FDA

Sesen Bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Friday, April 16, 2021 - 9:30pm

Each of the options was granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4).\nVicineum, a locally administered fusion protein, is Sesen Bio\xe2\x80\x99s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

Key Points: 
  • Each of the options was granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4).\nVicineum, a locally administered fusion protein, is Sesen Bio\xe2\x80\x99s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
  • In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells.
  • Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC.
  • Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma....

Friday, April 16, 2021 - 6:10pm

In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).\nOPDIVO can cause immune-mediated hepatitis.

Key Points: 
  • In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).\nOPDIVO can cause immune-mediated hepatitis.
  • Withhold OPDIVO depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
  • In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients.
  • Nivolumab plus chemotherapy versus chemotherapy as first-line treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma: first results of the CheckMate 649 study.

New Integrated Data and Follow-up Outcomes From Two TEPEZZA® (teprotumumab-trbw) Pivotal Trials Published in The Lancet Diabetes & Endocrinology

Friday, April 16, 2021 - 1:00pm

b'Horizon Therapeutics plc (Nasdaq: HZNP) today announced that new pooled data from the TEPEZZA\xc2\xae (teprotumumab-trbw) Phase 2 and Phase 3 clinical trials are now published in The Lancet Diabetes & Endocrinology .

Key Points: 
  • b'Horizon Therapeutics plc (Nasdaq: HZNP) today announced that new pooled data from the TEPEZZA\xc2\xae (teprotumumab-trbw) Phase 2 and Phase 3 clinical trials are now published in The Lancet Diabetes & Endocrinology .
  • The data further reinforce that TEPEZZA significantly improves proptosis (eye bulging) and diplopia (double vision) for TED patients in different subgroups, with most maintaining a long-term response.
  • Responses were also evaluated at seven weeks and 51 weeks after the final dose of TEPEZZA.
  • In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia.

Vicarious Surgical Inc. and D8 Holdings Corp. Announce Definitive Business Combination Agreement

Thursday, April 15, 2021 - 12:00pm

We consider Vicarious Surgical to be a thought leader in the surgical space and we believe the market is ready for surgical robots that drive efficiency and improved quality of patient care.

Key Points: 
  • We consider Vicarious Surgical to be a thought leader in the surgical space and we believe the market is ready for surgical robots that drive efficiency and improved quality of patient care.
  • There may be additional risks that neither Vicarious Surgical nor D8 presently know or that Vicarious Surgical and D8 currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements.
  • Vicarious Surgical and D8 anticipate that subsequent events and developments will cause Vicarious Surgical\xe2\x80\x99s and D8\xe2\x80\x99s assessments to change.
  • However, while Vicarious Surgical and D8 may elect to update these forward-looking statements at some point in the future, Vicarious Surgical and D8 specifically disclaim any obligation to do so.

InterVenn Biosciences Announces that Nobel Laureate James P. Allison, PhD, has Joined the Company’s Board of Advisors

Thursday, April 15, 2021 - 1:00pm

b'InterVenn Biosciences today announced that Nobel Prize recipient, James P. Allison, has joined the company\xe2\x80\x99s Board of Advisors, effective March 9, 2021.

Key Points: 
  • b'InterVenn Biosciences today announced that Nobel Prize recipient, James P. Allison, has joined the company\xe2\x80\x99s Board of Advisors, effective March 9, 2021.
  • Dr. Padmanee Sharma, MD, PhD, Dr. Allison\xe2\x80\x99s close collaborator at MD Anderson Cancer Center, is also joining InterVenn\xe2\x80\x99s Board of Advisors.\nDr.
  • He established a new principle for cancer therapy involving the activation of the immune system to fight cancer cells.
  • For more information about InterVenn Biosciences, please visit the company\xe2\x80\x99s website .\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210415005369/en/\n'

Merck and Ridgeback Biotherapeutics Provide Update on Progress of Clinical Development Program for Molnupiravir, an Investigational Oral Therapeutic for the Treatment of Mild-to-Moderate COVID-19

Thursday, April 15, 2021 - 11:45am

b'Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today provided an update on the clinical development program for molnupiravir (MK-4482/ EIDD-2801), an investigational orally available antiviral therapeutic.

Key Points: 
  • b'Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today provided an update on the clinical development program for molnupiravir (MK-4482/ EIDD-2801), an investigational orally available antiviral therapeutic.
  • View the full release here: https://www.businesswire.com/news/home/20210415005258/en/\n\xe2\x80\x9cWe continue to make progress in the clinical development of our antiviral candidate molnupiravir.
  • \xe2\x80\x9cData from Ridgeback Bio\xe2\x80\x99s EIDD-2801-2003 study (MK-4482-006) coupled with Merck\xe2\x80\x99s MK-4482-002 study provide compelling evidence for the antiviral activity of molnupiravir.
  • Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19.

Aural Analytics, Inc. and Healint, Pte. Ltd. Partner on Integration of Speech Analytics into Healint’s Suite of Clinical Trials and Widely Used Consumer Applications

Thursday, April 15, 2021 - 3:00pm

announced today they have entered into a strategic partnership to embed speech collection and analytics into Healint\xe2\x80\x99s widely used software applications.

Key Points: 
  • announced today they have entered into a strategic partnership to embed speech collection and analytics into Healint\xe2\x80\x99s widely used software applications.
  • These profiles can be used to create customized, bespoke cohorts of patients who experience specific symptoms that can be easily fine-tuned to suit a specific trial.
  • Aural Analytics\xe2\x80\x99 speech biomarkers platform is designed to support large-scale, late-phase, multi-language clinical trials and has been adopted in numerous studies by Pharmaceutical companies researching neurological and respiratory disease.
  • Healint's first global program - the Migraine Buddy platform and its apps - helps a thriving community of users manage and track their migraines.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210415005246/en/\n"

New Data Demonstrate How Cala Trio™ Enables a More Frequent Assessment of Hand Tremor Compared with In-Person Assessments in Patients with Essential Tremor and Supports Feasibility of Telemedicine Approaches for Essential Tremor Management

Thursday, April 15, 2021 - 4:00pm

Additional new data demonstrate that an evaluation of hand tremor can be performed via telemedicine appointment to prescribe Cala Trio\xe2\x84\xa2.

Key Points: 
  • Additional new data demonstrate that an evaluation of hand tremor can be performed via telemedicine appointment to prescribe Cala Trio\xe2\x84\xa2.
  • "The new data presented at AAN demonstrate that how the Cala Trio therapy can also be used for home-based tracking of action tremor severity and response to therapy.
  • Clinical ratings were correlated to simultaneously measured sensor assessments, suggesting motion sensors can provide a valid assessment of tremor outside the clinic.
  • Cala Trio, a non-invasive personalized solution that reduces hand tremors, is currently FDA-cleared for essential tremor.

Genentech’s Evrysdi Continues to Improve Motor Function and Survival in Babies With Type 1 Spinal Muscular Atrophy (SMA)

Thursday, April 15, 2021 - 6:00am

The data showed Evrysdi continued to improve motor function between months 12 and 24, including the ability to sit without support.

Key Points: 
  • The data showed Evrysdi continued to improve motor function between months 12 and 24, including the ability to sit without support.
  • The study also showed Evrysdi continued to improve survival, improve ability to feed orally and reduce the need for permanent ventilation*.
  • Basil Darras, Professor of Neurology at Harvard Medical School and Director of the Spinal Muscular Atrophy Program at Boston Children's Hospital.
  • Part 2 (n=180) evaluated motor function using total score of Motor Function Measure 32 (MFM-32) at 12 months.

Bristol Myers Squibb Receives European Commission Approval for Opdivo® (nivolumab) in Combination with Cabometyx® (cabozantinib) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

Wednesday, April 14, 2021 - 9:16pm

Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China.

Key Points: 
  • Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China.
  • In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 10% (5/49) of patients.
  • In patients receiving OPDIVO monotherapy in Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients.
  • In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), serious adverse reactions occurred in 47% of patients.