STAT
SEPTEMBER 11, 2023
The Food and Drug Administration announced Monday that it had greenlit two updated Covid-19 booster shots in people as young as 6 months old, triggering a process that could see the Moderna and Pfizer-BioNTech vaccines become available in doctors’ offices, clinics, and pharmacies later this week. The updated approvals relate only to the two messenger RNA vaccines on the U.S. market.
PharmaVoice
SEPTEMBER 11, 2023
After dropping its neuroscience program earlier this year, the clinical-stage oncology company is doubling down on a candidate targeting the MAPK pathway.
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STAT
SEPTEMBER 11, 2023
This story contains descriptions of an invasive medical procedure and mention of sexual assault. It’s been nearly three decades since Shelby Smith underwent a series of invasive procedures as a young child to diagnose the cause of recurring urinary tract infections. But the trauma of the procedure, which required her to be restrained while a physician threaded a catheter up her urinary tract without sedation, still impacts her profoundly.
ALiEM - Pharm Pearls
SEPTEMBER 11, 2023
A 29-year-old female with a past medical history of migraine headaches presented to the emergency department (ED) for several hours of bilateral eye pain, redness, and decreased visual acuity. The patient is a contact lens wearer. The night prior to presentation at 18:00, the patient inserted her contacts that she had washed and soaked in a hydrogen peroxide (H2O2) cleaning solution.
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
SEPTEMBER 11, 2023
Coronary stenting is, by some measures , the most overused procedure in hospitals. The problem costs the health system millions and unnecessarily exposes patients to risks of blood clots, torn arteries, infections, and other life-threatening injuries. In 2020, Medicare started paying physicians to place stents, balloons, and perform other procedures designed to open clogged coronary arteries outside of hospitals, in less expensive outpatient settings.
PharmaVoice
SEPTEMBER 11, 2023
Bill Sibold has led Sanofi's specialty care business unit for the past six years. He replaces Paul Friedman as head of the NASH drug developer.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
The Pharmacist
SEPTEMBER 11, 2023
The National Pharmacy Association (NPA) and independent pharmacy owners have invested a total of £1.2m into a pharmacy app which is designed to lessen operational burdens for independent community pharmacies. The cash injection into Charac, which allows pharmacists to manage repeat prescriptions, access patient records, create bookings and conduct consultations, aims to help ‘enhance’ the […] The post NPA puts cash injection into pharmacy app Charac appeared first on The Pharmacist.
BioPharma Dive
SEPTEMBER 11, 2023
The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.
The Pharmacist
SEPTEMBER 11, 2023
The government is set to review guidelines around the supply and prescribing of medicines as part of its new suicide prevention strategy for England, released today. The Medicines and Healthcare Regulatory Agency (MHRA) is to monitor whether retailers are complying with guidance around the sale of analgesics such as paracetamol, including promotions that exceed the […] The post Government to review medicine guidelines in new suicide prevention strategy appeared first on The Pharmacist.
BioPharma Dive
SEPTEMBER 11, 2023
Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.
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Pharma Times
SEPTEMBER 11, 2023
Both companies will work to advance the development of novel radiopharmaceuticals - News - PharmaTimes
The Pharmacist
SEPTEMBER 11, 2023
Clinicians have welcomed NICE's recent approval of tirzepatide for difficult-to-manage diabetes as a potential alternative to semaglutide and other glucagon-like peptide-1 receptor agonists (GLP-1 RAs). But while they have expressed hope that having multiple manufacturers of this class of drug could improve access, they have also raised concerns that tirzepatide, which can also be used […] The post Tirzepatide approval sparks hope though supply warnings remain appeared first on The Pharmac
Pharmaceutical Technology
SEPTEMBER 11, 2023
Kroger's settlement, alongside the review of the Purdue Pharma bankruptcy case, is proof that the opioid reckoning isn't over yet.
PharmExec
SEPTEMBER 11, 2023
Integrating artificial intelligence and advanced analytics throughout operations offers pharma companies a pathway to offset impending drug patent expirations.
Express Pharma
SEPTEMBER 11, 2023
Nitika Pharmaceuticals Specialties is set to unveil India’s largest Microcrystalline Cellulose manufacturing plant on September 16, 2023. This event will be graced by two distinguished leaders, Nitin Gadkari and Devendra Fadnavis. Nitika Pharmaceuticals is the sole excipient company in India to reap the benefits of production-linked incentives in the excipient category.
The Guardian - Pharmaceutical Industry
SEPTEMBER 11, 2023
Natural compound found in spice may reduce excess stomach acid as effectively as omeprazole, first study of its kind finds Turmeric may be as good for treating indigestion as medicine, a study suggests. A natural compound found in the culinary spice may be as effective as omeprazole, a drug used to reduce excess stomach acid and treat indigestion, according to the first study of its kind.
Express Pharma
SEPTEMBER 11, 2023
Pee Safe, a hygiene and wellness brand owned by Redcliffe Hygiene, has partially closed their Series B round. The company has received $3 million out of their total round size of $6 million (approximately R 50 crore). The funding was led by Natco Pharma and Rainmatter Health, supported by Nithin Kamath and Nikhil Kamath, founders of Zerodha. Alkemi Growth Capital, an existing investor, also participated in the round.
Pharma Times
SEPTEMBER 11, 2023
The platform will be used to advance the effectiveness of antibiotics - News - PharmaTimes
Express Pharma
SEPTEMBER 11, 2023
The FDA granted an orphan drug designation (ODD) to Redx’s zelasudil (RXC007) in August 2023. Zelasudil is an oral, selective rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibitor for the potential treatment of idiopathic pulmonary fibrosis (IPF). The FDA move will put RedX on the map as one of the key upcoming players in the treatment of IPF, says GlobalData.
Pharmaceutical Technology
SEPTEMBER 11, 2023
Pharmaceutical supply chain partners are trying to create an efficient cold chain system to transport cell and gene therapies.
World Pharma News
SEPTEMBER 11, 2023
Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today's actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc.
European Pharmaceutical Review
SEPTEMBER 11, 2023
A new strategy to detect lipopolysaccharide (LPS) in minutes in soluble samples has been developed by Japanese researchers. The platform holds potential in revolutionising how LPS is screened. High-throughput LPS detection of endotoxins was achieved by combining a fluorescent chemosensor with a flow injection analysis (FIA) system and a self-developed dual-wavelength fluorophotometer.
FDA Law Blog: Biosimilars
SEPTEMBER 11, 2023
By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.
European Pharmaceutical Review
SEPTEMBER 11, 2023
The Cell and Gene Therapy Catapult (CGT Catapult) is set to improve the process and efficiency of AAV manufacture for gene therapies as part of a two-year project alongside two other organisations. CGT Catapult will partner with contract development and manufacturing organisation (CDMO) Rentschler Biopharma and Refeyn Ltd to improve the process of manufacturing adeno-associated viruses (AAV) through automated and digital process analytical technologies (PAT).
BioPharma Dive
SEPTEMBER 11, 2023
The decision follows a review by a trial monitoring committee, which concluded data for the geographic atrophy treatment didn't support further development.
European Pharmaceutical Review
SEPTEMBER 11, 2023
Samsung Bioepis Co., Ltd. has entered into an agreement with Sandoz to commercialise SB17, a proposed biosimilar to Janssen Pharmaceuticals’ Stelara ( ustekinumab ). The reference medicine Stelara (ustekinumab) is a monoclonal antibody (mAb) treatment to interleukin (IL)-12/23 indicated for autoimmune disorders including Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
pharmaphorum
SEPTEMBER 11, 2023
WCLC: Data back first-line use of Gilead, AZ/Daiichi TROP2s Phil.
Drug Patent Watch
SEPTEMBER 11, 2023
Annual Drug Patent Expirations for CAPLYTA Caplyta is a drug marketed by Intra-cellular and is included in one NDA. It is available from two suppliers. There are fifteen patents protecting… The post New patent for Intra-cellular drug CAPLYTA appeared first on DrugPatentWatch - Make Better Decisions.
Putting Patients First Blog
SEPTEMBER 11, 2023
NHC comments on the 2024 Physician Fee Schedule September 11, 2023 By: Allen Pinn, Coordinator, Policy On July 13, the Centers for Medicare & Medicaid Services (CMS) released their proposed rule for the 2024 Physician Fee Schedule. Below is a summary of the NHC’s comments submitted September 11, 2023. Expansion of Medicare Telehealth Services Under the proposed rule, CMS has made several updates to Medicare telehealth services such as adding health and well-being coaches under the Medicare T
Drug Patent Watch
SEPTEMBER 11, 2023
Annual Drug Patent Expirations for UBRELVY Ubrelvy is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are five patents protecting… The post New patent for Abbvie drug UBRELVY appeared first on DrugPatentWatch - Make Better Decisions.
PharmExec
SEPTEMBER 11, 2023
Pharm Exec’s latest selections of notable biopharma brand launches—some with novel preemptive approaches—highlight products that are paving uncharted paths across a diverse disease landscape.
Drug Patent Watch
SEPTEMBER 11, 2023
TYZEKA (telbivudine) Novartis Patent: 7,589,079 Expiration: Sep 11, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit… The post Drug Patent Expirations for the Week of September 10, 2023 appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
SEPTEMBER 11, 2023
First-in-class BMS drug raises lung fibrosis hopes Phil.
Drug Patent Watch
SEPTEMBER 11, 2023
Annual Drug Patent Expirations for PROAIR+HFA Proair Hfa is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from five suppliers. There are… The post New patent expiration for Teva Branded drug PROAIR HFA appeared first on DrugPatentWatch - Make Better Decisions.
Pharmafile
SEPTEMBER 11, 2023
Sandoz has announced that it has entered into a development and commercialisation agreement with Samsung Bioepis, providing Sandoz the exclusive rights to commercialise the biosimilar SB17 ustekinumab in the US, Canada, EEA, Switzerland and the UK. Further terms of the agreement have not been announced. The drug’s reference medicine, Stelara, is a monoclonal antibody medication […] The post Sandoz announces deal to commercialise biosimilar ustekinumab in Europe and North America appeared f
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