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CDC Reports Another Death Linked to Recalled Eyedrops
The number of people with highly drug-resistant bacterial infections linked to contaminated eyedrops has reached 81, the Centers for Disease Control and Prevention reported Friday. The 81 cases, up from 68 identified in March, include 14 people who have been blinded and four others who had to have their eyeballs surgically removed.
Though most infections have been limited to the eyes, the bacteria can be fatal when it enters the bloodstream. As of Monday, the CDC said, four people have died.
Though many patients said they’d used multiple brands of eyedrops, EzriCare Artificial Tears was found to be a common brand among those infected. Opened bottles of the EzriCare eyedrops were also found to harbor the same bacteria found in samples taken from patients.
The EzriCare products were manufactured by Global Pharma Healthcare in India and sold mostly online. The CDC and FDA said people should stop using them, as well as two other eye products made by the same manufacturer: Delsam Pharma’s Artificial Tears and Delsam Pharma’s Artificial Eye Ointment.
FDA Advisors Recommend Pfizer’s RSV Vaccine for Infants but Raise Safety Concerns
The U.S. Food and Drug Administration’s independent panel of advisors Thursday recommended full approval of Pfizer’s vaccine that protects infants from respiratory syncytial virus but raised safety concerns over premature births that may be tied to the shot.
The committee unanimously said the vaccine efficacy data was sufficient. Ten of the advisors said the safety data on Pfizer’s shot was adequate, while four said it was not.
Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said he doesn’t believe there is enough data that indicates the safety of the vaccine is “reassuring.”
“If you’re in any sense risking premature births with this vaccine, I think there’ll be a big price to pay,” said Offit, who voted against the shot’s safety data.
Teva Plans to Cut Back Generic Drug Production Even as Shortages Intensify
Teva Pharmaceutical Industries Ltd. plans to cut back manufacturing of generic drugs, citing low profitability, at a time when shortages are intensifying and makers of these medicines are struggling to stay in business.
The Israel-based company is one of the world’s largest makers of generic drugs but has been contending with high debt as prices shrink across the board. Some nine out of 10 prescriptions filled in the U.S. are for generic drugs. The industry has been under increasing pressure, leading to a scarcity of crucial medicines like antibiotics and cancer treatments.
Those at High Risk of Mpox Should Get 2 Doses of Bavarian Nordic Vaccine, U.S. CDC Says
The U.S. Centers for Disease Control and Prevention is urging people at high risk of mpox to get two doses of Bavarian Nordic’s (BAVA.CO) Jynneos vaccine, based on new evidence from a U.S. study showing that the regimen is more effective at preventing infection than one shot.
The study, published on Thursday, offered some of the first evidence on the efficacy of the Jynneos vaccine, which was deployed last year during a global outbreak of mpox that affected more than 30,000 people in the United States.
The recommendations follow a health warning to U.S. physicians on Monday about the risk of a resurgence in cases this spring and summer as people gather for gay pride festivals and other events.
Teva Puts Rival to Prometheus, Pfizer Drugs at Center of Turnaround Plans
The race to develop the next blockbuster anti-inflammatory disease drug is heating up. In recent months, Merck & Co. and Pfizer have both made moves to advance a new type of experimental medicines for autoimmune conditions and now Teva is putting research money behind its own candidate.
At a Thursday event pitching investors on a turnaround plan, Teva executives said their drug targeting the protein TL1A will help the company sustain sales growth as it adds branded drugs to its core generics business.
Teva may need a better drug, as it could be one to two years behind rival therapies that originated in the laboratories of Pfizer and Prometheus Biosciences, both of which have completed some mid-stage tests. Prometheus recently agreed to be acquired by Merck for $10.8 billion, while Pfizer joined Roivant to create a company to advance its candidate.
BC Man Launches Lawsuit Against AstraZeneca, Federal Government Following Vaccine Injury
A B.C. man who developed severe health complications after receiving the AstraZeneca COVID-19 vaccine has launched a lawsuit against the pharmaceutical company, the federal and provincial governments, and the pharmacy that gave him the injection.
Ross Wightman, 41, of Lake Country, B.C., says he was temporarily paralyzed and developed Guillain-Barré Syndrome after he was given his one and only dose of the COVID-19 vaccine in April 2021.
Wightman was one of the first Canadians to have his vaccine injury certified for compensation from the federal government’s Vaccine Injury Support Program (VISP). The program offers financial compensation to Canadians who have experienced a serious and permanent injury as a result of receiving a Health Canada-authorized vaccine administered in Canada on or after December 8, 2020.
In his lawsuit submitted to B.C. Supreme Court, Wightman says he was not given adequate warning of the potential risks of the COVID-19 vaccine. The lawsuit names AstraZeneca Canada, Interior Health, the federal and provincial government, Verity Pharmaceuticals, Hogarth’s Clinic Pharmacy, and the person who administered the vaccine.
AbbVie’s Rinvoq Scores Its 7th FDA Nod, This One for Crohn’s Disease
In developing immunology treatment Rinvoq, AbbVie is employing the same game plan it used to make predecessor Humira a megablockbuster. And the company seems to be getting better at it.
Thursday, AbbVie scored its seventh FDA approval for Rinvoq in a span of fewer than four years, getting the JAK inhibitor across the finish line as a treatment for Crohn’s disease.
A look at Humira’s approval history shows that AbbVie has become more efficient in adding indications to its immunology blockbusters. After Humira was initially blessed in 2002, it took AbbVie 10 years to get the TNF blocker endorsed for its seventh disease type.
The green lights have come despite concerns that JAK inhibitors have heart-related side effects, and restrictions have been placed on their use. Rinvoq has sidestepped the issues to some degree, generating sales of $2.5 billion last year, which was a 52% increase from 2021.
As Humira reaches its patent cliff, AbbVie is pushing Rinvoq hard. In advertising last year, the company spent $426 million — the second-highest ad spend for drug last year, trailing only Regeneron and Sanofi’s Dupixent.
