EMA

Santhera Announces First Half-Year 2021 Financial Results and Updates on Corporate Progress

Friday, October 15, 2021 - 7:00pm

53 LR

Key Points: 
  • 53 LR
    Cash and cash equivalents of CHF8.0 million (as of June30, 2021)
    Net revenue CHF4.5 million (H1-2020: CHF7.8 million)
    Net result for period of CHF-20.5 million (H1-2020: CHF-31.8 million)
    Pratteln, Switzerland, October15, 2021 Santhera Pharmaceuticals (SIX: SANN) announces the Companys financial results for the first half-year ended June30, 2021, and provides an update on corporate progress.
  • Already in April 2021, Santhera and ReveraGen announced new clinical data of 2.5-year treatment outcome with vamorolone in patients with Duchenne muscular dystrophy (DMD).
  • Based on clinical trial results, including long-term safety data up to 30 months, vamorolone at doses up to 6mg/kg/day was generally well-tolerated.
  • In June 2021, Santhera announced positive topline results from its long-term Phase 4 LEROS study with Raxone (idebenone) in the treatment of LHON.

Sacituzumab Govitecan Receives Positive CHMP Opinion as 2L Treatment for Adult Patients With Metastatic Triple-Negative Breast Cancer

Friday, October 15, 2021 - 1:00pm

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers.

Key Points: 
  • TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers.
  • Patients were randomly allocated to receive either sacituzumab govitecan or a chemotherapy chosen by the patients treating physician.
  • TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers.
  • Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

Bio-Thera Solutions Expands Partnership with Pharmapark in Russia and other CIS Countries with Addition of BAT2206, a Stelara® Biosimilar

Friday, October 15, 2021 - 1:08pm

Bio-Thera and Pharmaparks partnership was initiated around a licensing and supply agreement for Pharmapark to distribute and market BAT2506, a golimumab biosimilar, in Russia and other CIS countries.

Key Points: 
  • Bio-Thera and Pharmaparks partnership was initiated around a licensing and supply agreement for Pharmapark to distribute and market BAT2506, a golimumab biosimilar, in Russia and other CIS countries.
  • Pharmapark will be responsible for filing the dossier in Russia and other CIS countries.
  • This partnership will leverage Pharmaparks strong local presence, sales and marketing capabilities in Russia and other CIS countries.
  • Bio-Thera is pleased to expand our partnership with Pharmapark to commercialize our ustekinumab biosimilar program in Russia and other CIS countries, said Dr. Shengfeng Li, CEO of Bio-Thera.

Arriello Board Advisors Publish Timely Market Strategy Advice as Biotechs Review their International PV Obligations

Thursday, October 14, 2021 - 7:00pm

in New Jersey have highlighted the main differences between the US and European PV expectations, both pre- and post-market.

Key Points: 
  • in New Jersey have highlighted the main differences between the US and European PV expectations, both pre- and post-market.
  • The experts pooled their advice for ambitious young biotechs looking to capitalize on global opportunities when they typically lack the scale of PV resources of much larger life sciences companies.
  • "This latest guide, providing biotechs with timely PV advice and tips on internal market strategy planning, is another fantastic example of the value they add to Arriello and to our global client base.
  • These services include market consultancy, global regulatory affairs strategy and implementation, full and local pharmacovigilance solutions, clinical drug safety and quality and compliance auditing systems.

Versa SASE Earns 2021 Cloud Computing Excellence Award

Thursday, October 14, 2021 - 1:00pm

Versa Networks today announced that Versa SASE (Secure Access Service Edge) has been named the 2021 Cloud Computing Excellence Award winner.

Key Points: 
  • Versa Networks today announced that Versa SASE (Secure Access Service Edge) has been named the 2021 Cloud Computing Excellence Award winner.
  • The Cloud Computing Excellence Award recognizes companies that have most effectively leveraged cloud computing in their efforts to bring new, differentiated services and solutions to market.
  • Recognizing leaders in the advancement of cloud computing, TMC is proud to announce Versa SASE as a recipient of the 2021 Cloud Computing Excellence Award, said Rich Tehrani , CEO, TMC.
  • It is rewarding to be recognized with the Cloud Computing Excellence Award for our cloud-delivered, differentiated SASE solution, said Michael Wood, Chief Marketing Officer for Versa Networks.

Latest EMA Radar™ Report on Workload Automation Provides In-Depth Insights Into 18 Vendor Solutions

Thursday, October 14, 2021 - 1:15pm

BOULDER, Colo., Oct. 14, 2021 /PRNewswire-PRWeb/ -- Enterprise Management Associates (EMA), a leading IT and data management research and consulting firm, today announced the release of its newest research, titled "EMA Radar for Workload Automation: Q4 2021."

Key Points: 
  • BOULDER, Colo., Oct. 14, 2021 /PRNewswire-PRWeb/ -- Enterprise Management Associates (EMA), a leading IT and data management research and consulting firm, today announced the release of its newest research, titled "EMA Radar for Workload Automation: Q4 2021."
  • Created to assist IT organizations that are procuring workload automation (WLA) solutions, EMA identifies the leading vendors in this space based on key criteria defined by EMA President and COO, Dan Twing.
  • Since the first EMA Radar Report on Workload Automation was released in 2010, workload automation software has become more important to the future of digital transformation and automation.
  • This trend is becoming more broadly accepted as a key part of the future of IT management.

Quantum Materials Corp Unveils Vac-Check™ an Anti-Counterfeit Test Kit to Combat Fake Vaccines

Thursday, October 14, 2021 - 11:30am

San Marcos, TX, Oct. 14, 2021 (GLOBE NEWSWIRE) -- Quantum Materials Corp (QMC) announces Vac-Check, a new tool to combat the global threat of fake vaccines.

Key Points: 
  • San Marcos, TX, Oct. 14, 2021 (GLOBE NEWSWIRE) -- Quantum Materials Corp (QMC) announces Vac-Check, a new tool to combat the global threat of fake vaccines.
  • Building on experience in nanomaterials, Quantum Material Corps scientists created a patent-pending, lateral flow assay powered by QMCs proprietary quantum dot technology to test vaccines at the point of use.
  • Quantum Materials Corp welcomes the opportunity to work with vaccine manufacturers to rapidly make this life saving technology widely available.
  • Other than as required by applicable law, Quantum Materials Corp does not undertake any obligation to update or revise any forward-looking information or statements.

Cantargia receives positive EMA opinion for orphan designation of nadunolimab for treatment of pancreatic cancer

Thursday, October 14, 2021 - 7:43am

STOCKHOLM, Oct. 14, 2021 /PRNewswire/ -- Cantargia AB today announced that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has issued a positive opinion for orphan designation of nadunolimab (CAN04) for treatment of pancreatic cancer.

Key Points: 
  • STOCKHOLM, Oct. 14, 2021 /PRNewswire/ -- Cantargia AB today announced that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has issued a positive opinion for orphan designation of nadunolimab (CAN04) for treatment of pancreatic cancer.
  • The COMP at the EMA has issued a positive opinion for orphan designation of CAN04 for treatment of pancreatic cancer.
  • The opinion is forwarded to the European Commission which is expected to grant the orphan designation within 30 days.
  • CAN04 was granted US Orphan Drug Designation for treatment of pancreatic cancer by the Food and Drug Administration (FDA) in September 2021.

Visibility and Invisibility of Credential Protection: Frank Ohlhorst and Attivo Networks Unpack the How and Why

Wednesday, October 13, 2021 - 2:00pm

Attivo Networks, the experts in preventing identity privilege escalation and detecting lateral movement attacks, today announced it will host a webinar titled: Visibility and Invisibility of Credential Protection.

Key Points: 
  • Attivo Networks, the experts in preventing identity privilege escalation and detecting lateral movement attacks, today announced it will host a webinar titled: Visibility and Invisibility of Credential Protection.
  • Eligible businesses can receive a free Active Directory Assessment and Summary Report from Attivo Networks.
  • In this session, Frank Ohlhorst and Carolyn Crandall will discuss:
    What identity protection looks like beyond traditional provisioning, connecting, and controlling identities.
  • What conditions allow attackers to leverage credentials, Active Directory, and the vast over-provisioning and policy drift of entitlements in the cloud.

ObsEva Announces Relationship with Syneos Health to Commercialize Linzagolix

Wednesday, October 13, 2021 - 6:00am

53 LR of the SIX Swiss Exchange

Key Points: 
  • 53 LR of the SIX Swiss Exchange
    GENEVA, Switzerland, October 13, 2021 ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company dedicated to improving womens reproductive health today announced a strategic relationship with Syneos Health (Nasdaq:SYHN), the only fully integrated biopharmaceutical solutions organization, to commercialize linzagolix.
  • Brian OCallaghan, CEO of ObsEva, commented, We are thrilled to work with Syneos Health on the commercialization of linzagolix.
  • With a leading womens health sales force, Syneos Health is uniquely suited to support our goal of offering relief to women suffering from uterine fibroids.
  • This Syneos Health relationship, together with the newly announced financing facility and revised Kissei license terms, provides ObsEva with a strong foundation to execute on its commercialization plans.