Our Next President and Healthcare Policy

Source: BioSpace, Karl Thiel (10/30/12)

"Both candidates paint this as a vitally important election between leaders with starkly different views of policy and governing. So if the fate of the life sciences potentially hangs in the balance, what are we likely to see in the months ahead?"

Here we sit less than a week from the election. You probably made up your mind long ago about which way you'll vote, and if you're anything like me, your decision is about more than one issue or even one area of policy. But whether or not things go your way--right now it's a toss-up who will win--it makes sense to think about what the future will bring. Both candidates paint this as a vitally important election between leaders with starkly different views of policy and governing. So if the fate of the life sciences potentially hangs in the balance, what are we likely to see in the months ahead?

A Repeal of Obamacare? This is really unlikely. President Obama, obviously, intends to stand by his signature legislation if reelected. Governor Mitt Romney, meanwhile, would need a majority vote in both the House and Senate to get a repeal. While he'd be likely to find that support from the House, winning a repeal vote from the Senate will very likely mean gaining the votes of Democrats and/or Independents. Moreover, he'd probably have to win a filibuster-proof supermajority of 60 Senators to really push through a repeal, which is a longshot at best.

FDA Funding Up or Down? This summer, the Food and Drug Administration Safety and Innovation Act was signed into law. It extends user fee programs for drugs and medical devices, and establishes a similar authority for generics and biosimilars. This seemed to make just about everyone happy--it received lopsided support in Congress and won praise from pharmaceutical, biotech, and device industry organizations.

Those user fees help the agency hire more reviewers, inspectors, and other staff. But the law also requires more from the agency in terms of inspections and action, and not everyone thinks the money being directed at hiring more employees will be sufficient. . .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.

Abiomed Shares Gain 8% After Firm Announces Record Q3 Revenue of $232 Million
Source: Streetwise Reports (01/28/2021)

Shares of cardiac medical device maker Abiomed Inc. traded higher after the company reported record revenue for Q3/21 despite the impact from COVID-19.

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.

Imagin Medical Is Bringing Cystoscopy into the 21st Century
Source: Dr. KSS, MD, PhD, for Streetwise Reports (01/21/2021)

Dr. KSS, MD, PhD, editor-in-chief of PubBio.co, profiles a small cap that "is poised to bring to clinic a next-generation of must-have cystoscopy equipment."

A Solace to the Stress of the SolarWinds Hack
Source: Jack Hurley for Streetwise Reports (01/21/2021)

Against the backdrop of the massive SolarWinds hack, value investor Jack Hurley discusses his investment thesis for Leonovus Inc, whose products provide an "ironclad level of cybersecurity."