STAT

JUNE 27, 2023

WASHINGTON — Grail is aggressively lobbying to get Medicare to pay for its cancer-screening test Galleri — but experts tell STAT that the company has a far more complicated path to that end than the makers of most medicines or medical devices. Grail’s controversial blood test Galleri screens for multiple cancers. The Food and Drug Administration has not yet approved it, so Medicare hasn’t had to make a decision on whether to cover it or not.

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PharmaVoice

JUNE 27, 2023

Intercept Pharmaceuticals has stepped out of the race to the first U.S. approved treatment for the complicated liver disease NASH, leaving room for other pharmas to get their foot in the door.

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STAT

JUNE 27, 2023

WASHINGTON — Hundreds of activists rallied today outside of the headquarters of the country’s largest health insurance lobbying group to protest against restrictions to coverage in private Medicare plans. The protesters were crammed into an already busy part of the city. A 10-minute walk from the Capitol building and a block off the National Mall, the headquarters for America’s Health Insurance Plans is located in a part of Washington that is crowded with tourists during the

Drug Pricing 298

Drug Pricing 298

European Pharmaceutical Review

JUNE 27, 2023

Riding on the momentum of the first faecal microbiota product approved for C. difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Recent developments in microbiome therapeutics In May this year, first-in-human study interim results revealed that a CRISPR-based microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”.

Immunity 100

Immunity Immunization Chemotherapy Vaccines 100

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

JUNE 27, 2023

Sometimes, an apple a day really is just what the doctor ordered. And for the past several years, organizations like About Fresh , the Boston-based nonprofit where I work, have been developing tools to make such produce prescriptions possible for those who can’t afford the fresh fruits and vegetables they need. Since January 2021, we have enrolled more than 4,101 Medicaid members in our Fresh Connect produce prescription program, and to date they have spent nearly $2.8 million on the fres

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BioPharma Dive

JUNE 27, 2023

A Duchenne gene therapy faces a crucial test, while highly anticipated study results are expected in lung cancer, obesity and heart disease.

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Orsini Pharmacy

JUNE 27, 2023

Orsini Specialty Pharmacy, a leading independent specialty pharmacy focused on rare diseases and gene therapies, has been selected by Sarepta Therapeutics, Inc. as one of its limited distribution providers of ELEVIDYS (delandistrogene moxeparvovec-rokl). ELEVIDYS is the first gene therapy for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne Muscular Dystrophy (DMD) with a confirmed mutation in the DMD gene and is contraindicated in patients with any deletion in

Specialty Pharmacies 98

Specialty Pharmacies 98

STAT

JUNE 27, 2023

Finding a new medicine is never easy. But developing treatments for patients with rare diseases — conditions that afflict fewer than 200,000 people in the United States — is particularly challenging. When there are only a few thousand or even a few hundred people living with a particular condition, finding enough patients for clinical trials can take years.

Drug Development 230

Drug Development 230

Pharma Times

JUNE 27, 2023

Update on radiosensitising impact of SFX-01 when treating common soft tissue sarcoma condition - News - PharmaTimes

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STAT

JUNE 27, 2023

Early this spring, dozens of volunteers fielding requests from people struggling with eating disorders — many of whom call amid mental health crises — received surprising and abrupt news: Their service at the National Eating Disorders Association would end within weeks. In their place, the nonprofit would offer an AI chatbot called Tessa.

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Pharmacy Management

Pharmaceutical Commerce

JUNE 27, 2023

In an interview at the DIA Global Annual Meeting with Pharma Commerce Editor, Nicholas Saraceno, Cal Collins, CEO of OpenClinica discusses impacting the broader supply chain.

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STAT

JUNE 27, 2023

Dear Readers, Today is an important day in the history of STAT: We have refreshed the look of our homepage and adjusted the teal color that has been synonymous with STAT since we launched nearly eight years ago.

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Express Pharma

JUNE 27, 2023

Lab relocations involve complex processes that require a high level of planning and preparation to enable successful moves without compromising on productivity and science. Our experienced personnel handles every aspect of your move: – Relocation planning and documentation – Layout consultation for your new site – Deinstallation, reinstallation, and performance verification – Instrument requalification and compliance testing – Inventory management – Post-move documentation We move it all.

Documentation 96

Documentation 96

STAT

JUNE 27, 2023

A year after two major drugmakers sued a wholesaler for its alleged role in distributing counterfeit HIV pills, the U.S. Food and Drug Administration warned the wholesaler for failing to ensure that “suspect” medicines did not enter the marketplace. In a June 8 letter, the agency rebuked Safe Chain Solutions for violating a federal law designed to bolster the integrity of the pharmaceutical supply chain.

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European Pharmaceutical Review

JUNE 27, 2023

Lonza and Vertex Pharmaceuticals Incorporated have agreed to collaborate to support the manufacture of Vertex’s Type 1 diabetes cell therapy portfolio. The companies will partner in the process development and manufacturing scale-up at a new, large-scale facility in Portsmouth, New Hampshire, US. Operated by Lonza, the 130,000 square foot facility is anticipated to create up to 300 new jobs at peak capacity.

Diabetes 94

Diabetes Immunity Immunization 94

STAT

JUNE 27, 2023

SAN DIEGO — It was Novo Nordisk’s Ozempic and Wegovy that set off a new era in obesity medicine, delivering unprecedented levels of weight loss and working its way into popular culture, inescapable ads, and hundreds of thousands of medicine cabinets. But Eli Lilly has been following close behind with new treatments, and after dropping result after result from successful trials at the American Diabetes Association conference here this past weekend, the Indianapolis-based drugmaker l

Diabetes 192

Diabetes Drug Development 192

European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. This follows FDA clearance of the Investigational New Drug (IND) application, enabling expansion to the US of the ongoing Phase Ib/II ABATE study of ACI-24.060 in Alzheimer’s patients and individuals with Down’s syndrome.

Vaccines 94

Vaccines Immunity Immunization 94

STAT

JUNE 27, 2023

Top of the morning to you. The middle of the week is upon us and, since you made it this far, why not forge ahead? After all, there is always light at the end of the proverbial tunnel. You never know what you may accomplish. So please join us as we celebrate this notion with a cup or three of delicious stimulation. Our choice today is … maple bourbon.

Diabetes 171

Diabetes 171

BioPharma Dive

JUNE 27, 2023

The treatment could become Pfizer’s first marketed gene therapy, an area the pharma has poured significant resources into in recent years.

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STAT

JUNE 27, 2023

Eli Lilly agreed to pay $2.4 million as part of a settlement with the U.S. Equal Employment Opportunity Commission, which had filed a lawsuit accusing the company of age discrimination in hiring sales representatives around the country over a recent four-year period. The agreement was disclosed in a consent decree in which Lilly is prevented from rejecting applicants for primary care sales positions in its diabetes and obesity business units based on age.

Diabetes 169

Diabetes 169

The Pharmacist

JUNE 27, 2023

The use of biologics in women with psoriasis who are either pregnant or planning to conceive is not associated with an increased risk of miscarriage, abortion or congenital malformations, according to the findings of a recent study. The available literature suggests that psoriasis improves during pregnancy although there is a slight risk of a disease flare following […] The post Study suggests biologics safe for pregnant women with psoriasis appeared first on The Pharmacist.

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World Pharma News

JUNE 27, 2023

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization application (MAA) for fidanacogene elaparvovec has also been accepted and is under review by the European Medicines Agency (EMA).

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Express Pharma

JUNE 27, 2023

Agilent University delivers training to build job-ready skills that you can put to work. Learn the essentials of new techniques or master real-world applications with advanced methodologies. Improve lab operations and minimize downtime with courses covering troubleshooting, maintenance, sample prep, and software operations for chromatography, mass spectrometry, spectroscopy, and more.

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PhRMA

JUNE 27, 2023

On May 11th of this year, the COVID-19 national public health emergency (PHE) officially ended, marking an incredible milestone in the fight against COVID-19. While the end of the PHE signals a new chapter in the fight against COVID-19, the biopharmaceutical industry’s work continues to ensure our health care system is well-prepared for any curve balls this virus might throw as well as staying ahead of the next pandemic.

Vaccines 90

Vaccines 90

Pharma Times

JUNE 27, 2023

The company is seeking to address the worldwide impact of group B streptococcus in older adults - News - PharmaTimes

Vaccines 106

Vaccines 106

European Pharmaceutical Review

JUNE 27, 2023

Included in this issue of European Pharmaceutical Review : FOREWORD Nitrosamines: the beginning of the end? David Elder, David P Elder Consultancy MANUFACTURING Meeting rising demands of a new radiotheranostic era Leila Jaafar-Thiel, Nuclidium AG Developing point‑of-care CAR T manufacturing Arnon Nagler, Sheba Medical Center and Tel Aviv University IN-DEPTH FOCUS: FORMULATION Titanium dioxide (E171) and its role in formulation Mike Tobyn, Bristol Myers Squibb, Jonathan Kaye, GSK David Harris

Vaccines 89

Vaccines Immunity Immunization 89

Express Pharma

JUNE 27, 2023

He joins Boehringer Ingelheim from AstraZeneca, where he was the Managing Director for India and Africa Cluster Head Boehringer Ingelheim announces the appointment of Gagandeep Singh as Managing Director and Head of Human Pharma India, effective July 10, 2023. He will also join the board of Boehringer Ingelheim India. Gagandeep succeeds Vani Manja, who moved to Boehringer Ingelheim UK in February 2023.

Communication 87

Communication Pharmaceutical Companies Pharmaceutical Companies 87

Pharmaceutical Technology

JUNE 27, 2023

Vertex and Lonza have entered a partnership to establish a facility in Portsmouth, US, to manufacture cell therapies for type 1 diabetes.

Diabetes 98

Diabetes 98

European Pharmaceutical Review

JUNE 27, 2023

Janssen’s investigational monoclonal antibody (mAb) therapy nipocalimab enabled 54 percent of participants in the proof-of-concept Phase II UNITY study to achieve a live birth at or after gestational age of 32 weeks without intrauterine transfusions (IUTs). These participants were at high risk of early-onset severe (EOS) haemolytic disease of the foetus and newborn (HDFN).

Immunity 85

Immunity Immunization Drug Development 85

Pharmaceutical Technology

JUNE 27, 2023

The FDA has accepted a biologics license application (BLA) for Pfizer's fidanacogene elaparvovec to treat adults with haemophilia B.

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Drug Channels

JUNE 27, 2023

Happy 247st birthday, America! Before you launch your July 4 festivities, Drug Channels offers some fireworks of our own: My $0.02 on the Humira price war—and the role of cost-plus pharmacy pricing Fresh evidence that formulary exclusions hurt patients Disturbing oncology drug benefit management Plus, an entertaining explanation of why the U.S. healthcare system is so hard to explain.

Biosimilars 80

Biosimilars 80

Pharmaceutical Technology

JUNE 27, 2023

UCB's Rystiggo has been granted FDA approval to treat myasthenia gravis in anti-AchR or anti-MuSK antibody-positive adults.

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Outsourcing Pharma

JUNE 27, 2023

The worldâs first anti-fibrotic small molecule inhibitor, discovered and designed by generative artificial intelligence (AI) has completed the first patient dose in a phase 2 clinical trial.

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World Pharma News

JUNE 27, 2023

Diabetes is a progressive disease that affects one's ability to control blood sugar levels. For many patients, the condition becomes more severe over time and blood sugar levels grow more difficult to manage. Glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide, have granted patients more control in lowering of blood sugar.

Diabetes 84

Diabetes 84

Outsourcing Pharma

JUNE 27, 2023

The Japanese company Shionogi has taken over the US biotech Qpex Biopharma for up to $140 million in a bid to expand its pipeline of antimicrobial drugs and boost its R&D muscle in infectious disease.

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