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Tuesday, October 26, 2021

Ocugen Stock Strikes Massive Gains Day Ahead Of Key Date

 Shares of Ocugen Inc. 

 (Get Free Alerts for OCGN) surged almost 12.3% in Monday’s regular trading session and another 38.5% in the after-hours session in anticipation of a key event taking place Tuesday.

What Happened: Ocugen's shares saw notable gains on Monday ahead of a key meeting on Tuesday of the World Health Organization’s (WHO) technical advisory group on whether to grant emergency use approval for the COVID-19 vaccine of Ocugen’s partner, India-based Bharat Biotech.

“WHO has been working closely with Bharat Biotech to complete the dossier. The technical advisory group will meet on Oct 26th to consider EUL for Covaxin,” WHO Chief Scientist Soumya Swaminathan said on Twitter recently.

Why It Matters: Ocugen is partnered with Bharat Biotech for the commercialization of Covaxin in the United States and Canada.

The WHO approval would enable the vaccine to be administered in low- and middle-income countries under the COVAX facility. It will also enable people inoculated with Covaxin to travel to other countries without restrictions.

According to Bharat Biotech, Phase 3 trials of Covaxin have demonstrated an efficacy rate of 77.8%. The vaccine was 63% effective against asymptomatic cases and 65% effective in countering the Delta variant of the coronavirus.

The Ocugen stock is also seeing high interest from retail investors and is among the most-discussed stocks on Reddit’s r/WallStreetBets forum.

https://www.benzinga.com/general/biotech/21/10/23550293/ocugen-stock-strikes-massive-gains-day-ahead-of-key-date-what-you-should-know

Lilly Moves Forward With Diabetes, Alzheimer's Drugs

 Eli Lilly & Co. said Tuesday it is proceeding with regulatory steps to seek approval for drugs to treat type 2 diabetes and Alzheimer's disease.

The Indianapolis-based pharmaceutical company said it has submitted for review its tirzepatide drug for type 2 diabetes using a priority-review voucher. Lilly also said it has initiated a rolling submission of its donanemab drug for Alzheimer's disease.

Lilly posted third-quarter revenue of $6.77 billion, a rise of 18% from the year-ago quarter. Earnings declined by 8% to $1.22 a share. Stripping out one-time items, the company's adjusted profit in the quarter was $1.94 a share.

Lilly said it expects full-year adjusted earnings of $7.95 a share to $8.05 a share.

https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-Moves-Forward-With-Diabetes-Alzheimer-s-Drugs-36782411/

Lilly, Pfizer End Program for Tanezumab Pain Drug

 Eli Lilly & Co. and Pfizer Inc. have ended development of a proposed osteoarthritis pain drug following negative feedback from U.S. and European regulators, Eli Lilly said Tuesday.

The Indianapolis drugmaker said the companies have discontinued their global clinical development program for tanezumab, an investigational nerve growth factor inhibitor that they have been collaborating on since 2013.

Eli Lilly said the companies made the decision after receiving a complete response letter from the U.S. Food and Drug Administration, indicating that the agency wouldn't approve their application for tanezumab in its current form.

An FDA advisory committee in March had voted overwhelmingly that the risks of the drug outweighed its benefits, even with a risk-mitigation strategy put forward by the companies.

The European Medicines Agency's Committee for Medicinal Products for Human Use last month recommended against approval of the drug in Europe.

New York-based Pfizer and Eli Lilly agreed in 2013 to develop and commercialize tanezumab, part of an investigational class of non-opioid pain medications known as nerve growth factor inhibitors, in a bid to address significant unmet needs in moderate-to-severe osteoarthritis.

https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-Pfizer-End-Program-for-Tanezumab-Pain-Drug-36783268/

Business groups ask to delay Biden Covid vaccine mandate until after holidays

 Worried that President Joe Biden’s Covid vaccine mandate for private companies could cause a mass exodus of employees, business groups are pleading with the White House to delay the rule until after the holiday season.

White House officials at the Office of Management and Budget held dozens of meetings with labor unions, industry lobbyists and private individuals last week as the administration conducts its final review of the mandate, which will require businesses with 100 or more employees to ensure they are vaccinated against Covid or tested weekly for the virus. It is estimated to cover roughly two-thirds of the private sector workforce.

OMB officials have several meetings lined up Monday and Tuesday with groups representing dentists, trucking companies, staffing companies and realtors, among others.

The American Trucking Associations, which will meet with the OMB on Tuesday, warned the administration last week that many drivers will likely quit rather than get vaccinated, further disrupting the national supply chain at time when the industry is already short 80,000 drivers.

The trucking association estimates companies covered by the mandate could lose 37% of drivers through retirements, resignations and workers switching to smaller companies not covered by the requirements.

“Now placing vaccination mandates on employers, which in turn force employees to be vaccinated, will create a workforce crisis for our industry and the communities, families and businesses we serve,” Chris Spear, the association’s president and CEO, wrote in a letter to the OMB last Thursday.

Retailers are also particularly concerned the mandate could trigger a spike in resignations that would exacerbate staffing problems at businesses already short on people, said Evan Armstrong, a lobbyist at the Retail Industry Leaders Association.

“It has been a hectic holiday season already, as you know, with supply chain struggles,” Armstrong told CNBC after a meeting with White House officials last Monday. “This is a difficult policy to implement. It would be even more difficult during the holiday season.”

Thirty percent of unvaccinated workers said they would leave their jobs rather than comply with a vaccine or testing mandate, according to a KFF poll published last month. Goldman Sachs, in an analysis published in September, said the mandate could hurt the already tight labor market. However, it said survey responses are often exaggerated and not as many people will actually quit.

The Occupational Safety and Health Administration delivered its final rule to the OMB on Oct. 12, and the mandate is expected to take effect soon after the agency completes its review.

The National Retail Federation, the trucking association and the retail leaders group are asking White House officials to give businesses 90 days to comply with the mandate, delaying implementation until late January at the earliest.

The Business Roundtable told CNBC it supports the White House’s vaccination efforts, but the administration “should allow the time necessary for employers to comply, and that includes taking into account employee retention issues, supply chain challenges and the upcoming holiday season.”

The U.S. Chamber of Commerce, which met with the OMB on Oct. 15, also asked the administration to delay implementing the rule until after the holiday season. Officials at the OMB declined to comment on the implementation period.

However, former officials at OSHA, which will enforce the mandate, told CNBC that businesses will likely have some time to implement the rules.

Jordan Barab, deputy assistant secretary of OSHA during the Obama administration, said the administration will probably give businesses about 10 weeks, as they did for federal contractors, until employees have to be fully vaccinated.

However, the compliance date could come sooner for weekly testing, he said.

“OSHA has always had provisions where its required equipment, for example, that may be in short supply to suspend enforcement if an employer can show its made a good faith effort to procure that equipment,” Barab said. “They may make a relatively early date for weekly testing but also provide some additional time in case supplies are not adequate.”

The National Association of Manufacturers, in a letter to the OMB and OSHA head James Frederick last Monday, asked the administration to exempt businesses from the requirements if they have already implemented companywide mandates, or achieved a certain level of vaccination among employees through voluntary programs if certified by a local public health agency.

Robyn Boerstling, a top lobbyist for the manufacturers’ group, called the federal requirements “redundant and costly” for companies that already support vaccination among their staff. Boerstling also expressed concern that businesses with barely more than 100 employees could lose valuable people to competitors who are not covered by the mandate.

“A realistic implementation period can allow for workforce planning that is necessary given the acute skilled worker shortage and ongoing supply chain challenges by supporting the need to keep manufacturing open and operational,” Boerstling wrote in the letter to the administration last Monday.

The American Trucking Associations, in its letter last week, also asked the administration to consider exempting truckers from the mandate, arguing that drivers are similar to remote workers because they do not interact with another employee for days or weeks at a time.

Industry lobbyists have also raised concerns about the cost of testing, and who will cover those costs. The Retail Industry Leaders Association believes employees who choose not to get vaccinated should pay for their weekly testing.

“If folks are allowed to refuse vaccination, and the employer takes testing obligations from a cost standpoint, then there’s no real motivation for those employees to get the vaccine,” Armstrong said. With an estimated 4 million unvaccinated retail workers, testing costs will also add up quickly, he said.

However, Barab said OSHA generally requires employers to cover the cost of equipment and procedures called for under its rules throughout the agency’s 50-year history.

Industry concerns about the impact of Biden’s vaccine mandate on employment come after a record 4.3 million workers quit their jobs in August, the highest level of turnover in 20 years. The retail industry was particularly hard hit, with 721,000 workers leaving their positions.

Goldman Sachs says the mandate would actually boost employment by reducing Covid transmission and mitigating health risks that have been a drag on labor force participation, encouraging many of the 5 million workers who have left the job market since the pandemic to return.

Global supply chains are also strained amid a surge in pandemic-related demand for durable goods, factory shutdowns in places like China and Vietnam, and a shortage of truck drivers and skilled longshoremen on the West Coast.

The White House admits there is little it can do to tackle the macro issues like increased demand and foreign factory operations. But it has recently taken some steps to help, like brokering a deal to keep major West Coast ports open 24 hours a day, seven days a week. 

“We’re already having supply chain issues; we’re already having workforce shortage issues,” Ed Egee, a top lobbyist at the National Retail Federation, told CNBC after the group’s meeting with the OMB last Tuesday. “This mandate cannot be implemented in 2021 without having serious repercussions on the American economy.”

Lilly kicks off application for Alzheimer's drug U.S. approval, ups outlook

 Eli Lilly on Tuesday raised its 2021 profit forecast, citing the strength in its core business and higher sales of its COVID-19 antibody therapies, and said it started the application process for the approval of its closely-watched Alzheimer's drug candidate.

The drugmaker, best known for its anti-depressant Prozac, is betting on new drug approvals to drive growth and offset competition for key drugs like insulin products Basaglar and Humalog and pricing pressures in the United States for other key drugs.

Lilly said it had submitted U.S. marketing application for experimental type 2 diabetes drug, tirzepatide, and started real-time review of data needed to secure regulatory approval for its Alzheimer's disease drug, donanemab.

"The timing is in-line with Street expectations, but this is still good news since the launch of both drugs are important, in our view, in 2022," Cantor Fitzgerald analyst Louise Chen said.

Lilly's shares are up about 45% so far this year, fueled largely by bets it will land another blockbuster with donanemab, which is set to compete upon approval with Biogen's Aduhelm, which also aims to remove clumps of a protein called beta amyloid from the brains of early stage Alzheimer's patients.

Lilly raised its forecast for this year's adjusted earnings per share to between $$7.95 and $8.05 from an earlier $7.80 to $8.00 range, despite missing third quarter profit estimates.

The company said it now expected COVID-19 therapies to bring in about $1.3 billion in sales in 2021, up from an earlier forecast of between $1.0 billion and $1.1 billion.

Demand for Lilly's COVID-19 antibody therapies, bamlanivimab and etesevimab, rose during the last three months as the spread of the Delta variant fueled a sharp rise in infections and hospitalizations in areas with low vaccination rates.

The therapies brought in $217 million in the third quarter, up from $149 million in the second.

https://finance.yahoo.com/news/lilly-third-quarter-profit-falls-103108251.html

Gilead, Merck Initiate Phase 2 Study of Oral Weekly HIV-1 Treatment Combo

  This Clinical Study is the First from Merck and Gilead’s Collaboration to Develop Potential Long-Acting HIV Treatment Options –

Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the start of a Phase 2 clinical study evaluating an investigational once-weekly oral combination treatment regimen of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy.

https://finance.yahoo.com/news/gilead-merck-initiate-phase-2-104500626.html

Novartis may divest generic unit Sandoz as price pressures mount

 Novartis has raised the prospect of divesting its generic drugs unit Sandoz after years of revamping the business, as price pressures mount in the off-patent drug sector.

"Novartis has commenced a strategic review of the Sandoz Division," the Swiss-based group said in statement alongside quarterly results in which it lifted its peak revenue estimate for its two best-selling pharmaceuticals.

Sandoz achieved sales of $9.7 billion last year, about 20 percent of the group's total, but Novartis on Tuesday warned it expected the unit's operating income to fall faster than previously expected this year.

"The review will explore all options, ranging from retaining the business to separation, in order to determine how to best maximize value for our shareholders," the statement said.

Novartis added it would have more to say on the review of Sandoz, which makes cheaper copies of drugs that have lost patent protection, by the end of next year.

"It's synergies versus freedom and the ability to allocate capital and all of these considerations will of course be undertaken now," Chief Executive Vas Narasimhan said in a media briefing.

He started setting up the generics business as an independent unit and slashing costs in early 2019, shortly after selling most of Sandoz's U.S. operations. Competitive pressures on prices, which have long been a burden, increased in the third quarter, with the U.S. market a particular challenge.

The company would not say whether rivals or financial investors might buy it, or whether Sandoz could be floated on the stock exchange.

Though the group's 2021 target for group earnings growth remained at a "mid-single digit" percentage rate, Novartis downgraded Sandoz's full-year outlook for operating income to a decline by a "mid to high teens” percentage rate," worse than the "low to midteens” seen previously.

https://finance.yahoo.com/news/novartis-more-bullish-cosentyx-entresto-052626740.html