Helping you make wiser investment decisions

Pharmaceuticals, health and wellness

AstraZeneca signed up to deliver U.K. shots first. Now it aims to supply COVID-19 vaccine worldwide: report

AstraZeneca, partnered with the University of Oxford on a leading COVID-19 vaccine candidate, has already inked a deal to supply millions of doses to the U.K. Now, the drugmaker is scouting for partnerships to make the potential vaccine available worldwide. The drugmaker is in talks with global groups and governments “with the aim of delivering a safe, effective and globally accessible vaccine as quickly as […]

Deciphera fills in where Blueprint falls short with early FDA nod in rare stomach cancer

In less than 24 hours, the FDA handed out one rejection and one thumbs-up to two rival drugs for a rare stomach cancer. On the heels of turning down Blueprint Medicines’ Ayvakit as a therapy for heavily pretreated patients with gastrointestinal stromal tumors (GIST), the FDA has green lit Deciphera Phamaceuticals’ Qinlock (ripretinib) as the first […]

Bristol Myers Squibb finally breaks into first-line lung cancer with Opdivo-Yervoy nod

It’s been a long road for Bristol-Myers Squibb’s Opdivo, but the immuno-oncology star finally has a place in the lucrative market for previously untreated non-small cell lung cancer. The FDA Friday approved Opdivo alongside fellow BMS checkpoint inhibitor Yervoy for first-line patients whose tumors test positive for biomarker PD-L1, giving patients a chemo-free option and […]

After sneak peak at early data, Operation Warp Speed head Slaoui ‘confident’ in COVID-19 vaccine by year’s end

It’s full speed ahead on a COVID-19 vaccine at the highest levels of U.S. government. After press reports and Senate testimony described a “Manhattan Project” for novel coronavirus vaccines, President Donald Trump officially unveiled the program and its leaders on Friday. At a Rose Garden event, Trump named former GlaxoSmithKline vaccine head Moncef Slaoui and four-star general Gustave […]

Bristol Myers snags Pomalyst green light in rare AIDS-related skin lesions

After getting the cold shoulder from regulators over its filing for CAR-T candidate ide-cel earlier this week, Bristol Myers Squibb at least has good news now for one of the products it acquired through its $74 billion Celgene buyout. The FDA green-lighted Pomalyst in patients with Kaposi sarcoma, a rare form of cancer that usually presents […]

HHS whistleblower Bright cites safety risks in questioning coronavirus vaccine timeline

Amid widespread speculation on COVID-19 vaccine timelines, former Biomedical Advanced Research and Development Authority (BARDA) chief turned whistleblower Rick Bright, M.D., joined the skeptics discounting the idea that immunizations could be made available in 12 to 18 months.  At a House of Representatives hearing focused on Bright’s whistleblower complaint against the Trump administration, he told lawmakers current vaccine expectations require everything going […]

Sanofi CEO: Up-front funding wins U.S. first access to coronavirus shot

As questions swirl over equitable access to COVID-19 vaccines, Sanofi CEO Paul Hudson has laid out some of his company’s plans should its program succeed, Bloomberg reports. A key point? The U.S. will be first in line. Shortly after the remarks made their rounds, representatives for the company said that the distribution plans are more […]

Gilead inks deals with generics makers to supply COVID-19 therapy remdesivir for 127 countries

After scoring an early authorization for its COVID-19 therapy remdesivir, Gilead Sciences has been on the hunt for manufacturing partners to help boost production. Through a series of licensing agreements with generics makers, Gilead has taken the first steps to build that network.  Gilead signed nonexclusive licensing agreements with five generic drug makers operating in India and […]

Novavax scores $384M deal, CEPI’s largest ever, to fund coronavirus vaccine work

After winning a small grant for early vaccine work in March, Novavax just won the largest-ever investment from CEPI, a global coalition aiding COVID-19 vaccine development.  The grant of up to $384 million from the Coalition for Epidemic Preparedness Innovations will fund Novavax’s COVID-19 vaccine testing through phase 2, plus early work to scale-up manufacturing. The funding follows a $4 million award back in March.  […]

Federal agency finds ‘reasonable grounds to believe’ Rick Bright’s whistleblower claims: NYT

Only days after former BARDA chief Rick Bright filed a whistleblower complaint alleging retaliation by the Trump administration, the U.S. Office of the Special Counsel has recommended his temporary reinstatement, the New York Times reports. The agency found “reasonable grounds to believe” HHS officials were retaliating against Bright when they re-assigned him to a new public-private […]

Gilead hit with Iranian cyberattack for role in COVID-19 response: report

Gilead Sciences has captured worldwide attention since its antiviral drug remdesivir was approved late last week as the first therapy to treat COVID-19. Now, as bad actors target companies at the head of the spear in the novel coronavirus response, Gilead might have found itself in their sights. Gilead was recently hit with an Iranian “password spraying” attack […]

Roche’s Kadcyla wins NICE backing in early breast cancer use

Unlike its first U.K. reimbursement negotiations, Roche’s HER2 antibody-drug conjugate sailed through a new NHS funding review that now puts it in line for earlier breast cancer use. Kadcyla has won National Institute for Health and Care Excellence (NICE) backing for routine NHS coverage to prevent HER2-positive breast cancer from returning after surgery in the […]