Pharmaceutical industry

Samsung Biologics enters into a development and manufacturing partnership with PharmAbcine for oncology and neovascular treatment

Monday, April 6, 2020 - 1:00am

SONGDO, South Korea, April 5, 2020 /PRNewswire/ --Samsung Biologics (207940.KS) entered into a strategic partnership with PharmAbcine for the development and manufacturing of PMC-402 pipeline, a next generation therapeutic antibody candidate to treat oncology and neovascular disorders.

Key Points: 
  • SONGDO, South Korea, April 5, 2020 /PRNewswire/ --Samsung Biologics (207940.KS) entered into a strategic partnership with PharmAbcine for the development and manufacturing of PMC-402 pipeline, a next generation therapeutic antibody candidate to treat oncology and neovascular disorders.
  • Under this agreement, Samsung will provide the full scope of its CDO services from cell line development, process development, cGMP clinical manufacturing to IND filing support.
  • PharmAbcine is a clinical-stage biotech company developing fully human therapeutic antibodies to treat cancer and neovascular disease.
  • "Offering full range of services in development, manufacturing, and laboratory testing from our state-of-the-art facilities, Samsung Biologics works intimately with our clientsto reach IND and market Faster & Better," said Tae-Han Kim, CEO of Samsung Biologics.

Sun BioPharma Announces Pause in Enrollment of Clinical Trial of SBP-101 for Patients with Pancreatic Cancer

Friday, April 3, 2020 - 9:46pm

MINNEAPOLIS, MN, April 03, 2020 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, today announced it will pause enrollment in its ongoing clinical trial of SBP-101.

Key Points: 
  • MINNEAPOLIS, MN, April 03, 2020 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, today announced it will pause enrollment in its ongoing clinical trial of SBP-101.
  • The COVID-19 pandemic has affected the conduct of clinical trials at our US and Australian sites.
  • Patients currently enrolled in the clinical trial will continue to be treated.
  • Sun BioPharmas development program is currently targeting pancreatic cancer; its initial product candidate is SBP-101 for the treatment of patients with metastatic pancreatic cancer.

FPP and Inventia Sign Licensing and Supply Agreement

Friday, April 3, 2020 - 8:00pm

(FPP), a pharmaceutical company involved in the Development, Sales, Marketing and Distribution of Generic Pharmaceuticals, and Inventia Healthcare Limited (Inventia), a company involved in the Development, Manufacturing and Licensing of pharmaceuticals, are pleased to announce the signing of an agreement for the Licensing, Supply and Distribution of an ANDA developed by Inventia recently approved by the FDA and scheduled to launch this Summer.

Key Points: 
  • (FPP), a pharmaceutical company involved in the Development, Sales, Marketing and Distribution of Generic Pharmaceuticals, and Inventia Healthcare Limited (Inventia), a company involved in the Development, Manufacturing and Licensing of pharmaceuticals, are pleased to announce the signing of an agreement for the Licensing, Supply and Distribution of an ANDA developed by Inventia recently approved by the FDA and scheduled to launch this Summer.
  • The ANDA product will be Sold and Distributed by FPP in the FPP Label within the US.
  • "We are excited to work with Inventia on this opportunity and look forward to launching the product ", said Larry J. Lapila, President of FPP.
  • "Inventia is excited to add a new partner to the current portfolio of ANDAs and we are working together with FPP towards a successful launch of the product", said Ankur J. Shah, Whole-time Director of Inventia.

2020 Cirrhosis Clinical Trials Overview by Trial Status & Phase, Sponsor Type, End Point Status, Region and Country - ResearchAndMarkets.com

Friday, April 3, 2020 - 6:02pm

The "Cirrhosis Global Clinical Trials Review, H1, 2020" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Cirrhosis Global Clinical Trials Review, H1, 2020" clinical trials has been added to ResearchAndMarkets.com's offering.
  • This clinical trial report, Cirrhosis Global Clinical Trials Review H1, 2020 provides an overview of Cirrhosis Clinical trials scenario.
  • The report provides top line data relating to the clinical trials on Cirrhosis.
  • The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type.

ICON Signs New Service Agreement With Pfizer

Friday, April 3, 2020 - 2:05pm

ICON plc, (NASDAQ: ICLR) a leading global provider of drug and device development and commercialisation services to the pharmaceutical, biotechnology and medical device industries, today announced it has signed a three-year agreement with Pfizer Inc. (NYSE:PFE).

Key Points: 
  • ICON plc, (NASDAQ: ICLR) a leading global provider of drug and device development and commercialisation services to the pharmaceutical, biotechnology and medical device industries, today announced it has signed a three-year agreement with Pfizer Inc. (NYSE:PFE).
  • Under the terms of the agreement, Pfizer has the right to extend the term for up to an additional two years.
  • The agreement builds on the companies' existing relationship, under which ICON provides global expertise in the planning, execution, management and conduct of clinical trials.
  • We look forward to continuing our strong relationship with Pfizer to help advance their pipeline and deliver continued innovation in the drug development process."

FHI Clinical Providing Full-Service CRO Capabilities for Coronavirus (COVID-19) Clinical Trial

Friday, April 3, 2020 - 2:00pm

FHI Clinical Inc. announces today it has partnered with Infectious Disease Research Institute (IDRI) , a Seattle-based not-for-profit organization, to provide full-service contract research organization (CRO) capabilities for an immunotherapy clinical trial to combat moderate to severe cases of COVID-19.

Key Points: 
  • FHI Clinical Inc. announces today it has partnered with Infectious Disease Research Institute (IDRI) , a Seattle-based not-for-profit organization, to provide full-service contract research organization (CRO) capabilities for an immunotherapy clinical trial to combat moderate to severe cases of COVID-19.
  • Casper is hopeful this immunotherapy can be introduced to the market within a year, pending clinical trial success.
  • When an outbreak like coronavirus occurs, new therapies and vaccines are vital and require rapid start-up of clinical trials, commented Ted FitzGerald, FHI Clinical president and CEO.
  • FHI Clinical is a full-service contract research organization (CRO) with the global expertise, responsive approaches and proven solutions to manage complex clinical research in resource-limited settings around the world.

Vivera Pharma CEO Exposes Questionable Practices of Importers of Fraudulent Chinese COVID-19 Tests

Friday, April 3, 2020 - 2:00pm

The Company takes the recent surge in fraudulent testing devices from China and elsewhere seriously.

Key Points: 
  • The Company takes the recent surge in fraudulent testing devices from China and elsewhere seriously.
  • Viveras tests are validated by extensive clinical data from its German manufacturing partners.
  • As opportunistic importers of cheaply-made testing devices take unfair advantage of rampant fear, the Food and Drug Administration (FDA) cannot move fast enough to shut them down.
  • FDA is not moving fast enough to approve legitimate tests, and this is allowing too many opportunities for Chinese tests to flood the market.

Novan Receives Verbal Guidance from FDA for SB206 and Announces Sato Program Advancement

Friday, April 3, 2020 - 1:15pm

The purpose of the meeting was to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application (NDA).

Key Points: 
  • The purpose of the meeting was to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application (NDA).
  • Based on guidance received during the meeting, the Company understands the FDA will consider one additional pivotal trial (B-SIMPLE4), if successful, to be supported by the previously completed B-SIMPLE2 trial.
  • In addition, the FDA provided guidance with regard to both the study design for B-SIMPLE4 and expectations for a future NDA submission.
  • Sato is a tremendously valuable business and development partner and we look forward to continued collaboration to progress the program.

La Jolla Pharmaceutical Company to Provide GIAPREZA™ (Angiotensin II) for Named Patient Emergency Use in Patients with Septic Shock Due to COVID-19 at University Hospital Frankfurt in Germany

Friday, April 3, 2020 - 1:30pm

Patients who became critically ill developed respiratory failure, septic shock and/or multiple organ failure.

Key Points: 
  • Patients who became critically ill developed respiratory failure, septic shock and/or multiple organ failure.
  • La Jolla is committed to helping patients suffering from life-threatening diseases, and we hope that GIAPREZA will positively impact these patients, said Lakhmir Chawla, M.D., Chief Medical Officer, La Jolla Pharmaceutical Company.
  • GIAPREZA is marketed in the U.S. by La Jolla Pharmaceutical Company on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary.
  • La Jolla Pharmaceutical Company is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases.

BioCryst Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Friday, April 3, 2020 - 12:00pm

The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

Key Points: 
  • The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).
  • The options have an exercise price of$2.00 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date.
  • Each stock option has a 10-year term and is subject to the terms and conditions of BioCrysts Inducement Equity Incentive Plan and a stock option agreement covering the grant.
  • BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease.