Cybin bags breakthrough tag for psychedelic depression drug
pharmaphorum
MARCH 14, 2024
Cybin files a $150m placement on the back of new clinical data with its psychedelic drug CYB003 for depression and an FDA breakthrough designation.
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pharmaphorum
MARCH 14, 2024
Cybin files a $150m placement on the back of new clinical data with its psychedelic drug CYB003 for depression and an FDA breakthrough designation.
pharmaphorum
MAY 23, 2023
Grünenthal’s non-opioid pain drug gets breakthrough tag Phil.Taylor Tue, 05/23/2023 - 08:20 Bookmark this
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pharmaphorum
OCTOBER 3, 2022
The third ALS treatment to be given FDA approval, following Mitsubishi Tanabe’s Radicava ($170,000 per year) and generic drug riluzole – Relyvrio is priced at around $12,500 per 28-day prescription. Currently, the ALS drug is priced about five times higher than the top of a value-based range. ALS affects over 30,000 people in the US.
Pharmaceutical Technology
FEBRUARY 29, 2024
LUT014 is being investigated in an ongoing Phase II trial as a first-line treatment for EGFR inhibitor-induced acneiform rash, for which there is no approved drug.
Pharmaceutical Technology
FEBRUARY 12, 2024
The humanised monoclonal antibody DISC-3405 is under investigation in a Phase I clinical trial, with data expected this year.
pharmaphorum
DECEMBER 23, 2021
Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. HER3 is expressed in more than 80% of EGFR-mutant NSCLC, and overexpression is associated with poor outcomes, but no HER3-targeted drugs have been approved to date.
Fierce Pharma
APRIL 29, 2024
The price tag includes both the approved cancer drug Qinlock and another Deciphera candidate heading to the FDA’s desk in the coming months.
Drug Topics
NOVEMBER 3, 2023
During a session at AMCP Nexus, presenters discussed the delicate balance between cost and innovation as it relates to forthcoming oncology treatments.
Fierce Pharma
MARCH 20, 2024
After scoring an FDA nod Monday for the first gene therapy to treat the rare genetic disease metachromatic leukodystrophy (MLD) in the U.S., Kyowa Kirin and its subsidiary Orchard Therapeutics have | After scoring an FDA nod Monday for the first gene therapy to treat the rare genetic disease metachromatic leukodystrophy in the U.S.,
Fierce Pharma
MAY 14, 2024
regulators last month, Eisai and Biogen’s effort to deploy a more convenient version of their Alzheimer’s disease drug Leqembi appears to be back on track. After suffering a setback with U.S.
The Checkup by Singlecare
NOVEMBER 22, 2023
Skin tags are one of those things you probably don’t think about until you spot one. At first glance, you may fear it’s a symptom of psoriasis , eczema , HPV warts, or skin cancer —but skin tags are common, noncancerous, and essentially harmless. Read on to see what experts say about the following 13 home remedies for skin tags.
Pharmaceutical Technology
OCTOBER 9, 2023
The FDA decision follows a similar designation for the vaccine UV1 against malignant melanoma in December 2021.
Pharmaceutical Technology
JANUARY 31, 2024
The FDA has granted an orphan drug designation to Revolo’s ‘1104, with plans for a Phase IIb study later this year.
The Checkup by Singlecare
FEBRUARY 17, 2024
Skin tags , also called acrochordons, are harmless growths that can occur anywhere on your body but tend to develop in more friction-heavy areas like the armpit, the neck along the seat belt line where clothes and jewelry touch, under the breasts, in the groin, or on the face—specifically, the eyelid. What causes skin tags on eyelids?
Pharmaceutical Technology
FEBRUARY 22, 2024
Harmony is advancing pitolisant into a Phase III clinical trial that is expected to start in Q1 2024.
Pharmacy Times
APRIL 17, 2023
Although payers have become somewhat accustomed to the high cost of specialty drugs, the price tags for gene therapies are causing “sticker shock.”
Pharmaceutical Technology
OCTOBER 17, 2023
The Netherlands-based company’s treatment has been awarded the designation by the US FDA following a successful Phase I trial.
Pharmaceutical Technology
NOVEMBER 20, 2023
NeoImmuneTech is developing NT-17, an IL-7 treatment, to promote rapid T-cell recovery in patients with acute radiation syndrome.
STAT
APRIL 12, 2024
In response to controversy, a group of Colorado lawmakers is abandoning a bill that would have required a new state board — which is chartered with setting caps for the cost of medicines — to create exemptions for rare disease drugs. Continue to STAT+ to read the full story…
Pharmaceutical Technology
APRIL 25, 2024
A Senate Committee is investigating the “outrageously high” US price tags of the blockbuster diabetes and obesity drugs.
Pharmaceutical Technology
AUGUST 1, 2023
Vepdegestrant was awarded the Innovation Passport designation for treating advanced or metastatic breast cancer.
STAT
JANUARY 30, 2024
In response to concerns over multimillion-dollar price tags for new gene therapies for sickle cell disease, the U.S. government on Tuesday announced a long-awaited “access model” designed to blunt the cost that state Medicaid programs would pay for these curative treatments. million and $3.1
PharmaShots
MARCH 24, 2023
PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)
The People's Pharmacy
JUNE 5, 2023
People often want to know how to make skin tags go away. Here is one person’s story on how to avoid skin tags. Lowering Blood Sugar Helped Reader Avoid Skin Tags: Q. I had a number of skin tags on my neck. Then I noticed that the skin tags had totally disappeared. How Can You Avoid Skin Tags?
PharmaShots
JUNE 13, 2023
Eisai's and Merck Announces EU's Marketing Approval of Lenvima (lenvatinib mesylate) for Hepatocellular Carcinoma Published: 23 Aug,2018 | Tags: Eisai, Merck, Approval, Lenvima, HCC, 2. Pfizer to co-promote Exact Sciences Cologuard Published: 22 Aug,2018 | Tags: Exact, Pfizer, Agreement, Promote, Cologuard 7.
Pharma Tutor
OCTOBER 13, 2022
DRUG REPURPOSING : A REVIEW. Read more about DRUG REPURPOSING : A REVIEW Log in or register to post comments Read more about DRUG REPURPOSING : A REVIEW Log in or register to post comments Email : charmiagarwal823@gmail.com. Thu, 10/13/2022 - 15:56. Review Articles.
STAT
NOVEMBER 16, 2023
Food and Drug Administration for a host of manufacturing violations at one of its plants in India, the latest instance in which the company was tagged by the regulator for quality-control problems. Reddy’s Laboratories, one of the world’s largest generic drugmakers, was cited by the U.S.
STAT
JANUARY 6, 2023
Food and Drug Administration has granted accelerated approval to the widely anticipated Alzheimer’s drug from Eisai and Biogen, a key question is the extent to which payers — private and public — will cover the treatment. Such decisions are based on myriad factors, starting with the average $26,500 price tag.
STAT
MARCH 10, 2023
By law, Medicare will have to take a medication’s efficacy and its research and development costs into account when it starts to negotiate drug prices — but recent research shows pharma companies ignore those factors when they pick prices for their products. But neither factor has much effect, the studies concluded.
STAT
DECEMBER 12, 2023
The news comes as researchers are still processing the Food and Drug Administration’s landmark approval of two cutting-edge sickle cell therapies, one made by Vertex Pharmaceuticals and CRISPR Therapeutics and the other by Bluebird Bio. These drugs have price tags of $2.2 million and $3.1 million, respectively.
PharmaShots
APRIL 7, 2023
TG Therapeutics Receives EMA’s CHMP Positive Opinion of Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis Date: Apr 3, 2023 | Tags: TG Therapeutics, Briumvi, Ublituximab-xiiy, Multiple Sclerosis, Regulatory, EMA, CHMP BMS Receives EMA’s CHMP Positive Opinion of Breyanzi (lisocabtagene maraleucel) for (..)
PharmaShots
MARCH 24, 2023
PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)
STAT
OCTOBER 27, 2022
Amid sporadic shortages of a drug that is essential in preparing patients for lifesaving, cancer-fighting treatments, one manufacturer has returned to the market — but is selling its medicine for 10 to 20 times the prices offered by the only other companies with available supplies. Continue to STAT+ to read the full story…
PharmaShots
JUNE 2, 2023
Impact Therapeutics Entered into a License and Collaboration Agreement with Eikon Therapeutics to Develop and Commercialize IMP1734 Date: June 02, 2023 | Tags: Impact Therapeutics, Eikon Therapeutics, IMP1734, Pharma, China, Hong Kong, Macau, Taiwan BMS’ Mavacamten Receives the NICE Recommendation for the Treatment of Obstructive Hypertrophic (..)
STAT
JANUARY 10, 2023
Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems. Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S.
Pharmaceutical Technology
SEPTEMBER 30, 2022
Spark Therapeutics’ Luxturna, indicated for inherited retinal disease (IRD), was the first gene therapy to be approved, in 2017, with a price tag of $850,000 for each eye. bluebird then broke its own pricing record when the $3m Skysona was approved, and now faces the unique challenge of selling the world's two most expensive drugs.
PharmaShots
MAY 19, 2023
Alimera Acquires Rights from EyePoint Pharmaceuticals to Commercialise Yutiq in the US Date: May 19, 2023 | Tags: Alimera, EyePoint Pharmaceuticals, Yutiq, Iluvien, chronic non-infectious uveitis, US, Pharma Sobi Reports EMA’s Validation of MAA for Efanesoctocog Alfa to Treat Haemophilia A Date: May 19, 2023 | Tags: Sobi, Efanesoctocog Alfa, (..)
PharmaShots
JUNE 16, 2023
Date: June 12, 2023 | Tags: Novartis, Chinook Therapeutics, Atrasentan, Zigakibart, BION-1301, IgA nephropathy, M&A, ~$3.5B Date: June 12, 2023 | Tags: Novartis, Chinook Therapeutics, Atrasentan, Zigakibart, BION-1301, IgA nephropathy, M&A, ~$3.5B
PharmaShots
MARCH 17, 2023
5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years Date: Mar 15, 2023 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted 5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years Date: Mar 15, 2023 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted
PharmaShots
MAY 26, 2023
Takeda and HUTCHMED's Fruquintinib Receives Priority Review from the US FDA to Treat Metastatic Colorectal Cancer Date: May 26, 2023 | Tags: Takeda, HUTCHMED, Fruquintinib, Metastatic Colorectal Cancer, Regulatory, Priority Review, US, FDA Gilead Receives EMA’s CHMP Positive Opinion to Extend the Use of Veklury (remdesivir) for COVID-19 Date: (..)
pharmaphorum
DECEMBER 24, 2021
The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. The $56,000-a-year price tag for the drug, which has now been cut in half in the US, also hasn’t helped the drugmakers make a case for Aduhelm with US payers.
STAT
JANUARY 31, 2024
… Novo Nordisk has begun to increase availability of its blockbuster obesity drug Wegovy for new patients in the U.S. Overall, Novo saw 154% growth in obesity drug revenue in 2023, driven by sales of its older obesity drug Saxenda and the launch of Wegovy in additional countries.
PharmaShots
APRIL 14, 2023
Ocugen Reports Preliminary Results from the P-I/II Trial of OCU400 for the Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis Date: Apr 14, 2023 | Tags: Ocugen, OCU400, Retinitis Pigmentosa, Leber Congenital Amaurosis, Clinical Trial, P-I/II Trial Candesant Biomedical Receives the US FDA Clearance of Brella SweatControl Patch for Primary (..)
Pharma Tutor
JULY 13, 2022
A REVIEW ON COMPUTER AIDED DRUG DESIGN (CAAD) AND IT’S IMPLICATIONS IN DRUG DISCOVERY AND DEVELOPMENT PROCESS. Read more about A REVIEW ON COMPUTER AIDED DRUG DESIGN (CAAD) AND IT’S IMPLICATIONS IN DRUG DISCOVERY AND DEVELOPMENT PROCESS Log in or register to post comments About Authors. Sayyed , Ms. Review Articles.
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