Digital health tech: a solution to substance use disorders?
Pharmaceutical Technology
JULY 4, 2023
Substance use disorders leave people with long-term negative mental and physical health implications and can lead to death.
Tue.Jul 04, 2023
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Toxic Leadership in Healthcare
The Honest Apothecary
JULY 4, 2023
Jeremy, an HR business partner to the nursing staff of a medium sized community hospital, arrived at his desk at 8:30am on Monday to a familiar sight. There, sitting on his desk, was yet another resignation letter from a nurse on the 7th floor. Tina’s floor. Over the past 6 months Jeremy had 5 such letters reach his desk. Each one a subtle reminder to him that his organization is dealing face-to-face with the problem with toxic leadership in healthcare. “I regret to inform you that m
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Rationing strategies proliferate with cancer drugs in short supply
Pharmaceutical Technology
JULY 4, 2023
While drug shortages have been a major cause for concern over the past few years, medications to treat cancer are in particularly short supply.
Complex road ahead, despite phase 3 progress, for Annovis’ buntanetap in Parkinson’s Disease
Outsourcing Pharma
JULY 4, 2023
Drugs like Annovis Bioâs buntanetap and prasinezumab have the potential to ârevolutionize the treatment of Parkinsonâs Diseaseâ says analytics company, GlobalData, an analytics company, but it is a complex road ahead.
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.
Teva reveals critical Ajovy data
Pharma Times
JULY 4, 2023
Therapy has been developed to reduce the frequency, duration and severity of migraine attacks - News - PharmaTimes
ISO publishes standard on bacterial endotoxin testing
European Pharmaceutical Review
JULY 4, 2023
The International Organization for Standardization (ISO) has published its new standard Sterilization of health care products — Microbiological methods — Part 3 Bacterial endotoxin testing ( ISO 11737-3:2023). The document contains requirements and guidance for testing for bacterial endotoxins. This includes products that must be non-pyrogenic based on either intended use or non-pyrogenic label claim, or both.
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Lupin gets tentative US FDA approval for Dolutegravir Tablets for Oral Suspension
Express Pharma
JULY 4, 2023
Lupin announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA), Dolutegravir Tablets for Oral Suspension, 5 mg, to market a generic equivalent of Tivicay PD Tablets for Oral Suspension, 5 mg of ViiV Healthcare Company. This product will be manufactured at Lupin’s Nagpur facility in India.
King’s College London and Pioneer Group in incubator link-up
Pharma Times
JULY 4, 2023
Collaboration aims to revitalise two empty sites on the South Bank of London by providing several laboratories - News - PharmaTimes
Samsung Biologics signs manufacturing deals worth $897 mn with Pfizer
Express Pharma
JULY 4, 2023
South Korea’s Samsung Biologics announced two deals with Pfizer worth a combined $897 million to manufacture products for the US pharma firm. The latest deals will see the biotech division of the Samsung Group produce biosimilar products ranging from oncology and inflammation to immunotherapy in the period to 2029 at its new Plant 4 in South Korea.
Guide to Data Integrity
European Pharmaceutical Review
JULY 4, 2023
Included in this Guide to Data Integrity: The significance of data integrity in pharmaceutical manufacturing Are you leveraging all the information from your quality control data? A secure, compliant and powerful data management system is critical for maintaining your data integrity compliance. Considerations for safety data migration methods Pharmacovigilance regulation in the EU and beyond has continued to grow and become more stringent over the last decade.
5 Reasons to Upgrade Your Pharmacy Management Software
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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.
Vaping industry opposed to pharmacy-only vape sales
The Pharmacist
JULY 4, 2023
Representatives of the UK vaping industry have signalled their opposition to e-cigarettes being made only available to purchase from pharmacies, citing concerns about public perception. In an evidence session last week, the Health and Social Care Committee heard of ongoing concerns around an increase in the number of children and young people using vape products […] The post Vaping industry opposed to pharmacy-only vape sales appeared first on The Pharmacist.
Abeona Therapeutics raises funds to launch cell therapy
Pharmaceutical Technology
JULY 4, 2023
Abeona Therapeutics has raised $25m from its current select investors to launch and commercialise its cell therapy, EB-101.
NHS plan to improve workforce capacity predicts increase in hub and spoke dispensing
The Pharmacist
JULY 4, 2023
NHS England (NHSE) has pointed to hub and spoke dispensing in its long-term workforce plan as a way to free up capacity within community pharmacy to deliver more clinical services. The plan published last week said that modelling estimates that hub and spoke dispensing will increase 2% a year. And it said that this would […] The post NHS plan to improve workforce capacity predicts increase in hub and spoke dispensing appeared first on The Pharmacist.
Syngene to acquire multi-modal facility from Stelis Biopharma
Express Pharma
JULY 4, 2023
Syngene announced the acquisition of Unit 3 biologics manufacturing facility in Bangalore, India, from Stelis Biopharma. The companies have entered into a binding term sheet and, on completion of the transaction, the site will add 20,000 liters of installed biologics drug substance manufacturing capacity for Syngene. The site has the potential for future expansion up to a further 20,000 liters of biologics drug substance manufacturing capacity.
International regulation: the importance of quality assurance in drug development
European Pharmaceutical Review
JULY 4, 2023
As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. However, critical disciplines within the field responsible for ensuring safe and effective drug products, including quality assurance and compliance, remain mysterious or invisible to many.
Merck India appoints Pratima Reddy as Country Speaker
Express Pharma
JULY 4, 2023
Merck announced that Pratima Reddy is their Country Speaker for India. Reddy takes on this role in addition to leading healthcare strategy and operations in India as GM and Managing Director of Merck Specialities India. In her current role, Reddy continues to demonstrate focused leadership to drive positive business outcomes through inclusive and strategic thinking and collaborative execution.
Formulation In-Depth Focus 2023
European Pharmaceutical Review
JULY 4, 2023
Trends in capsule formulation In this Q&A, Recipharm’s Torkel Gren discusses developments in capsule formulation, including the shift away from gelatine and the potential for growth in the inhalation capsule market. Titanium dioxide: are there alternatives? Mike Tobyn from Bristol Myers Squibb, Jonathan Kaye from GSK, David Harris from MSD and Eli Lilly’s Jason Melnick discuss the role of E171 (titanium dioxide) in the identification of solid oral dosage forms.
FDA approves Pfizer's NGENLA™, a long-acting once-weekly treatment for pediatric growth hormone deficiency
World Pharma News
JULY 4, 2023
Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
Recommendations and considerations for bacteriophage therapy usage in clinical settings
European Pharmaceutical Review
JULY 4, 2023
The rise in antimicrobial resistance , 1 lack of significant antimicrobial discovery in recent years, and increasing instances of multidrug-resistant (MDR) microorganisms 2 have propelled the interest in bacteriophage (Phage) therapy as a potential new course of treatment. Patients with implantable devices are more prone to biofilm-mediated infections, 3 while other infections such as skin structure infections, chronic lung diseases resulting from respiratory infections, and urinary tract infect
Providing access to quality vaccines in low- and middle-income countries
pharmaphorum
JULY 4, 2023
Providing access to quality vaccines in low- and middle-income countries Mike.
Novel oral therapy shows potential in plaque psoriasis
European Pharmaceutical Review
JULY 4, 2023
JNJ-2113, the first and only oral interleukin-23 receptor (IL-23R) antagonist peptide in development for moderate-to-severe plaque psoriasis (PsO) has demonstrated positive results in a Phase II trial. Janssen’s Phase IIb FRONTIER 1 clinical trial for adult participants achieved all primary and secondary efficacy endpoints, according to topline results showcased by Bissonnette R, Pinter A, Ferris L, et al. at the World Congress of Dermatology 2023.
Clerkenwell Health to sponsor Psych Symposium London as it urges NHS to ‘embrace’ psychedelics
Outsourcing Pharma
JULY 4, 2023
Clerkenwell Health, a specialist clinical research organisation (CRO) focused on supporting clients with the design and delivery of psychedelic-assisted therapy trials, is sponsoring the upcoming Psych Symposium 2023 on Thursday 6 July in London.
Janssen celebrates positive results for JNJ-2113A in psoriasis trial
pharmaphorum
JULY 4, 2023
Janssen celebrates positive results for JNJ-2113A in psoriasis trial Eloise.
5 Critical Keys to Avoid Derailment of Drug Development: Delaying the Application of a First-Rate Quality System is Risky Business
PharmaTech
JULY 4, 2023
Any responsible business or industry takes quality seriously. It’s crucial to customer safety and satisfaction, and its prioritization in the development of healthcare products and services – especially pharmaceuticals – is obviously even more so. Nonetheless, it can be easy in development for smaller teams and companies to overlook some components of Quality, despite governmental requirements around complex quality initiatives.
Psychedelics and mental health: The time is now?
pharmaphorum
JULY 4, 2023
Psychedelics and mental health: The time is now? Nicole.
NHS 75: Pharmacists share their ‘birthday wishes’ for the health service
The Pharmacist
JULY 4, 2023
To mark the 75th birthday of the NHS, The Pharmacist has sought a selection of ‘birthday wishes’ from across the profession and is encouraging others to join the conversation on Twitter using #NHSBirthdayWish. We have asked those working in both community and practice settings to share their hopes for the future of the NHS, as […] The post NHS 75: Pharmacists share their ‘birthday wishes’ for the health service appeared first on The Pharmacist.
Retaining the human quality of healthcare in DTx
pharmaphorum
JULY 4, 2023
Retaining the human quality of healthcare in DTx Mike.
Taiho’s LYTGOBI tablets receive European Commission marketing authorisation
Pharmaceutical Business Review
JULY 4, 2023
The authorisation is based on the data from the global, open label FOENIX-CCA2 trial. It enrolled a total of 103 adult patients from the Netherlands, UK, Spain, Italy, France, and Germany. Patients with unresectable, locally advanced or metastatic intrahepatic CCA harboring FGFR2 gene fusion or rearrangement were enrolled in the study. They were treated with 20mg LYTGOBI once a day until disease progression or unacceptable toxicity.
New tentative approval for Mylan Labs drug posaconazole
Drug Patent Watch
JULY 4, 2023
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So it begins: next Humira biosimilars launch in US
pharmaphorum
JULY 4, 2023
So it begins: next Humira biosimilars launch in US Nicole.
Amneal receives Xyrem generic approval after patent disputes
Pharmaceutical Technology
JULY 4, 2023
Amneal follows a successful year of approvals with six more approvals for generics across multiple indications.
Worrying signs for trial diversity require broad industry action
pharmaphorum
JULY 4, 2023
Worrying signs for trial diversity require broad industry action Mike.
US FDA declines to approve Amneal’s Parkinson’s treatment
Pharmaceutical Technology
JULY 4, 2023
The US FDA has issued a complete response letter to Amneal Pharmaceuticals, declining to approve its IPX203 to treat Parkinson’s disease.
Using Analytical Advancements to Assess Biosimilarity
PharmaTech
JULY 4, 2023
When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle.
Moderna seeks EMA approval for modified Covid-19 vaccine
Pharmaceutical Technology
JULY 4, 2023
Moderna has filed a regulatory application seeking EMA approval for its modified Covid-19 vaccine targeting the XBB.1.5 sub-variant.
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