STAT
MAY 29, 2023
For busy primary care physicians like me, an annual physical with a 27-year-old male is a blessing. Since we’re always running late, a quick visit with a young healthy adult offers the rare chance to get back on schedule. But I didn’t give my own doctor that chance to get back on schedule when I went to see him for my physical a few months ago.
ALiEM - Pharm Pearls
MAY 29, 2023
Massive epistaxis is considered a medical emergency that requires immediate attention. Symptoms of massive epistaxis include sudden and heavy bleeding from the nose, difficulty breathing, dizziness, and a rapid heartbeat. If left untreated, it can lead to significant blood loss, shock, airway obstruction, and even death. We report a case of a 50-year-old man with end stage renal disease with massive nasal bleeding from the left nostril, shortness of breath, and confusion.
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Pharmaceutical Technology
MAY 29, 2023
Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. Inpefa is a once-daily oral tablet indicated as an inhibitor of sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1). It is intended to lower the risk of cardiovascular death, urgent heart failure visit, and hospitalisation for heart failure.
Express Pharma
MAY 29, 2023
Hefei Tianhui Biotechnology (HTIT) has recently submitted a marketing authorisation application (MAA) in China for the world’s first oral insulin for type 2 diabetes (T2D). If approved, China will become the world’s first country with oral insulin availability, says GlobalData. According to GlobalData’s Pharma Intelligence Center, there are only two oral insulins in Phase III globally.
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.
European Pharmaceutical Review
MAY 29, 2023
A neurosteroid drug was one of two medicines recommended for approval at the Committee for Medicinal Products for Human Use (CHMP) ’s May 2023 meeting. Ztalmy (ganaxolone) received a positive opinion for epileptic seizures associated with cyclin-dependent kinase-like 5 deficiency disorder. This genetic condition is defined by seizures starting during infancy.
Express Pharma
MAY 29, 2023
GSK announced a partnership with Amitabh Bachchan to raise awareness about shingles, a painful condition that affects one out of three adults above the age of 50 years. The campaign film captures the agonising pain caused by shingles and its debilitating impact on the people living with it. It gives an important message that it is possible to protect ageing adults against this pain through vaccination.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
World Pharma News
MAY 29, 2023
Why do some people develop Alzheimer's disease while others don't? And, even more puzzlingly, why do many individuals whose brains are chock-full of toxic amyloid aggregates - a telltale sign of Alzheimer's brain pathology - never go on to develop Alzheimer's-associated dementias? University of Pittsburgh School of Medicine researchers appear to have found the answer.
Pharma in Brief
MAY 29, 2023
On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection ( CSP Guidance ). The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices.
Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced a 13% drop in company filings mentions of big data in Q1 2023 compared with the previous quarter, with the highest share accounted for by Novartis with 185% year-on-year increase, according to GlobalData’s analysis of over 603 pharmaceutical company filings. The big data landscape is rapidly evolving and pharma companies are increasingly integrating big data analytics into their value chains.
Pharmaceutical Business Review
MAY 29, 2023
This recommendation is for ZTALMY to serve as the adjunctive treatment of epileptic seizures related with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age. ZTALMY may be continued in those patients who are aged 18 years and more. A serious and rare genetic disorder, CDKL5 deficiency disorder (CDD) is characterised by early‑onset, difficult‑to‑control seizures besides severe neuro‑developmental impairment.
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PharmaTech
MAY 29, 2023
Do you face challenges when it comes to smaller production quantities, more specialization and many product creations. Flexibility is the answer. With the help of agile systems pharmaceutical manufacturers can overcome these challenges just as easy. Learn how flexible systems bring the decisive advantage to simply switch between the technologies of which you can benefit already in the development phase of solids.
Drug Patent Watch
MAY 29, 2023
NUZYRA (omadacycline tosylate) Paratek pharms inc Patent: 7,553,828 Expiration: Jun 2, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact… The post Drug Patent Expirations for the Week of May 28, 2023 appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced a 17% rise in company filings mentions of blockchain in Q1 2023 compared with the previous quarter, with the highest share accounted for by Bayer, according to GlobalData’s analysis of over 60 pharmaceutical company filings. GlobalData’s Blockchain Market Size, Share, Trends, and Segment Forecast to 2030 report offers insights on application of blockchain in healthcare and other key sectors.
RX Note
MAY 29, 2023
Introduction System Restore is a powerful Windows feature that allows you to restore your computer to a previous point in time. This can be useful if you have installed a new program or driver that has caused problems with your computer, or if you have accidentally deleted or corrupted files. How System Restore Works System Restore works by creating restore points at regular intervals.
Pharma Leaders
MAY 29, 2023
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Marinus Pharmaceuticals’ ZTALMY (ganaxolone) oral suspension. This recommendation is for ZTALMY to serve as the adjunctive treatment of epileptic seizures related with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age.
Pharmaceutical Technology
MAY 29, 2023
FivepHusion has collaborated with Treehill Partners and Syneos Health to strategically progress development and commercialisation of its chemotherapeutic formulation Deflexifol in markets across the globe. Under the partnership, Treehill will support FivepHusion with operational, strategic and transactional expertise along with integrated business development.
pharmaphorum
MAY 29, 2023
EU approval for Novartis’ sickle cell drug set to be pulled Phil.
Pharmaceutical Technology
MAY 29, 2023
The US Food and Drug Administration (FDA) has accepted Iovance Biotherapeutics’ biologics license application (BLA) for lifileucel to treat advanced melanoma. Lifileucel is a tumour infiltrating lymphocyte (TIL) therapy developed to treat advanced melanoma patients who advanced on or after prior anti-PD-1/L1 therapy and targeted therapy. It has been granted priority review by the FDA, with a target action date of 25 November this year, under the Prescription Drug User Fee Act (PDUFA).
PharmaTech
MAY 29, 2023
In order to achieve the desired properties in a solid medicinal product, a granulate must be optimally prepared. Did you know that you can have a significant influence on the material properties of your granulate using different granulation techniques? The wet granulation of pharmaceutical granulate mixtures with subsequent fluidized bed drying represents the most important step in the manufacture of solids.
Pharmaceutical Technology
MAY 29, 2023
Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU). A protein-based vaccine, Nuvaxovid has been recommended for MA for use as a primary series in individuals of the age 12 years and above and as a booster in those aged 18 years and older to prevent Covid-19.
PharmaTech
MAY 29, 2023
Do you face challenges when it comes to smaller production quantities, more specialization and many product creations. Flexibility is the answer. With the help of agile systems pharmaceutical manufacturers can overcome these challenges just as easy. Learn how flexible systems bring the decisive advantage to simply switch between the technologies of which you can benefit already in the development phase of solids.
Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced a 38% drop in company filings mentions of virtual care in Q1 2023 compared with the previous quarter, with the highest share accounted for by ICON with 25% year-on-year decrease, according to GlobalData’s analysis of over 88 pharmaceutical company filings. GlobalData’s Telehealth Market Size by Segments, Share, Trends, and Forecast, 2022-2030 report provides key insights into business strategies, trends driving the telehealth market and granul
PharmaTech
MAY 29, 2023
In order to achieve the desired properties in a solid medicinal product, a granulate must be optimally prepared. Did you know that you can have a significant influence on the material properties of your granulate using different granulation techniques? The wet granulation of pharmaceutical granulate mixtures with subsequent fluidized bed drying represents the most important step in the manufacture of solids.
PharmaShots
MAY 29, 2023
Shots: The MHLW has approved Ultomiris (C5 complement inhibitor) for the prevention of relapses in patients with AQP4 Ab+ neuromyelitis optica spectrum disorder (NMOSD) incl. neuromyelitis optica The approval was based on the P-III trial (CHAMPION-NMOSD) evaluating Ultomiris in 58 patients across North America, the EU, Asia-Pacific & Japan. The trial met its 1EPs of time to first on-trial relapse as confirmed by an independent adjudication committee, zero relapses were seen with a median tre
Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced a 24% drop in company filings mentions of regenerative medicine in Q1 2023 compared with the previous quarter, with the highest share accounted for by Sarepta Therapeutics with 20% year-on-year decrease, according to GlobalData’s analysis of over 578 pharmaceutical company filings. GlobalData’s Regenerative Medicine in Medical thematic intelligence report provides an overview of the current landscape, including healthcare, technology, regulato
PharmaShots
MAY 29, 2023
Shots: The EMA’s CHMP adopted the positive opinion recommending the approval of Opdivo + Pt-based CT for resectable NSCLC who are at a high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1% The opinion was based on the P-III trial (CheckMate -816) evaluating Opdivo (360mg, q3w) + CT vs CT alone which showed an improvement in EFS & pCR with 3 cycles of Opdivo + CT vs CT alone The safety profile was consistent with prior reported studies while the 3yr. data sho
Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced an 18% drop in company filings mentions of orphan designated drugs in Q1 2023 compared with the previous quarter, with the highest share accounted for by Horizon Therapeutics with 50% year-on-year increase, according to GlobalData’s analysis of over 182 pharmaceutical company filings. GlobalData’s New Drug Approvals and Their Contract Manufacture report provides critical insight into the contract manufacturing organization (CMO) industry by an
PharmaShots
MAY 29, 2023
Shots: The companies collaborated to discover & develop novel therapies for patients with neurodegenerative diseases incl. Parkinson's disease The collaboration will combine companies’ expertise and resources in developing NurrOn's ATH-399A & other compounds targeting Nurr1 for neurodegenerative disorders. The P-I trial of ATH-399A is expected to be initiated in 2023 The companies also continue to advance the therapy in other neurodegenerative diseases.
Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced a 30% drop in company filings mentions of microbiome in Q1 2023 compared with the previous quarter, with the highest share accounted for by Novozymes with 9% year-on-year decrease, according to GlobalData’s analysis of over 50 pharmaceutical company filings. GlobalData’s Microbiome-Targeting Therapeutics in Infectious Diseases – Thematic Research report provides information on market classification by therapy and technologies, regulatory and m
PharmaShots
MAY 29, 2023
Shots: This is a P-Ib dose-expansion study, evaluating the safety, tolerability, PK/PD, and preliminary efficacy of porustobart/HBM4003 (0.45 mg/kg) + toripalimab (240 mg Q3W) in patients (n=28) with advanced HCC and other solid tumors Patients (n=16) who failed previous anti-VEGFR treatment while have not received anti-PDL1 treatment (Cohort 1) and patients (n=12) who failed previous anti-PD-L1 and anti-VEGFR treatments (Cohort 2) As of 9 Dec 2022, the median follow-up time was 3.6mos. while th
Pharmaceutical Technology
MAY 29, 2023
The global pharmaceutical industry experienced a 27% drop in company filings mentions of future of work in Q1 2023 compared with the previous quarter, with the highest share accounted for by Moderna with 13% year-on-year decrease, according to GlobalData’s analysis of over 419 pharmaceutical company filings. GlobalData’s Future of Work – Thematic Research report explains how the theme future of work is impacting the workforce across different sectors, it presents key technology, macroecono
PharmaShots
MAY 29, 2023
Shots: David first talked about Clarivate’s Highly Cited Researchers 2022 list. He said that the list picks out 6,938 individuals at universities, research institutes, and commercial organizations across 69 countries/regions He also elucidated the methodology used by Clarivate to create the list and how the pharma companies can benefit from this list to strengthen their strategies The interview showcases how Clarivate is working to provide actionable information and insights that bring new
pharmaphorum
MAY 29, 2023
SGLT latecomer Lexicon gets heart failure okay Phil.
PharmaShots
MAY 29, 2023
Shots: The P-III trial evaluating Imfinzi + Pt-based CT, followed by Imfinzi with Lynparza or Imfinzi alone as maintenance therapy vs Pt-based CT alone in 699 patients at 253 study locations across 22 countries incl. the US, EU, South America & Asia The results showed a significant & clinical improvement in PFS, greater benefits were seen with the combination of Lynparza + Imfinzi as maintenance treatment while OS data were immature & favorable trends were reported for both a treatme
Welltopia Pharmacy
MAY 29, 2023
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