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Gaza to Get 1.2 Million Polio Vaccines Amid Outbreak Fears
The World Health Organization (WHO) has announced plans to send 1.2 million polio vaccines to Gaza after the virus was detected in wastewater.
The agency’s chief, Dr Tedros Adhanom Ghebreyesus, outlined plans for two rounds of vaccination, targeting 600,000 children under the age of eight. The first round is due to start on 17 August.
It will be a “huge logistical challenge” to ensure the 1.2 million vaccine doses are deployed successfully, said WHO official Andrea King.
Vaccines need to be continuously stored in a limited temperature range — from the moment they are manufactured until they are administered — which presents a technical challenge during ongoing hostilities.
Testing run by WHO last month showed that sewage samples collected in two areas of Gaza were positive for polio.
FDA Approves Purdue Pharma’s Controversial New Overdose-Reversal Medication
Purdue Pharma, the company best known for fueling the opioid crisis by misleadingly marketing the infamous painkiller OxyContin, received approval on Wednesday for a new auto-injector device used to reverse opioid overdoses.
The announcement represents the latest in a string of recent approvals for products that use nalmefene, essentially a more powerful version of its better-known chemical cousin, naloxone. The approval is likely to spark anger on multiple fronts. Primarily, amid the overdose epidemic, Purdue is viewed as a national villain. Its questionable marketing tactics for OxyContin, in particular, are blamed for turbocharging, beginning in the late 1990s, a wave of opioid addiction.
The company and its founders and owners, the Sackler family, have been the subject not only of countless lawsuits but also of major books and TV shows.
Many corners of the addiction advocacy community view Purdue with immense suspicion, and resent the company’s attempts to play a role in addressing a crisis it helped create. In its statement, the company noted that it plans to sell Zurnai at cost and that it also doesn’t turn a profit on its existing nalmefene drug, which is used in hospital settings.
Bavarian Nordic Scores $157 Million Contract to Replenish U.S. Supplies of Smallpox/Mpox Vaccine Jynneos
Following the commercial launch of Bavarian Nordic’s smallpox/mpox vaccine Jynneos earlier this year, the Danish company has locked up yet another supply agreement with the U.S. government.
The Biomedical Advanced Research and Development Authority (BARDA) is handing Bavarian Nordic $156.8 million to “partly replenish” vaccine stocks in response to the 2022 outbreak of mpox, the disease formerly known as monkeypox. Previously, BARDA chipped in on the development of a freeze-dried version of the vaccine, which won its first FDA approval in 2019.
The replenishment agreement is necessary to fulfill Bavarian Nordic’s existing pact with the U.S. to supply a next-generation, freeze-dried version of its shot for smallpox preparedness, the company explained in a release.
Bavarian Nordic is set to receive $139.7 million for the vaccine bulk product itself, which will be manufactured and invoiced in 2024. The remaining $17 million covered by the contract will help fuel additional services from 2025 through 2027, including storage of vaccine doses in the U.S., Bavarian Nordic said.
Third Trial Over Zantac Cancer Claims Ends With Hung Jury
The third trial over claims that discontinued heartburn drug Zantac ended in a mistrial on Wednesday when jurors could not agree about whether pharmaceutical company Boehringer Ingelheim was responsible for an Illinois man’s cancer. Martin Gross alleged in his lawsuit in state court in Chicago that he developed prostate cancer from a carcinogenic contaminant called NDMA found in the drug. His lawyer, Sean Grimsley, said he would take his case to trial again.
First approved by U.S. regulators in 1983, Zantac became the world’s best-selling medicine in 1988 and one of the first to top $1 billion in annual sales. It was sold at different times by Boehringer Ingelheim, GSK (GSK.L), Pfizer (PFE.N) and Sanofi (SASY.PA), all of which have faced thousands of lawsuits.
Two such cases previously went to trial, both ending in verdicts for the defense — one for Boehringer Ingelheim and GSK in May, and the other for GSK on Monday.
Sanofi has agreed to settle about 4,000 cases against it, while Pfizer has reportedly agreed to settle more than 10,000. The companies have also settled some individual cases before trial.
FDA Blasts Bristol Myers Over Misleading Krazati Efficacy Claims
The FDA has taken Bristol Myers Squibb to task for making false or misleading claims about the efficacy of Krazati on the website for the KRAS cancer drug.
Krazati, which BMS acquired in its $5.8 billion takeover of Mirati Therapeutics, has accelerated approval in KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer.
BMS presented data from the trial that supported authorization on the efficacy page of a Krazati website aimed at healthcare professionals. The FDA and multiple complainants have taken issue with the efficacy page.
Leaders from the FDA’s Office of Prescription Drug Promotion set out the perceived problems with the page in an untitled letter to BMS. The letter describes issues with multiple measures of efficacy shared on the Krazati website.
Novavax Cuts 2024 Revenue Forecast, Shrinks European Presence
Novavax (NVAX.O) on Thursday trimmed its annual revenue forecast again and said it would pare back its presence in Europe through the rest of the year, ahead of handing over the rights to sell its COVID-19 vaccine to partner Sanofi (SASY.PA) in 2025.
The company’s vaccine had failed to make a significant dent in the market share of early COVID-vaccine entrants such as Pfizer/BioNTech (PFE.N), (22UAy.DE) and Moderna (MRNA.O), and last year raised doubts about its ability to remain in business.
The company has sought authorization for its fall-season COVID shot targeting the JN.1 strain from the U.S. and European regulators.
Novavax, which missed second-quarter revenue and profit estimates, cut its full-year forecast range for total revenue to $700 million to $800 million, from between $970 million and $1.17 billion.
German Panel Endorses GSK, Pfizer RSV Vaccines for Elderly
Germany’s influential vaccine advisory panel said on Thursday that everyone in the country who is 75 years old or older should receive one of two new vaccines against the common respiratory infection RSV.
The panel of independent experts known as STIKO said in a statement that one shot, either Pfizer‘s (PFE.N) Abrysvo or Arexvy by GSK (GSK.L), should be administered ideally in September or October before the cold season.
STIKO said in June all infants in the country should receive AstraZeneca (AZN.L) and Sanofi‘s (SASY.PA) jointly owned antibody therapy to protect them against RSV.
STIKO advice is widely followed by family doctors in Germany, Europe’s largest pharmaceutical market.
