The Labor Department said on Monday the White House Office of Management and Budget had completed its regulatory review of the rule known as an emergency temporary standard. The White House said in September the rule would cover more than 80 million private-sector employees.
- Third quarter 2021 net revenues of $52.1 million; net loss of $4.4 million and diluted loss per share of ($0.37) --
-- Third quarter adjusted non-GAAP EBITDA of $16.6 million and adjusted non-GAAP diluted earnings per share of $1.01 --
-- FDA approves supplemental new drug application for Purified Cortrophin™ Gel for the treatment of certain chronic autoimmune disorders; full-scale launch planned for early Q1 2022 --
-- Acquisition of Novitium Pharma LLC is expected to close in November 2021 --
-- Launched Nebivolol Tablets simultaneously from two manufacturing sites --
ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ: ANIP) today announced business highlights and financial results for the three months ended September 30, 2021.
Third Quarter and Recent Business Highlights:
The U.S. Food and Drug Administration (FDA) approved the Company’s supplemental new drug application (sNDA) for Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) (Cortrophin Gel) for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis, in addition to excess urinary protein due to nephrotic syndrome.
The Company plans full-scale Cortrophin Gel launch in the first quarter of 2022.
The acquisition of Novitium Pharma LLC is expected to close in November 2021; and
Launched Nebivolol Tablets simultaneously from two manufacturing sites. Nebivolol is the generic version of the reference listed drug (RLD) Bystolic®.
Third Quarter 2021 Financial Highlights:
Net revenues were $52.1 million compared to $53.0 million in Q3 2020.
GAAP net loss was $4.4 million and diluted GAAP loss per share was ($0.37).
Adjusted non-GAAP EBITDA was $16.6 million.
Adjusted non-GAAP diluted earnings per share was $1.01.
Cash and cash equivalents were $15.3 million, net accounts receivable was $106.7 million, and face value of debt was $202.9 million as of September 30, 2021.
"The approval of Cortrophin Gel marks a critical milestone for ANI. During the past five years, we have made a significant investment in establishing and updating manufacturing processes and ensuring a sustainable, U.S.-based supply chain for this important product. Physicians now have a much-needed treatment option for patients with acute exacerbations of multiple sclerosis and rheumatoid arthritis, as well as nephrotic syndrome, who can benefit from a repository corticotropin. We have built an experienced rare disease leadership team to drive a full-scale commercial launch early in the first quarter of 2022," said Nikhil Lalwani, President and CEO of ANI.
A little known biotech company, ABVC BioPharma Inc., soared in U.S. premarket trading amid increasing chatter on trading social network StockTwits.
The Fremont, California-based firm’s shares jumped as much as 930% in premarket trading and the stock was up 254% at 10:17 a.m. in New York. More than 50 million shares had been traded in the stock by that time, compared to its 12-month daily average of around 660,000.
At the end of trading on Friday, the stock had a market capitalization of $68.1 million. That now stands at around $242 million.
The company has filed for $50 million mixed securities shelf on Friday. It announced restructuring of a joint venture last month and filed for patent applications for some medicines treating depression and attention-deficit hyperactivity disorder in September.
https://finance.yahoo.com/news/tiny-u-biotech-jumps-930-142156758.html
The London-listed company also said that under the deal, which is expected to close in the fourth quarter of 2021, Covis will also cover certain ongoing development costs related to the medicines.
AstraZeneca, which has several new medicines in its pharmaceutical pipeline, including COVID-19 drugs and a vaccine, expects the agreement to help sharpen its focus on priority medicines in its respiratory and immunology portfolio.
Covis had previously acquired the rights to other respiratory medicines Alvesco, Omnaris and Zetonna from AstraZeneca in 2018.
Eklira and Duaklir, used to treat chronic obstructive pulmonary disease (COPD) or smokers' lung, had generated revenues of $143 million for AstraZeneca in geographies covered by a previous deal when the drugmaker had bought those rights.
More than 24,000 city workers will be forced to stay home Monday when Mayor de Blasio’s COVID-19 vaccine mandate goes into effect, raising concerns about the impact on emergency response times in the five boroughs.
“That’s the question everyone’s asking: How many more minutes will it take to respond, how many more lives will be lost as a result?” one Manhattan patrol cop told The Post on Sunday.
“There’s a correlation between time and mortality that a lot of people in City Hall don’t understand. Unfortunately, the only way they’re going to get the message is by seeing the numbers rise and rise. And seeing how crime is already on the rise, they really need to look at their priorities and decide if this is a good idea, and they need to do it soon.”
Despite a 14 percent bump in the number of city government workers who have gotten at least one shot since de Blasio announced the mandate on Oct. 20, thousands of others would still rather be placed on unpaid leave than get jabbed.
That includes, roughly, more than 8,000 cops, 3,700 FDNY employees — including smoke eaters and EMS — and nearly 2,000 sanitation workers, according to City Hall statistics.
The latest data from City Hall showed that 91 percent of the city workforce has adhered to the mandate to get the first dose of the COVID-19 vaccine but that 24,200 are unvaxxed, as of 8 p.m. Saturday.
Members of the FDNY have been among those vehemently opposed to de Blasio’s order, which included a Friday 5 p.m. deadline for a $500 bonus for getting the shot.
On Saturday, 26 fire companies across the five boroughs were shuttered due to manpower shortages — with at least 20 still out of action Sunday.
Thousands of unvaccinated NYPD employees will be allowed to continue to remain on the job, but only if they applied for medical or religious exemptions which will be reviewed by the NYPD Equal Employment Opportunity Division.
But the impact on city services has already begun.
On Friday, Ladder Co. 45 in Washington Heights had to respond to a building fire on W. 186th Street without Engine Co. 93, which was undermanned and out of service.
Fire officials confirmed that ladder company firefighters had to run into the burning building to save two people — before any water was sprayed on the flames because the nearest backup engine company was 11 minutes away, fire officials confirmed.
“They’re lucky to be alive,” one emergency response expert said, calling the rescue “incredibly dangerous.”
That source added, “It’s forcing the guys and gals who are on duty to take extra risks here. Firefighting is a very coordinated, a very multitasked operation.”
In fiscal year 2021, the emergency response time average was 5 minutes and 23 seconds, while response time for structure fires was an average of 4 minutes, 52 seconds. For the NYPD, response time to critical calls clocked in at 6 minutes, 42 seconds for this same week in 2019, according to city data.
FDNY sources said desperate brass have ordered firefighters who went on duty Sunday night to stay at their firehouses until it can be staffed — with 2,000 smoke eaters currently on medical leave.
More than half of those have yet to be vaccinated, the sources said.
Meanwhile, sources said 700 cops on non-patrol assignments are being dispatched to city street beats to fill in the gaps.
“They want to maintain the staffing levels of patrol,” one cop told The Post, “to handle emergencies and take care of the public.”
The re-assigned officers will spread out over three shifts.
The impact on city residents goes beyond first-responders, with sanitation workers now working overtime to tackle mounting track piles.
“To help meet service needs, sanitation workers are working 12-hour shifts and will be working Sundays as needed, including today to continue our work picking up trash and recycling,” department spokeswoman Belinda Mager said in an email Sunday. “
The Police Benevolent Association, the NYPD’s largest police union, mounted legal challenges to the mandate, though so far to no avail.
Hundreds of city workers have also taken to the streets, last week protesting the mandate at a rally outside Gracie Mansion in Manhattan.
The mayor issued an ultimatum when he announced the mandate, giving all city workers until 9 a.m. Monday to get at least one COVID-19 shot or get furloughed and go home.
https://nypost.com/2021/10/31/nyc-vax-mandate-will-force-24k-city-workers-to-stay-home-stats/
A declassified U.S. intelligence report saying it was plausible that the COVID-19 pandemic originated in a laboratory is unscientific and has no credibility, Chinese foreign ministry spokesman Wang Wenbin said in a statement on Sunday.
The updated U.S. intelligence briefing, published on Saturday, said that a natural origin and a lab leak were both plausible hypotheses to explain how SARS-CoV-2, the virus responsible for COVID-19, first infected humans, but that the truth may never be known.
In a response Sunday on the website of China's Ministry of Foreign Affairs, Wang said "a lie repeated a thousand times is still a lie", adding that U.S. intelligence services "have a reputation for fraud and deception."
"The tracing of the origins of the novel coronavirus is a serious and complex issue that should and can only be researched through the cooperation of global scientists," he said.
China has consistently denied allegations that the virus was leaked from a specialist laboratory in the city of Wuhan, where COVID-19 was first identified at the end of 2019.
Wang also repeated China's calls for the United States to open up its own laboratory at Fort Detrick to international experts.
A joint study by China and the World Health Organization published this year all but ruled out the theory that COVID-19 originated in a laboratory, saying that the most likely hypothesis was that it infected humans naturally, probably via the wildlife trade.
Critics said the study failed to investigate the Wuhan labs and did not examine the raw data required to understand the virus's early transmission routes.
The WHO last month established a new Scientific Advisory Group on Pandemic Origins (SAGO) and called on China to supply the raw data to help any new investigation. China has declined, citing patient privacy rules.
In an open letter to WHO Director General Tedros last week, a group of scientists critical of the organisation said that although they welcomed a new investigation into COVID-19's origins, the proposed composition of the SAGO panel lacked the necessary skills and impartiality.
