Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.

Novavax Forecasts Higher-Than-Expected Revenue; Shares Surge

Reuters reported:

COVID-19 vaccine maker Novavax Inc (NVAX.O) on Tuesday forecast much higher 2023 revenue than Wall Street expected and announced plans to cut a quarter of its workforce, spurring hopes of a recovery for the cash-strapped biotech, and its shares jumped 40%.

In February, the company raised doubts about its ability to remain in business, due to uncertainty about 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi.

Novavax, whose COVID vaccine is its lone marketed product after 35 years in business, is relying on launching an updated COVID shot this fall to match circulating strains and cost cuts to improve its prospects.

The Maryland-based drugmaker on Tuesday also unveiled promising early data for its COVID and flu combination vaccine. It said it now expects 2023 revenue between $1.4 billion and $1.6 billion, compared with analysts’ estimates of $831.6 million, according to Refinitiv data.

Drugmakers Set Strategy for Legal Fight Against U.S. Pricing Regulation

Reuters reported:

Some of the world’s biggest drugmakers are laying the legal groundwork to fight the U.S. plan to negotiate drug prices for its Medicare health coverage, including the argument that a ban against speaking about these talks violates constitutional rights, according to six industry sources.

The Biden Administration’s signature drug pricing reform, part of the Inflation Reduction Act (IRA), aims to save $25 billion through price negotiations by 2031 for Americans who pay more for medicines than any other country.

The pharmaceutical industry says the law, passed last year, will result in a loss of profits that will force them to pull back on developing groundbreaking new treatments.

The blood thinner Eliquis from Bristol Myers Squibb (BMY.N) and Pfizer (PFE.N), Pfizer’s breast cancer drug Ibrance and AbbVie‘s (ABBV.N) leukemia treatment Imbruvica are likely to be among 10 big-selling medicines subject to the negotiations.

Enfamil Infant Formula Lawsuit Filed Over Preemie’s Serious NEC Injuries

AboutLawsuits.com reported:

A West Virginia mother has filed a lawsuit against Enfamil infant formula manufacturers, indicating her premature child developed NEC (necrotizing enterocolitis) after being fed the cow’s milk-based product in the hospital.

Sandra Hayes filed the complaint last month in the U.S. District Court for the Southern District of Indiana, pursuing damages on behalf of herself and her son, Adam.

The Enfamil infant formula lawsuit alleges that Mead Johnson & Company, LLC has known about the serious health risks their product posed for premature newborns, but continued to promote the product for use by hospitals and parents while withholding safety warnings to maximize profits.

Hayes now joins other families of preterm infants nationwide who are now pursuing NEC infant formula lawsuits against Mead Johnson and Abbott Laboratories, which manufactures competing Similac products.

Bacterial Infection Linked to Recent Baby Formula Shortage May Join Federal Disease Watchlist

CNN Health reported:

U.S. health officials may soon ask states to notify them of any cases of infants with serious infections caused by Cronobacter sakazakii, bacteria that can contaminate infant formula. Cronobacter infections typically strike infants who are less than 2 months old, and they can be fatal or permanently disabling.

In an outbreak that the U.S. Centers for Disease Control and Prevention investigated last year, four babies were sickened, including two who died. All the infants had been fed baby formula manufactured at the same factory in Sturgis, Michigan, triggering an extensive investigation by the U.S. Food and Drug Administration and ultimately stopping production at the facility for months. The shutdown worsened ongoing supply chain issues and threw the country into a nationwide shortage.

These infections are thought to be infrequent, but the true burden in the U.S. is unknown because Cronobacter is not currently part of the National Notifiable Diseases Surveillance System, a list of about 120 illnesses given special priority by the CDC because they’ve been deemed to be important to public health.

A work group was formed in the winter to assess conditions, risks and surveillance processes related to the bacterial infection, and it will present recommendations to advance Cronobacter surveillance in June. Adding Cronobacter infections to the national watchlist is among the strategies being considered.

As COVID Vaccine Sales Plummet, BioNTech Looks for New Growth Opportunities

Fierce Pharma reported:

​​After raking in billions with its Pfizer-partnered vaccine, BioNTech is turning to new ventures as its revenues plummet. BioNTech reported first-quarter revenues of €1.27 billion (1.4 billion), a far cry from 2022’s first-quarter haul of €6.37 billion ($7.03 billion). Despite the downturn, the quarter went “fully to our expectations,” CFO Jens Holstein said on a conference call.

Sales-wise, the current quarter should be the weakest of 2023, Holstein said. The company’s COVID-19 vaccine revenue guidance for 2023 stands at €5 billion ($5.4 billion), which is “something we can live with,” the CFO added.

Meanwhile, BioNTech believes the United States’ transition to a commercial COVID-19 vaccine market could provide new growth opportunities.

The company’s pipeline includes multiple oncology ventures, including a HER2-targeted antibody-drug conjugate (ADC) that it’s working on with DualityBio. The company is also advancing a CAR-T cell therapy and a Genentech-partnered mRNA cancer vaccine candidate.

EzriCare Artificial Tears Lawsuit Indicates Exposure to Bacteria in Eye Drops Caused Vision Damage

AboutLawsuits.com reported:

A California man has filed a lawsuit against the manufacturers of EzriCare Artificial Tears, alleging that exposure to Pseudomonas aeruginosa bacteria in the recalled eye drops caused him to develop a severe infection and permanent vision damage.

The complaint was filed by Jamie Foti in the U.S. District Court District Central District of California, Southern Division on May 3, claiming the manufacturers advertised the eye drop products as safe for use, while failing to thoroughly test the products for bacterial contamination.

The case joins a growing number of EzriCare Artificial Tears lawsuits now being pursued by consumers nationwide, who have experienced Pseudomonas aeruginosa infections that have caused a wide range of health problems, including vision problems, bloodstream infections and death.

A number of eyedrops class action lawsuits have also been filed against the manufacturers, seeking damages on behalf of all consumers who purchased the Artificial Tears products that were recalled in February 2023.

Rise of Mpox Cases in Chicago Raises Concern About Possible Summer Spread

NBC News reported:

A recent uptick in mpox diagnoses in Chicago, some of them in people vaccinated against the virus, has raised concerns about a possible increase in cases among gay and bisexual men during the summer.

Diagnosed cases have been “increasing slightly” in eight countries in the past three weeks, including France and several countries in East Asia, said Dr. Rosamund Lewis, the technical lead for mpox at the World Health Organization. About half of the recent French cases were in vaccinated people.

Chicago’s weekly mpox case rate is the highest since early November. According to Centers for Disease Control and Prevention data, which is updated biweekly, the U.S. has had a rolling seven-day average of no more than 17 diagnoses since mid-February.