Prescribed Reading: More backlash to drug pricing
A weekly guide to the goings-on in the biopharma industry.
Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
In case you missed it
- Cost watchdog says MS drugs are priced too high
- Biotech execs talk payers, investors and challenges
- Heat Biologics acquires Pelican Therapeutics for I/O pipeline
Mergers & analysis
The negotiation happening this week was in the Oval Office – Democratic congressmen brought a draft bill to the President that would allow the government to directly negotiate drug prices under Medicare.
The idea of negotiating drug prices was floated by the President himself during the campaign, but he has pulled back from the idea since taking office.
Yet, that wasn’t the only talk of drug pricing this week. Gilead executives drew the ire of pharmacy benefit manager Express Scripts by accusing the middleman of keeping drug prices inflated.
A top executive at Express Scripts has challenged the hepatitis C drugmaker to lower the wholesale acquisition cost on all of its hepatitis C drugs to $50,000 for a course of treatment, from the current cost of $89,000. The PBM even went as far as to ask Gilead to reimburse the difference retroactively.
Meanwhile, a group of senators pressed Marathon Pharmaceuticals on its ballsy pricing of the steroid that was recently approved to treat the rare disease Duchenne muscular dystrophy. This latest bad pricing behavior has once again raised concerns that pharma companies are gaming the system and abusing the incentives under the Orphan Drug Act.
A few high profile pharma executives gathered in Washington this week to talk about the prospects of immunotherapy treatments. Leaders from both Novartis and Merck & Co conceded checkpoint inhibitors still can’t treat the entire population of cancer patients and there needs to be more work done on the biomarker side to better understand the science behind these high-profile drugs.
Meanwhile, companies and scientists are keeping an eye on data that will be coming out of two meetings in the next month – the American College of Cardiology conference that begins on March 17 and the American Association of Cancer Research conference in early April, both in Washington, DC.
People are watching some of the preclinical data for Bluebird bio’s CAR-T therapy, as well as OncoMed Pharmaceuticals’ TIGIT inhibitor, an emerging immunotherapy target.
PTC Therapeutics refuses to give up on getting ataluren approved for Duchenne muscular dystrophy in the U.S. despite being rejected by the FDA last year and the agency refusing to revisit the application.
The company announced the acknowledgement by the FDA of PTC’s filing over protest for Translarna as a treatment for DMD. It was a rare regulatory path that is unlikely to get PTC the result it desires – Translarna will likely be rejected again because it is not effective.
Other companies have taken this path in the past and it did not help them gain approval either.
Meanwhile, Seattle Genetics finally got to move forward with two Phase 1 trials of its blood cancer drug vadastuximab talirine after the Food and Drug Administration lifted a partial clinical hold that the agency put on the drug in December due to safety concerns stemming from four patients deaths from hepatotoxicity.
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