a Science Partner Journal, introduces a groundbreaking end-to-end deep learning framework, known as Knowledge-Empowered Drug Discovery (KEDD), aimed at revolutionizing the field of drug discovery. This innovative framework adeptly integrates structured and unstructured knowledge, enhancing the AI-driven exploration of molecular dynamics and interactions.

78

78