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Monday, August 24, 2020

Trevena launches TRV027 study in COVID-19 patients in London

Trevena (NASDAQ:TRVN) perks up 8% premarket in reaction to the announcement that its collaborator Imperial College London has initiated a proof-of-concept study for TRV027 in COVID-19 patients.

The trial will enroll ~60 hospitalized, non-ventilated patients aged 18 or older with a confirmed COVID-19 infection.

The primary objective is to evaluate whether TRV027 reduces abnormal clotting associated with COVID-19. The study will also assess the effect of TRV027 on lung function and other clinical outcomes.

Top-line data are expected in Q1 2021.


Kazia Therapeutics’ paxalisib an Orphan Drug in U.S. for malignant glioma August 24, 2020

The FDA has granted Orphan Drug Designation (ODD) to Kazia Therapeutics’ (NASDAQ:KZIA) paxalisib (formerly GDC-0084) for the treatment of malignant glioma, which includes Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly aggressive childhood brain cancer.

Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.

Receipt of ODD follows award of Rare Pediatric Disease Designation for DIPG on August 7.

“We look forward to seeing initial data from the ongoing phase I study in DIPG at St Jude Children’s Research Hospital during the second half of calendar 2020,” commented Dr. James Garner, CEO.

Kazia expects to present further data from its ongoing phase II study of paxalisib in glioblastoma at the Society for Neuro-Oncology Annual Meeting in November 2020.


Tiziana nabs new U.S. patent for TZLS-501 in potential COVID-19 treatment

The USPTO has granted Tiziana Life Sciences (NASDAQ:TLSA) a patent for methods and use of fully human monoclonal antibody (mAb; TZLS-501) that recognizes both IL-6 receptor (IL-6R) and IL-6 receptor complex with IL-6 (IL-6R/IL-6) for prophylactic and therapeutic intervention for human diseases.

The Patent No. 10,759,862 will be published on September 1. This additional patent on TZLS-501 is significant for the potential treatment of COVID-19 and acute respiratory distress syndrome (ARDS).

“We are expediting the clinical development of TZLS-501, GMP manufacturing, simultaneously developing inhalation delivery directly to the lungs using a nebulizer and conducting the inhalation safety toxicology studies in Cynomolgus monkeys. Completion of these studies will enable us to file an IND and initiate a clinical trial in COVID-19 patients by Q1 2021,” added Dr. Kunwar Shailubhai, CEO and CSO of Tiziana.


Bristol-Myers Squibb to acquire protein engineer Forbius

Bristol-Myers Squibb (NYSE:BMY) has agreed to acquire privately held Forbius, a clinical-stage protein engineering company with a line-up of candidates for cancer and fibrosis.

The lead drug is AVID200, a transforming growth factor (TGF) beta inhibitor in Phase 1 development for solid tumors, systemic sclerosis and myelofibrosis.

Under the terms of the deal, Forbius equity holders will receive an upfront payment and milestones. Specific financial terms are not disclosed.

The transaction should close next quarter.


Merck’s Keytruda nabs two nods in Japan

August 24, 2020

The Japanese Ministry of Health, Labor and Welfare’s Pharmaceuticals and Medical Devices Agency has approved Merck’s (NYSE:MRK) Keytruda (pembrolizumab) for patients with PD-L1-positive resectable, advanced or recurrent esophageal squamous cell carcinoma who have progressed after chemo.
The regulator also approved a new dosing regimen for the PD-1 inhibitor, 400 mg every six weeks as an intravenous infusion over 30 minutes across all adult indications (original regimen, still available, is 200 mg every three weeks).

Convalescent plasma players rally on FDA emergency use nod

August 24, 2020

Immunoglobulin therapy providers are in the green premarket on the heels of the FDA nod for emergency use of convalescent plasma for COVID-19.
Kamada (NASDAQ:KMDA) (+23%), Grifols (NASDAQ:GRFS) (+6%), XBiotech (NASDAQ:XBIT) (+9%), Cerus (NASDAQ:CERS) (+20%), ADMA Biologics (NASDAQ:ADMA) (+70%)

Sunday, August 23, 2020

Returning from overseas, out of state? CDC lifts 14-day quarantine recommendation

Travelers returning from a trip outside the country or their state no longer face recommendations from the Centers for Disease Control and Prevention to self-quarantine for 14 days upon return. 

The CDC updated its travel requirements online Friday, advising travelers to “follow state, territorial, tribal and local recommendations or requirements after travel.” Previous guidelines recommended a 14-day quarantine for those returning from international destinations or areas with a high concentration of coronavirus cases. 

Though it still notes that those exposed to the coronavirus pose a risk of infecting others for 14 days, the CDC’s page on traveling amid the pandemic recommends that travelers, “regardless of where you traveled or what you did during your trip,” follow social distancing guidelines indoors and outdoors, wear a mask outside the home, wash hands often and look out for COVID-19 symptoms upon their return home.

“You may have been exposed to COVID-19 on your travels,” the page reads. “You may feel well and not have any symptoms, but you can be contagious without symptoms and spread the virus to others. You and your travel companions (including children) pose a risk to your family, friends and community for 14 days after you were exposed to the virus.”

USA TODAY reached out to the CDC for comment. 


Individual states have a mix of quarantine requirements and recommendations for visitors and residents returning from travels overseas and from other states. 

Some discourage interstate travel by requiring or recommending that visitors and residents returning from other states quarantine; others require a recent negative COVID-19 test in lieu of a blanket quarantine policy.

Anyone looking to go on a road trip or take a summer vacation should check government websites for their destination and anywhere they plan to stop overnight.