Majority in India's big states with COVID-19 antibodies- survey

 More than 70% of people in eight of India's large states are estimated to have COVID-19 antibodies, a government survey showed on Wednesday, suggesting that a second surge in infections affected many more people than the reported figures.

The survey, which tested a sample of the population for the presence of COVID-19 antibodies, was conducted in June and July and showed that two-thirds of India's 1.3 billion people were likely to have been exposed to the virus.

The sero-prevalance survey, which tested around 29,000 people across the country, showed that in eight of India's largest and most populous states, more than 70% had antibodies for COVID-19, according to a government statement.

In the central state of Madhya Pradesh, 79% of its estimated population of 70.3 million had antibodies, the survey showed.

At least 75% of the population in the impoverished and densely populated eastern state of Bihar showed the presence of antibodies, as did 71% of the 220 million people in the country's most populous state of Uttar Pradesh, data showed.

India's daily cases have fallen after a devastating second wave that overwhelmed the healthcare system. On Wednesday, it reported 43,654 new cases and 640 deaths, down from a peak of 414,188 daily cases reported on May 7.

India's vaccination has picked up after a lull in April and May, but it may still not be able to meet its stated aim of inoculating all 950 million adults by the end of the year.

As of Wednesday, a total of 440 million Indian adults had received at least one COVID-19 shot, with just over 10% of its eligible population fully vaccinated.

https://in.news.yahoo.com/majority-indias-big-states-covid-121258052.html

Homeland Security Department imposes employee mask mandate

 The U.S. Department of Homeland Security on Wednesday said all of its employees, regardless of vaccination status, will need to wear a mask indoors and physically distance.

The department said the policy takes effect on Wednesday.

As the virulent Delta variant of the coronavirus blazes through parts of the United States and immunizations lag, the federal government is once again racing to contain the pandemic that began more than a year ago, in the hopes of avoiding future nationwide shutdowns.

The Centers for Disease Control issued guidance on Tuesday that vaccinated people should wear masks in certain situations, including schools, and President Joe Biden's administration on Monday required that Veterans Affairs staff all receive vaccinations.

Biden is expected to announce further mandates for federal agencies on Thursday.

https://news.yahoo.com/u-homeland-security-department-imposes-145927770.html

After FDA Scolding, CytoDyn Investor Groups Seek New Direction

 Two months after the U.S. Food and Drug Administration (FDA) publicly scolded CytoDyn for misrepresentation of clinical trial data for an investigational monoclonal antibody, activist investors led by Paul Rosenbaum are pushing for the election of new board members to guide the company and its future.

In a filing with the U.S. Securities and Exchange Commission earlier this month, Rosenbaum and his investment group nominated five directors to elect the CytoDyn board. 

The nominees include Rosenbaum, Chief Executive Officer of SWR Corporation; Thomas Errico, Associate Director of Pediatric Orthopedic and Neurosurgical Spine at Nicklaus Children's Hospital Center for Spinal Disorders and FDA consultant; Bruce Patterson, Chief Executive Officer of IncellDx; Peter Staats, Chief Medical Officer of electroCore and CMO of the National Spine and Pain Centers; and Melissa A. Yaeger, who currently serves as Principal for Regulatory Consulting Group.

In the filing, Rosenbaum said the five director candidates have the support of 28 retail investor groups who own a significant stake in CytoDyn. The investor group argues that the current leadership of CytoDyn has "mishandled the stewardship" of Leronlimab, the company's investigational monoclonal antibody. 

Leronlimab, a CCR5 antagonist, had been under development as a potential therapeutic for HIV and cancer. However, the company expanded that research into COVID-19 during the pandemic.

In March, CytoDyn announced the antibody fell short in a Phase III COVID study. However, as BioSpace previously reported, the company attempted to push a positive narrative using data from a small subgroup of patients who were on mechanical ventilation. 

CytoDyn argued that those patients saw a 24% decrease in all-cause mortality and a six-day reduction in hospitalization following treatment with Leronlimab. Shortly after that, the company issued a statement highlighting what it said was an "age adjustment analysis" that indicated Leronlimab decreased mortality in older patients.

The FDA rejected the data, noting that no amount of positive spin from CytoDyn could show a statistical significance in the treatment of COVID-19. Following that public chastisement, shares of CytoDyn plunged more than 27%. And shares have continued to slide. It closed at $1.66 on Friday. 

Rosenbaum and his investor group said they believe Leronlimab is an extraordinary drug and that the company's growth hinges on its success. Due to the public chastising from the FDA, Rosenbaum and his associates said they believe that the current company leadership has soured its relationship with the FDA. 

CytoDyn "needs leadership that can obtain regulatory approval for the drug in an expedient fashion," the group said in its filing. The filing states that the slate of new directors will provide a fresh perspective for the board and have relevant experience in finance, medicine, and regulatory oversight. 

"This is not a short-term, opportunistic shareholder using activism to bump the stock price, but a Group who has been patient shareholders for seven years and is only resorting to activism after years of being ignored by management. Often fights like this come down to the power of the argument, and the Group has a strong argument," the group said.

Rosenbaum is no stranger to proxy fights. In 2000, he led an activist group of investors that won a full slate of new board members for Rentrak Corporation. 

https://www.biospace.com/article/cytodyn-investor-groups-band-together-field-slate-of-new-directors-following-fda-scolding/

Arena In-Licenses Aristea Product For Immune-Mediated Inflammatory Diseases

 

• Arena Pharmaceuticals Inc (NASDAQ: ARNA) and Aristea Therapeutics Inc have collaborated to develop RIST4721 for palmoplantar pustulosis (PPP) and other neutrophil-mediated diseases.

• RIST4721 is an oral CXCR2 antagonist being developed by Aristea.

• Under the terms of the agreement, Arena will pay upfront $60 million to Aristea and make a $10 million equity investment in Aristea's Series B financing.

• In return, Aristea has granted Arena an exclusive option to acquire Aristea, including rights to all CXCR2 programs, upon completing the Phase 2b study of RIST4721 in PPP.

• The agreement also provides a framework during the option period for the companies to jointly explore the development of other neutrophil-mediated diseases, including hidradenitis suppurativa (HS) and inflammatory bowel disease (IBD), potentially generating multiple data readouts during the option period.

https://finance.yahoo.com/news/arena-pharma-licenses-aristeas-cxcr2-105857543.html

Stryker upped to Outperform from Market Perform by Northland

 Target to $310 from $248

https://finviz.com/quote.ashx?t=SYK&ty=c&ta=1&p=d

Infinity Pharma upped to Overweight from Equal Weight by Wells Fargo

 Target to $14 from $4

https://finviz.com/quote.ashx?t=INFI

Legal wrangles hold up U.S. vaccine donations to India

 Two months after India dropped local-trial rules for COVID-19 vaccines approved by developed countries, not a single dose has arrived as New Delhi dithers over legal protection sought by companies like Pfizer and Moderna.

The United States has in recent weeks donated millions of vaccine doses to countries such as Bangladesh, Bhutan and South Korea. Supplies to India, however, are stuck pending conclusion of some "legal requirements", according to the global COVAX vaccine platform through which such doses are routed.

India's drugs regulator gave emergency use authorisation to the Moderna vaccine in June, as the United States readied donations for India. Fellow U.S. companies Pfizer and Johnson & Johnson have not formally sought permission for the use of their shots in India.

But India has not met requests for granting the manufacturers indemnity from lawsuits.

India's junior health minister told parliament on Tuesday that a team of officials had been formed to engage with the vaccine makers.

"This team is in continuous dialogue with Pfizer, Moderna and Johnson & Johnson to discuss and address various issues including the issue of indemnity," Bharati Pravin Pawar said.

Pfizer said it was in discussions with authorities to make its vaccine, developed with Germany's BioNTech, available in India. It declined to share details of the negotiations, citing confidentiality.

Moderna and J&J did not respond to requests for comment.

India's health and foreign ministries did not respond to requests for comment on the indemnity issue.

Vaccine alliance Gavi, which co-leads the COVAX facility, said legal protections for vaccine suppliers were mandatory.

"All facility participants must have signed indemnity agreements with the manufacturers in question in order to receive doses through COVAX – which would also be true for doses received via bilateral deals," a Gavi spokesperson said in an email.

India is heavily reliant on the AstraZeneca vaccine produced by the Serum Institute of India (SII). Bharat Biotech - maker of India's only approved home-grown shot - is struggling to boost supply.

SII has already told the government that any indemnity for foreign vaccine companies should also apply to Indian producers.

One government source said Moderna's Indian partner Cipla had offered to bear some legal responsibilities for the vaccine's use in the country, but that the proposal had been rejected by the U.S. company.

"The government cannot give indemnity to anyone," the official said, declining be named as the discussions were private and no decisions had been finalised.

"The government is saying domestic companies can give indemnity on behalf of their foreign partners."

Cipla declined to comment ahead of its financial results.

India has administered 441 million total vaccine doses, the largest of any country after China. But only 10% of its adult population of about 944 million people has been inoculated with both doses, with 47% receiving at least one shot. 

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Legal-wrangles-hold-up-U-S-vaccine-donations-to-India-35983324/