CGMP

ASC Therapeutics Appoints Gene and Cell Therapy Manufacturing Veteran Gary Potter to lead Global Operations

Tuesday, September 28, 2021 - 1:00am

ASC Therapeutics, a privately held biopharmaceutical company pioneering the development of transformative in-vivo gene replacement, gene editing and allogeneic cell therapies for hematologic and other rare disorders announces the appointment of Gary Potter as Senior Vice President, Global Operations.

Key Points: 
  • ASC Therapeutics, a privately held biopharmaceutical company pioneering the development of transformative in-vivo gene replacement, gene editing and allogeneic cell therapies for hematologic and other rare disorders announces the appointment of Gary Potter as Senior Vice President, Global Operations.
  • Gary Potter will lead the global teams responsible for drug substance and drug product process development, manufacturing, and supply chain for gene and cell therapies required for all phases of clinical development and commercialization for all ASC Therapeutics programs.
  • Ruhong Jiang, ASC Therapeutics CEO said I am extraordinarily confident that Gary Potter brings the right expertise, leadership skills and motivation for our global operations, focusing initially on drug product readiness for our clinical programs for ASC618 second-generation gene therapy and ASC930 allogeneic cell therapy.
  • Gary Potter, ASC Therapeutics SVP Global Operations, stated I am thrilled to join ASC Therapeutics, a leader in transformative gene and cell therapies extraordinarily well positioned to benefit from cost-reduction opportunities in manufacturing across the world.

Neurophth Announces the Completion of GMP Manufacturing Facility for Gene Therapy Products According to International Standards

Monday, September 27, 2021 - 4:00pm

Neurophth's proprietary manufacturing processes will take advantage of single-use equipment to aid in quick and effective product changeovers and equipment cleaning.

Key Points: 
  • Neurophth's proprietary manufacturing processes will take advantage of single-use equipment to aid in quick and effective product changeovers and equipment cleaning.
  • "Neurophth's own cGMP production facility is designed to enable us to reach manufacturing scales suitable for future commercial production and the facility is also co-located with our development laboratories," said Bin Li, Chairman and Founder at Neurophth.
  • We look forward to supporting Neurophth in the long run to strengthen its innovation and lead China's ocular gene therapy products and ultimately benefit patients around the world."
  • Neurophth has initiated the scaling up in-house manufacturing process in single-use technologies to support future commercial demand at the Suzhou facilities.

Ambys Medicines Announces Presentation on Novel Liver Cell Therapy Platform for Severe Liver Diseases, and Opening of its cGMP Cell Therapy Manufacturing Facility

Monday, September 27, 2021 - 2:00pm

This is a critical step towards Ambys' goal of providing an off-the-shelf treatment capable of revolutionizing care for patients with severe liver disease.

Key Points: 
  • This is a critical step towards Ambys' goal of providing an off-the-shelf treatment capable of revolutionizing care for patients with severe liver disease.
  • The company also announced the opening of a state-of-the-art manufacturing facility in South San Francisco, Calif., which will be outfitted for industrial-scale expansion and production of hepatocytes under current Good Manufacturing Practices (cGMP).
  • Ambys Medicines is a cell and gene therapy company focused on unlocking the full potential of hepatocyte transplantation and transforming the treatment of severe liver disease.
  • Ambys' proprietary cell therapy platform potentially solves the supply constraints that have hindered progress, catalyzing the field and fundamentally transforming the approach to treating severe liver disease.

iBio Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Provides Corporate Update

Monday, September 27, 2021 - 12:30pm

BRYAN, Texas, Sept. 27, 2021 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), a developer of next-generation biopharmaceuticals and pioneer of the sustainable, plant-based FastPharming Manufacturing System®, today announced its financial results for the fiscal fourth quarter and year ended June 30, 2021.

Key Points: 
  • Fiscal Fourth Quarter and Recent Business Developments:
    In June 2021, iBio established a new drug discovery team based in San Diego.
  • Fiscal Fourth Quarter and Recent Corporate Developments:
    Throughout fiscal 2021 and FY22 year-to-date, iBio increased its bench strength and enhanced its leadership team to support its growth strategy.
  • R&D and G&A expenses for the fourth quarter and full fiscal year 2021 increased significantly over the comparable periods in fiscal year 2020.
  • G&A expense was up $10.6 million to $22.0 million in fiscal 2021, rising $3.5 million to $6.6 million in the fourth quarter.

NanoViricides, Inc. Invites You to Join Us at the Benzinga Healthcare Small Cap Conference for Update on Pan-Coronavirus COVID-19 Drug Development Program

Monday, September 27, 2021 - 11:45am

The Benzinga Healthcare Small Cap Conference bridges the gap between Small Cap companies, investors, and traders.

Key Points: 
  • The Benzinga Healthcare Small Cap Conference bridges the gap between Small Cap companies, investors, and traders.
  • Learn about small cap investing with clearly defined Educational Modules, take a look at a curated group of Small Cap investment opportunities, and connect with the healthcare Small Cap audience in an intimate, virtual setting.
  • We invite investors and all interested parties to explore healthcare small cap investment opportunities through two days of networking, dealmaking and discovery.
  • The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.

Life Science Logistics Expands Into Raleigh-Durham as Demand for Pharma Mixed-use Storage + Distribution Booms

Friday, September 24, 2021 - 3:30pm

This new storage and distribution facility will create 50-100 new jobs.

Key Points: 
  • This new storage and distribution facility will create 50-100 new jobs.
  • Demand for pharmaceutical and medical device temperature-controlled storage and distribution in Raleigh-Durham has never been greater, adds Beeny.
  • ft. of controlled-temperature (20-25 degrees Celsius) and cold chain (2-8 degrees Celsius) storage space, and will serve as yet another well-positioned location in LSLs storage and distribution network.
  • Founded in 2006, DFW-based Life Science Logistics (LSL) is a leading, national provider of end-to-end, high-quality, customizable healthcare supply chain solutions.

Arranta Bio Announces First End-to-End Manufacturing for mRNA Vaccines in its Commercial-ready GMP Facility

Thursday, September 23, 2021 - 2:00pm

WATERTOWN, Mass., Sept. 23, 2021 /PRNewswire/ --Arranta Bio ("Arranta"), a leading contract development and manufacturing organization (CDMO) supporting advanced therapy pioneers, today announced plans to establish contract manufacturing capacity for messenger RNA (mRNA) vaccines.

Key Points: 
  • WATERTOWN, Mass., Sept. 23, 2021 /PRNewswire/ --Arranta Bio ("Arranta"), a leading contract development and manufacturing organization (CDMO) supporting advanced therapy pioneers, today announced plans to establish contract manufacturing capacity for messenger RNA (mRNA) vaccines.
  • Arranta intends to support product innovators using an mRNA platform to develop vaccines, for example, vaccines targeting infectious diseases, as well as therapeutic vaccines, such as those targeting cancer.
  • mRNA vaccines are a relatively new class of vaccines.
  • Prophylactic vaccines have been recently validated with the successful commercialization of COVID-19 vaccines, while therapeutic immuno-oncology focused vaccines offer significant promise to cancer patients.

Pluristem CEO Issues Shareholder Update

Wednesday, September 22, 2021 - 1:15pm

HAIFA, Israel, Sept. 22, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), a leading biotechnology company, today issued an update to its shareholders from its Chief Executive Officer and President Yaky Yanay.

Key Points: 
  • HAIFA, Israel, Sept. 22, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), a leading biotechnology company, today issued an update to its shareholders from its Chief Executive Officer and President Yaky Yanay.
  • We also expect to continue the development of the program and to initiate a Phase II study in hematological indication.
  • Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care.
  • For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Cyclerion Announces Publication of Preclinical Data Demonstrating Reduction in Neuroinflammation by Brain-Penetrant sGC Stimulator

Wednesday, September 22, 2021 - 1:00pm

These data suggest that CNS penetrant sGC stimulators, such as Cyclerion development candidates CY6463 and CY3018, could provide therapeutic benefit to individuals living with CNS diseases associated with neuroinflammation.

Key Points: 
  • These data suggest that CNS penetrant sGC stimulators, such as Cyclerion development candidates CY6463 and CY3018, could provide therapeutic benefit to individuals living with CNS diseases associated with neuroinflammation.
  • CY6463 is the first brain-penetrant sGC stimulator to be developed as a symptomatic and potentially disease-modifying therapy for serious CNS diseases.
  • Cyclerion is advancing novel, first-in-class, CNS-penetrant, sGC stimulators that modulate a key node in a fundamental CNS signaling pathway.
  • The multidimensional pharmacology elicited by the stimulation of sGC has the potential to impact a broad range of CNS diseases.

Oxford Biomedica announces strategic investment by Serum Life Sciences Ltd

Wednesday, September 22, 2021 - 12:00pm

Oxford, UK 22 September, 2021: Oxford Biomedica plc (LSE:OXB) (Oxford Biomedica or the Group), a leading gene and cell therapy group, today announces that Serum Life Sciences Ltd (SLS), a subsidiary company of Serum Institute of India Pvt Ltd (Serum Institute of India), has agreed to invest just over 50 million in the Group in return for new ordinary shares representing 3.9% of the outstanding shares after the capital increase (the Transaction).

Key Points: 
  • Oxford, UK 22 September, 2021: Oxford Biomedica plc (LSE:OXB) (Oxford Biomedica or the Group), a leading gene and cell therapy group, today announces that Serum Life Sciences Ltd (SLS), a subsidiary company of Serum Institute of India Pvt Ltd (Serum Institute of India), has agreed to invest just over 50 million in the Group in return for new ordinary shares representing 3.9% of the outstanding shares after the capital increase (the Transaction).
  • John Dawson, Chief Executive Officer of Oxford Biomedica, said: We are delighted that Serum Life Sciences Ltd, a subsidiary company of Serum Institute of India, has made this strategic investment into Oxford Biomedica.
  • Oxford Biomedica plc: T: +44 (0)1865 783 000 / E: ir@oxb.com
    Serum Life Sciences Ltd is a subsidiary company of Serum Institute of India Pvt Ltd. Its global sales office in London will market COVID-19 vaccines manufactured by Serum Institute of India Pvt Ltd (SII).
  • Oxford Biomedica (LSE:OXB) is a leading, fully integrated, gene and cell therapy group focused on developing life changing treatments for serious diseases.