Author's posts
New GI Treatment Voquenza Approved For Helicobacter Pylori Infection; Other Indications May Follow
In May, FDA approved Voquenza (vonoprazan fumarate), in combination with anti-biotics, for H.pylori infection. In March, Phathom Pharmaceuticals submitted an NDA to FDA for the use of vonoprazan as a treatment for the healing of all grades of erosive r…
ICER’s Favorable Assessment Of Bluebird Bio’s Gene Therapy Zynteglo May Have Important Pricing And Reimbursement Implications
A June FDA advisory committee will be a huge moment for struggling bluebird bio. A positive decision by FDA coupled with the favorable ICER assessment could lead to a robust cash flow. Being considered cost-effective may offer Zynteglo a distinct advan…
FDA Commissioner Califf Says Business Of Health Is Booming In U.S. But Patients’ Outcomes Aren’t Improving
“I think that is an American problem right now,” Califf asserted, noting that the business of healthcare has never been better, but the outcomes of the people the system is trying to serve are not getting better.
Covid-19 Has Made Tuberculosis Even More Of A Forgotten Pandemic
The impact of the Covid-19 pandemic goes well beyond the disease itself. It extends to neglected tropical diseases, as well as the big three infectious diseases malaria, HIV/AIDS, and tuberculosis, by crowding out R&D funds and disrupting non-Covid-19 …
CMS’s Decision To Restrict Coverage Of Aduhelm Very Unlikely To Impact Other Accelerated Approvals In Other Classes
One could argue that CMS is restricting coverage of a particular instance of an accelerated approval and a set of potential approvals for a narrowly defined sub-class of beta amyloid-directed monoclonal antibodies. And this particular decision has no u…
Eli Lilly’s Weight Loss Drug, Tirzepatide, Shows Promising Phase 3 Results: If Approved, Next Hurdle Would Be Reimbursement
Eli Lilly’s weight loss drug, tirzepatide, showed substantial potential in a large Phase 3 study, the results of which were reported on April 28th. If tirzepatide gets approved, it could become a blockbuster. But, this isn’t a sure thing. It will have …
Insulin Bill Would Help Diabetic Patients By Lowering Out-Of-Pocket Costs, But It Wouldn’t Bring Prices Down
The insulin bill would help insured diabetic patients by lowering out-of-pocket costs at the pharmacy counter, but it would not bring prices down. Contrary to what many in the media say, as well as several top Democrats who support the bill, this legis…
Dr. Paul Farmer’s Legacy Was To Transform The Field Of Global Public Health
Farmer left behind a “generational legacy” that forever changed the way we view global public health. He helped alter the top-down approach of healthcare assistance to one of localized aid, working with local governments and medical professionals to de…
Bluebird Bio Has Serious Cash Flow Concerns; Inability To Strike Reimbursement Deals In Europe Partly To Blame
Bluebird bio’s exit from Europe last year signals rough seas ahead for gene therapy developers, who are trying to gain market access for their products. Evidently, bluebird bio couldn’t strike deals with European payers for its EMA-approved gene therap…
Covid-19 Fallout: Ruinous Effects Of Politicization Of Public Health Agencies, Such As The CDC
Public health has been hijacked by politics, and it has occurred throughout the Covid-19 pandemic, during both the Trump and Biden Administrations. In order to renew the public’s trust in public health, it’s vital that agencies such as the CDC be as ap…
