Chloroarenes

Addex ADX71149 Receives IND Approval to Start a Phase 2a Clinical Study in Epilepsy

Thursday, January 21, 2021 - 6:00am

IND approval for the mGlu2 epilepsy study is great news to start 2021 and will be the first of three clinical studies we expect to be initiate this year, said Tim Dyer, CEO of Addex.

Key Points: 
  • IND approval for the mGlu2 epilepsy study is great news to start 2021 and will be the first of three clinical studies we expect to be initiate this year, said Tim Dyer, CEO of Addex.
  • Wed like to thank the team involved for their continued support and moving quickly to get this clinical study ready for patient enrolment.
  • The primary objective of the study is to evaluate the efficacy of JNJ-40411813 (ADX71149) in combination with levetiracetam using a time-to-event endpoint.
  • Addex's third clinical program, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc, is scheduled to enter a phase 2a proof of concept clinical study for the treatment of epilepsy in Q2 2021.

PharmaTher Signs Exclusive Worldwide License Agreement for Patented Ketamine Formulation Targeting Mental Health, Neurological and Pain Disorders

Tuesday, January 19, 2021 - 12:33pm

We believe KETABET has the potential to change the way mental health, neurological and pain disorders will be treated for the hundreds of millions of people globally who are suffering from these debilitating conditions, said Fabio Chianelli, CEO of PharmaTher.

Key Points: 
  • We believe KETABET has the potential to change the way mental health, neurological and pain disorders will be treated for the hundreds of millions of people globally who are suffering from these debilitating conditions, said Fabio Chianelli, CEO of PharmaTher.
  • We are pursuing the clinical development of KETABET to overcome the current limitations of ketamine and to unlock the known potential therapeutic value of ketamine for FDA approval.
  • Ketamine was approved by the FDA in 1970 and is clinically used for analgesia, sedation, and anesthetic induction.
  • These range from the common problems such as aging, cancer, infectious diseases, mental disorders, occupational diseases, to health policy.

Positive Phase 1 results in high-dose setanaxib trial

Monday, January 18, 2021 - 7:13am

The Phase 1 study demonstrated that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified.

Key Points: 
  • The Phase 1 study demonstrated that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified.
  • The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA.
  • The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day.
  • Previously, doses of up to 800 mg/day were evaluated in a 24-week Phase 2 trial in PBC patients.

Positive Phase 1 results in high-dose setanaxib trial

Monday, January 18, 2021 - 7:11am

The Phase 1 study demonstrated that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified.

Key Points: 
  • The Phase 1 study demonstrated that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified.
  • The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA.
  • The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day.
  • Previously, doses of up to 800 mg/day were evaluated in a 24-week Phase 2 trial in PBC patients.

Puma Biotechnology Presents Interim Results from the Biliary Tract Cancers Cohort of the Phase II SUMMIT “Basket” Trial of Neratinib at ASCO GI

Friday, January 15, 2021 - 1:03pm

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced interim results from the biliary tract cancers cohort of the ongoing SUMMIT trial of neratinib at the virtual 2021 Gastrointestinal Cancers Symposium hosted by the American Society of Clinical Oncology (ASCO GI) that is currently taking place.

Key Points: 
  • Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced interim results from the biliary tract cancers cohort of the ongoing SUMMIT trial of neratinib at the virtual 2021 Gastrointestinal Cancers Symposium hosted by the American Society of Clinical Oncology (ASCO GI) that is currently taking place.
  • View the full release here: https://www.businesswire.com/news/home/20210115005058/en/
    The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study that included a cohort evaluating the safety and efficacy of neratinib administered daily to patients who have HER2 (ERBB2) mutation-positive advanced biliary cancer.
  • 24 patients had received prior systemic chemotherapy with a median of 2 prior lines of therapy (range 0-7) before entering the trial.
  • Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357.

Boehringer Ingelheim receives EMA marketing authorization for NexGard® COMBO, the first isoxazoline-based full endectocide for cats

Wednesday, January 13, 2021 - 9:00am

Boehringer Ingelheim, a global leader in animal health, is proud to announce that it has received marketing authorization from the EMA (European Medicine Agency) and European Commission for its NexGard COMBO topical solution for cats.

Key Points: 
  • Boehringer Ingelheim, a global leader in animal health, is proud to announce that it has received marketing authorization from the EMA (European Medicine Agency) and European Commission for its NexGard COMBO topical solution for cats.
  • NexGard COMBO offers unparalleled protection for cats: It kills a broader range of parasites than any other isoxazoline-based cat parasiticide currently available on the market.
  • NexGard COMBO is the first isoxazoline-based full endectocide developed specifically for cats, shares Dr. Craig Beck, Global Franchise Head NexGard, Boehringer Ingelheim Animal Health.
  • Were dedicated to being the global leader in feline health care and the launch of NexGard COMBO for cats expands our trusted feline product portfolio.

IBSA Reacquires Commercial Rights to the Flector® Brand in the US

Tuesday, January 12, 2021 - 6:00pm

With the return of the commercial rights of Flector, a product that IBSA has developed, IBSA now offers two prescription topical drugs to treat acute pain due to minor strains, sprains, and contusions.

Key Points: 
  • With the return of the commercial rights of Flector, a product that IBSA has developed, IBSA now offers two prescription topical drugs to treat acute pain due to minor strains, sprains, and contusions.
  • As of January 2021, marketing rights for Flector have reverted to IBSA, the originator of the product.
  • A promotional program is available to support Flector prescribers and patients with product samples, literature, and improved patient savings programs.
  • Information about Flector and Flector savings programs can be found at www.Flector.com.

AzurRx BioPharma and First Wave Bio Announce Allowance of U.S. Patent Application for Niclosamide as Treatment for COVID-19 Gastrointestinal Infections

Tuesday, January 12, 2021 - 1:30pm

AzurRx anticipates initiating a Phase 2 trial of oral niclosamide, also called FW-1022, in patients with COVID-19, in the first half of 2021.

Key Points: 
  • AzurRx anticipates initiating a Phase 2 trial of oral niclosamide, also called FW-1022, in patients with COVID-19, in the first half of 2021.
  • We are greatly encouraged by the allowance of the patent application, said James Sapirstein, President and CEO of AzurRx BioPharma.
  • Mr. Sapirstein continued, We believe that there is both a significant unmet clinical need in treating COVID-19 GI infections and a substantial untapped market opportunity.
  • AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical companyspecializingin the development of targeted, non-systemic therapies forgastrointestinal (GI) diseases.

Eisai to Present Abstracts on Lenvatinib at 2021 Gastrointestinal Cancers Symposium

Tuesday, January 12, 2021 - 3:37am

TOKYO, Jan 12, 2021 - (JCN Newswire) - Eisai Co., Ltd. has announced that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib") will be given at the Gastrointestinal Cancers Symposium Virtual Meeting, from January 15 to 17, 2021.

Key Points: 
  • TOKYO, Jan 12, 2021 - (JCN Newswire) - Eisai Co., Ltd. has announced that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib") will be given at the Gastrointestinal Cancers Symposium Virtual Meeting, from January 15 to 17, 2021.
  • In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.
  • Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer.
  • Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.

Dr. George Fareed and Colleagues Urge Early Outpatient Treatment for COVID-19

Monday, January 11, 2021 - 2:00pm

Widely available treatments can reduce COVID-19 illness severity, hospitalization and mortality when used early.

Key Points: 
  • Widely available treatments can reduce COVID-19 illness severity, hospitalization and mortality when used early.
  • The outpatient therapies include combinations of widely available drugs and nutraceuticals (zinc, vitamin D, vitamin C, quercetin) as well as anti-infectives, steroids and anticoagulants if necessary.
  • The article notes that dozens of countries around the world are already using these drugs for early outpatient treatment of COVID-19, including some like Brazil and India which are widely distributing ivermectin and hydroxychloroquine in at-home treatment kits.
  • "Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-risk SARS-CoV-2 infection (COVID-19)."