Pharmaceutical Technology

FEBRUARY 8, 2023

The US Food and Drug Administration (FDA) has accepted Aldeyra Therapeutics’ new drug application (NDA) for topical ocular reproxalap to treat signs and symptoms of dry eye disease. It also includes evaluation in dry eye chamber challenge and natural environment settings, crossover and parallel-group study designs.

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Pharmaceutical Business Review

OCTOBER 1, 2023

As part of the divestment, Bausch + Lomb acquired approved therapeutic Xiidra; SAF312 (libvatrep), investigational therapy; and pre-clinical asset OJL332. Xiidra is indicated to treat dry eye disease’s signs and symptoms while SAF312 (libvatrep) is being developed as a first-in-class treatment for chronic ocular surface pain (COSP).

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RX Note

JANUARY 11, 2024

Introduction Watery eye is a common eye complaint, and it can be due to many factors and conditions. Main Causes Hypersecretion/reflex tearing causing eye to produce excess tear. The commonest cause is dry eye , other causes include eyelid malposition (e.g. For example, Lubricating eye drops soothe dry eyes.

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Mayo Clinic 40

pharmaphorum

AUGUST 23, 2022

If completed, the deal will add two commercial products to Alcon’s range – glaucoma therapies Rocklatan (netarsudil/latanoprost) and Rhopressa (netarsudil) – as well as a pipeline of clinical and preclinical drug candidates currently headed by AR-15512, in phase 3 for dry eye disease.

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Pharmaceutical Technology

MARCH 30, 2023

Under the agreement’s terms, TOI will receive exclusive rights to develop and commercialise Galimedix Therapeutics’ disease-modifying compound, GAL-101. It is currently ready to enter Phase II/III clinical trials. GAL-101 binds to a specific motif from Aβ that is exposed only in the misfolded Aβ monomer form and can be targeted.

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Compounding 52

pharmaphorum

SEPTEMBER 15, 2022

Aldeyra Therapeutics’ dogged persistence with its drug eye disease therapy reproxalap – despite mixed results in a phase 3 trial – may be paying off. The post Aldeyra spies FDA filing ahead for dry eye drug reproxalap appeared first on. Sales were nevertheless solid at $468 million and $1.29

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Packaging 52

European Pharmaceutical Review

NOVEMBER 17, 2023

ADvocate 1 and ADvocate 2, which evaluated lebrikizumab as monotherapy, demonstrated early clinical efficacy at week 16, reducing disease extent and severity by at least 75 percent in almost six out of 10 patients. Common reactions included conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.

Hospitals 86

Hospitals 86

PharmaShots

JUNE 9, 2023

Shots: Zhaoke Ophthalmology to get an exclusive right to register, import, promote, distribute, market, and sell the Eye Lipid Mobilizer, a medical device for DED in Greater China (mainland China, Hong Kong, Macau, and Taiwan), South Korea & the ASEAN countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand (..)

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pharmaphorum

OCTOBER 18, 2022

Oculis SA, a global biopharmaceutical company that develops treatments for saving sight and improving eye care with breakthrough innovations, is to combine with the European Biotech Acquisition Corp (EBAC), a special purpose acquisition company (SPAC) that has screened over 100 European biotechnology companies.

Diabetes 57

Diabetes 57

pharmaphorum

APRIL 19, 2022

RudaCure is a four-year-old biotech company based in the South Korea, focusing on ocular disease and chronic pain with a pair of potentially first-in-class drugs. million in Series A funding and has partnered with Hanlim Pharmaceuticals, a local pharma company, to develop and distribute its drug candidate for Dry Eye Disease.

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Pharmaceutical Companies Pharmaceutical Companies Communication Drug Development 52

Pharmaceutical Technology

OCTOBER 18, 2022

Oculis works on developing product candidates for areas with substantial medical needs, including diabetic macular oedema (DME), dry eye disease (DED) and glaucoma. The portfolio of the company comprises three clinical-stage product candidates, namely OCS-01, OCS-02 and OCS-05.

Diabetes 59

Diabetes 59

pharmaphorum

SEPTEMBER 14, 2022

SparingVision has raised €75 million in second-round funding that will be used to fund clinical trials of gene therapies for ocular diseases retinitis pigmentosa (RP) and dry age-related macular degeneration (AMD). Testing in dry AMD will follow later on, if data from the lead indication is positive.

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pharmaphorum

NOVEMBER 16, 2022

Wykoff about the results from Apellis Pharmaceuticals’ OAKS study on intravitreal pegcetacoplan for geographic atrophy (GA), otherwise known as atrophic or dry age-related macular degeneration (AMD), a leading cause of blindness worldwide. As the name suggests, AMD is an age-related disease; it becomes more prevalent as we get older.

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Immunity Immunization Hospitals Drug Development 104

Putting Patients First Blog

APRIL 11, 2023

April is Sjögren’s Awareness Month: A Time to Highlight Patients and the Message that Sjögren’s is a Serious and Systemic Autoimmune Disease! This is critical because Sjögren’s is a misunderstood and underdiagnosed disease. Sjögren’s (“SHOW-grins”) is a systemic autoimmune disease that affects the entire body.

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Immunity Immunization 98

RX Note

JULY 29, 2023

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. Doses slowly titrated up to 480 mg daily have been reported in a small number of cases with severe, resistant disease. paediatric, pregnant, or psychiatric patients).

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Labelling Dosage Immunity Immunization 40

pharmaphorum

DECEMBER 22, 2021

Gyroscope Therapeutics and its gene therapy for the sight-robbing disease geographic atrophy (GA) has been acquired by a big pharma company – but likely not the one you would expect. It is vying to become the first therapy for the disease, which affects around eight million people globally, according to Novartis.

Immunity 104

Immunity Immunization 104

pharmaphorum

JANUARY 19, 2023

Representing a significant milestone for Vaxxas, it builds on its pre-clinical portfolio into mRNA vaccines, with the potential to expand the company’s vaccine technology pipeline across a number of diseases, including COVID-19.

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Vaccines Immunity Immunization 104

PharmaShots

FEBRUARY 10, 2023

LEO Pharma Reports P-III Trial (DELTA 2) Results of Delgocitinib for Chronic Hand Eczema Date: Feb 10, 2023 | Tags: LEO Pharma, Delgocitinib, Chronic Hand Eczema, Clinical Trial, P-III, DELTA 2 Trial GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Regular Approval for Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer (..)

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Biosimilars 40

PharmaShots

FEBRUARY 10, 2023

LEO Pharma Reports P-III Trial (DELTA 2) Results of Delgocitinib for Chronic Hand Eczema Date: Feb 10, 2023 | Tags: LEO Pharma, Delgocitinib, Chronic Hand Eczema, Clinical Trial, P-III, DELTA 2 Trial GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Regular Approval for Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer (..)

Biosimilars 40

Biosimilars 40

PharmaShots

JUNE 9, 2023

Quell Therapeutics Signed an Exclusive Option and License Agreement with AstraZeneca to Develop, Manufacture and Commercialize Engineered Treg Cell Therapies Date: June 09, 2023 | Tags: Quell Therapeutics, AstraZeneca, Engineered Treg Cell Therapies, Type 1 Diabetes, Inflammatory Bowel Disease, Biotech, Treg cell engineering modules Astellas and the (..)

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Biosimilars Diabetes 40

pharmaphorum

NOVEMBER 1, 2021

Scemblix (asciminib) was one of a clutch of high risk, high reward drug candidates for a range of diseases that Novartis chief executive Vas Narasimhan said last year were flying under-the-radar of industry watchers, but could potentially develop into blockbusters.

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Labelling 113

pharmaphorum

NOVEMBER 8, 2021

French drugmaker Sanofi has made a $40 million investment in Gyroscope Therapeutics, with another $20 million potentially on offer as the UK biotech advances its clinical-stage gene therapies for ophthalmic diseases. At the moment there is no approved therapy for the disease, which affects around five million people globally.

Immunity 52

Immunity Immunization 52

RX Note

AUGUST 4, 2023

In applying eye ointment , the method of administration should include the critical step which spreads the ointment Blink your eye gently several times, then close your eye for 1 to 2 minutes; OR Gently close the eye and roll the eyeball in all directions. Try not to blink and do not rub.

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Patient Counseling Communication Inpatient Diabetes 52

Quality Matters

JUNE 12, 2023

In 2022, the FDA approved several new complex generic products including cyclosporine ophthalmic emulsion eye drops for treatment of the condition commonly known as dry eye and budesonide and formoterol fumarate dihydrate inhalation aerosol for the treatment of certain pulmonary conditions, among others. According to the U.S.

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Generic Medicine Dosage Prescription Filling Diabetes 52

RX Note

MARCH 1, 2023

In applying eye ointment , the method of administration should include the critical step which spreads the ointment Blink your eye gently several times, then close your eye for 1 to 2 minutes; OR Gently close the eye and roll the eyeball in all directions. Try not to blink and do not rub.

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Patient Counseling Diabetes 52

Digital Pharmacist

OCTOBER 24, 2022

Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials. . Common adverse effects include musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, and abdominal pain , among others. . following data from the CENTAUR Phase 2 Clinical Trials. .

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pharmaphorum

APRIL 23, 2021

. “The ability to tune gene-editing activity to a specific level is an important innovation that has the potential to address several serious diseases,” said Vertex’s chief scientific officer David Altshuler in a statement, which did not disclose the specific diseases covered by the partnership.

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Compounding 52

PharmaShots

JANUARY 31, 2023

Total Employees: 6 IPO Announced Date: Mar 18, 2022 Headquarters: London, UK IPO Date: Jul 20, 2022 Stock Exchange: NASDAQ Virax is a global biotech company primarily engaged in the sale, distribution, and marketing of diagnostic test kits and med-tech and PPE products for the detection and diagnosis of viral diseases. Funding Value: $7.7M

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Vaccines Immunity Immunization Diabetes 40

FADIC

OCTOBER 24, 2023

Do you have any medical condition other than anxiety, such as diabetes or any cardiac disease ? I t is a c hronic disease not curable, but your medicine will help you avoid any further complications and make your life more flexibl e. B e careful not to use it near your eyes. A nd if so, how many times a day?

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Community Pharmacies Diabetes 52

The Thyroid Pharmacist

JULY 21, 2022

In my clinical experience, I’ve seen many cases of thyroid problems go undiagnosed (or misdiagnosed) because most doctors don’t perform a comprehensive test panel. However, I’ve found that many doctors don’t test for Hashimoto’s, despite having their patients present with symptoms of thyroid disease. The Thyroid Screening Test.

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Dosage Immunity Immunization Diabetes 75

PharmaShots

FEBRUARY 9, 2023

Introduction: AMD, an eye disease that can cause of loss of eyesight/blur vision mostly in people ≥50 years of age and it is the leading cause of visual impairment worldwide. Dry AMD: It is also called atrophic AMD. There’s no treatment for late dry AMD 2. It occurs when macula gets thinner with age.

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Insurance Coverage and Processing Department of Veterans Affairs 40

The Thyroid Pharmacist

AUGUST 23, 2023

However, this amount may not meet the needs of those with autoimmune thyroid disease. This is because most dietary sources of B1 (fortified grains, beef liver, pork, dried milk, eggs, legumes, peas, nuts, and seeds) are omitted on grain-free healing diets, which are often recommended for those with autoimmune thyroid disease.

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Med Ed 101

DECEMBER 25, 2022

This disease has two major symptoms that pharmacists should pay EXTREMELY close attention to. The disease can cause significant dry eyes and dry mouth. […]. Sjogren’s Syndrome is not very common but I do see this diagnosis in practice periodically.

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RX Note

JUNE 3, 2023

A colleague told me that not all pharmacists are professionally trained to perform their clinical service. Medicines (Advertisement & Sale) Act 1956 and Regulations What are the listed disease where no one shall take any part in the publication of any advertisement ? Introduction Learning is a never-ending journey.

Health and Personal Care Stores 40

Health and Personal Care Stores Chemotherapy Compounding Dosage 40

pharmaphorum

AUGUST 6, 2020

The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population and included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%) and dry eye (19%).

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Adverse Reactions Packaging 86

PharmaShots

FEBRUARY 8, 2023

Shots: The US FDA has accepted the NDA of reproxalap, a small-molecule modulator of RASP for dry eye disease. the P-III trial (TRANQUILITY-2) in 361 patients with dry eye disease. The expected PDUFA date is Nov 23, 2023 The NDA was based on the safety & efficacy results from 5 trials, incl.

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The Thyroid Pharmacist

JANUARY 27, 2023

One of the kind ladies offered, “Yes it is, we just close our eyes if we don’t want to see.” However, as the infrared sauna has gained in popularity, the demand to understand how it can help those of us with autoimmune disease has increased as well. I have to admit, I was a bit frazzled!

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Diabetes Immunity Immunization Packaging 98