Biopharmaceutical

MANDARA Phase III data published in New England Journal of Medicine show remission is an achievable goal in eosinophilic granulomatosis with polyangiitis (EGPA) with FASENRA

Retrieved on: 
Friday, February 23, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Metabolism, AstraZeneca, Hypereosinophilic syndrome, Chronic pain, Growth, Skin, Fatigue, Immunology, Polyp (medicine), Efficacy, COPD, Biopharmaceutical, Social media, Placebo, Safety, Treatment, Chronic obstructive pulmonary disease, ClinicalTrials.gov, Abstract (summary), Respiratory Medicine, OCS, Bell, Rash, Biomarker, Heart, HES, Sinusitis, Inflammation, Weight loss, Asthma, Gastrointestinal tract, Death, OLE, Disease, Pharmaceutical industry

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases.

Key Points: 
  • AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases.
  • Fasenra met the primary endpoint in the MANDARA Phase III trial in eosinophilic granulomatosis with polyangiitis (EGPA).
  • Burden of illness and costs associated with eosinophilic granulomatosis with polyangiitis: evidence from a managed care database in the United States.
  • A Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) (NATRON).

Silence Therapeutics Achieves $10 Million Milestone Payment from AstraZeneca Collaboration Following the Initiation of Phase 1 Trial

Retrieved on: 
Friday, February 23, 2024
Health, Genetics, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Therapy, AstraZeneca, Metabolism, SVP, Silence Therapeutics, Polycythemia, RNA, DSM-IV codes, Clinical trial, Small RNA, Biopharmaceutical, Pharmaceutical industry

Silence Therapeutics plc, Nasdaq: SLN (“Silence” or “the Company”), an experienced and innovative biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines, today announced that the initiation by AstraZeneca of a phase 1 clinical trial of the first product candidate under its siRNA (short interfering RNA) collaboration, has triggered a $10.0 million milestone payment to Silence.

Key Points: 
  • Silence Therapeutics plc, Nasdaq: SLN (“Silence” or “the Company”), an experienced and innovative biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines, today announced that the initiation by AstraZeneca of a phase 1 clinical trial of the first product candidate under its siRNA (short interfering RNA) collaboration, has triggered a $10.0 million milestone payment to Silence.
  • “This represents the first clinical milestone under our collaboration with AstraZeneca and the third program to enter the clinic from our mRNAi GOLD™ platform,” said Craig Tooman, President and CEO of Silence.
  • Silence and AstraZeneca initiated a multi-target collaboration in March 2020 focused on using Silence’s proprietary mRNAi GOLD™ platform to develop siRNA therapeutics for cardiovascular, renal, metabolic and respiratory diseases.
  • Under the agreement, AstraZeneca will pay Silence an option fee of $10 million for each selected target at the point of candidate nomination.

MRM Health Initiates Clinical Research in Parkinson’s Disease

Retrieved on: 
Tuesday, February 20, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Health Technology, Clinical Trials, Other Health, Therapy, Biopharmaceutical, PD, Caregiver, Ethics, Principal, Blood, Inflammatory Bowel Diseases, ClinicalTrials.gov, University, GI, DSM-IV codes, Capri, Patient, MRM, Disease, CGMP, Trial of the century, Observational study, Partnership, Pharmaceutical industry

The clinical research is being conducted in close collaboration with Nimble Science and the University of Calgary, Canada.

Key Points: 
  • The clinical research is being conducted in close collaboration with Nimble Science and the University of Calgary, Canada.
  • The clinical study is expected to enroll up to 100 subjects, including an age-matched healthy volunteer cohort.
  • The trial will run in Calgary Parkinson’s Research Initiative (CaPRI) with Dr. Davide Martino and is registered on Clinicaltrials.gov with number NCT06003608.
  • MRM Health recently obtained positive phase 2a clinical data with MH002 in Ulcerative Colitis and has an ongoing clinical study in Pouchitis.

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer

Retrieved on: 
Monday, February 19, 2024
Biotechnology, FDA, Other Health, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical Trials, Metabolism, Immunotherapy, AstraZeneca, News, Daiichi Sankyo, National Cancer Institute, Lung cancer, Triple-negative breast cancer, Immunology, Patient, Cleavage, Biopharmaceutical, Social media, Progression-free survival, Treatment, BLA, Docetaxel, IHC, DXD, Pharmacotherapy, NSCLC, Breast cancer, Gefitinib, PD-1, Safety, Lung, Pemetrexed, PFS, American Cancer Society, Pircher, Observational study, MD, Sapporo Medical University, Food, Cancer, ADC, OS, Immunoglobulin G, Death, Medicine, Pharmaceutical industry

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.

Key Points: 
  • AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.
  • In patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful PFS benefit and a numerically favorable OS trend.
  • Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Datopotamab deruxtecan has the potential to offer patients with previously treated advanced nonsquamous non-small cell lung cancer an effective and tolerable alternative to conventional chemotherapy.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.

New to The Street Airs Episode 556 Featuring Five Corporate Interviews, Broadcast on the FOX Business Network Monday, February 19, 2024, at 10:30 PM PT

Retrieved on: 
Friday, February 16, 2024
Carbon, Hospital, Watt, Mining, News, Somnolence, DNX, Bacteria, FINRA, Global X ETFs, Patient, Corporation, BTC, POW, Biopharmaceutical, Television, Carbon footprint, Pain, Wind, CDI, Vancomycin, Fox Business, Ecosystem, SBP, Interview, Miner, Partnership, Woman, Nursing, Sleep, ESG, Insomnia, Business, Decentralization, EnergySolutions, Fibromyalgia, Tonix Pharmaceuticals, MD, Sustainability, FDA, Patent, SBC, Food, Tongue, United States patent law, Medicine, Headache, Publication, Cryptocurrency

New to The Street's Episode 556 line-up features the following five (5) Corporate interviews:

Key Points: 
  • New to The Street's Episode 556 line-up features the following five (5) Corporate interviews:
    2).
  • Tonix's new drug, called Tonmya™, is a new class of medicine that controls pain in those who have fibromyalgia.
  • Fibromyalgia is common in women who have been unsuccessful in finding current marketplace drugs limited in the treatment success.
  • Clinical studies have shown that Tonmya™ can eliminate most pain, enhance sleep, and diminish fatigue in patients.

Simulations Plus Extends Collaboration with Major Toxicology Research Agency

Retrieved on: 
Thursday, February 15, 2024
Health, Technology, Software, Research, Science, Pharmaceutical, Biotechnology, SLP, Environ, Division, Metabolism, Toxicology, Toxicity, North American Menopause Society, Absorption, Biopharmaceutical, Animal, NIEHS, Skin, Risk, Vivo, ADMET, Safety, DTT, Computation, Cheminformatics, Environmental health, Pharmacokinetics, Simulations Plus, Child, Machine learning, Human, Environment, Pharmaceutical industry

“At NIEHS, we seek to expand scientific knowledge and approach methods linking the environment and human health.

Key Points: 
  • “At NIEHS, we seek to expand scientific knowledge and approach methods linking the environment and human health.
  • “Importantly, these tools are being investigated for their potential to address a critical gap in toxicology research for understanding and modeling human bioactivation of environmental chemicals through xenobiotic metabolism,” Ferguson added.
  • Principal Scientist in the Cheminformatics Solutions team at Simulations Plus.
  • It is the leading physiologically based pharmacokinetic/physiologically based biopharmaceutics modeling (PBPK/PBBM) platform, built and refined over 25 years on the most up-to-date scientific research.

Groundbreaking Innovation in Musculoskeletal Healthcare Takes Center Stage at AAOS 2024 Annual Meeting: CytexOrtho Named OrthoPitch Technology Competition Winner

Retrieved on: 
Wednesday, February 14, 2024
Multi-monitor, SAN, Committee, Doctor of Philosophy, DBT, MD, Physician, FDA, Surgeon, Cell, Biopharmaceutical, Therapy, Joint, Health, Patient, Clinical trial, Medicine, MCRA, AAOS, American Academy, Medical device

SAN FRANCISCO, Feb. 14, 2024 /PRNewswire/ -- The American Academy of Orthopaedic Surgeons (AAOS) named CytexOrtho the winner of the inaugural OrthoPitch Technology Competition during the AAOS 2024 Annual Meeting in San Francisco.

Key Points: 
  • SAN FRANCISCO, Feb. 14, 2024 /PRNewswire/ -- The American Academy of Orthopaedic Surgeons (AAOS) named CytexOrtho the winner of the inaugural OrthoPitch Technology Competition during the AAOS 2024 Annual Meeting in San Francisco.
  • Through the competition, the AAOS, the world's largest medical association of musculoskeletal specialists, aims to fuel innovation and foster advancements with the potential to improve or transform existing standards of orthopaedic care.
  • "Being named winner of the first OrthoPitch competition validates the hard work our team at CytexOrtho has devoted to helping patients through this technology," Dr. Estes said.
  • Ultimately, CytexOrtho was named the winner, impressing both the judges and audience, which contributed to the outcome via a live online vote.

Catalent, Inc. Reports Second Quarter Fiscal 2024 Results

Retrieved on: 
Friday, February 9, 2024
Biotechnology, Pharmaceutical, Genetics, Health, Novo, PCH, COVID-19, CTLT, GAAP, Ratio, Biopharmaceutical, Patient

Catalent, Inc. (NYSE: CTLT), the leader in enabling the development and supply of better treatments for patients worldwide, today announced financial results for the second quarter of fiscal 2024, which ended December 31, 2023.

Key Points: 
  • Catalent, Inc. (NYSE: CTLT), the leader in enabling the development and supply of better treatments for patients worldwide, today announced financial results for the second quarter of fiscal 2024, which ended December 31, 2023.
  • “I am proud of the progress the Catalent team made in our second quarter and our ongoing momentum, including strong non-COVID sequential revenue growth in both the Biologics and PCH segments.
  • EBITDA (loss) from operations(1) was $6 million, a decrease of $258 million from the $264 million reported in the second quarter a year ago.
  • Second quarter fiscal 2024 Adjusted EBITDA(1) was $124 million, or 12.0% of net revenue, compared to $283 million, or 24.6% of net revenue, in the second quarter a year ago.

New to The Street Announces its 553rd Episode TV Line Up, Featuring Five Corporate Guests, Airing on the FOX Business Network, Monday, February 5, 2024, 10:30 PM PT

Retrieved on: 
Friday, February 2, 2024
Parent, Nursing, Multi, OTCQB, Wind, Bacteria, Foodservice, News, Biopharmaceutical, DNX, COVID, FDA, Host, Name, WNBA, Business development, Privacy, Female, Endeavor Group Holdings, Major League, NFL, Woman, Partnership, Internet, Nord Anglia Education, Big Tech, BPEA EQT, Student, Television presenter, CDI, OTCQX, Virtual reality, IMG, Collection, FRA, Patient, Publication, Marketing, Vancomycin, Blood, Brain, IP, Tune, Cancer, Hospital, Interview, PROMO, MLS, Genetics, Athlete, Street, BPEA, Education, IMG Academy, Major League Soccer, Sport, Online shopping

Specializing in sales/marketing, revenue management solutions, and guest services, property owners and renters have had great experiences when engaging the Company .

Key Points: 
  • Specializing in sales/marketing, revenue management solutions, and guest services, property owners and renters have had great experiences when engaging the Company .
  • With a national footprint, property owners can expand beyond local or regional markets, optimizing rental listings to increase rental opportunities.
  • Heather explains that owners become actual CEOs of their properties, enhanced by a back-office team using technology and providing service support.
  • The Compass Collection can assist an owner looking for a more sophisticated level of infrastructure, which can promote higher revenues and rental bookings.

New to The Street TV Announces Episode #552 with its Five Business Guest Interviews, Airs on Bloomberg TV as Sponsored Programming, Tonight, February 1, 2024, at 9:30 PM PT

Retrieved on: 
Thursday, February 1, 2024
Parent, Travel, Nursing, Multi, OTCQB, Wind, Bacteria, Foodservice, News, Biopharmaceutical, DNX, COVID, FDA, Host, Name, WNBA, Privacy, Female, Decentralization, Endeavor Group Holdings, Major League, NFL, Woman, Partnership, Internet, Coffee, Nord Anglia Education, Big Tech, BPEA EQT, Student, Bloomberg Television, Television presenter, CDI, OTCQX, Virtual reality, Consultant, IMG, FRA, Patient, Publication, Vancomycin, Blood, Brain, IP, Tune, Cancer, Hospital, Interview, PROMO, MLS, Genetics, Athlete, BPEA, Stone Brewing Co., Education, IMG Academy, Major League Soccer, Sport

New to The Street's TV episode #552 will air the following five (5) business interviews:

Key Points: 
  • New to The Street's TV episode #552 will air the following five (5) business interviews:
    1).
  • As a clinical-stage biopharmaceutical business, ACXP is developing a new class of antibiotics for life-threatening bacterial infections.
  • Based on positive data from Phase 2a and Phase 2b, management is now going forward with the FDA Phase 3.
  • The Company compared its top-line data with the currently used standard-of-care drugs in the marketplace, and Ibezapolstat has impressive positive results .