STAT

APRIL 25, 2023

As the overdose crisis rages on and the pandemic-fatigued public runs low on empathy, there have been increasing calls for expanded involuntary commitment for people with substance use disorder. Some of the advocacy for more coercive treatment seems rooted in a disdain for people who use drugs, most especially when their drug use occurs visibly and in close geographic proximity to affluence, for example in San Francisco or in the Massachusetts Avenue and Melnea Cass area of Boston which borders

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PharmaVoice

APRIL 25, 2023

The longtime pharma leader is stepping down from his role as chair of Regeneron’s board in June after decades in drug development.

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Drug Development 265

STAT

APRIL 25, 2023

This is part of a series about new obesity drugs that are transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years. Read more about  The Obesity Revolution. S hira Rosenbluth went on her first diet at 10 years old. It was her own idea: She’d learned that a neighbor was doing some sort of junior WeightWatchers program, and her parents encouraged her to stick with it even after Rosenbluth changed her mind.

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LifeProNow

APRIL 25, 2023

April 25, 2023: “GSK announced that the EMA validated the Company’s Type II Variation for a potential new indication for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with a type of gynaecological cancer known as mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.

Chemotherapy 130

Chemotherapy 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

APRIL 25, 2023

WASHINGTON — Consumers turning to melatonin gummies to get some help falling asleep might be getting a lot more help than they bargained for, according to a new study published Tuesday in the Journal of the American Medical Association. Researchers tested the melatonin concentration in more than two dozen gummy dietary supplements that recently launched and that were available at mainstream retailers like Amazon and Walmart.

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Dosage Labelling 243

BioPharma Dive

APRIL 25, 2023

Biogen’s drug failed the key study meant to show it can slow the nerve-destroying disease, but the drug’s effect on a protein of interest led the FDA to conditionally clear it for market.

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European Pharmaceutical Review

APRIL 25, 2023

The R21/Matrix-M malaria vaccine, developed by the University of Oxford , has been approved for use in Ghana (13 April 2023) and was authorised for use in Nigeria on 17 April. [Regulatory] approval of the [R21/Matrix-M ] malaria vaccine in Ghana was the first in the world” Approval of the malaria vaccine in Ghana was the first in the world. Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months.

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Vaccines Immunity Immunization 108

FDA Law Blog: Biosimilars

APRIL 25, 2023

By Philip Won & Jeffrey K. Shapiro — Does your firm manufacture a “cyber device”? A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” If a device uses software that connects to the internet, it is most likely a cyber device and subject to new section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.

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Documentation Labelling Communication 105

The Pharmacist

APRIL 25, 2023

Pharmacy leaders have called for community pharmacy to be given a greater role in preventing ill health at today’s Westminster Health Forum. Dr Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies (AIMp) and Helga Mangion, policy advisor at the National Pharmacy Association (NPA), made the case for community pharmacy to help tackle […] The post Pharmacy could play key role in prevention agenda, say sector leaders appeared first on The Pharmacist.

Community Pharmacies 94

Community Pharmacies 94

Digital Pharmacist

APRIL 25, 2023

f you’re an independent pharmacy owner or pharmacist, you’re probably aware of the upcoming changes to DIR fees that will take effect in 2024. These changes are intended to reduce the financial burden on independent pharmacies and increase transparency in the pharmacy benefit management (PBM) industry – but the journey to get there may have some hurdles to jump when it comes to cash flow.

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Independent Pharmacies Drug Utilization Review Drug Pricing Pharmacy Management 98

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The Pharmacist

APRIL 25, 2023

The UK Government has rejected a recommendation for a specific pharmacy workforce plan, but has said it remains committed to ‘maximising the use of the skills’ of those in the sector. The notion came within the government’s response to a Health and Social Care Committee report into recruitment, retention and training across health and social […] The post Government rejects call for pharmacy-specific workforce plan appeared first on The Pharmacist.

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PhRMA

APRIL 25, 2023

There is increasing talk about making changes to our health care system to lower costs for patients and address misaligned incentives. These are important conversations that could lead to meaningful improvements, but only if policymakers take a holistic approach to address all the health care drivers. Far too often, there is a singular focus on prescription medicines, ignoring the other parts of the supply chain that are key drivers of U.S. health care spending.

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The Pharmacist

APRIL 25, 2023

Marc Brooks, head of pharmacy at Lincolnshire Co-op, talks to Saša Janković about running offsite NHS flu vaccination clinics. Service type: Offsite NHS flu vaccination clinics Name and location of pharmacy: 17 venues across Lincolnshire Name of head of pharmacy: Marc Brooks Why did you start offering this service? The main reason was to be able to make […] The post Offsite flu vaccination: 'We made good use of venues such as community centres' appeared first on The Pharmacist.

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Vaccines 76

BioPharma Dive

APRIL 25, 2023

The company cut about 20 early-stage projects, including nine solid tumor programs, after reviewing their strategic fit and commercial potential.

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The Pharmacist

APRIL 25, 2023

Taking short breaks from sitting to undertake light exercise – also known as ‘activity snacking’ – can help people with type 1 diabetes better manage their blood sugar levels, new research has suggested. A small study funded by Diabetes UK found that activity snacking could offer people ‘a simple, cost-free’ way to help keep their blood […] The post Study suggests 'activity snacking' helps people with type 1 diabetes appeared first on The Pharmacist.

Diabetes 76

Diabetes 76

European Pharmaceutical Review

APRIL 25, 2023

The National Institute for Health and Care Excellence (NICE) has approved monoclonal antibody (mAb) drug daratumumab (Darzalex ® ) in combination with bortezomib (Velcade ® ) and dexamethasone (DVD) for myeloma at first relapse in England.  The new treatment can increase remission times by more than two years, research has shown. Approximately 3,000 myeloma patients will be able to benefit from the combination treatment each year on the NHS.

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Immunity Immunization 86

EMCrit Project

APRIL 25, 2023

CAR-T cell therapy is rapidly expanding as a miraculous therapy for numerous malignancies. However, it also causes a variety of unique and severe side-effects, which frequently cause ICU admission. This chapter explores current approaches to complications including CRS (cytokine release syndrome), HLH (hemophagocytic lymphohistiocytosis), and ICANS (immune effector cell-associated neurotoxicity syndrome).

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Immunity Immunization 86

BioPharma Dive

APRIL 25, 2023

Results from a small trial suggested Morphic's pill could be effective in treating inflammatory bowel disease, briefly lifting the company’s valuation by hundreds of millions of dollars.

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Pharma Times

APRIL 25, 2023

Therapy provides immunisation against infection caused by hepatitis A in children aged 12 months to 15 years

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BioPharma Dive

APRIL 25, 2023

The company has scrapped two experimental medicines, ended research into eye diseases and “refocused” its gene therapy investment. Yet, its CEO says he’s not opposed to adding new programs via acquisitions.

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PharmExec

APRIL 25, 2023

Digital and innovation leader takes issue with the current state of pharma marketing and suggests new approaches are needed.

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Express Pharma

APRIL 25, 2023

Biocon Biologics and Serum Institute of Life Sciences (SILS) have reached an agreement to withdraw from the original equity structure contemplated under their strategic alliance announced in Sep, 2021. While Biocon Biologics had received approval from the National Company Law Tribunal (NCLT) in Karnataka, SILS was awaiting approval from the NCLT in Maharashtra to complete the merger.

Vaccines 76

Vaccines 76

cureatr

APRIL 25, 2023

In early April 2023, the Centers for Medicare & Medicaid Services (CMS) released the 2024 Medicare Advantage and Part D Final Rule. Most of us expected it to finalize several significant changes related to the Part D Medication Therapy Management (MTM) Program, most notably the eligibility criteria. These revised eligibility requirements, outlined in the 2024 proposed rule, would dramatically alter the MTM Program and the delivery of MTM services, including substantially increasing Part D po

Medication Therapy Management (MTM) 70

Medication Therapy Management (MTM) 70

Express Pharma

APRIL 25, 2023

Sun Pharmaceutical Industries announced that one of its wholly-owned subsidiaries has launched a novel ophthalmology treatment, CEQUA, in India for patients who have Dry Eye Disease (DED) with inflammation, a commonly occurring condition. CEQUA is the first dry eye treatment available in India that is delivered with nanomicellar (NCELL)* technology.

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The Guardian - Pharmaceutical Industry

APRIL 25, 2023

Rather than board the injection bandwagon, Britain should be taxing unhealthy food and clamping down on marketing Humankind has been freed from the threat of disease by some wonderful, transformative inventions, from smallpox injections to the Covid vaccinations. With all due respect, I don’t think the so-called skinny jab is one of them. A boom in injectable weight-loss drugs, such as Wegovy from the Danish pharmaceutical giant Novo Nordisk, a biological type 2 diabetes medication containing se

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Diabetes Vaccines 69

Drug Channels

APRIL 25, 2023

Baseball season is here! While we wait for the Phillies turnaround, let’s oil up our gloves, lace up our cleats, and run the bases around this month's biggest hits: Foul ball : OptumRx prefers higher prices for the first Humira biosimilar Strikeout : Copay accumulators hurt health equity Bench warmer : Surprise? Amazon has still not disrupted healthcare Spitting mad : Shady alternative funding programs (AFPs) face more scrutiny Plus, I sit down with Mark Cuban—and take a selfie.

Biosimilars 66

Biosimilars 66

Pharmafile

APRIL 25, 2023

The National Institute for Health and Care Excellence (NICE) has submitted a Final Appraisal Document (FAD) for the use of Darzalex (daratumumab) with bortezomib and dexamethasone (DVd) for adults with previously treated multiple myeloma. It now has 15 days to be accepted, rejected and/or amended ‒ if accepted, it will be used to establish NICE’s guidance on the use of DVd in the National Health Service (NHS).

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Documentation Communication 58

Pharma Times

APRIL 25, 2023

The link-up will enable the company to identify new motor neurone disease biomarkers

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Pharmafile

APRIL 25, 2023

GSK has announced that the European Medicines Agency (EMA) has validated the company’s Type II Variation for a new indication for Jemperli (dostarlimab) alongside chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. The EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected to soon begin the formal review process and make its recommendation to the European

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Chemotherapy Communication 58

Express Pharma

APRIL 25, 2023

Venus Remedies has secured marketing authorisation from the UK for Cisplatin, a chemotherapy drug used as a first-line treatment for advanced ovarian cancer, testicular cancer and bladder carcinoma. This marketing authorisation granted to Venus Pharma, the German subsidiary of Venus Remedies, will enable the company to offer its cancer drugs to the National Health Service (NHS) in the UK and neighbouring countries.

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Chemotherapy 54

Drug Patent Watch

APRIL 25, 2023

Annual Drug Patent Expirations for FOTIVDA Fotivda is a drug marketed by Aveo Pharms and is included in one NDA. It is available from one supplier. There are three patents… The post New patent expiration for Aveo Pharms drug FOTIVDA appeared first on DrugPatentWatch - Make Better Decisions.

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Express Pharma

APRIL 25, 2023

Close to 100 bikers, and doctors riding pillion, came together to embark on the road less travelled to raise awareness about chronic disease: obesity. Novo Nordisk collaborated with United Diabetes Forum (UDF) and Harley Owners Group to orchestrate a 90-minute ride from Bandra to Worli in Mumbai. Vikrant Shrotriya, MD and Corporate VP, Novo Nordisk India said, “Obesity is often not considered as a disease even though it is one.

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Diabetes 54

Drug Patent Watch

APRIL 25, 2023

Annual Drug Patent Expirations for VAZALORE Vazalore is a drug marketed by Plx Pharma and is included in one NDA. It is available from one supplier. There are four patents… The post New patent for Plx Pharma drug VAZALORE appeared first on DrugPatentWatch - Make Better Decisions.

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Putting Patients First Blog

APRIL 25, 2023

Minority health: the importance of patient navigation and access to timely care. April 25, 2023 By: Karen Mancera-Cuevas, DrPH, MS, MPH, CHES, Senior Director of Health Equity Navigating through the health care system can be very daunting for diverse patients. Hurdles are often set up along the way impeding access to care, that include understanding the realities of the health care system and obtaining a general grasp of provider instructions due to health literacy challenges.

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Mayo Clinic Documentation Diabetes 52

Drug Patent Watch

APRIL 25, 2023

Annual Drug Patent Expirations for RHOPRESSA Rhopressa is a drug marketed by Aerie Pharms Inc and is included in one NDA. It is available from one supplier. There are thirteen… The post New patent for Aerie Pharms drug RHOPRESSA appeared first on DrugPatentWatch - Make Better Decisions.

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