Costly Track-and-Trace Provision Dropped from Pending FDA Bill

Source: Associated Press, Matthew Perrone (6/19/12)

"Pharmaceutical companies have gotten more aggressive in pushing for a national framework to avoid the costs of complying with individual state tracking laws. Industry groups said they would continue working toward a federal track-and-trace system."

Associated Press, Matthew Perrone

A bill designed to beef up the safety of the nation's prescription drug supply is poised to pass Congress, but without a tracking system that public health advocates say is critical to weeding out counterfeit pharmaceuticals.

House and Senate lawmakers agreed late Monday on compromise legislation that helps supplement the U.S. Food and Drug Administration's budget. The two chambers previously passed separate versions of the bill, which also increases safety inspections and penalties against drug counterfeiters.

Lawmakers dropped a Senate provision that would have created a national network for tracking drug shipments and preventing counterfeit and stolen drugs from entering the U.S. supply chain. Pharmaceutical companies and regulators have argued over the cost and scope of the network for over a decade, though industry observers hoped this year's must-pass FDA bill might provide a vehicle for a compromise.

Key lawmakers said Tuesday they were unable to bridge disagreements over the so-called track-and-trace system. . .View Full Article

Novavax Shares Shoot 65% Higher on Phase 3 COVID-19 Vaccine Trial's 89.3% Effectiveness
Source: Streetwise Reports (01/29/2021)

Novavax Inc. shares established a new 52-week high after the firm's COVID-19 vaccine demonstrated an 89.3% efficacy rate in a Phase 3 trial in the U.K. and also showed efficacy against the South African variant in a Phase 2b trial.

Sorrento Shares Rise 35% After Firm Posts Positive Data from Phase 1b ICU COVID-19 Trial
Source: Streetwise Reports (01/27/2021)

Shares of Sorrento Therapeutics traded higher after the company released positive preliminary results from it of Phase 1b COVI-MSC™ Study for treatment of hospitalized ICU COVID-19 patients.

Life Sciences Co. Receives Large Livestock Feed Order from New Client in Mexico
Source: Streetwise Reports (01/27/2021)

Avivagen Inc. reported it has secured a six tonne order for OxC-beta™ Livestock from a new customer in Queretaro City, Mexico.

Coverage Initiated on Biotech 'Improving Drugs Via Prodrug'
Source: Streetwise Reports (01/27/2021)

KemPharm's key near-term catalyst, lead value driver and other pipeline drug candidates are discussed in a ROTH Capital Partners report.

Vir Shares Climb 48% on Initial Phase 1 Chronic Hepatitis B Trial Data
Source: Streetwise Reports (01/26/2021)

Vir Biotechnology shares traded higher after the company reported data from its Phase 1 Chronic Hepatitis B Study that showed VIR-3434 significantly and rapidly reduced hepatitis B surface antigen.

Aurinia Pharma Shares Open at 52-Week High as FDA Approves Adult Lupus Nephritis Drug
Source: Streetwise Reports (01/25/2021)

Shares of Aurinia Pharmaceuticals traded 30% higher after the company reported that the U.S. Food and Drug Administration approved its LUPKYNIS™ (voclosporin) for use in treating adults with active lupus nephritis.

AzurRx Doses First Two People in Expanded Phase 2b Trial of Cystic Fibrosis Patients
Source: Streetwise Reports (01/22/2021)

AzurRx BioPharma shares traded 45% higher after the firm advised it had dosed the first two patients in its Phase 2b OPTION 2 Extension Study of MS1819 for treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis.

Gritstone Oncology Licenses LNP Platform from Genevant Sciences to Develop COVID-19 Vaccine
Source: Streetwise Reports (01/20/2021)

Shares of Gritstone Oncology reached a new 52-week high price after the company advised it entered into a non-exclusive licensing agreement with Genevant Sciences to develop and commercialize self-amplifying RNA vaccines for use against SARS-CoV-2.

Biotech Given Go-Ahead to Proceed with Phase 3 COVID-19 Study
Source: Streetwise Reports (01/20/2021)

Algernon Pharmaceuticals reported that it has been granted approval from the Data and Safety Monitoring Board to conduct a Phase 3 Study of Ifenprodil for SARS-CoV-2.

Aclaris Shares Triple in Value on Positive Topline Data from Phase 2a Rheumatoid Arthritis Trial
Source: Streetwise Reports (01/19/2021)

Shares of Aclaris Therapeutics Inc. soared to a new 52-week high after the company reported positive preliminary topline data from its Phase 2a trial of oral ATI-450 for moderate to severe rheumatoid arthritis.