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Abbott, Baby Formula Makers Face FTC Probe for Potential Collusion

Reuters reported:

The U.S. Federal Trade Commission (FTC) is probing whether Abbott Laboratories (ABT.N) and other companies that make baby formula colluded in bidding on state contracts, according to a document posted on the agency’s website.

The FTC is looking into whether the companies “engaged in collusion or coordination with any other market participant regarding the bidding,” according to the document. The Wall Street Journal was the first to report the probe.

There has been increased focus on the formula market since Abbott’s February 2022 closure of a plant in Sturgis, Michigan and subsequent recalls, which together caused a nationwide shortage of formula.

The FTC document is the latest step in a disagreement between the agency and Abbott over how much information the company was required to provide in response to a demand issued in January.

FDA Grants Full Approval to Paxlovid to Treat COVID in High-Risk Adults

NBC News reported:

The Food and Drug Administration on Thursday granted full approval to Pfizer’s COVID antiviral pill, Paxlovid, for adults who are at high risk of getting severely sick with the virus.

Paxlovid is specifically advised for the treatment of mild to moderate COVID in adults older than 50 and people who suffer from certain medical conditions that place them at a higher risk of ending up in the hospital or dying from COVID.

The FDA first made Paxlovid available in December 2021 under emergency use authorization for high-risk individuals ages 12 and up. Under that designation, the FDA quickly approved the treatment based on preliminary clinical trial data.

The U.S. has 1.1 million courses of the treatment available for free nationwide. Once that runs out, the government will shift the distribution of Paxlovid to the commercial market. That means Pfizer will sell Paxlovid directly to healthcare providers at a price the company hasn’t disclosed. Paxlovid is priced at about $530 per course now.

BioNTech Is Proceeding With COVID Shot in Line With WHO Guidance

Reuters reported:

Germany’s BioNTech (22UAy.DE) said it was on track to introduce a COVID-19 shot by the early fall in the northern hemisphere that is adapted to currently dominant virus variants in line with recommendations by the World Health Organization.

BioNTech was targeting regulatory approval by the end of the summer to allow for a seasonal vaccination campaign to start in early autumn, CEO and co-founder Ugur Sahin told shareholders at the biotech firm’s annual general meeting on Thursday.

BioNTech is collaborating on the vaccine with Pfizer (PFE.N) in markets outside of greater China.

BioNTech/PFizer’s new formulation would aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, as preferred by the WHO, Sahin said, adding that the partners would introduce a ready-to-use single dose, a change from the multi-dose vials that were standard during the pandemic.

DEA’s Failure to Punish Distributor Blamed in Opioid Crisis Raises Revolving Door Questions

Associated Press reported:

The U.S. Drug Enforcement Administration has allowed one of the nation’s largest wholesale drug distributors to keep shipping highly addictive painkillers for nearly four years after a judge recommended it be stripped of its license for its “cavalier disregard” of thousands of suspicious orders fueling the opioid crisis.

The DEA did not respond to repeated questions from The Associated Press about its handling of the case against Morris & Dickson Co. or the involvement of a high-profile consultant the company had hired to stave off punishment and who is now DEA Administrator Anne Milgram’s top deputy.

But the delay has raised concerns about how the revolving door between government and industry may be impacting the DEA’s mission to police drug companies blamed for tens of thousands of American overdose deaths.

Shreveport, Louisiana-based Morris & Dickson, the nation’s fourth-largest wholesale drug distributor with $4 billion a year in revenue and nearly 600 employees, has said losing its license would effectively shut it down and have a “catastrophic” effect on patients in 29 states.

First New ‘Quit-Smoking’ Drug in 20 Years Shows Promising Results in U.S. Trial: ‘Hope and Excitement’

Fox News reported:

A new drug may be on the horizon to help people kick the world’s deadliest habit. Achieve Life Sciences, Inc., a Seattle, Washington-based pharmaceutical company, has announced positive results from the Phase 3 trial of a drug called cytisinicline.

Medications to help people quit smoking have been limited. There are currently only two non-nicotine therapies approved by the Food and Drug Administration (FDA), and no new drugs have been introduced in nearly 20 years.

The only two non-nicotine therapies on the market today are Varenicline tartrate (brand names Chantix and Champix) and Bupropion hydrochloride (marketed as Wellbutrin and Zyban). Both have been linked with some serious side effects.

This was Achieve’s second Phase 3 study of cytisinicline. Data from the two Phase 3 trials have shown very low rates of side effects, with no serious treatment-related adverse events reported.

‘A Gamechanger’: New Meningitis Vaccine Hailed as Major Step

The Guardian reported:

The NmCV-5 vaccine, developed by the Serum Institute of India and the global health organization PATH, will protect against the five main meningococcal strains found in Africa, including the emerging X strain, for which there is currently no licensed injection.

Vaccine trials were conducted among 1,800 people aged from two to 29 in Mali and the Gambia in 2021, according to a report published on Wednesday in the New England Journal of Medicine. Researchers found that NmCV-5 generated a strong immune response against all five strains.

The cost of available vaccines, which protect against four strains of meningitis, is currently too high for most African countries, which need tens of millions of doses. The MenAfriVac, rolled out in 2010, substantially reduced cases of meningococcal A, but large-scale epidemics linked to the other strains are common in Africa. NmCV-5 will be available in the coming months.

After Years of Litigation, Gilead and Teva’s HIV Antitrust Trial Kicks Off in California

Fierce Pharma reported:

Gilead Sciences and Teva Pharmaceutical Industries have spent years defending against claims they worked together to thwart competition to Gilead’s lucrative portfolio of HIV medicines. Now, the case is finally heading to trial.

Gilead and Teva’s HIV antitrust trial kicked off Wednesday in a California federal court, launching a courtroom showdown in which the two must defend against claims they colluded to delay generic competition to Gilead’s HIV meds.

UnitedHealthcare, the largest health insurer in the U.S., alleges the companies ran a pay-for-delay scheme that prevented cheaper HIV generics from entering the market in a timely manner. UnitedHealthcare is accompanied by other plaintiffs including CVS Pharmacy, Rite Aid and Walgreens, among others.

FDA Approves New Antibiotic for Hospital-Acquired Pneumonia

BioPharma Dive reported:

The Food and Drug Administration on Tuesday approved a new drug for hospital-acquired pneumonia caused by a difficult-to-treat type of bacteria.

The drug, which will be sold as Xacduro by Innoviva Specialty Therapeutics, targets susceptible strains of Acinetobacter baumannii-calcoaceticus complex, which can cause infections throughout the body and can become resistant to existing treatments.

Xacduro was associated with abnormal liver function tests, and its labeling contains warnings for hypersensitivity reactions and Clostridioides difficile-associated diarrhea.

The drug was submitted to the FDA by Entasis Therapeutics, which was acquired by Innoviva last year and recently merged with another company Innoviva bought, La Jolla Pharmaceutical, to create Innoviva Specialty Therapeutics.