Thu.Dec 14, 2023

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When Dobbs forced one doctor to shutter his abortion clinic, he took his mission on the road

STAT

On June 24, 2022, Aaron Campbell turned away patients at his abortion clinic for the first time. Earlier that day, the 32-year-old doctor had received word that the Supreme Court had just handed down a consequential decision in Dobbs v. Jackson, upending the constitutional right to an abortion in the U.S. The lawyers at Campbell’s clinic, the Knoxville Center for Reproductive Health in Knoxville, Tennessee, urged him to stop performing all abortions immediately.

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The many ‘myths’ of clinical trial diversity, and Genentech’s fight to disrupt them

PharmaVoice

Genentech’s chief diversity officer Quita Highsmith is on a crusade to prove that much of what the industry believes about clinical trial diversity is wrong.

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Trending Sources

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North Carolina attorney general sues HCA for lapses at Mission Health

STAT

North Carolina’s attorney general alleges in a new lawsuit that HCA Healthcare is violating the terms of the agreement that allowed it to buy Mission Health, a formerly nonprofit health system. In the complaint filed Thursday , attorney general Josh Stein said HCA, the country’s largest for-profit hospital chain, is not providing the quality, consistent emergency and cancer care that it committed to delivering across Mission’s six western North Carolina hospitals.

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From Fear to Passion: Embracing the Unexpected Journey into Pediatric Pharmacy with Dr. Stephen Small!

Pharmacy Is Right For Me

An Unexpected Path Deciding exactly what you want to do or where you want to go in life is difficult. What if you don’t like where you end up? What if you change your mind? Dr. Stephen Small is a prime example of what it looks like to not only change your mind but to embrace the unexpected. Dr. Small is a pediatric clinical pharmacist specialist but if you had asked him years earlier, he would not have thought that he would end up working with children, “Pediatrics was actually the only specialt

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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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STAT+: Sanders blames food companies for diabetes epidemic

STAT

WASHINGTON — Sen. Bernie Sanders (I-Vt.) has a new corporate target: the food industry. Sanders held a hearing today on diabetes that implicated both the food and drug industries in what the American Diabetes Association estimates is a $413 billion annual cost to the health care system. That’s up 27% over the past six years, he said, and he warned that new weight loss drugs could send health care spending to the stratosphere.

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Warning issued over fake pharmacy scam callers

The Pharmacist

A scam alert has been issued over fraudsters phoning patients and pretending to be from a pharmacy. The scammers claim to be ringing to arrange delivery of medication, and ask patients to confirm their full name, date of birth, address and some banking details. According to Audit Yorkshire, which runs a counter fraud service for […] The post Warning issued over fake pharmacy scam callers appeared first on The Pharmacist.

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Apellis eye drug likely to be rejected in Europe, company says

BioPharma Dive

According to Apellis executives, reviewers in Europe are skeptical of the benefits of its geographic atrophy medicine, Syfovre, and appear poised to recommend against approval at a meeting next month.

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STAT+: Jay Bradner, former Novartis research leader, to head up Amgen’s scientific efforts

STAT

Jay Bradner, a former top research leader at Novartis, is joining Amgen as its new chief scientific officer, the California company announced Thursday.   Bradner is taking over for Amgen veteran David Reese in the role. Reese is becoming the company’s chief technology officer. “For more than 40 years, Amgen’s focus on innovation has enabled us to deliver life-changing medicines to patients suffering from serious diseases around the world,” Robert Bradway, Am

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PharmaKure and UiTM enter research partnership for Alzheimer’s disease

Pharma Times

The collaboration aims to develop biomarker-based diagnostics for the condition - News - PharmaTimes

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Opinion: In mifepristone case, the Supreme Court must affirm the FDA’s authority. Medical innovation is at risk

STAT

On Wednesday, the Supreme Court announced it will soon weigh in on a case that challenges how the Food and Drug Administration regulates mifepristone , a drug it approved almost 25 years ago that is used to terminate pregnancy. The case, the Alliance for Hippocratic Medicine v. FDA, is disguised as a dispute over safety. In reality, it’s about whether the courts will go along with overturning, for political reasons, the authority of the FDA as the scientific arbiter of approval of ne

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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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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

In the ever-evolving landscape of regulatory decisions, the quest for safeguarding public health remains paramount. Decisions to remove medicines from market are not taken lightly and are often based upon all evidence available to inform a benefit/risk balance. This evidence can come from a range of sources, such as randomised controlled trials (RCTs), observational studies, and spontaneous reporting.

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STAT+: Amputees have better balance, less pain after electrical stimulation, study finds

STAT

For years, Lauren Gavron relied on oxycodone to quiet the pain in her missing lower left limb. But she hated the fog that came with it, preventing her from feeling comfortable enough to drive. When researchers at the University of Pittsburgh delivered electric jolts to her spine in 2021, the Duquesne, Pennsylvania resident was shocked to feel that pain temporarily melt away — and to feel sensation in her prosthetic foot, improving her walk and balance.

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Central procurement of adult flu vaccines in England to be explored

The Pharmacist

NHS England (NHSE) and the government will undertake a ‘cost-benefit analysis’ examining the case for central procurement of adult flu vaccines, a new vaccine strategy published this week has revealed. NHSE also said that it would pursue legislative change ‘that could enable the safe movement of vaccines across providers where appropriate and thereby support collaboration […] The post Central procurement of adult flu vaccines in England to be explored appeared first on The Pharmacist.

Vaccines 101
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Opinion: Europe’s lessons for the U.S. on how to cover weight loss drugs

STAT

It’s no secret that the obesity epidemic in the United States has reached alarming levels, with rates surpassing 40% of the population. Despite a robust focus on wellness and exercise in the media, post-pandemic America continues to rank among the global leaders in obesity rates. Estimates indicate that treating obesity will be expensive, but those sums pale in comparison to the estimated direct and indirect costs of $1.7 trillion that obesity places on the U.S. health care system today.

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Patient Centric Diabetes Care

PharmExec

A discussion of the current standard for diabetes care and how the importance of patient centricity, including addressing patient's mental health, are imperative to the future of the space.

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STAT+: Why FDA product recalls have spiked in recent years

STAT

Either American products are getting worse, or scrutiny over their safety is getting tougher. Whichever the case, product recalls by the Food and Drug Administration and the Consumer Product Safety Commission (CPSC) more than doubled between 2018 and 2022, according to new research published on Wednesday by life sciences software company MasterControl.

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Sano Genetics launches ‘Light the Way’ programme for MND

Pharma Times

The free programme will be offered to those who are affected by the condition - News - PharmaTimes

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Is it time to worry about Moderna?

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with the fallout from Pfizer’s downbeat update, a new entrant in obesity research, and an orthogonal CRISPR business.

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Study Highlights Need for Pharma Industry to Address Stigmatization of Acne

PharmExec

JAMA Network study evaluates current attitudes toward individuals with acne with a call for pharma companies to focus efforts on helping to overcome these stigmas.

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Listen: FTC v. biotech, Pfizer’s kitchen sink, & Vertex’s future

STAT

Is no one safe from the FTC? Has Pfizer bottomed out? And is biotech finally back? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we delve into the fallout over the FTC’s move to block what looked like a humdrum biotech deal between Sanofi and Maze Therapeutics, a surprising twist that leaves an unanswered question.

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Zydus receives final approval from the USFDA for Darunavir Tablets 600 mg and 800 mg

Express Pharma

Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency Virus (HIV-1) from multiplying in the body Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Darunavir Tablets 600 mg and 800 mg, and tentative approval for 75 mg and 150 mg tablets (USRLD: Prezista Tablets, 75 mg, 150 mg, 600 mg, and 800 mg).

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Morning Rounds: Teen pregnancies down, but remain higher in the U.S. 

STAT

Understand how science, health policy, and medicine shape the world everyday. Sign up for our Morning Rounds newsletter here. Good morning. Reproductive health is dominating the news and the newsletter this morning. We also have a look at the decade-long battle over a patent for CRISPR. It’s been a rollicking ride.

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AstraZeneca receives CDSCO approval to market its inhalation aerosol

Express Pharma

The pressurised metered dose inhaler is recommended for the treatment and maintenance of patients with Chronic Obstructive Pulmonary Disease (COPD) AstraZeneca India has announced that it has received Central Drugs Standard Control Organisation (CDSCO) approval to market its inhalation aerosol, a triple combination of budesonide (160 mcg), glycopyrrolate (9 mcg), and formoterol fumarate (4.8 mcg).

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Mission Therapeutics moves kidney disease drug to phase 2 after FDA approval

Outsourcing Pharma

Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.

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Zenex announces acquisition of Ayurvet

Express Pharma

This move aims to enable Zenex to strengthen its portfolio of offerings by adding herbals and furthering the quality of its overall animal health portfolio globally Zenex, animal health company has announced a 100 per cent acquisition of Ayurvet. Ayurvet, a company founded by Pradip Burman, is provider of natural ayurvedic and herbal medicines, feed supplements and topical treatments for farm and companion animals.

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FDA grants Priority Review to Amgen's tarlatamab application for advanced small cell lung cancer

World Pharma News

Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab. Tarlatamab is a potential first-in-class, investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) therapy for the treatment of adult patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

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Celadon securing contracts for supply of pharma-grade medicinal cannabis

Outsourcing Pharma

Celadon Pharmaceuticals has today (December 14) announced its first supply of it pharmaceutical-grade breakthrough cannabis-based medicine.

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‘Transparency needed’ around new professional leadership group

The Pharmacist

More clarity about the direction of the new pharmacy professional representation group is needed, the director of the Royal Pharmaceutical Society (RPS) in England has said. In an interview with The Pharmacist last month, James Davies said he hoped that more transparency and information about the group and what it is seeking to do would […] The post ‘Transparency needed’ around new professional leadership group appeared first on The Pharmacist.

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New approach for synthesis of oligonucleotide conjugates

European Pharmaceutical Review

In collaboration with Novo Nordisk, a research group from Denmark’s Aarhus University have devised a method to simplify the construction of an entire library of therapeutic oligonucleotide-peptide conjugates. Specifically, the researchers discovered a synthesis method for oligonucleotide (ON) conjugates that incorporates built-in handles and a special linker, enabling easy linkage of ONs to a peptide marker by adjusting the pH.

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Trade & Channel Strategies 2023: An Interview with Bill Trombetta, PhD, Professor Emeritus, St. Joseph's University

Pharmaceutical Commerce

Bill Trombetta, PhD, discusses successfully navigating what he calls “the coming perfect storm” in healthcare.

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Enrolment complete for Lindus Health and Thirty Madison's pilot dermatology study

Outsourcing Pharma

UK-based Lindus Health and US-based Thirty Madison today (December 14) announced they have completed the enrolment of a trial to assess their personalized dermatology telemedicine platform, Facet.

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Trade & Channel Strategies 2023: An Interview with Douglas Bock of Archbow Consulting

Pharmaceutical Commerce

Partner for Archbow Consulting discusses the conference, the IRA, and specifics of PAP business rules

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Atropos Health and SEQSTER partner to save time, money and accelerate drug development

Outsourcing Pharma

Patient centric, healthcare data tech company, SEQESTER says it can now deliver real-time and real-world data layering in artificial intelligence (AI) to accelerate drug discovery, thanks to its partnership with Atropos Health.

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Astellas secures EC approval for VMS treatment, fezolinetant

European Pharmaceutical Review

The European Commission has approved Astellas Pharma’s Veozatm (fezolinetant) for treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Fezolinetant is a nonhormonal neurokinin 3 (NK3) receptor antagonist. It works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to modulate neuronal activity in the hypothalamus, reducing the number and intensity of hot flashes and night sweats.

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Identifying the Most Prevalent Challenges that Impact Product Launch Success

PharmExec

In-depth study outlines the top five reasons biopharma products miss launch forecasts.

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