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Tuesday, March 2, 2021

Applied DNA, Evvivax Initiate Phase I Trial of LinearDNA™ COVID Vax for Cats

 - Vaccine Candidate Previously Demonstrated Antibodies and T-cell Response in Mouse Models -

- Clinical Trial to Serve as Initial Validation of LinearDNA Platform in Large Mammals with Potential Advantages in Manufacturing, Storage, and Distribution over Other Vaccines -

https://www.biospace.com/article/releases/applied-dna-and-evvivax-initiate-phase-i-of-clinical-trial-to-evaluate-lineardna-covid-19-vaccine-candidate-for-feline-veterinary-market/

Eyenovia: FDA Accepts MydCombi Application

 Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for MydCombi™, a unique fixed combination mydriatic (pupil dilation) agent for potential use in the over 80 million comprehensive eye exams currently conducted each year in the United States. If approved, MydCombi would be the first microdosed ocular therapeutic applied with a high precision smart delivery system, the Optejet®.

“We are excited to see MydCombi, with our proprietary microdose array print technology, move closer to potential approval, with an expected PDUFA date in the fourth quarter of this year. MydCombi may address many of the current shortfalls of pupil dilation, which according to market research may be responsible for millions of people choosing not to undergo a comprehensive eye exam,” said Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia.

https://www.businesswire.com/news/home/20210302005329/en/Eyenovia-Announces-FDA-Acceptance-of-the-MydCombi-NDA

Cerecor sees shares jump on COVID-19 readout, seeks EUA

 Cerecor, which has a market cap of less than $400 million and some small, low-key raises and pacts over the years, saw its shares bounce around 15% premarket this morning on new phase 2 data for its experimental COVID-19 drug.

The asset, a monoclonal antibody known as CERC-002, saw top-line data at the start of the year but now has more details. The test breaks down like this: It saw all patients hospitalized with COVID-19 associated pneumonia and mild to moderate acute respiratory distress syndrome.

A total of 83 patients were randomized to get the standard of care at the sites plus either a single dose of 1,200 mg of CERC-002 or placebo subcutaneously; 62 patients were included in the intention-to-treat (ITT) analysis of the primary endpoint.

The trial hit this endpoint, which was the proportion of patients alive and free of respiratory failure over the 28-day study period, compared to placebo, though the p-value was very close, at 0.044, for the ITT population.

The drug performed best in patients over 60 (34 in total), though again, the statistical significance here was tight at a p-value of 0.042. The drug was tested alongside steroids and Gilead’s remdesivir.

At both the 28-day and the 60-day final time points, the biotech said “approximately 50% trend in mortality reduction (22.5% vs 10.8%) was observed.” The company did not say whether it had tested the drug on newer variants of the SARS-CoV-02 virus, which could dampen the affect of mAbs.

Cerecor has asked the FDA for both breakthrough-therapy and fast-track tags for the med in COVID-19 and plans to meet with the FDA “to discuss the potential path” to an emergency use authorization and approval.

https://www.fiercebiotech.com/biotech/little-cerecor-sees-shares-jump-covid-readout-seeks-eua-though-margins-success-are-thin

Merck, Johnson & Johnson partner on COVID-19 vaccine manufacturing

 Merck & Co. is teaming up with rival Johnson & Johnson to help manufacture its recently-approved COVID-19 vaccine as the nation seeks to eliminate the virus in part through a mass inoculation effort. Two White House officials confirmed the partnership to Fox News.

Johnson & Johnson previously agreed to supply the U.S. with 100 million doses of its one-shot vaccine by June, but White House officials said the company had struggled with supply and material issues.

Last week, ahead of the FDA's emergency use authorization, Jeff Zients, White House COVID-19 coordinator, had said the Biden administration was working to further "accelerate the pace and timeframe" for which the company delivered the agreed-upon supply after learning that Johnson & Johnson had fallen behind in their production schedule. 

President Joe Biden is expected to formally announce the partnership between rivals Merck and Johnson & Johnson later Tuesday.

https://www.foxnews.com/health/merck-johnson-johnson-partner-on-covid-19-vaccine-manufacturing

Jefferies Downgrades FibroGen (FGEN) to Hold

 Analyst Michael Yee cuts from Buy.

https://www.streetinsider.com/Analyst+Comments/UPDATE%3A+Jefferies+Downgrades+FibroGen+%28FGEN%29+to+Hold/18060706.html

MorphoSys AG preliminary results for fiscal year 2020 exceed guidance

 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) today announces that according to the analysis of the preliminary results during the ongoing year end closing process, MorphoSys' outlook has been exceeded.

Group revenues for 2020 are expected to amount to EUR 327.7 million and therefore slightly above the upper end of the guidance range from EUR 317 to 327 million. Group revenues include EUR 18.5 million (USD 22.0 million) revenues from product sales of Monjuvi as well as EUR 42.5 million for royalties on net sales of Tremfya. EBIT (Earnings before Interests and Taxes) for 2020 is expected to be EUR 27.4 million, and therefore significantly above the upper end of the guidance range of EUR 10 to 20 million. Expenses for research and development are expected to amount to EUR 141.4 million and therefore slightly above the guided range of EUR 130 to 140 million.

https://www.marketscreener.com/quote/stock/MORPHOSYS-AG-436425/news/MorphoSys-nbsp-Ad-hoc-MorphoSys-AG-preliminary-results-for-the-fiscal-year-2020-exceeding-guidanc-32582135/

Austria and Denmark break ranks with EU to produce vaccines with Israel

 The move by the two EU member states comes amid rising anger over delays in ordering, approving and distributing vaccines that have left the 27-member bloc trailing far behind Israel’s world-beating vaccination campaign.

Austrian Chancellor Sebastian Kurz said while the principle that the EU procures vaccines for member states was correct, the European Medicines Agency (EMA) had been too slow to approve them and lambasted pharmaceutical companies’ supply bottlenecks.

“We must therefore prepare for further mutations and should no longer be dependent only on the EU for the production of second-generation vaccines,” the conservative chancellor said in a statement on Tuesday.

Danish Prime Minister Danish Mette Frederiksen was also critical of the EU’s vaccine programme.

“I don’t think it can stand alone, because we need to increase capacity. That is why we are now fortunate to start a partnership with Israel,” she told reporters on Monday.

When asked if Denmark and Austria wanted to take unilateral action in obtaining vaccines, Frederiksen said: “You can call it that.”

Kurz and Frederiksen are due to travel to Israel this week to see Israel’s rapid vaccine roll-out up close.

SIDE ORDERS

A growing number of EU countries have placed side orders for doses of vaccines from Russia and China, even though the EMA has yet to rule on whether they are both safe and effective.

Slovakia on Monday ordered 2 million doses of Russia’s Sputnik V vaccine. It expects half to arrive this month as it looks to step up vaccinations amid a surge in COVID-19 infections and deaths.

The neighbouring Czech Republic - currently facing the worst COVID-19 outbreak of any EU country - is also considering ordering Russia’s Sputnik V.

Hungary, meanwhile, has taken delivery of a vaccine developed by China’s Sinopharm, with Prime Minister Viktor Orban announcing on Sunday that he had received the shot.

FIRST MOVERS

Kurz said Austria and Denmark, as members of the First Mover Group, would work with Israel on vaccine production against mutations of the coronavirus and jointly research treatment options.

Experts reckon that Austria will have to vaccinate two-thirds of the population, equivalent to more than 6 million people annually, in the coming years, Kurz said.

He said he would inspect pharmaceutical companies with domestic production including Pfizer, Novartis. Polymun and Boehringer Ingelheim as well as speak to leading scientists and physicians on Tuesday.

Germany last month set up a task force to address bottlenecks in the supply chain of vaccine production and boost local manufacturing to protect itself against future pandemics.

https://www.reuters.com/article/us-health-coronaviurs-vaccine-europe/austria-and-denmark-break-ranks-with-eu-to-produce-vaccines-with-israel-idUSKBN2AU11D