Pharmaceutical Technology

AUGUST 5, 2022

In addition, for doctors who do use Lucentis, there will be added pressure from payers to switch to Cimerli with its direct interchangeability with Lucentis approved. The post FDA approves Coherus’ Cimerli for DME, with year-long interchangeability exclusivity appeared first on Pharmaceutical Technology.

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XTalks

SEPTEMBER 6, 2022

Doctors may prescribe a proton pump inhibitor (PPI), such as omeprazole, which blocks acid-producing cells to protect the gastric ulcer from acid while it heals naturally. If the suspected cause of a gastric ulcer is due to an NSAID, another type of pain reliever may be recommended, such as paracetamol.

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FDA Approval Containment Pharmacy Medicine 98

Fierce Pharma

AUGUST 30, 2023

Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases.

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FDA Approval Doctors Doctor Manufacturing 110

NPR Health - Shots

APRIL 8, 2023

Some doctors prescribe sublingual immunotherapy, known as SLIT, a serum taken as drops under the tongue. Patients like it, but it is not FDA-approved, so insurance usually doesn't cover it. Image credit: Drew Angerer/Getty Images)

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Allergies FDA Approval Doctors Doctor 115

XTalks

NOVEMBER 4, 2021

We are proud to offer Vuity as a first-of-its-kind once-daily eye drop that we believe will change the way people and their eye doctors approach presbyopia. The FDA approval of Vuity exemplifies our continued pursuit of innovative new treatments that push the boundaries of what’s possible in eye care.”.

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FDA Approval Drug Delivery Systems Trials Drug Delivery 98

World of DTC Marketing

JUNE 2, 2021

SUMMARY: Doctors said they were dissatisfied were marketing emails (46%), telephone sales calls with sales reps (42%), and both webinars and websites (each at 39%) from pharma companies, according to Indegene. One of our tests, one of the most read emails, had a subject line of “new label information for prescribing just FDA approved.”

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Doctors Doctor Sales Marketing 180

World of DTC Marketing

JUNE 6, 2021

The headlines read “FDA approves obesity drug that helped people cut weight 15%” But buyer beware. My guess is Norvo will heavily discount the product via coupons or cards, but ultimately patients working with their doctor will determine if it’s successful. appeared first on World of DTC Marketing.com.

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Drugs Cosmetics Production FDA Approval 318

World of DTC Marketing

FEBRUARY 2, 2022

While some doctors have been eager to start prescribing the newly approved drug, others had criticized the FDA for clearing the drug before studies proved it works. ” A physician on STAT News wrote, “the consequences of FDA approval are as disturbing as they are vast.

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FDA Approval Drugs Doctors Doctor 239

Fierce Pharma

JULY 13, 2023

After a full FDA approval last week triggered Medicare coverage of Eisai and Biogen’s Leqembi, doctors are still trying to work out the logistics of testing and reimbursement. But at least two experts remain positive about the drug’s efficacy and safety profile.

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FDA Approval Doctors Doctor Drugs 78

STAT News

DECEMBER 30, 2022

The Food and Drug Administration’s approval of Wegovy, Novo Nordisk’s latest obesity drug, for adolescents aged 12 years and older opens up a highly-anticipated tool in the fight against childhood obesity, but some doctors warn the sought-after medication isn’t a magic bullet. Read the rest…

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FDA Approval Doctors Doctor Drugs 98

Fierce Pharma

MAY 29, 2024

Stimulants are typically the go-to option for doctors prescribing treatments for attention-deficit hyperactivity disorder (ADHD). Tris Pharma has won FDA approval for Onyda XR (clonidine hydrochloride).

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FDA Approval Doctors Doctor 76

Fierce Pharma

JULY 17, 2023

Apellis Pharmaceuticals' Syfovre, after achieving the first FDA approval for advanced eye disease geographic atrophy, has been associated with rare but severe side effects, according to the America | The American Society of Retinal Specialists sent out a note to doctors on Saturday warning of eye inflammation cases in patients who took Syfovre, (..)

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FDA Approval Doctors Doctor 86

pharmaphorum

NOVEMBER 24, 2020

The disease is also difficult to diagnose and often takes around six years before doctors correctly identify it. Alnylam’s Givlaari, FDA-approved a year ago for acute hepatic porphyria, costs $575,000 per year at full price in the US, although after discounts the figure is more likely to be in the region of $442,000 per year.

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FDA Approval Gene Silencing Drugs RNA 52

Pharmaceutical Technology

MARCH 24, 2023

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

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FDA Approval Marketing Manufacturing Sales 147

XTalks

OCTOBER 4, 2022

Guerbet, a pharmaceutical company based in France that specializes in medical imaging, obtained US Food and Drug Administration (FDA) approval for Elucirem (gadopiclenol), a new macrocyclic GBCA. Elucirem is indicated for use in adults and children aged 2 years and older, for contrast-enhanced MRI. What is Unique About Elucirem?

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XTalks

NOVEMBER 15, 2024

You know how to protect against COVID and flu so ask your pharmacist or doctor about scheduling an RSV vaccine, too.” The approval is pivotal as it opens up the vaccine to the under-60 adult population. Because moments like these matter,” the commercial ends off saying.

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Vaccination Vaccine Gene Therapy RNA 105

XTalks

JUNE 17, 2024

Numerous doctors offer minimally invasive treatments aimed at reducing the visibility of frown lines. Efficacy and Safety of Letybo FDA approval was granted based on encouraging outcomes from three completed Phase III trials, encompassing over 1,000 participants across the US and Europe.

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FDA Approval Marketing Botox Clinical Trials 52

World of DTC Marketing

JUNE 17, 2021

SKIMMERS SUMMARY: Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product.

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FDA Approval Drugs Clinical Trials Clinical Trials 164

pharmaphorum

AUGUST 13, 2020

There have been no signs of liver toxicity in the 80 patients treated so far, but the FDA is warning doctors to monitor renal function as this issue has been observed in patients taking antisense oligonucleotides. The post NS Pharma takes on Sarepta as FDA approves DMD drug appeared first on.

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FDA Approval Drugs Gene Trials 52

pharmaphorum

APRIL 27, 2021

Cognoa has filed for FDA approval of a digital device that could be used to diagnose autism, which the company argues could redefine care standards. . Autism can be difficult to diagnose as there are no medical markers to show its presence – instead doctors look at the child’s developmental history and behaviour to make a diagnosis.

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Doctors Doctor FDA Approval Trials 105

Pharmacy Checkers

FEBRUARY 14, 2020

I have reported this to the FDA and will be seeing my doctor this week. Apparently, the FDA had approved Budeprion XL 300mg after undergoing no actual testing. Of our most merciful health insurance companies, few are willing to cough up the cost of expensive brand meds when there’s an FDA-approved generic on the market.

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Branding FDA Approval Pharmacy Bioequivalency 62

XTalks

OCTOBER 28, 2024

Insulet SmartAdjust Technology for Type 2 Diabetes: Simplified Insulin Dosing In August, the US Food and Drug Administration (FDA) approved Omnipod 5 for type 2 diabetes , marking it as the first automated insulin dosing device for this population.

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Insulin FDA Approval Marketing Doctors 105

World of DTC Marketing

JUNE 23, 2021

SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. Biogen’s Aduhelm won FDA approval after discovering that some patients on higher dosages had displayed improvement of.39

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Drugs FDA Approval Doctors Doctor 218

XTalks

OCTOBER 7, 2022

The approval of omidenepag isopropyl ophthalmic solution 0.002% provides doctors with another safe and effective option to use when treating patients with these sight-threatening conditions,” said Jason Bacharach, MD, and Medical and Research Director at North Bay Eye Associates, Inc., in the press release.

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pharmaphorum

OCTOBER 21, 2021

Many are still predicting multibillion-dollar sales for the drug, albeit with a longer runway, despite reservations about its clinical efficacy among doctors and payers. Analysts meanwhile have suggested that Aduhelm may start to pick up momentum if that review is positive.

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Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Gilenya is an oral medication for multiple sclerosis.

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The Pharma Data

MAY 19, 2023

ABBOTT RECEIVES FDA APPROVAL FOR TACTIFLEX™ ABLATION CATHETER FOR TREATMENT OF ABNORMAL HEART RHYTHM Abbott (NYSE: ABT) today announced that the U.S. 6 “Abbott is leading the way in helping doctors manage common arrhythmias with the most holistic portfolio for this condition in the world,” said Christopher Piorkowski, M.D.,

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FDA Approval Doctors Doctor Branding 52

The Pharma Data

JULY 29, 2021

BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Tell your doctor if you have any breathing-related problems. Tell your doctor if you have any breathing-related problems. About BOTOX ®. Cornea problems have been reported. versus 0.4%, respectively).

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Botox FDA Approval Doctors Doctor 52

pharmaphorum

JUNE 14, 2022

Eli Lilly and Incyte’s Olumiant has secured the first FDA approval for a systemic drug to treat alopecia areata, an autoimmune condition causing patchy hair loss that affects more than 700,000 people in the US.

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FDA Approval Trials Doctors Doctor 98

Pharmaceutical Technology

JULY 28, 2022

Roche’s Susvimo (ranibizumab sustained release formulation) follows a similar theme; patients who are implanted with Susvimo are expected to visit their doctor only twice a year to have the implant refilled so that the medicine can be delivered to their eyes continuously. The therapy received FDA approval in October last year.

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XTalks

MAY 26, 2023

Krystal Biotech’s Vyjuvek has been awarded US Food and Drug Administration (FDA) approval to make it the first topical gene therapy for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB).

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Gene Therapy Gene FDA Approval Dermatology 97

Scienmag

NOVEMBER 8, 2020

Rutgers study also finds doctors continue to prescribe antipsychotic medications without the recommended psychiatric consultation for non FDA-approved conditions The use of antipsychotics in young children is declining but doctors continue to prescribe these medications off-label for conditions not approved by the Food and Drug Administration and without (..)

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FDA Approval Doctors Doctor Drugs 40

XTalks

JUNE 26, 2024

percent reporting unmet healthcare needs and barriers such as inadequate information, poor access to treatment and unsatisfactory patient-doctor relationships. The stigma surrounding hyperhidrosis often prevents patients from seeking treatment, with 64.8

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Clinical Trials Clinical Trials Dermatology FDA Approval 103

XTalks

JUNE 19, 2023

Talk to a doctor about Nurtec ODT.” New Migraine Drugs In March this year, Pfizer announced the US Food and Drug Administration (FDA) approval for their novel migraine nasal spray Zavzpret (zavegepant) , touted as “the EpiPen of migraines” due to its rapid action.

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FDA Approval Trials Doctors Doctor 97

XTalks

MAY 1, 2023

RELATED: Sacral Nerve Stimulation Study with Neuspera’s Nuvella System Moves into Second Phase FDA-Approved Axonics Therapies Axonics has recently launched two SNM implantable neurostimulators (INS). The Axonics R20 has received FDA approval in January of this year.

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Drugs FDA Approval Doctors Doctor 98

pharmaphorum

JUNE 13, 2022

” Armed with the new data, the Swiss biotech intends to file for FDA approval of cami, and if approved it will be ADC’s second commercial product after Zynlonta (loncastuximab tesirine), used as a third-line treatment for diffuse large b-cell lymphoma (DLBCL). .

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Drugs Antibody FDA Approval Doctors 98

Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. John’s doctor was skeptical of drugs bought online from other countries. and arguably just as safe.

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FDA Approval Branding Pharmacy Manufacturing 62