NCE

Novan Reports Safety Data from B-SIMPLE4 Pivotal Phase 3 Study of SB206

Thursday, September 23, 2021 - 1:00pm

DURHAM, N.C., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced the comprehensive safety data readout as part of the Company’s B-SIMPLE4 pivotal Phase 3 study of SB206 for the treatment of molluscum contagiosum (“molluscum”).

Key Points: 
  • Scar formation was assessed by the investigator, regardless of the size of the scar, throughout the study for TEAEs, as well as occurrence.
  • The TEAEs for scarring throughout the study were slightly higher in the vehicle group (6.3%) vs. SB206 (4.7%).
  • Subjects treated with SB206 showed a lower occurrence of scarring at the Week-24 visit when compared to vehicle (4.0% in vehicle vs. 2.7% in SB206).
  • The Company plans to present topline efficacy and safety results at upcoming medical congresses and conferences.

BIORCHESTRA appoints pharma veteran and Moderna and Akcea (Ionis) CMO "Dr. Louis St. L. O'Dea" as CMO of BIORCHESTRA

Thursday, September 23, 2021 - 1:00pm

In addition, their proprietary exosome-based diagnostic that detects and quantifies markers of neuroinflammation and neurodegeneration facilitates patient selection and treatment monitoring.

Key Points: 
  • In addition, their proprietary exosome-based diagnostic that detects and quantifies markers of neuroinflammation and neurodegeneration facilitates patient selection and treatment monitoring.
  • BIORCHESTRA has been recently recognized for its achievements by Johnson & Johnson in their Innovation QuickFire Challenge in Neuroscience in June, 2021.
  • [i][ii]
    Reflecting the success of its research and development programs and anticipating its international expansion and entry into clinical development, the BIORCHESTRA has appointed Dr. Louis St.L.
  • O'Dea (MB, BCh, BAO, FRCP has worked as CMO in global pharmaceutical companies such as Serono, Moderna, Akcea (Ionis), Radius and Oxford Immunotec for 28 years.

Novan to Present at the Cantor Fitzgerald Virtual Global Healthcare Conference

Monday, September 20, 2021 - 2:00pm

DURHAM, N.C., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the Company or Novan) (Nasdaq: NOVN), today announced that Paula Brown Stafford, President and Chief Executive Officer of Novan, will participate in a fireside chat hosted by Jennifer Kim, Vice President, Equity Research, at the Cantor Fitzgerald Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 8:00 AM ET.

Key Points: 
  • DURHAM, N.C., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the Company or Novan) (Nasdaq: NOVN), today announced that Paula Brown Stafford, President and Chief Executive Officer of Novan, will participate in a fireside chat hosted by Jennifer Kim, Vice President, Equity Research, at the Cantor Fitzgerald Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 8:00 AM ET.
  • In addition to the fireside chat, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference.
  • Novan, Inc. is a pre-commercial nitric oxide-based pharmaceutical company focused on dermatology and anti-infective therapies.
  • We leverage our core synergies of science, capital, resources and patient needs to create value by bringing new nitric oxide-based medicines to market.

Relmada Therapeutics to Present at Oppenheimer Fall Healthcare Life Sciences and MedTech Summit

Friday, September 17, 2021 - 1:00pm

CORAL GABLES, Fla., Sept. 17, 2021 /PRNewswire/ --Relmada Therapeutics, Inc. (NASDAQ: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that Sergio Traversa, Chief Executive Officer of Relmada, will present at the annual Oppenheimer Fall Healthcare Life Sciences and MedTech Summit, on September 21, 2021, at 12:25 pm ET.

Key Points: 
  • CORAL GABLES, Fla., Sept. 17, 2021 /PRNewswire/ --Relmada Therapeutics, Inc. (NASDAQ: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that Sergio Traversa, Chief Executive Officer of Relmada, will present at the annual Oppenheimer Fall Healthcare Life Sciences and MedTech Summit, on September 21, 2021, at 12:25 pm ET.
  • The ongoing RELIANCE Clinical Research Program is designed to evaluate the potential for REL-1017 as the first rapid-acting, oral, once-daily antidepressant treatment.
  • Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD).
  • Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

COVID-19 Scoop: Epoch-Making GoldenBiotech's Oral COVID-19 New Drug Trial Got Green Light from the FDA to Extend Recruiting Severe COVID-19 Patients

Thursday, September 16, 2021 - 11:05am

The total trial subjects will remain the same, 174 patients in total.

Key Points: 
  • The total trial subjects will remain the same, 174 patients in total.
  • The trial recruiting is expedited in full swing covering the USA, Peru and Argentina where the new upheaval pandemic is rampant with highly transmitted SARS-CoV2 variants.
  • "So far, there is no oral drug approved or receives the EUA from the FDA for COVID-19 treatment.
  • It also received the ODD for the treatment of Pancreatic Cancer from European EMA in 2017.

Awakn Life Sciences Reports Second Quarter 2021 Financial Results and Business Highlights

Wednesday, September 15, 2021 - 12:30pm

Toronto, Ontario--(Newsfile Corp. - September 15, 2021) - Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a biotechnology company with clinical operations developing and delivering psychedelic medicines to better treat Addiction, today is reporting its financial results and business highlights for the three and six months ended July 31, 2021.

Key Points: 
  • Toronto, Ontario--(Newsfile Corp. - September 15, 2021) - Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a biotechnology company with clinical operations developing and delivering psychedelic medicines to better treat Addiction, today is reporting its financial results and business highlights for the three and six months ended July 31, 2021.
  • All results are reported under International Financial Reporting Standards ("IFRS") and in Canadian dollars, unless otherwise specified.
  • Anthony Tennyson, Chief Executive Officer of Awakn Life Sciences, commented, "Our team has achieved many accomplishments in a short period of time since going public in June of 2021.
  • About Awakn Life Sciences Corp.
    Awakn Life Sciences is a biotechnology company with clinical operations, researching, developing, and delivering psychedelic medicine to better treat Addiction.

Seqens Appoints Bob Huang Managing Director of North American CDMO Operations

Tuesday, September 14, 2021 - 2:46pm

Seqens CDMO North America (formerly known as PCI Synthesis, Inc.), a pharmaceutical manufacturer of new chemical entities (NCEs), active pharmaceutical ingredients (APIs) and other specialty chemical products, today announced that Bob Huang has joined as Managing Director for North America.

Key Points: 
  • Seqens CDMO North America (formerly known as PCI Synthesis, Inc.), a pharmaceutical manufacturer of new chemical entities (NCEs), active pharmaceutical ingredients (APIs) and other specialty chemical products, today announced that Bob Huang has joined as Managing Director for North America.
  • Bob Huang is responsible for expanding Seqens CDMO NAs presence as the ideal manufacturing partner with global capabilities.
  • Seqens CDMO NAs location in the Boston area, a world-renowned life sciences hub, provides us with enormous opportunities to provide our expertise, as well as our spirit of innovation in the community to become a global CDMO destination, said Bob Huang, Managing Director, Seqens CDMO North America.
  • Seqens CDMO North America (formerly PCI Synthesis) is a pharmaceutical development CDMO (Contract Development and Manufacturing Organization) based in Newburyport, Mass.

Novan Engages Syneos Health as Commercial Solutions Provider for SB206

Wednesday, September 8, 2021 - 2:00pm

DURHAM, N.C., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced its selection of Syneos Health (Nasdaq: SYNH), a fully integrated biopharmaceutical solutions organization, as its commercial solutions provider for SB206 for the treatment of molluscum. The strategic relationship with Syneos Health will focus on implementing the SB206 prelaunch strategy and commercial preparation, followed by sales of SB206, if approved by the U.S. Food and Drug Administration. SB206, Novan’s lead product candidate, utilizes its innovative and proprietary NITRICILTM technology platform.

Key Points: 
  • The strategic relationship with Syneos Health will focus on implementing the SB206 prelaunch strategy and commercial preparation, followed by sales of SB206, if approved by the U.S. Food and Drug Administration.
  • Syneos Health is an industry leader for helping biopharma companies commercialize products and is the longest-tenured U.S. provider of outsourced field teams.
  • Novan and Syneos Health began working together in 2019 to assess molluscum market data.
  • Michelle Keefe, President, Commercial Solutions at Syneos Health, added, We are proud to expand our relationship with Novan, and be part of filling a high unmet medical need in the dermatology and pediatric spaces with SB206.

Enabling Clinical Development of Poorly Soluble Molecules Through Formulation Solutions, Upcoming Webinar Hosted by Xtalks

Wednesday, September 8, 2021 - 1:30pm

The role of a preclinical formulator requires a thorough understanding of many aspects of the drug development process.

Key Points: 
  • The role of a preclinical formulator requires a thorough understanding of many aspects of the drug development process.
  • Apart from the knowledge of various formulation parameters, a preclinical formulator should have understanding of impact of physchem properties on drug absoprion, toxicology, pharmacokinetics and analytical techniques.
  • Join Sreehari Babu Putchakayala, VP & Head, Formulation Development Solutions, Aragen Life Sciences , in a live webinar on Friday, September 24, 2021 at 11am EDT (4pm BST/UK) to hear about novel formulation approaches to overcome solubility issues and enable clinical development of NCEs.
  • For more information, or to register for this event, visit Enabling Clinical Development of Poorly Soluble Molecules Through Formulation Solutions.

Novan to Present at H.C. Wainwright 23rd Annual Global Investment Conference

Tuesday, September 7, 2021 - 2:00pm

DURHAM, N.C., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the Company or Novan) (Nasdaq: NOVN), today announced that Paula Brown Stafford, President and Chief Executive Officer of Novan, will participate in a fireside chat during the September 13th 15th H.C. Wainwright 23rd Annual Global Investment Conference.

Key Points: 
  • DURHAM, N.C., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the Company or Novan) (Nasdaq: NOVN), today announced that Paula Brown Stafford, President and Chief Executive Officer of Novan, will participate in a fireside chat during the September 13th 15th H.C. Wainwright 23rd Annual Global Investment Conference.
  • In addition to the fireside chat, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference.
  • For more information about the event, please visit the conference website: hcwevents.com/annualconference/.
  • The Companys lead product candidate is SB206, a topical gel with antiviral properties, for the treatment of molluscum.