MAA

Amylyx Pharmaceuticals Provides Update on Ongoing Regulatory Review of AMX0035 for the Treatment of ALS in the European Union

Retrieved on: 
Tuesday, May 30, 2023
Research, Neurology, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Head, The New England Journal of Medicine, European Medicines Agency, Survival, Clinical trial, Committee for Medicinal Products for Human Use, Sodium, Marketing, Medication, EMA, Committee, Amylyx Pharmaceuticals, Globalization, Journal, European, Journal of Neurology, Neurosurgery, and Psychiatry, Psychiatry, MAA, AMX0035, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ALS, Food, CHMP, Audit, Pharmaceutical industry, Neurosurgery

“We disagree with the current view expressed by the CHMP and remain confident in the data from the CENTAUR trial.

Key Points: 
  • “We disagree with the current view expressed by the CHMP and remain confident in the data from the CENTAUR trial.
  • Should a negative opinion ultimately be issued, we intend to request a formal re-examination procedure,” said Tammy Sarnelli, Global Head, Regulatory Affairs and Clinical Compliance at Amylyx.
  • The CHMP is expected to adopt a formal opinion on the MAA at its next meeting, which will be held June 19-22, 2023.
  • ALS affects approximately 29,000 people in the U.S. and more than 30,000 people are estimated to be living with ALS in Europe (European Union and United Kingdom).

Mithra - Letter to Shareholders and Corporate Update

Retrieved on: 
Thursday, May 25, 2023
Highbridge, Gedeon Richter, Letter, Mayo Clinic, Drawing, Endometrium, Therapy, Arthralgia, File, Marketing, Birth, Silence Therapeutics, NDA, BL 2.75-inch mountain gun, Ageing, Woman, Quality of life, Hospira, Research, Negotiation, Attention, Brain, DRSP, Hot, GSI, MITRA, Incidence, Communication, EUR, Dementia, CDMO, System, Patient, CEST, Estrogen, Brussels Stock Exchange, Menopause, Liver, Growth, Mortality, MAA, FDA, Zealand Pharma, Management, Risk management, Pharmaceutical industry, Medical device, Security (finance), Mithra, Estetrol, White box

Donesta® filing rescheduled for H2 2023 - still expecting U.S. approval in H1 2024

Key Points: 
  • Donesta® filing rescheduled for H2 2023 - still expecting U.S. approval in H1 2024
    Liege, Belgium, 25 May 2023 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, (the "Company" or "Mithra"), today published a Corporate Update and Letter to Shareholders from recently appointed Chief Executive Officer, Dr. David Horn Solomon.
  • I accepted the role because my analysis revealed strong fundamentals and tremendous potential to create significant value for Mithra shareholders.
  • Collectively, the Mithra leadership understands that our ability to create value for our shareholders is a primary directive that goes hand in hand with developing medicines for women.
  • I look forward to continuing with increased transparency and regular communications to providing updates on our progress to you, our shareholders.

Dr. Burkhard Blank Joins MannKind as Executive Vice President of Research & Development and Chief Medical Officer

Retrieved on: 
Wednesday, May 24, 2023
COPD, Research and development, Doctor of Pharmacy, Diabetes, Internal medicine, Boehringer Ingelheim, NDA, CMO, Acorda Therapeutics, Açorda, EMA, Development, Professional corporation, NTM, MD, Patient, Growth, MAA, FDA, IPF, Therapy, Idiopathic pulmonary fibrosis, MannKind Corporation, Pharmaceutical industry

DANBURY, Conn., May 24, 2023 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced Burkhard Blank, MD, has joined the company as Executive Vice President, Research & Development and Chief Medical Officer, effective today.

Key Points: 
  • DANBURY, Conn., May 24, 2023 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced Burkhard Blank, MD, has joined the company as Executive Vice President, Research & Development and Chief Medical Officer, effective today.
  • Blank will report directly to Michael Castagna, PharmD, Chief Executive Officer, and will serve on the company’s executive leadership team.
  • “Burkhard is an accomplished R&D leader and CMO whose experience will be beneficial as we continue to drive our pipeline and future growth,” said Dr. Castagna.
  • Dr. Blank recently served as CMO/Head of R&D at Pharnext SA after serving seven years in the same position at Acorda Therapeutics.

Habu Announces Collaboration With Microsoft Azure to Deliver Zero-Trust Data Clean Room

Retrieved on: 
Tuesday, May 23, 2023
Data Management, Advertising, Communications, Security, Technology, Software, Networks, Product management, Pressure, TLS, Intelligence, Microsoft, Privacy, Confidentiality, Organization, RSA, Running, Data analysis, SKR, Machine learning, Microsoft Azure, Ecosystem, AES, MAA, AKV, Microsoft Build, Rest, Video game, Online shopping, Habu, Azure

Habu, a global innovator in data clean room software, today announced a collaboration with Microsoft Azure to integrate its Data Clean Room applications with Azure confidential computing enabling businesses to unlock insights from sensitive data without sacrificing security, privacy, or performance.

Key Points: 
  • Habu, a global innovator in data clean room software, today announced a collaboration with Microsoft Azure to integrate its Data Clean Room applications with Azure confidential computing enabling businesses to unlock insights from sensitive data without sacrificing security, privacy, or performance.
  • Habu is a pioneer in creating data clean room software designed to make data collaboration safe and easy.
  • With this relationship, Habu’s fully interoperable hybrid clean room pattern has been upgraded to support Azure confidential computing .
  • “Our collaboration with Habu will help customers achieve their data privacy needs while running in Habu clean rooms on Microsoft Azure confidential computing."

HuidaGene Therapeutics Appoints Alvin Luk as Chief Executive Officer

Retrieved on: 
Wednesday, May 24, 2023
SAB, Spark Therapeutics, Indian Institutes of Technology, CRISPR, Drug development, Biogen, Biotechnology, Roche, Gene editing, Coronavirus Scientific Advisory Board, Science, Bayer, Patient, Capital, Growth, Entrepreneurship, Rare, MAA, Therapy, BLA, IND, News, Alvin, Pharmaceutical industry, Medical device

SHANGHAI and CLINTON, N.J., May 24, 2023 /PRNewswire/ -- HuidaGene Therapeutics (辉大基因; HuidaGene), a clinical-stage genome-editing company, today announced the appointment of gene therapy industry veteran, Alvin Luk, Ph.D., M.B.A., C.C.R.A., as Co-Founder, Member of the Board of Directors, and Chief Executive Officer.

Key Points: 
  • SHANGHAI and CLINTON, N.J., May 24, 2023 /PRNewswire/ -- HuidaGene Therapeutics (辉大基因; HuidaGene), a clinical-stage genome-editing company, today announced the appointment of gene therapy industry veteran, Alvin Luk, Ph.D., M.B.A., C.C.R.A., as Co-Founder, Member of the Board of Directors, and Chief Executive Officer.
  • My team and I look forward to working closely with Alvin to ensure continuity, build on the progress HuidaGene made, and deliver value to our stakeholders."
  • We warmly welcome Alvin to join the HuidaGene team and provide direct guidance for the ongoing IITs, IND submissions, and international collaborations.
  • For more information about Dr. Luk, please see recent news of 'HuidaGene Appoints New Members to the Scientific Advisory Board' ( https://www.prnewswire.com/news-releases/huidagene-appoints-new-members-... ).

HuidaGene Therapeutics Appoints Alvin Luk as Chief Executive Officer

Retrieved on: 
Wednesday, May 24, 2023
SAB, Spark Therapeutics, Indian Institutes of Technology, CRISPR, Drug development, Biogen, Biotechnology, Roche, Gene editing, Coronavirus Scientific Advisory Board, Science, Bayer, Patient, Capital, Growth, Entrepreneurship, Rare, MAA, Therapy, BLA, IND, News, Alvin, Pharmaceutical industry, Medical device

SHANGHAI and CLINTON, N.J., May 24, 2023 /PRNewswire/ -- HuidaGene Therapeutics (辉大基因; HuidaGene), a clinical-stage genome-editing company, today announced the appointment of gene therapy industry veteran, Alvin Luk, Ph.D., M.B.A., C.C.R.A., as Co-Founder, Member of the Board of Directors, and Chief Executive Officer.

Key Points: 
  • SHANGHAI and CLINTON, N.J., May 24, 2023 /PRNewswire/ -- HuidaGene Therapeutics (辉大基因; HuidaGene), a clinical-stage genome-editing company, today announced the appointment of gene therapy industry veteran, Alvin Luk, Ph.D., M.B.A., C.C.R.A., as Co-Founder, Member of the Board of Directors, and Chief Executive Officer.
  • My team and I look forward to working closely with Alvin to ensure continuity, build on the progress HuidaGene made, and deliver value to our stakeholders."
  • We warmly welcome Alvin to join the HuidaGene team and provide direct guidance for the ongoing IITs, IND submissions, and international collaborations.
  • For more information about Dr. Luk, please see recent news of 'HuidaGene Appoints New Members to the Scientific Advisory Board' ( https://www.prnewswire.com/news-releases/huidagene-appoints-new-members-... ).

Freeline Granted ILAP Designation in United Kingdom by MHRA for FLT201, an Investigational Gene Therapy for the Treatment of Gaucher Disease

Retrieved on: 
Monday, May 22, 2023
Gaucher's disease, National Health Service, Health care, Healthcare Improvement Scotland, Wales, Marketing, MD, Patient, National Institute for Health and Care Excellence, Innovation, NHS, MAA, Therapy, NICE, SMC, MHRA, Disease, Pharmaceutical industry, Gaucher

Medicines and Healthcare products Regulatory Agency (MHRA).

Key Points: 
  • Medicines and Healthcare products Regulatory Agency (MHRA).
  • “We believe FLT201 has life-changing potential for people with Gaucher disease type 1, the most common type of the disease,” said Pamela Foulds, MD, Chief Medical Officer of Freeline.
  • Existing therapies come with a heavy life-long treatment burden, and even with treatment, many patients continue to experience serious symptoms.
  • We believe that FLT201 may improve outcomes for patients with a one-time gene therapy.

Marketing Authorisation Application for lecanemab submitted in Great Britain: BioArctic

Retrieved on: 
Monday, May 22, 2023
CET, Health care, Lecanemab, Brain, Clarity, Eisai, Co-promotion, Marketing Authorisation Application, MAA, Innovation, AD, Neurotoxicity, MHRA, Disease, Pharmaceutical industry, Biogen

Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).

Key Points: 
  • Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

Marketing Authorisation Application for lecanemab submitted in Great Britain: BioArctic

Retrieved on: 
Monday, May 22, 2023
CET, Health care, Lecanemab, Brain, Clarity, Eisai, Co-promotion, Marketing Authorisation Application, MAA, Innovation, AD, Neurotoxicity, MHRA, Disease, Pharmaceutical industry, Biogen

Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).

Key Points: 
  • Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

MAA Shareholders Elect John Case and Tamara Fischer to Board of Directors

Retrieved on: 
Wednesday, May 17, 2023
Realty Income, Executive, Professional Football Compensation Committee, PwC, REIT, EVP, Senior advisor, Real estate investing, Annual general meeting, Partner, Cooper, CFO, Knowledge, MAA, Principal, NYSE, EPR Properties, Management, Shareholder

GERMANTOWN, Tenn., May 17, 2023 /PRNewswire/ -- Mid–America Apartment Communities, Inc., ("MAA") (NYSE: MAA) today announced that shareholders elected new directors, John Case and Tamara Fischer, to the Board of Directors at the company's 2023 Annual Meeting of Shareholders held on May 16, 2023.

Key Points: 
  • GERMANTOWN, Tenn., May 17, 2023 /PRNewswire/ -- Mid–America Apartment Communities, Inc., ("MAA") (NYSE: MAA) today announced that shareholders elected new directors, John Case and Tamara Fischer, to the Board of Directors at the company's 2023 Annual Meeting of Shareholders held on May 16, 2023.
  • Both directors will serve as independent directors until the 2024 Annual Meeting of Shareholders.
  • In conjunction with the appointments, the Board of Directors increased the size of the board to 13, as it executes its long–term director succession plans.
  • Ms. Fischer's public board experience includes currently serving on the board of directors for National Storage Affiliates Trust since 2020 and past service on the board of directors of Duke Realty Corporation from 2020 until 2022.