CMC

Capricor Therapeutics Announces Upcoming Type-B Meeting with the FDA to Discuss Commercial Manufacturing Planning with an Aim to Expedite BLA Pathway for CAP-1002 in Duchenne Muscular Dystrophy

Retrieved on: 
Tuesday, February 27, 2024
Therapy, SAN, Regenerative Medicine Advanced Therapy, Biotechnology, Chemistry, FDA, DMD, Duchenne muscular dystrophy, BLA, Phase 3, Patient, Biologics license application, Exosome, CMC, Pharmaceutical industry

SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- – Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, announced today that the Company has been granted an in-person Type-B meeting with the U.S. Food & Drug Administration (FDA) scheduled for late March.

Key Points: 
  • SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- – Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, announced today that the Company has been granted an in-person Type-B meeting with the U.S. Food & Drug Administration (FDA) scheduled for late March.
  • In the upcoming meeting with the FDA, the Company intends to discuss its proposed chemistry, manufacturing and controls (CMC) plans for commercial launch, if approved which may enable opportunities to expedite the pathway to a Biologics License Application (BLA) submission.
  • The Company has previously been granted Regenerative Medicine Advanced Therapy (RMAT) and orphan drug designations for the use of CAP-1002 in Duchenne muscular dystrophy (DMD) and these designations enable sponsors to work closely with the FDA and receive its guidance on potential expedited pathways for approval.
  • “At Capricor, we remain focused on getting to approval as quickly as possible and we look forward to providing more details after this meeting.”

Cielo Announces Private Placement of Convertible Debenture Units for up to $5.0 Million to Advance Renewable Fuel Projects, Confirms Final Credit Facility Draw and Magazine Feature

Retrieved on: 
Thursday, February 22, 2024
Debenture, Debt, News, Sale, Indian stock exchange, Conversion, Forced conversion, Acceleration, Finance Secretary (India), Principal, Expander, Finder, Private, Convertible, Convertible bond, NEWS, CMC, Calendar, Carbon, Issue date, Exchange, Biomass, Security (finance)

CALGARY, Alberta, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Cielo Waste Solutions Corp. (TSXV:CMC; OTCQB:CWSFF) (“Cielo” or the “Company”), a renewable fuel company leveraging market ready licensed technology to produce low carbon fuel from wood by-products, is pleased to announce that it proposes to undertake a non-brokered private placement offering of unsecured convertible debenture units of the Company (collectively, the "Convertible Debenture Units") at a price of $1,000 per Convertible Debenture Unit for targeted gross proceeds of up to $5,000,000 (the "Private Placement").

Key Points: 
  • The Private Placement and a concurrent final draw from Cielo’s existing secured credit facility, as described below, represent an important shift in the Company’s financing strategy to utilize convertible instruments versus traditional forms of debt.
  • In addition, Cielo is also pleased to share that the Company has been featured in the Winter 2024 edition of Canadian Biomass Magazine , with further details provided below.
  • The Company intends to close the Private Placement in one or more tranches throughout February and early March.
  • Finder's fees of cash and/or non-transferrable warrants may be paid in connection with the Private Placement in accordance with applicable laws.

CHO Plus Strengthens and Expands Leadership Team with Key Appointment

Retrieved on: 
Tuesday, February 27, 2024
Research, FDA, Genetics, Clinical Trials, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, Therapy, Gene, Doctor of Philosophy, GSK, Cell, BMS, Patient, CMC, ImClone Systems

Privately held CHO Plus, Inc. ( www.CHO-Plus.com ), an early-stage biotechnology innovation company, announced today the appointment of Joseph Tarnowski, PhD as Chief Technology and Business Officer.

Key Points: 
  • Privately held CHO Plus, Inc. ( www.CHO-Plus.com ), an early-stage biotechnology innovation company, announced today the appointment of Joseph Tarnowski, PhD as Chief Technology and Business Officer.
  • Joe previously held senior leadership positions at GSK, BMS, and ImClone, developing CMC and manufacturing capabilities for biopharmaceuticals and cell and gene therapies.
  • Joe is widely respected for his scientific expertise as well as for his leadership skills throughout the biopharmaceutical industry.
  • He will be instrumental in helping CHO Plus achieve broad adoption of its patented technologies.”

Rocket Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Progress

Retrieved on: 
Monday, February 26, 2024
FDA, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, PKD, Personalized medicine, EMA, Research, MAA, Investment, Marketing, Food, Arrhythmogenic cardiomyopathy, Circulation, BLA, PDUFA, Fanconi anemia, Conference, Safety, DCM, European Medicines Agency, Food and Drug Administration, Muscle weakness, Efgartigimod alfa, Pyruvate kinase deficiency, Patient, Disorder, Clinical trial, Medication, ACM, IND, AAV, CGMP, CMC, Priority review, Pharmaceutical industry

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today reported financial and operational results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today reported financial and operational results for the fourth quarter and year ended December 31, 2023.
  • “I am pleased with the strong results Rocket delivered in 2023, as we closed another successful year of progress across all six disclosed gene therapy programs spanning our AAV cardiovascular and LV hematology portfolios,” said Gaurav Shah, M.D., Chief Executive Officer, Rocket Pharma.
  • Results from the study demonstrated the potential of RP-A601 as a gene therapy for patients with PKP2-ACM.
  • As of December 31, 2023, Rocket had cash, cash equivalents and investments of $407.5 million.

Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam

Retrieved on: 
Friday, February 23, 2024
Research, Infectious Diseases, FDA, Hospitals, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Urinary tract infection, CRL, New Drug Application, Multimedia, Chemistry, Food, Pyelonephritis, Symantec Endpoint Protection, Patient, Medicine, Melinta Therapeutics, Medication, NDA, CMC, Pharmaceutical industry

This press release features multimedia.

Key Points: 
  • This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20240223169844/en/
    The CRL did not identify clinical safety or efficacy issues in the NDA, and the FDA did not request any new clinical trials to support the approval of cefepime-taniborbactam.
  • The FDA requested additional chemistry, manufacturing, and controls (CMC) and related data about the drug, testing methods, and manufacturing process.
  • “While we are disappointed with this setback, we maintain utmost confidence in cefepime-taniborbactam.

Charles River and Wheeler Bio Complete Agreement to Accelerate the Journey from Discovery and CMC Development to Manufacturing

Retrieved on: 
Wednesday, February 21, 2024
Health, Medical Devices, General Health, Research, Science, Pharmaceutical, Biotechnology, A-DNA, CRL, LEAP, Entrepreneurship, OK, Chemistry, CDMO, Safety, Wheeler, CGMP, Organization, Patient, Portable, IND, Control, CMC, Pharmaceutical industry

Combining Charles River’s industry-leading experience in antibody discovery services, safety, and analytics with Wheeler’s Portable CMC® platform will accelerate therapeutic discovery to IND submission timelines.

Key Points: 
  • Combining Charles River’s industry-leading experience in antibody discovery services, safety, and analytics with Wheeler’s Portable CMC® platform will accelerate therapeutic discovery to IND submission timelines.
  • This umbrella offering efficiently connects the preclinical, clinical manufacturing, and release testing journeys, significantly reducing the complexity of managing multiple vendor relationships.
  • Integrating CMC development early in discovery enables therapeutic developers to collaborate with experts across the organizations to utilize phase-appropriate manufacturing and analytics.
  • Wheeler’s mission is to solve translational challenges inherent in advancing from discovery to CMC development and early-clinical trial material supply.

Exelon Reports Fourth Quarter and Full Year 2023 Results and Initiates 2024 Financial Outlook

Retrieved on: 
Wednesday, February 21, 2024
Utilities, Energy, Constellation, Commonwealth Edison, Generation, Weather, Maryland Public Service Commission, Natural gas, PECO, Growth, ACE, Table, PHI, BSC, Treasury, Carbon, Infrastructure, Series, BGE, GAAP, Gas, MRP, DPL, ICC, Electricity, Corporation, Illinois Commerce Commission, CMC, Bank

Exelon Corporation (Nasdaq: EXC) today reported its financial results for the fourth quarter and full year 2023.

Key Points: 
  • Exelon Corporation (Nasdaq: EXC) today reported its financial results for the fourth quarter and full year 2023.
  • Adjusted (non-GAAP) Operating Earnings for the fourth quarter of 2023 increased to $0.60 per share from $0.43 per share in the fourth quarter of 2022.
  • ComEd's fourth quarter of 2023 GAAP Net Income increased to $268 million from $211 million in the fourth quarter of 2022.
  • PHI’s fourth quarter of 2023 GAAP Net Income increased to $101 million from $90 million in the fourth quarter of 2022.

jCyte, Inc. Announces Positive Pre-Phase 3 FDA Type B Meeting and Outlines Plans to Start Pivotal Trial of jCell® for Retinitis Pigmentosa in the Second Half of 2024

Retrieved on: 
Wednesday, February 21, 2024
Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, Retinitis pigmentosa, National Eye Institute, Doctor of Philosophy, Retina, MD, NIH, FDA, News, Food, Entrepreneurship, RP, Perseverance, UC, Patient, Clinical trial, Type, CMC, Pharmaceutical industry

Additionally, the company is gearing up to commence its pivotal US trial for jCell in the second half of 2024.

Key Points: 
  • Additionally, the company is gearing up to commence its pivotal US trial for jCell in the second half of 2024.
  • Sholar was also delighted with the FDA’s responses to jCyte’s description of its CMC program.
  • “We are pleased with the Type B meeting minutes, which enable us to move forward with the US pivotal trial.
  • The treatment has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation and is administered as a minimally invasive intravitreal injection.

Bicycle Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 20, 2024
Biotechnology, General Health, Pharmaceutical, Health, Toxicity, Growth, Ovarian cancer, Radiopharmaceutical, Patient, Anal cancer, Bicycle, McKinsey & Company, Head, Cervical cancer, EV, Neoplasm, ATM, Therapy, Food and Drug Administration, TNBC, Net, Former, CMC, Thromboxane A2, Immune system, NSCLC, MUC, Peripheral neuropathy, SunOpta, Safety, Ovary, Participation, Knowledge, Novartis, Lazard, BRC, FDA, Cancer, Food, Pembrolizumab, Government, ADC, Brentuximab vedotin, CD137, Pharmaceutical industry

Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided recent corporate updates.

Key Points: 
  • Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided recent corporate updates.
  • We continue to demonstrate our ability to develop highly differentiated, precision-guided therapeutics that may offer greater tolerability and lead to enhanced benefit for patients,” said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics.
  • Validating the company’s Bicycle® Radio Conjugates (BRC™) pipeline and partner for success, with updates expected from its wholly owned BRC program by mid-2024.
  • Advancing the company’s Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) immune-oncology pipeline through innovative partnerships.

Wheeler Bio Seals Agreement with Charles River to Offer Portable CMC® to Discovery Clients to Accelerate Their Journey to First-in-Human Use

Retrieved on: 
Thursday, February 29, 2024
Investigational New Drug, CRL, Charles River Laboratories, LEAP, Entrepreneurship, OK, ATUM, Chemistry, CDMO, Safety, CHO, CGMP, Organization, Portable, Control, IND, CMC, Partnership, Pharmaceutical industry

The collaboration is designed to enable a swift transition from pre-clinical stages directly to human clinical trials.

Key Points: 
  • The collaboration is designed to enable a swift transition from pre-clinical stages directly to human clinical trials.
  • Combining Charles River's industry-leading experience in antibody discovery services, safety, and analytics with Wheeler's Portable CMC® platform will accelerate therapeutic discovery to Investigational New Drug (IND) submission timelines.
  • Wheeler Bio's mission is to solve translational challenges inherent in advancing from discovery to CMC development and early-clinical trial material supply.
  • Jesse McCool, CEO and Co-Founder of Wheeler Bio, stated, "Wheeler is excited to expand our relationship with Charles River and to link with their discovery organization.