Aminopyridines

LianBio Appoints Pascal Qian as General Manager of China

Retrieved on:

Monday, August 2, 2021

Health, Biotechnology, Chemical compounds, Organic compounds, Aminopyridines, Thioethers, Chloroarenes, Specialty drugs, Protein kinase inhibitors, Palbociclib, Sunitinib, Axitinib, Crizotinib, Qian

LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, today announced that it has appointed Pascal Qian to the position of China General Manager.

Key Points:

LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, today announced that it has appointed Pascal Qian to the position of China General Manager.
Mr. Qian has extensive experience launching products in China, including Verzenio, Tyvyt, Elunate, Afinitor, Votrient, Sutent, Vfend and Singulair.
He has also led new product development initiatives in China for multiple globally developed drugs, including crizotinib, axitinib and palbociclib.
Mr. Qian most recently served as the Vice President, Head of Oncology Business Unit, at Lilly China.

Catalyst Pharmaceuticals Comments on Recent Decision by Health Canada to Re-issue an NOC for Ruzurgi®

Retrieved on:

Monday, June 28, 2021

Amifampridine, Aminopyridines, Catalyst, Canadas, Kye, Kayleigh McEnany, Health care

Health Canada's original NOC for Ruzurgi for marketing in Canada was quashed in a recent decision of the Federal Court of Canada, which sent the matter back to Health Canada to re-determine its decision to grant marketing authority to Ruzurgi despite Firdapse's data protection rights under Canadian law.

Key Points:

Health Canada's original NOC for Ruzurgi for marketing in Canada was quashed in a recent decision of the Federal Court of Canada, which sent the matter back to Health Canada to re-determine its decision to grant marketing authority to Ruzurgi despite Firdapse's data protection rights under Canadian law.
Patrick J. McEnany, Catalyst's Chairman and CEO commented: We are obviously disappointed with Health Canadas decision to re-issue an NOC for Ruzurgi.
Catalyst and its Canadian sublicensee, KYE Pharmaceuticals ("KYE"), are currently evaluating their further litigation options to challenge Health Canadas most recent decision, since such decision means that the data protection that Catalyst and KYE are entitled to under Canadian law has not been recognized by Health Canada.
Further, Canadas national healthcare regulatory agency, Health Canada, recently approved the use of Firdapse (amifampridine) for the treatment of patients in Canada with LEMS.

Catalyst Pharmaceuticals Announces Exclusive License and Supply Agreement with DyDo Pharma for the Development and Commercialization of Firdapse® in Japan

Retrieved on:

Monday, June 28, 2021

Amifampridine, Aminopyridines, Health care

Under the terms of the agreement, DyDo Pharma will have joint rights to develop Firdapse (amifampridine phosphate), and exclusive rights to commercialize the product, in Japan.

Key Points:

Under the terms of the agreement, DyDo Pharma will have joint rights to develop Firdapse (amifampridine phosphate), and exclusive rights to commercialize the product, in Japan.
DyDo Pharma will be responsible for funding all clinical, regulatory, marketing and commercialization activities in Japan.
Catalyst will be responsible for clinical and commercial supply, as well as providing support to DyDo Pharma in its efforts to obtain regulatory approval for the product from the Japanese regulatory authorities.
We are very pleased to have acquired a license for the Japanese rights for Firdapse, which Catalyst sells in the United States, said Yasunori Inaoka, president and representative director of DyDo Pharma.

G1 Therapeutics Presents Phase 1 Data at ASCO Describing Favorable Safety Profile and Evidence of Antitumor Activity of Rintodestrant Combined with Palbociclib in Patients with ER+/HER2- Advanced Breast Cancer

Retrieved on:

Friday, June 4, 2021

Chemical compounds, Organic compounds, Heterocyclic compounds, Protein kinase inhibitors, Breakthrough therapy, Aminopyridines, Lactams, Palbociclib, G1 Therapeutics, Breast cancer, HER2/neu, Selective estrogen receptor degrader

The Phase 1, first-in-human, open-label study evaluated rintodestrant in women with ER+/HER2- advanced breast cancer after progression on endocrine therapy.

Key Points:

The Phase 1, first-in-human, open-label study evaluated rintodestrant in women with ER+/HER2- advanced breast cancer after progression on endocrine therapy.
The study comprised three parts: dose escalation of monotherapy rintodestrant (part 1), dose expansion of monotherapy rintodestrant (part 2), and rintodestrant in combination with palbociclib therapy (part 3).
The results of part 1 and 2 were presented at the 2020 San Antonio Breast Cancer Symposium (SABCS) ( 2020 poster ).
G1 Therapeutics and the G1 Therapeutics logo are trademarks of G1 Therapeutics, Inc.

Catalyst Pharmaceuticals to Participate in Two Upcoming Investor Conferences

Retrieved on:

Wednesday, May 19, 2021

Psychoactive drugs, Drugs, Receptor agonists, Amifampridine, Aminopyridines, XC2, Catalyst, MDMA, Catalyst Pharmaceuticals

With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, first- or best-in-class medicines for other rare diseases.

Key Points:

With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, first- or best-in-class medicines for other rare diseases.
Catalyst\'s New Drug Application for Firdapse\xc2\xae (amifampridine) 10 mg tablets for the treatment of adults with LEMS was approved in 2018 by the\xc2\xa0U.S.
Copies of Catalyst\'s filings with the SEC are available from the SEC, may be found on Catalyst\'s website, or may be obtained upon request from Catalyst.
Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.\n'

Early amcenestrant data featured at ASCO support its potential to become a new endocrine backbone therapy for ER+/HER2- breast cancer

Retrieved on:

Wednesday, May 19, 2021

Chemical compounds, Organic compounds, Aminopyridines, Cyclopentanes, Palbociclib, Piperazines

\xe2\x80\x9cThe analysis also demonstrated no clinically significant cardiac or ocular findings and an overall safety profile in line with what we saw in the monotherapy setting.

Key Points:

\xe2\x80\x9cThe analysis also demonstrated no clinically significant cardiac or ocular findings and an overall safety profile in line with what we saw in the monotherapy setting.
Amcenestrant 200mg daily in combination with palbociclib demonstrated a favorable overall safety profile (n=39), with treatment related adverse events (TRAEs) attributable to amcenestrant similar to those observed with monotherapy.
For all grade events, amcenestrant TRAEs occurred in 72% and to palbociclib in 90% of patients, and for grade \xe2\x89\xa53 in 15% and 46% of patients, respectively.
The most frequent non-hematological amcenestrant TRAEs included fatigue (18%) and nausea (18%), all grade \xe2\x89\xa42.

Acorda Therapeutics First Quarter 2021 Update: Webcast/Conference Call Scheduled for May 6, 2021

Retrieved on:

Thursday, April 29, 2021

Biotechnology, Pharmaceutical, Health, Medical devices, 4-Aminopyridine, Aminopyridines, Forward-looking statement, XC2

For the Webcast you will receive an email 2 hours prior to the start of the call with the link to join.

Key Points:

For the Webcast you will receive an email 2 hours prior to the start of the call with the link to join.
The presentation will be available on the Investors section of www.acorda.com .\nA replay of the call will be available from 7:30 p.m.
Acorda also markets the branded AMPYRA\xc2\xae (dalfampridine) Extended Release Tablets, 10 mg.\nThis press release includes forward-looking statements.
All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking.

Real-World Evidence Supports Effectiveness of First-line IBRANCE® (palbociclib) Combination Therapy in HR+, HER2- Metastatic Breast Cancer

Retrieved on:

Thursday, March 25, 2021

These findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research .

Key Points:

These findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research .
With more than six years of patient experience, a positive benefit-risk profile, strong clinical data and robust real-world data, the totality of evidence solidifies the role of IBRANCE plus endocrine therapy as a treatment for patients with HR+, HER2- metastatic breast cancer.
The analysis also showed the two-year OS rate was 78.3% in the IBRANCE group and 68.0% with letrozole.
The findings from this landmark real-world study align with the positive impact that I have seen in my own patients treated with IBRANCE combination therapy.

Breast Cancer Index™ demonstrates its ability to predict preferential endocrine benefit irrespective of risk for HR+ early-stage breast cancer patients

Retrieved on:

Thursday, December 17, 2020

Breast cancer, Cancer, Health, Aminopyridines, Protein kinase inhibitors, Kathleen I. Pritchard, Breast cancer management

San Diego, CA, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Evidence demonstrating the ability of Breast Cancer Index to predict preferential endocrine benefit irrespective of clinical risk for HR+ early-stage breast cancer patients was highlighted during a Spotlight session on December 9that this years San Antonio Breast Cancer Symposium.

Key Points:

San Diego, CA, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Evidence demonstrating the ability of Breast Cancer Index to predict preferential endocrine benefit irrespective of clinical risk for HR+ early-stage breast cancer patients was highlighted during a Spotlight session on December 9that this years San Antonio Breast Cancer Symposium.
The Investigation on the Duration of Extended Adjuvant Letrozole (IDEAL) trial examined the Breast Cancer Index (BCI) HOXB13/IL17BR (H/I) ratio and its ability to predict benefit from extended endocrine therapy.
The Breast Cancer Index (BCI) allows us to sort out the patients who will benefit from extended endocrine therapy from those who will not (but who will suffer the harms).
Breast Cancer Index is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early stage, HR+ breast cancer.

Catalyst Pharmaceuticals Announces Filing of Patent Infringement Actions Against Jacobus Pharmaceuticals and PantherRx

Retrieved on:

Monday, October 19, 2020

Amifampridine, Aminopyridines, Patent, Catalyst Pharmaceuticals, Health, Companies

The 893 patent is exclusively licensed to Catalyst Pharmaceuticals and covers certain methods for treating disease using amifampridine drug products, including Catalysts Firdapse product, in patients who are slow metabolizers of amifampridine.

Key Points:

The 893 patent is exclusively licensed to Catalyst Pharmaceuticals and covers certain methods for treating disease using amifampridine drug products, including Catalysts Firdapse product, in patients who are slow metabolizers of amifampridine.
The lawsuit alleges that the Ruzurgi product infringes the 893 patent when administered in accordance with its product labeling.
The lawsuit seeks damages and injunctive relief to prevent further marketing of Ruzurgi in violation of Catalysts patent rights.
Catalyst remains confident in its patent portfolio, and has filed several additional patent applications claiming priority from the 893 patent to enhance the protection of the Firdapse patent estate.