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Tuesday, June 30, 2020

Sinovac Biotech reports Q1 results

Sinovac Biotech (NASDAQ:SVA): Q1 GAAP EPS of -$0.07.
Revenue of $15.39M (-57.9% Y/Y)

‘Human pandemic potential’ in swine flu strain in China pigs

Chinese researchers have reportedly identified a new strain of the swine flu that has the potential to become a pandemic.
Scientists in China say the strain, which emerged recently, is carried by pigs but can infect humans. A study of the new virus was published Monday in the Proceedings of the National Academy of Sciences.
Researchers say the virus has “all the hallmarks” of being highly adapted to spread from person to person and trigger a global outbreak.
Given that it’s a new development, people will likely have little to no immunity.
Professor Kin-Chow Chang and his colleagues at Nottingham University say they are closely monitoring this new strain, which they are calling G4 EA H1N1.
The new strain, of which they found evidence among people who work in Chinese slaughterhouses, can grow and multiply in the cells lining human airways.
Kin-Chow told the BBC: “Right we are distracted with coronavirus, and rightly so. But we must not lose sight of potentially dangerous new viruses.”
The last swine flu pandemic began in Mexico in 2009 but was not as deadly as initially feared. Many older people had some immunity to it because it was similar to older strains.
Robert Webster, an influenza investigator, told Science magazine it’s “a guessing game” if the new virus will evolve to transmit between humans.
“We just do not know a pandemic is going to occur until the d–n thing occurs,” he said. “Will this one do it? God knows.”

Osmotica Pharma submits amended NDA for arbaclofen extended release tablets

Osmotica Pharmaceuticals (NASDAQ:OSMT) has resubmitted its New Drug Application (NDA) to the FDA for arbaclofen extended release tablets for the alleviation of spasticity in multiple sclerosis (MS) patients.
This resubmission also includes the full results of the second Phase 3 efficacy study. The safety and efficacy results from these studies, together with the entire data package from clinical development program, support the clinical significance of arbaclofen ER as a potential treatment for MS spasticity.

MediWound files U.S. application for NexoBrid

June 30, 2020

MediWound (NASDAQ:MDWD) and exclusive North America licensee Vericel (NASDAQ:VCEL) announce the submission of a U.S. marketing application seeking approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.
Vericel acquired the rights in May 2019 in an agreement valued up to $150M. MDWD will supply NexoBrid at a transfer price plus a fixed margin percentage.

GW Pharma announces plan to commercialize nabiximols in the U.S.

GW Pharmaceuticals (NASDAQ:GWPH) announces strategy for bringing its pipeline product nabiximols to the U.S. market.
The company plans to commence a Phase 3 clinical program, including, MS Spasticity Clinical program, Spinal Cord Injury spasticity program and Post Traumatic Stress Disorder program which will provide multiple opportunities for an NDA submission, as early as 2021.
The company will host a webcast today, from 10:00am to 12:00pm EDT to provide insight into the U.S. Phase 3 clinical program and commercial opportunity for nabiximols.
Nabiximols is a botanical medicine formulated from extracts of the cannabis plant. The product is sold as a mouth spray intended to alleviate neuropathic pain, spasticity, overactive bladder, and other symptoms of multiple sclerosis.

Can-Fite announces final data from mid-stage study of Namodenoson in NASH

Can-Fite BioPharma (NYSEMKT:CANF) reports the final analysis of results from a 60-subject Phase 2 clinical trial evaluating Namodenoson (formerly CF102) in patients with nonalcoholic fatty liver disease (NAFLD) with or without nonalcoholic steatohepatitis (NASH).
The 25 mg oral dose produced statistically significant results in all efficacy measures while being safe and well-tolerated.
Liver fat volume decreased the most in the 25 mg arm (102.1 – unit of measurement not provided) compared to placebo (33.0) (p=0.027).
The percent decrease in fat volume in the 25 mg arm was 4.33% versus 2.61% in the control arm (p=0.036).
Levels of two key liver enzymes, AST and ALT, were significantly reduced as was liver fibrosis and steatosis (25 mg).
All cases of NASH resolved in the 25 mg arm.
Phase 3 studies are next up.
Shares ahead 7% premarket on increased volume.

Centene unit to acquire membership of Medicaid plan in Illinois

Centene’s (NYSE:CNC) Illinois subsidiary, Meridian Health Plan of Illinois has entered into a Member Transfer Agreement with NextLevel Health Partners (NLHP), a health plan serving Medicaid members in Cook County, Illinois.
Under the agreement, Meridian will be assigned 100% of NLHP’s approx. 54,000 members who access benefits from the Illinois’ HealthChoice Illinois Program.
As part of the agreement, Meridian has executed a care coordination agreement with NLHP to ensure continuity of care for a subset of the assigned membership, effective concurrently with the closing of the transaction.
Centene provided the initial capital NLHP needed to obtain its HMO licensure at the end of 2017.
The transaction is expected to close in July.