FDA puts breakthrough tag on Roche, Lilly Alzheimer’s test
pharmaphorum
APRIL 11, 2024
Roche and Eli Lilly have been granted breakthrough status by the FDA for their pTau217 blood test for Alzheimer's disease.
tag fda 
MindMed gets FDA breakthrough tag for LSD in anxiety
pharmaphorum
MARCH 8, 2024
In another inflection point for the psychedelic medicines category, Mind Medicine (MindMed) has claimed breakthrough status from the FDA for its LSD-based treatment candidate MM120 as a treatment for anxiety.
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Click bags FDA breakthrough tag for schizophrenia DTx
pharmaphorum
JANUARY 4, 2024
Digital health company Click Therapeutics has won an FDA breakthrough device designation for CT-155, a digital therapeutic (DTx) for the negative symptoms of schizophrenia, like social withdrawal and apathy, that tend not to respond well to antipsychotic drugs.
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FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag
pharmaphorum
JANUARY 5, 2022
The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. The post FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag appeared first on. Preliminary results from that study showed a 53.8%
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Lutris wins FDA orphan drug tag for EGFR inhibitor-induced rash candidate
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.
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Blue Note leukaemia DTx gets FDA breakthrough tag
pharmaphorum
JANUARY 11, 2022
A prescription digital therapeutic (DTx) for leukaemia patients developed by Blue Note Therapeutics has been awarded breakthrough device status by the FDA. Last year, Biofourmis said its heart failure tool BiovitalsHF was the first DTx to be awarded breakthrough status by the FDA.
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FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag
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. The post FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag appeared first on.
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STAT+: FDA cites Dr. Reddy’s for quality control problems at a biologics plant
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.
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FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag
pharmaphorum
JUNE 8, 2021
The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. The post FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag appeared first on.
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STAT+: FDA scolds Sun Pharmaceutical for serious quality control problems at a key plant in India
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.
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NorthSea Therapeutics bags FDA rare paediatric disease tag for NASH drug
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.
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FDA approves Duchenne gene therapy with hefty $3.2m price tag
Pharmaceutical Technology
JUNE 23, 2023
Sarepta will now need to complete a confirmatory trial to prove the therapy improves physical function and mobility.
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PharmaShots Weekly Snapshot (August 20-24, 2018)
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.
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PharmaShots Weekly Snapshots (March 20 - 24, 2023)
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 (..)
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PharmaShots Weekly Snapshots (June 12 – 16, 2023)
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
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PharmaShots Weekly Snapshots (April 03 - 07, 2023)
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 (..)
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PharmaShots Weekly Snapshots (June 19 – 23, 2023)
PharmaShots
JUNE 23, 2023
Gilead Receives EMA’s CHMP Positive Opinion of Trodelvy (sacituzumab govitecan) for Pre-Treated HR+/HER2- Metastatic Breast Cancer Date: June 23, 2023 | Tags: Gilead, Trodelvy, sacituzumab govitecan, HR+/HER2- Metastatic Breast Cancer, Regulatory, EMA, CHMP, Positive Opinion Sarepta Therapeutics’ Elevidys Receives the US FDA’s Accelerated (..)
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40 PharmaShots Weekly Snapshots (April 24 - 28, 2023)
PharmaShots
APRIL 28, 2023
Difficile Infection Date: Apr 27, 2023 | Tags: Seres Therapeutics, Nestlé Health Science, Vowst, C.
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PharmaShots Weekly Snapshots (May 01 - 05, 2023)
PharmaShots
MAY 5, 2023
Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive EC’s Marketing Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease Date: May 05, 2023 | Tags: Chiesi Global Rare Diseases, Protalix BioTherapeutics, PRX-102, pegunigalsidase alfa, Fabry Disease, Regulatory, EC, Marketing Authorization Kinoxis Therapeutics (..)
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PharmaShots Weekly Snapshots (April 10 - 14, 2023)
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 (..)
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PharmaShots Weekly Snapshots (May 22 - 26, 2023)
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: (..)
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PharmaShots Weekly Snapshots (May 15 - 19, 2023)
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 Weekly Snapshots (April 17 - 21, 2023)
PharmaShots
APRIL 21, 2023
Oblato Reports the First Patient Enrolment of OKN-007 in the P-I Clinical Trial for Recurrent High-Grade Glioma Date: Apr 21, 2023 | Tags: Oblato, OKN-007, Recurrent High-Grade Glioma, Regulatory, Henry Ford Health System CARsgen's CT041 Receives the US FDA’s IND Clearance for the Postoperative Adjuvant Therapy of Pancreatic Cancer Date: (..)
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PharmaShots Weekly Snapshots (February 20 - 24, 2023)
PharmaShots
FEBRUARY 24, 2023
Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive
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PharmaShots Weekly Snapshots (January 30 - February 03, 2023)
PharmaShots
FEBRUARY 3, 2023
4D Molecular Therapeutics Receives the US FDA’s IND Clearance of 4D-150 for the Treatment of Diabetic Macular Edema Date: Feb 03, 2023 | Tags: 4D Molecular Therapeutics, 4D-150, Diabetic Macular Edema, Regulatory, US, FDA, IND AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma (..)
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40 PharmaShots Weekly Snapshots (March 13 - 17, 2023)
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
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PharmaShots Weekly Snapshots (May 29 - June 02, 2023)
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 (..)
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PharmaShots Weekly Snapshots (January 23 - 27, 2023)
PharmaShots
JANUARY 27, 2023
Magenta Therapeutics Pauses the P-I/II Study in AML Patients Date: Jan 27, 2023 | Tags: Magenta Therapeutics, MGTA-117, AML, Clinical Trial, P-I/II Ipsen Receives CHMP Negative Opinion for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva Date: Jan 27, 2023 | Tags: Ipsen, Palovarotene, Fibrodysplasia Ossificans Progressiva, Regulatory, CHMP, (..)
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PharmaShots Weekly Snapshots (June 05 – 09, 2023)
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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40 PharmaShots Weekly Snapshots (May 08 - 12, 2023)
PharmaShots
MAY 12, 2023
Sanofi Reports P-IIIb Trial (HARMONIE) Results of Nirsevimab for the Prevention of Hospitalizations due to RSV-Related LRTD Date: May 12, 2023 | Tags: Sanofi, Nirsevimab, RSV-Related LRTD, Clinical Trial, P-IIIb, HARMONIE Trial G1 Therapeutics Presents Preliminary Results from P-II Trial of Trilaciclib for Triple-Negative Breast Cancer at ESMO 2023 (..)
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PharmaShots Weekly Snapshots (February 13 - 17, 2023)
PharmaShots
FEBRUARY 17, 2023
Iveric Bio Reports the US FDA Acceptance of NDA and Granted Priority Review of Avacincaptad Pegol for Geographic Atrophy Date: Feb 17, 2023 | Tags: Iveric Bio, Avacincaptad Pegol, Geographic Atrophy, Regulatory, US, FDA, NDA, Priority Review ALX Oncology Reports the First Patient Dosing of Evorpacept in the P-I Study (ASPEN-07) for the Treatment of (..)
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40 PharmaShots Weekly Snapshots (February 06 - 10, 2023)
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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40 PharmaShots Weekly Snapshots (February 06 - 10, 2023)
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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bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies
Pharmaceutical Technology
SEPTEMBER 30, 2022
After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September. They usually face resistance from insurers and may struggle to gain coverage at launch.
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Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA
pharmaphorum
DECEMBER 24, 2021
Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm. The post Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA appeared first on.
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PharmaShots Weekly Snapshots (March 20 - 24, 2023)
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 (..)
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PharmaShots Weekly Snapshots (March 27 - 31, 2023)
PharmaShots
MARCH 31, 2023
PDS Biotech to Initiate P-III Trial (VERSATILE-003) of PDS0101 + Keytruda (pembrolizumab) for Head and Neck Cancer Date: Mar 31, 2023 | Tags: PDS Biotech, PDS0101, Keytruda, pembrolizumab, Head, Neck Cancer, Clinical Trial, P-III, VERSATILE-003 Trial Omega Therapeutics Entered into a Clinical Supply Agreement with Roche to Evaluate OTX-2002 for Hepatocellular (..)
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Amylyx ALS drug draws criticism over $158,000 price tag
pharmaphorum
OCTOBER 3, 2022
Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry. ALS affects over 30,000 people in the US.
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Axsome bounces back as FDA clears depression drug
pharmaphorum
AUGUST 21, 2022
Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. The post Axsome bounces back as FDA clears depression drug appeared first on. Following after is AXS-12 (reboxetine) for narcolepsy, which could be filed in 2023.
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J&J gets first approval for multiple myeloma bispecific Tecvayli
pharmaphorum
AUGUST 25, 2022
Talquetamab has also shown promise in myeloma in the phase 1 MonumenTAL-1 study, which showed a 70% overall response rate (ORR) with the drug, and claimed a breakthrough designation from the FDA in June. A marketing application for teclistamab is also under review at the FDA, with a decision expected later this month or in early September.
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Second unanimous FDA adcomm vote boosts bluebird bio
pharmaphorum
JUNE 12, 2022
bluebird bio started last week on tenterhooks, as FDA advisors cast their eyes over data for two gene therapy candidates that are key to its future as a commercially viable concern. Beti-cel has already been approved for marketing in Europe as Zynteglo, with a price tag of around $1.8
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Pear claims breakthrough tag for alcohol use disorder DTx
pharmaphorum
NOVEMBER 24, 2021
Digital health company Pear Therapeutics has won FDA breakthrough device status for reSET-A, its development-stage prescription digital therapeutic (DTx) for people with alcohol-use disorder. The post Pear claims breakthrough tag for alcohol use disorder DTx appeared first on. Photo by thom masat on Unsplash.
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Biogen’s Aduhelm rollout goes from bad to worse
pharmaphorum
OCTOBER 21, 2021
Vounatsos also insisted that Aduhelm’s price tag has not been a factor discouraging treatment with the drug. Biogen stumped up $1.525 billion upfront for rights to the drug and another Sage candidate for neurological diseases last year, when the expectation was that Aduhelm was unlikely to get FDA approval.
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FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar
pharmaphorum
NOVEMBER 19, 2020
Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival.
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