Lactams

Rafael Pharmaceuticals Crosses Enrollment of 150 Patients in Pivotal Phase 3 Trial (ARMADA 2000) of CPI-613® (Devimistat) for Relapsed or Refractory Acute Myeloid Leukemia (AML)

Retrieved on: 
Tuesday, March 30, 2021

There are currently no standard therapy for AML patients who suffer a relapse , and the prognosis for older patients is grim.

Key Points: 
  • There are currently no standard therapy for AML patients who suffer a relapse , and the prognosis for older patients is grim.
  • As patients face a diagnosis with relapsed or refractory AML, the potential of these treatments is incredibly important.
  • Ultimately, it is these milestones that will shepherd us towards finding treatment options for patients who need them most.
  • The business and operations of the company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements.

9 million fake sedative pills removed from circulation by Hungarian and Norwegian Police

Retrieved on: 
Tuesday, March 30, 2021

Over 9 million counterfeit sedative tablets have been seized as a result of a joint operation between the Hungarian National Police (Magyar Rendrsg) and the Norwegian Police (Politi) with the support of Europol and Eurojust.

Key Points: 
  • Over 9 million counterfeit sedative tablets have been seized as a result of a joint operation between the Hungarian National Police (Magyar Rendrsg) and the Norwegian Police (Politi) with the support of Europol and Eurojust.
  • The criminals were producing counterfeit Clonazepam tablets in an underground laboratory.
  • The counterfeit pills were sold across Europe, with Norway being one of the main destinations.
  • Europols Analysis Project COPY falling under Europols European Economic and Financial Crime Centre (EFECC) was central in this investigation.

Benign Prostatic Hyperplasia Treatment Market by Type, End User and Region - Global Forecast to 2026

Retrieved on: 
Monday, March 29, 2021

DUBLIN, March 29, 2021 /PRNewswire/ -- The "Benign Prostatic Hyperplasia Treatment Market by Type (Drug (Alpha Blockers(Tamsulosin, Doxazosin), 5-Alpha Reductase Inhibitors (Finasteride, Dutasteride), Surgical Treatment (TURP, TUMT, TUNA)), End User (Hospitals) - Global Forecast to 2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, March 29, 2021 /PRNewswire/ -- The "Benign Prostatic Hyperplasia Treatment Market by Type (Drug (Alpha Blockers(Tamsulosin, Doxazosin), 5-Alpha Reductase Inhibitors (Finasteride, Dutasteride), Surgical Treatment (TURP, TUMT, TUNA)), End User (Hospitals) - Global Forecast to 2026" report has been added to ResearchAndMarkets.com's offering.
  • The global benign prostatic hyperplasia treatment market is projected to reach USD 14.1 billion by 2026 from USD 10.8 billion in 2021, at a CAGR of 5.3% from 2021 to 2026.
  • Drug treatment is expected to hold the largest share of the benign prostatic hyperplasia treatment market, by type in 2021.
  • On the basis of region, the benign prostatic hyperplasia treatment market is segmented into North America, Europe, Asia Pacific, and the Rest of the World.

Pacira Announces FDA Approval of Supplemental New Drug Application for EXPAREL® (bupivacaine liposome injectable suspension) in Pediatric Patients

Retrieved on: 
Monday, March 22, 2021

With this approval, EXPAREL is the first and only FDA approved long-acting local analgesic for the pediatric population as young as age six.

Key Points: 
  • With this approval, EXPAREL is the first and only FDA approved long-acting local analgesic for the pediatric population as young as age six.
  • Since initial approval in 2011, more than 8 million patients have been treated with EXPAREL.
  • The sNDA was based on the positive data from the Phase 3 PLAY study of EXPAREL infiltration in pediatric patients undergoing spinal or cardiac surgeries.
  • Per FDA guidance, the primary objectives of the PLAY study were to evaluate the pharmacokinetics and safety of EXPAREL.

VistaGen’s Poster Presentation at the Anxiety and Depression Association of America’s 2021 Annual Conference Differentiates PH94B’s Mechanism of Action from Highly-Addictive Benzodiazepines

Retrieved on: 
Monday, March 22, 2021

PH94Bs MOA is, therefore, fundamentally differentiated from the MOA of benzodiazepines such as alprazolam, diazepam and lorazepam, which are direct GABA-A receptor positive modulators.

Key Points: 
  • PH94Bs MOA is, therefore, fundamentally differentiated from the MOA of benzodiazepines such as alprazolam, diazepam and lorazepam, which are direct GABA-A receptor positive modulators.
  • Among VistaGens core goals is for PH94B to displace these and other widely-used but highly-addictive benzodiazepines in the acute treatment paradigm for SAD and other anxiety disorders and phobias.
  • PH94B also has therapeutic potential in a wide range of additional anxiety disorders and phobias.
  • To help differentiate PH94Bs mechanism of action from that of benzodiazepines, VistaGen studied whether PH94B had positive modulatory effects on GABA receptors.

Clovis Oncology’s Rubraca® (rucaparib) Significantly Improves Progression-Free Survival versus Chemotherapy in Patients with Later-line Ovarian Cancer Associated with a BRCA Mutation

Retrieved on: 
Friday, March 19, 2021

The data demonstrate that Rubraca significantly improves PFS compared to standard-of-care chemotherapy, including platinum-based chemotherapy, among patients with advanced, relapsed ovarian cancer and a deleterious BRCA mutation who have received two or more prior lines of chemotherapy.

Key Points: 
  • The data demonstrate that Rubraca significantly improves PFS compared to standard-of-care chemotherapy, including platinum-based chemotherapy, among patients with advanced, relapsed ovarian cancer and a deleterious BRCA mutation who have received two or more prior lines of chemotherapy.
  • The primary efficacy population (n=325) comprised the group of patients with a deleterious tumor BRCA mutation and excluded those with a BRCA reversion mutation as determined by a blood test.
  • The median PFS for the patients in the efficacy population treated with rucaparib was 7.4 months versus 5.7 months among those who received chemotherapy.
  • The median PFS for the patients in the ITT population treated with rucaparib was 7.4 months versus 5.7 months among those who received chemotherapy.

Post-Hoc Analysis of Phase 3 Study Examines Effect of Early Intervention with Edaravone on Survival and Disease Progression Milestone Events in ALS Patients

Retrieved on: 
Thursday, March 18, 2021

This post-hoc analysis assessed the double-blind, placebo-controlled 24-week Phase 3 study of edaravone, including an additional 24-week open-label period with all patients receiving IV edaravone (i.e., edaravone-edaravone [EE] vs. placebo-edaravone [PE] groups).

Key Points: 
  • This post-hoc analysis assessed the double-blind, placebo-controlled 24-week Phase 3 study of edaravone, including an additional 24-week open-label period with all patients receiving IV edaravone (i.e., edaravone-edaravone [EE] vs. placebo-edaravone [PE] groups).
  • During the open-label period, there were two deaths in the EE group and four in the PE group.
  • Survival analysis of the cumulative occurrence of milestone events (death, tracheostomy, PAV and hospitalization due to ALS progression) showed a 53 percent relative risk reduction in the EE group, with a hazard ratio of 0.47.
  • "I'm encouraged by the findings of this post-hoc analysis," said Benjamin Rix Brooks, M.D., an ALS specialist and lead author of the study.

Recent Developments in the Ovarian Cancer Market - Key Opinion Leader Views - ResearchAndMarkets.com

Retrieved on: 
Monday, March 15, 2021

This report presents key opinion leader (KOL) views on recent developments in the ovarian cancer market.

Key Points: 
  • This report presents key opinion leader (KOL) views on recent developments in the ovarian cancer market.
  • Is Zejula likely to displace other PARP inhibitors already available on the market for the treatment of ovarian cancer?
  • Should Rubraca's sNDA receive FDA approval, how likely is the drug to gain extensive market share ahead of its competitors?
  • What is the view of the experts on having three PARP inhibitors for the treatment of ovarian cancer?

Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Aquestive Therapeutics, Inc. (AQST)

Retrieved on: 
Friday, March 12, 2021

Glancy Prongay & Murray LLP (GPM) reminds investors of the upcoming April 30, 2021 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired Aquestive Therapeutics, Inc. (Aquestive or the Company) (NASDAQ: AQST ) securities between December 2, 2019 and September 25, 2020, inclusive (the Class Period).

Key Points: 
  • Glancy Prongay & Murray LLP (GPM) reminds investors of the upcoming April 30, 2021 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired Aquestive Therapeutics, Inc. (Aquestive or the Company) (NASDAQ: AQST ) securities between December 2, 2019 and September 25, 2020, inclusive (the Class Period).
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.
  • Its most advanced proprietary product candidate is Libervant, a buccal soluble film formulation of diazepam for the treatment of recurrent epileptic seizures.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.

Oncolytics Biotech® Announces Upcoming Presentations at the AACR Annual Meeting

Retrieved on: 
Wednesday, March 10, 2021

Oncolytics will provide details on the results described in this abstract following publication of the abstract and corresponding poster at the AACR Annual Meeting in April, in accordance with conference embargo policies regarding late-breaking abstracts.

Key Points: 
  • Oncolytics will provide details on the results described in this abstract following publication of the abstract and corresponding poster at the AACR Annual Meeting in April, in accordance with conference embargo policies regarding late-breaking abstracts.
  • New preclinical studies identify the mechanisms of therapeutic synergy between pelareorep and the CDK4/6 inhibitor palbociclib.
  • Data show that combining pelareorep with palbociclib augmented pelareorep-induced endoplasmic reticulum (ER) stress signaling and increased innate immune activation and effector function.
  • Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements.