May, 2024

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My rendezvous with the raw milk black market: quick, easy, and unchecked by the FDA

STAT

WASHINGTON — It’s Friday May 10, and I’m on my way to what feels like the world’s weirdest drug deal. I received a text the day before from a man named Karl. My order would be arriving from Maryland between 2 and 4 p.m. at the northwest D.C. drop site. It’ll be safely wrapped in ice packs, he assured me.

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As AI proliferates in pharma, regulators look to catch up in clinical trials

PharmaVoice

The FDA’s newly launched Center for Clinical Trial Innovation potentially opens the door for more efficient and expanded AI use, but leaves pharmas wanting more guidance.

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Ajax, aiming for a better JAK drug, raises $95M to begin first tests

BioPharma Dive

Goldman Sachs and Eli Lilly are among those backing the startup, which claims its prospect could be more potent than the myelofibrosis therapies that have come to market in recent years.

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Ten pharmacies closing every week, NPA analysis suggests

The Pharmacist

The equivalent of 10 local pharmacies are closing their doors each week, according to analysis by the National Pharmacy Association (NPA). And the number of bricks and mortar pharmacies closing between January and April 2024 is nearly 50% higher than in the same period last year, the NPA said. The association’s analysis of NHS Business […] The post Ten pharmacies closing every week, NPA analysis suggests appeared first on The Pharmacist.

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Position Your Pharmacy for Expansion

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.

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Bayer cutbacks start to be felt with 1,500 jobs shed in Q1

pharmaphorum

Bayer's first-quarter results update shows its headcount has shrunk by around 1,500 since the start of the year, suggesting promised job cuts are starting to take hold

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AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases

Pharmaceutical Technology

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

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More Trending

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As drug shortages reach record highs, regulators float next steps

PharmaVoice

With many chemo and ADHD drugs stuck in stubborn shortages, several agencies are looking for new solutions to boost supplies.

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Patient dies in Pfizer study of Duchenne gene therapy

BioPharma Dive

Pfizer said the patient, a young boy who was treated earlier last year, had died suddenly. The company is working with trial researchers to investigate further.

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BREAKING: Government publishes hub and spoke consultation response

The Pharmacist

Hub and spoke dispensing between pharmacies owned by different legal entities will be allowed from 1 January 2025, subject to parliamentary approval, the government has announced. In its consultation response published today, the government proposed introducing two models of hub and spoke dispensing across legal entities. In one model the hub would directly supply the […] The post BREAKING: Government publishes hub and spoke consultation response appeared first on The Pharmacist.

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ICER raps conduct of Lykos’ psychedelic trial for PTSD

pharmaphorum

The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).

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5 Reasons to Upgrade Your Pharmacy Management Software

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.

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog: Biosimilars

By Jeffrey N. Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.

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CDC launching wastewater dashboard to track bird flu virus spread

STAT

Reluctance among dairy farmers to report H5N1 bird flu outbreaks within their herds or allow testing of their workers has made it difficult to keep up with the virus’s rapid spread , prompting federal public health officials to look to wastewater to help fill in the gaps. On Monday, the Centers for Disease Control and Prevention is expected to unveil a public dashboard tracking influenza A viruses in sewage that the agency has been collecting from 600 wastewater treatment sites around the

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Revealed: key files shredded as UK government panic grew over infected blood deaths lawsuit

The Guardian - Pharmaceutical Industry

Lost documents prevented victims from finding out the truth, official inquiry told Disastrous failures that caused the contaminated blood scandal were denied by ministers for decades after officials destroyed, lost and blocked access to key documents, memos submitted to the official inquiry reveal. Several batches of files involving the work of a blood safety advisory committee were shredded as the government faced the threat of legal action, documents show.

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Drug patents protect pharma profits. Track when they’ll expire here.

BioPharma Dive

Intellectual property is the foundation of the drug industry’s business model. This database will track key patent expiry dates for 30 top-selling medicines.

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Patients 'put at risk' as pharmacies face medicine shortages 'multiple times a day'

The Pharmacist

Eight in 10 pharmacy team members report that medicine shortages are putting patients’ health at risk, according to a survey by Community Pharmacy England (CPE). The Pressures Survey, completed by more than 900 pharmacy owners and over 2,000 pharmacy team members, found that medicine supply issues were affecting the majority of pharmacy teams (72%) ‘multiple […] The post Patients 'put at risk' as pharmacies face medicine shortages 'multiple times a day' appeared first o

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FDA clears Roche self-collection system for HPV screening

pharmaphorum

The FDA has approved Roche's HPV self-sampling solution that the company says can tackle unequal access to screening that can put women at risk of cervical cancer

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Potential best-in-class antibody shows “remarkable efficacy” in atopic dermatitis

European Pharmaceutical Review

New data from a Phase IIa trial in moderate-to-severe atopic dermatitis has demonstrated that a novel monoclonal antibody (mAb) could facilitate dosing every 12 weeks for induction therapy. This is due to a 31-day half-life at anticipated therapeutic dose levels, Inmagene Biopharmaceuticals confirmed. Humanised anti-OX40 IgG1 mAb IMG-007 works via a silenced antibody -dependent cellular cytotoxicity (ADCC) function, Inmagene explained.

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After decades fighting Big Tobacco, Cliff Douglas now leads a foundation funded by his former adversaries

STAT

“Does it trouble you to answer that question?” one of New York’s highest paid attorneys asked Cliff Douglas, then a 36-year-old activist who had found himself at the center of a $10 billion libel lawsuit brought by the cigarette giant Philip Morris. Philip Morris’ lawyer Herbert Wachtell demanded to know: Were cigarette companies intentionally killing people?

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Data for First-in-Class IV-Administered Gene Therapy to Treat Epilepsy Presented at ASGCT 2024

PharmaTech

The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.

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CG follows big IPO with new results for bladder cancer drug

BioPharma Dive

Newly disclosed Phase 3 results presented Friday match findings the biotech disclosed last year, while offering a more comprehensive look at how its drug stacks up to rival therapies.

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Have your say on PCN pharmacy and you could win a £200 voucher

The Pharmacist

Together with our sister publications, The Pharmacist has launched a survey to hear what pharmacists think about the last five years of change in primary care. The State of Primary Care Survey asks how the changes to the NHS — the launch of primary care networks (PCNs) in 2019 and the shift to integrated care systems (ICSs) in 2022 […] The post Have your say on PCN pharmacy and you could win a £200 voucher appeared first on The Pharmacist.

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Prevention revolution: How digital tools can help us get ahead of health problems

pharmaphorum

Discover how digital tools can provide insights to help us. Digital technology could be a game-changer that offers the elusive promise of tackling the root cause, not just the conditions themselves, when it comes to human health.

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The Promise of RFID for Improving Medication Inventory Management

Pharmaceutical Commerce

Radio frequency identification (RFID) not only helps hospitals boost their medication safety standards, as it also allows clinicians to continue to provide quality patient care.

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Opinion: A dose of reality on adult vaccinations

STAT

The number of children who received their routine vaccinations declined during the pandemic, so public health officials have been focusing on getting kids back up to date. They should also be paying attention to adults as a new, first-of-its-kind report quantifying the economic impact of adult immunizations makes clear. Researchers at the nonprofit Office of Health Economics , based in London, analyzed four adult vaccine programs — for the flu, pneumonia, respiratory syncytial virus (RSV)

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Cresset establishes new HQ in Bengaluru

Express Pharma

Cresset, a provider of solutions for Computational Drug Discovery and Development that accelerate research outcomes, is expanding its existing Asia Pacific presence by creating a new headquarters in Bengaluru, one of India’s leading centers for biotechnology and pharmaceutical research. The press release states that the new India site will support the growing demands of Cresset’s APAC customer base, and increase its reach in a range of markets across the region, including South Korea, Japan, Ch

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AstraZeneca withdraws COVID-19 vaccine, citing declining demand

BioPharma Dive

The move ends a turbulent saga for AstraZeneca, which successfully developed a coronavirus shot but struggled to sell it amid competition and the emergence of rare but serious side effects.

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ARRS funding for DPPs could support community trainees

The Pharmacist

NHS England (NHSE) wants Additional Roles Reimbursement Scheme (ARRS) funding that has recently been unlocked for designated prescribing practitioners (DPPs) ‘to support trainee pharmacists across sectors of practice’, a conference has heard. Last week at the Clinical Pharmacy Congress (CPC) in London, a new opportunity to use ARRS funding for pharmacy training roles was announced. […] The post ARRS funding for DPPs could support community trainees appeared first on The Pharmacist.

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Report warns economic instability has hit UK drug discovery

pharmaphorum

A UK report has said that inflation and geopolitical instability have led to a “dramatic drop” in investment in smaller companies developing new medicines, with a knock-on effect on the entire life sciences industry.

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LogiPharma Europe 2024: World Courier President Talks Mitigating Supply Chain Risks

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno at LogiPharma Europe, Nick Porter, President, World Courier discusses mitigating supply chain risks, the future of artificial intelligence in pharma logistics, and more.

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What we know about extreme heat’s health impacts after the hottest summer on record

STAT

Last summer’s heat waves demonstrated all the ways that extreme heat takes a toll on the human body. In cities across the U.S. from Phoenix to New York, people suffered from heat exhaustion, heat stroke, heat cramps, and more. In Texas, more than 300 people died from heat last year — the highest number since the state started tracking the deaths in 1989.

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Deal activity in pharma industry in April 2024

Express Pharma

In April 2024, the healthcare industry reported 96 deals worth $13.4 billion, compared to the last 12-month (April 2023 to March 2024) average of 94 deals worth $20 billion. Vertex Pharmaceuticals Inc, a biotechnology company, to acquire Alpine Immune Sciences Inc, a clinical stage biotechnology company, for a consideration of approximately $4.9 billion in cash; Ono Pharmaceutical, an immuno-oncology company to acquire Deciphera Pharmaceuticals Inc, a biopharmaceutical company focused on disco

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Reunion raises over $100M to build a better psychedelic drug

BioPharma Dive

The funding will help Reunion pay for a mid-stage study testing its most advanced medicine — essentially a synthetic version of the hallucinogenic psilocin — in women with postpartum depression.

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Pharmacists must be kept 'better in the loop' over medicine shortages

The Pharmacist

Community pharmacists must be kept better informed about medicine shortages, with greater transparency required from supply chains, the chief executive of the Independent Pharmacies Association (IPA) has urged. Dr Leyla Hannbeck also said the fact that pharmacists are unable to make minor amendments in the case of medicines shortages ‘has to change’.

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Updated BIOSECURE Act draft clears House committee

pharmaphorum

House Oversight Committee passes BIOSECURE Act, which would restrict US companies from contracting with Chinese biotechs including WuXi AppTec, MGI and BGI

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The top pharmaceutical companies by R&D expenditure

Pharmaceutical Technology

From Merck & Co to Sanofi, Pharmaceutical Technology lists the leading pharmaceutical companies spending the most on R&D in 2023.