Scuttled by a bad IV bag? A small biotech is slapped with a hold following three SAEs

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Contents

July 7, 2022 07:23 AM EDT

Scut­tled by a bad IV bag? A small biotech is slapped with a hold fol­low­ing three SAEs

John Carroll

Editor & Founder

Shares of DiaMedica $DMAC are being savaged Thursday morning after the biotech put out word that the FDA has slapped a clinical hold on its sole clinical asset following a series of adverse events among patients enrolled in their Phase II/III study.

The Minneapolis-based biotech floated an IPO on Nasdaq in 2018 on its hopes for DM199, which they believed would help blood flow in patients suffering from acute ischemic stroke and chronic kidney disease by targeting low levels of KLK1.

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Richard Gonzalez, AP Images

July 7, 2022 11:57 AM EDT

Sen­a­tors again point to Ab­b­Vie as a poster child for re­form. On­ly this time Dems are tar­get­ing a low, low tax rate

John Carroll

Editor & Founder

In the first 4 years after AbbVie split away from Abbott with its big cash cow Humira in tow back in 2013, the pharma giant paid an effective tax rate that ranged anywhere from 20% to 25%. But after dipping a bit in 2017, their tax rate plunged into single digits, rising to 12.5% last year — still far below the US corporate tax rate of 21%.

Sales in 2021 hit $56 billion, which a new Senate Finance Committee report makes clear depended heavily on the regular price increases pushed for Humira, which accounts for a 470% price hike over the time since the drug was first approved.

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July 6, 2022 07:24 AM EDTUpdated 07:42 AM

The 2022 End­points 11 is com­ing. Do you know a biotech that should be on the list?

John Carroll

Editor & Founder

It’s time for some fun.

Over the past 20 years or so, I’ve made it my mission to hunt down some of the most promising private biotechs in the industry to feature in an annual report I now call the Endpoints 11. And we’re back on track for the next big round of awards.

Every now and then I’m asked what the basic criteria is for inclusion. It’s simple. If you’re out to do big things in drug development, break new ground, go to that proverbial next level with an outstanding team, promising science and marquee backers — or promise to make a colossal noise if you fail — then you should make the short list.

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July 7, 2022 02:30 PM EDT

No­vo Nordisk work­ers in Ko­rea protest af­ter break­down in salary and perks ne­go­ti­a­tions — re­port

Paul Schloesser

Associate Editor

While inflation is up globally, a few pharmas have been getting hit by union complaints over pay raises that are below inflation rates. Now another Big Pharma is facing a potential strike.

As first reported by Korea Biomedical Review, 100 unionized Novo Nordisk Korea workers gathered in front of the company’s headquarters in Seoul earlier Thursday to protest a failed end to wage negotiations and cuts to some employee incentives. The union has a total of 118 Novo Nordisk employees.

Reality star and talk show host Karamo Brown hosts discussions about HIV prevention in a new ViiV campaign (Photo courtesy ViiV Healthcare)

July 7, 2022 02:12 PM EDT

Vi­iV boosts HIV pre­ven­tion mes­sag­ing with cam­paigns, celebri­ty spokes­peo­ple and frank con­ver­sa­tions

Beth Snyder Bulik

Senior Editor

ViiV Healthcare is doubling down on HIV prevention. The HIV specialist majority owned by GSK is launching a branded Apretude pre-exposure prophylaxis (PrEP) campaign with celebrity host Karamo Brown, along with two concurrent unbranded initiatives.

Brown, one of the popular “Queer Eye” reality stars and host of his own upcoming talk show “Karamo,” opens up the conversation about sex positivity in the new campaign video on the Apretude website. The “People Talk PrEP” series discusses sex, stigma and the new bimonthly HIV preventative with four people who are all taking PrEP medications.

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From a Pfizer warehouse in Memphis, TN. (Photo courtesy of Pfizer)

July 7, 2022 01:55 PM EDTUpdated 02:31 PM

Phar­ma­cists ‘ready to get to work’ af­ter new FDA au­tho­riza­tion al­lows them to pre­scribe Pfiz­er’s Covid-19 an­tivi­ral

In an effort to make Pfizer’s Covid-19 antiviral Paxlovid more accessible, the FDA on Wednesday authorized state-licensed pharmacists to prescribe it, with some limitations. However, the move is getting mixed reviews from health experts who disagree on who’s qualified to write prescriptions.

Despite an overall increase in Paxlovid prescriptions over the last several months, a “substantially lower” amount of pills was dispensed in high-vulnerability zip codes, according to a recent CDC report. That’s because while most Americans live within five miles of a pharmacy, many can’t reach a healthcare provider authorized to prescribe the drug.

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Ying Huang, Legend Biotech CEO

July 7, 2022 10:08 AM EDTUpdated 01:27 PM

UP­DAT­ED: Leg­end scraps tri­al of its fol­low-up au­tol­o­gous CAR-T weeks af­ter clin­i­cal hold was lift­ed

Kyle LaHucik

Associate Editor

Six weeks after getting its clinical hold lifted, Legend Biotech has decided to terminate the Phase I study of its CAR-T targeting CD4+.

The news was tucked into an SEC filing, and Legend confirmed to Endpoints News in an email that the US study of LB1901 was scrapped, as well as a separate investigator-initiated Phase I study in China of a similar product (LCAR-T2C) using the same CAR protein.

Only one patient had been enrolled in Legend’s Phase I study and the biotech never resumed the trial after the February clinical hold was lifted in late-May, a company spokesperson told Endpoints.

Alex Zhavoronkov (L) and Jeffrey Rothstein (Insilico/Johns Hopkins)

July 7, 2022 09:10 AM EDT

As ALS pa­tients unite around Amy­lyx, a new pa­per hints at po­ten­tial drug­gable tar­gets

ALS is a debilitating, universally fatal disease. As motor neurons die, patients lose their abilities to walk, cut their own food, swallow and eventually, breathe. Most patients die within three to five years of symptom onset, and there are few approved treatments that only modestly impact function and survival.

Though patients and advocates have rallied around an experimental drug from Amylyx Pharmaceuticals, currently being reviewed by the FDA, they continue to emphasize how more work needs to be done. Research into ALS pathology remains scant relative to other fields, as scientists have yet to discover a confirmed biomarker that measures patients’ progress and have only identified a handful of genetic targets implicated in the disease.

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July 7, 2022 01:03 PM EDT

Man­u­fac­tur­ing roundup: WuXi con­tin­ues its ex­pan­sion dri­ve with an­oth­er plant open­ing in Changzhou; Swiss biotech nets an­oth­er ac­qui­si­tion

Tyler Patchen

News Reporter

The CDMO WuXi STA has been rapidly expanding over the past year, and its next opening will expand its offering in the peptide sector.

WuXi has opened two new large-scale oligonucleotide and peptide manufacturing facilities at its campus in Changzhou, China, according to the company. However, the financial and employment details have not been disclosed to Endpoints News.

The new 30,000 square-foot facility for oligonucleotide development and manufacturing contains four oligonucleotide production lines and more than 20 small- to mid-scale production lines that should increase the overall manufacturing capacity of a single synthesis run from 1.9 mol to 6.0 mol.

July 7, 2022 02:16 PM EDT

Africa strikes deal with Pfiz­er for Covid-19 an­tivi­ral — re­port

As the FDA looks to make Pfizer’s Covid-19 antiviral more accessible in the US, Africa’s CDC has reportedly struck an agreement with the pharma giant to increase supplies across the continent.

The health agency has reached a memorandum of understanding with Pfizer which will allow African countries to access Paxlovid at cost, according to a Reuters report. 

The news comes just a few months after researchers with the Drugs for Neglected Diseases Initiative reported that they were denied access to Paxlovid for use in a large study in 10 African countries in a variety of settings and in some combinations with other therapies. Pfizer allegedly told the researchers that it already had plans to conduct similar trials, according to a Nature report. 

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