Growth factors

Spectrum Pharmaceuticals Announces That the ROLONTIS® (eflapegrastim) Pre-Approval Inspection Has Been Initiated

Retrieved on: 
Tuesday, June 1, 2021

I would like to confirm that the FDA has initiated its inspection of the ROLONTIS manufacturing facility, said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals.

Key Points: 
  • I would like to confirm that the FDA has initiated its inspection of the ROLONTIS manufacturing facility, said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals.
  • ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs.
  • SPECTRUM PHARMACEUTICALS, INC. and ROLONTIS are registered trademarks of Spectrum Pharmaceuticals, Inc. and its affiliate.
  • REDEFINING CANCER CARE and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

FibroGen to Present at Upcoming Investor Conferences

Retrieved on: 
Thursday, May 27, 2021

A replay will be available for approximately 30 days.

Key Points: 
  • A replay will be available for approximately 30 days.
  • FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics.
  • The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs.
  • Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

OncXerna Therapeutics to Present at Jefferies Virtual Healthcare Conference

Retrieved on: 
Tuesday, May 18, 2021

b'WALTHAM, Mass., May 18, 2021 (GLOBE NEWSWIRE) -- OncXerna Therapeutics, Inc., a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its first-in-class targeted oncology therapies, today announced that Laura Benjamin, Ph.D., Founder and CEO of OncXerna, will present at the Jefferies Virtual Healthcare Conference taking place June 1-4, 2021.\nThe live presentation will occur on June 4, 2021 from 10:30 a.m. to 10:55 a.m.

Key Points: 
  • b'WALTHAM, Mass., May 18, 2021 (GLOBE NEWSWIRE) -- OncXerna Therapeutics, Inc., a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its first-in-class targeted oncology therapies, today announced that Laura Benjamin, Ph.D., Founder and CEO of OncXerna, will present at the Jefferies Virtual Healthcare Conference taking place June 1-4, 2021.\nThe live presentation will occur on June 4, 2021 from 10:30 a.m. to 10:55 a.m.
  • This allows OncXerna to pair those patients with OncXerna\xe2\x80\x99s clinical-stage therapies and known mechanism of action that directly address these biologies, to dramatically improve patient outcomes.
  • OncXerna is targeting patients whose dominant tumor biology is driven by angiogenesis with a focus beyond VEGF to include broader anti-angiogenic pathways.
  • OncXerna\xe2\x80\x99s clinical trials currently combine bavituximab with KEYTRUDA\xc2\xae to test the hypothesis that relieving immunosuppression can enhance responses to checkpoint inhibitors.

Scholar Rock Announces Publication of Phase 1 Clinical Trial Data Evaluating Apitegromab in Healthy Volunteers in the Journal Advances in Therapy

Retrieved on: 
Tuesday, May 11, 2021

A total of 66 healthy volunteers were enrolled and randomized to receive either intravenous (IV) apitegromab or placebo at doses between 1 mg/kg and 30 mg/kg.

Key Points: 
  • A total of 66 healthy volunteers were enrolled and randomized to receive either intravenous (IV) apitegromab or placebo at doses between 1 mg/kg and 30 mg/kg.
  • Key findings shared in Advances in Therapy include:\nSingle- and multiple-ascending doses of apitegromab were safe and well-tolerated at IV doses up to 30 mg/kg.
  • Scholar Rock recently announced positive 12-month top-line data from the TOPAZ trial demonstrating the transformative therapeutic potential of apitegromab in patients with Type 2 and Type 3 SMA.
  • Scholar Rock believes that inhibiting myostatin activation with apitegromab may promote a clinically meaningful improvement in motor function in patients with SMA.

HAGENS BERMAN, NATIONAL TRIAL ATTORNEYS, Alerts FibroGen (FGEN) Investors to EXPANDED FRAUDULENT PERIOD in Securities Fraud Action: Investors Should Secure Counsel

Retrieved on: 
Saturday, May 8, 2021

To support this marketing edge, FibroGen presented data from phase 3 trials purportedly showing roxadustat was safer than EPO, among other at risk populations, in incident dialysis patients.\nBut after the market closed on Apr.

Key Points: 
  • To support this marketing edge, FibroGen presented data from phase 3 trials purportedly showing roxadustat was safer than EPO, among other at risk populations, in incident dialysis patients.\nBut after the market closed on Apr.
  • 6, 2021, FibroGen stunningly admitted to altering stratification factors to make roxadustat\xe2\x80\x99s hazard ratios indicate lower risk relative to EPO.
  • On this news, the Company\xe2\x80\x99s share price fell over 43%, to close at $19.74 per share on Apr.
  • For the latest news visit our newsroom or follow us on Twitter at @classactionlaw .\n'

BioLineRx Announces Positive Top-Line Results from GENESIS Phase 3 Trial of Motixafortide in Stem-Cell Mobilization for Autologous Bone Marrow Transplantation in Multiple Myeloma Patients

Retrieved on: 
Tuesday, May 4, 2021

The addition of Motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one apheresis session, compared to 10.8% in the G-CSF arm an 8.2-fold increase.

Key Points: 
  • The addition of Motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one apheresis session, compared to 10.8% in the G-CSF arm an 8.2-fold increase.
  • "This is a great achievement in alleviating the burden for the patients and reducing hospital resources.
  • I believe these results make the combination of Motixafortide and G-CSF a very attractive candidate for use in all patients with multiple myeloma undergoing autologous stem-cell transplantation.
  • "\n"These strikingly positive data significantly exceeded our expectations, and are truly transformational for our company," stated Philip Serlin, Chief Executive Officer of BioLineRx.

Innovent Announces First Patient Dosed in the Phase 2 Clinical Trial of IBI302, a First-in-class Ophthalmic Anti-VEGF and Anti-Complement Bispecific Fusion Protein for Neovascular Age-Related Macular Degeneration

Retrieved on: 
Thursday, April 29, 2021

As the world\'s first bispecific fusion protein targeting VEGF and complement, IBI302 can simultaneously inhibit the proliferation of VEGF-mediated signaling pathway and reduce the inflammatory response mediated by complement activation.

Key Points: 
  • As the world\'s first bispecific fusion protein targeting VEGF and complement, IBI302 can simultaneously inhibit the proliferation of VEGF-mediated signaling pathway and reduce the inflammatory response mediated by complement activation.
  • The overall safety profile is similar to that of marketed single-target anti-VEGF drugs.
  • IBI302 was designed to provide more targeted treatment and interventions to the cause of nAMD by adding additional targets.
  • The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners.

HAGENS BERMAN, NATIONAL TRIAL ATTORNEYS, Encourages FibroGen (FGEN) Investors with Losses to Contact Its Attorneys Now, Announces Filing of Securities Fraud Class Action

Retrieved on: 
Tuesday, April 20, 2021

To support this marketing edge, FibroGen presented data from phase 3 trials purportedly showing roxadustat was safer than EPO, among other at risk populations, in incident dialysis patients.\nBut after the market closed on Apr.

Key Points: 
  • To support this marketing edge, FibroGen presented data from phase 3 trials purportedly showing roxadustat was safer than EPO, among other at risk populations, in incident dialysis patients.\nBut after the market closed on Apr.
  • 6, 2021, FibroGen stunningly admitted to altering stratification factors to make roxadustat\xe2\x80\x99s hazard ratios indicate lower risk relative to EPO.
  • On this news, the Company\xe2\x80\x99s share price fell over 43%, to close at $19.74 per share on Apr.
  • For the latest news visit our newsroom or follow us on Twitter at @classactionlaw .\n'

Therapeutic Solutions International Spin-Off Campbell Neurosciences Identifies Mechanism of Action for Umbilical Cord Blood Derived NarcoStem™ Drug Rehabilitation Product

Retrieved on: 
Monday, April 19, 2021

This is not something that ketamine, CBD, or psilocybin are capable of doing.

Key Points: 
  • This is not something that ketamine, CBD, or psilocybin are capable of doing.
  • Demonstration that BDNF mediates therapeutic activities of NarcoStem helps accelerate the timeline for clinical translation of this inhalable therapeutic.
  • Unfortunately, it is almost impossible to provide recombinant BDNF directly into the brain due to its size and half live.
  • "\nTherapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases.

Outlook on the $30 Billion Vascular Endothelial Growth Factor Inhibitor Global Market to 2030 - Identify Growth Segments for Investment

Retrieved on: 
Thursday, April 8, 2021

This report provides strategists, marketers and senior management with the critical information they need to assess the global vascular endothelial growth factor (VEGF) inhibitor market.

Key Points: 
  • This report provides strategists, marketers and senior management with the critical information they need to assess the global vascular endothelial growth factor (VEGF) inhibitor market.
  • The vascular endothelial growth factor (VEGF) inhibitor market global report answers all these questions and many more.
  • Market Characteristics - The market characteristics section of the report defines and explains the vascular endothelial growth factor (VEGF) inhibitor market.
  • The top 10 companies in the market occupied 99% of market share in the global vascular endothelial growth factor (VEGF) inhibitor market.