Fierce Biotech

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Updated: 5 hours 52 min ago

COVID-19: Bio researchers race to repurpose everything from antiviral to anticancer discoveries

7 hours 17 min ago
Several academic institutions and biotech startups are stepping up with ideas of how to take existing research and pivot it towards potential solutions to COVID-19. It may take several months for these efforts to bear fruit, at which point this pandemic may have ended, but the scientists leading the charge believe their discoveries will help fend off future outbreaks.

ACC: Regeneron's Praluent sidekick cuts cholesterol in half—even in hard-to-treat patients

11 hours 8 min ago
Regeneron revealed last summer that its latest cholesterol fighter, evinacumab, cut “bad” cholesterol in half for patients with a rare genetic disorder. Now, in full results presented virtually at the annual meeting of the American College of Cardiology (ACC), together with the World Congress of Cardiology, the drug did even better in a group of particularly hard to treat patients.

Battelle deploys decontamination system for reusing N95 masks

11 hours 43 min ago
Battelle received an emergency go-ahead from the FDA over the weekend to deploy its decontamination system for personal protective equipment, allowing healthcare workers to clean and reuse scarce N95 respirator masks.

Not so fast using CPAPs in place of ventilators. They could spread the coronavirus

12 hours 35 min ago
The limited supply of ventilators is one of the chief concerns facing hospitals as they prepare for more COVID-19 cases. In Italy, where hospitals have been overwhelmed with patients in respiratory failure, doctors have had to make difficult life-or-death decisions about who gets a ventilator and who does not.

J&J, BARDA commit $1B to COVID-19 vaccine R&D

13 hours 22 min ago
Johnson & Johnson has joined with a U.S. government agency to commit $1 billion to development of a COVID-19 vaccine. J&J plans to have a vaccine in the clinic by September, win emergency use authorization early next year and add capacity to make more than 1 billion doses. 

COVID-19 causes Moderna to pause a clutch of clinical trials

15 hours 11 min ago
Moderna has become the latest company to hit pause on clinical trials in response to the COVID-19 pandemic. The biotech, which is leading efforts to develop a COVID-19 vaccine, is pausing enrollment in some infectious and rare disease trials while continuing to try to add patients to its cancer studies.

Aveo gives up on ficlatuzumab in acute myeloid leukemia, citing COVID-19

16 hours 25 sec ago
Back in 2012, Aveo announced that its second most advanced asset, ficlatuzumab, had flopped in a midstage cancer test; for years, we heard nothing about this drug.

GigaGen jumps into COVID-19 arena with polyclonal antibodies

Sun, 03/29/2020 - 19:05
Mining the blood of recovered patients for treatments during a pandemic isn’t a new idea. Takeda and Grifols are already doing it, working on antibody-rich drugs made from the plasma of patients who have fought off COVID-19 infection. GigaGen thinks its approach could be even better.

ACC: MyoKardia's mavacamten reduces heart stress signs in targeted biomarker study

Sun, 03/29/2020 - 13:11
The former Fierce 15 winner delivered new cardiac biomarker data showing its late-phase mavacamten compound can help improve signs of heart stress and injury in hypertrophic cardiomyopathy.

ACC: 10-year coronary stent outcomes similar to bypass surgery, but less durable

Sun, 03/29/2020 - 09:48
In one of the longest studies to date in high-risk heart disease, researchers found no significant difference in death rates over more than 10 years—as well as in cases of heart attack or stroke—between people that had received a drug-eluting stent for their blocked coronary artery compared with those who underwent standard bypass surgery.

ACC: Medtronic's renal denervation study returns, showing drops in stubbornly high blood pressure

Sun, 03/29/2020 - 07:51
Medtronic is back with new data finally demonstrating the effectiveness of its catheter-based ablation procedure aimed at the kidneys to help lower high blood pressure where multiple medications have failed.

ACC: Edwards’ TAVR safety study holds equal to open surgery after 2 years in low-risk patients

Sun, 03/29/2020 - 05:19
In 2019, Edwards Lifesciences presented data showing that patients undergoing less-invasive, transcatheter aortic valve replacement procedures performed better after one year compared to those who had had open heart surgery. That study continues, and now—at the two-year mark—the data indicates that both sets of patients fare equally well when it comes to risks of stroke, hospitalization and death.

ACC: New owner Novartis presents pooled inclisiran data cutting LDL cholesterol by half

Sat, 03/28/2020 - 11:33
A new, late-phase analysis of the cholesterol-lowering inclisiran—a PCSK9 drug picked up by Novartis through its $9.7 billion acquisition of The Medicines Company—showed that it was able to cut LDL levels by 51% after nearly a year-and-a-half of treatment.

Abbott to ship portable, 5-minute coronavirus tests nationwide

Sat, 03/28/2020 - 10:14
Abbott is launching a rapid coronavirus test able to deliver positive results in as little as five minutes, from a table-top box the size of a small toaster oven.

ACC: Bayer and Merck’s vericiguat leads off virtual meeting with positive phase 3 heart failure data

Sat, 03/28/2020 - 06:17
After teasing positive top-line results last November, a deeper dive into Merck & Co. and Bayer’s heart failure drug vericiguat helped kick off this year’s scientific meeting of the American College of Cardiology, presented virtually as a late-breaking trial.

U.S. agencies to collaborate on wide-scale 3D printing of ventilator parts and medical supplies

Fri, 03/27/2020 - 08:01
Demand for critical medical supplies continues to rise, as does the number of COVID-19 cases, and 3D printers have been seen as a way to help bolster manufacturing capabilities, wherever it is needed. Now, the FDA will be working with government and public-private partners to distribute and evaluate 3D designs and models, in a bid to provide desperately needed hardware and parts.

Preventing Type 1 diabetes by deleting a stress response gene

Fri, 03/27/2020 - 06:45
Scientists at the University of Wisconsin - Madison are proposing a new approach to preventing Type 1 diabetes: by deleting a gene in insulin-producing beta cells that controls the response to stress. When they removed the gene, called IRE1-alpha, in mice engineered to be susceptible to the disease, the beta cells produced insulin normally and evaded attack from the immune system.

Vertex guns for virtual trials but hits pause, sees delays for 'some new study starts'

Fri, 03/27/2020 - 05:32
Vertex is keeping mum on exact details but, as with the rest of its biopharma peers, is seeing trial disruption due to the COVID-19 pandemic.

Big Pharma companies join forces for fightback against COVID-19

Fri, 03/27/2020 - 04:09
A who’s who of leading biopharma companies have joined forces to strengthen the drug industry’s response against the COVID-19 pandemic. Companies including Novartis and Pfizer are contributing to the joint response through actions including the sharing of proprietary compound libraries.

FDA moots virtual AdComms but delays GSK, Intercept meetings

Fri, 03/27/2020 - 03:21
The FDA has expressed an openness to using virtual advisory committee meetings to mitigate the restrictions on face-to-face interactions imposed by COVID-19. However, that openness is yet to translate into action, with the FDA delaying meetings to discuss submissions by GlaxoSmithKline and Intercept Pharmaceuticals rather than having people participate remotely.