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Tuesday, June 1, 2021

Supreme Court rebuffs J&J appeal over $2 billion baby powder judgment

 The U.S. Supreme Court on Monday declined to hear Johnson & Johnson's bid to overturn a $2.12 billion damages award to women who blamed their ovarian cancer on asbestos in the company's baby powder and other talc products.

The justices turned away a J&J appeal and left in place a Missouri state court ruling in litigation brought by 22 women whose claims were heard together in one trial.

The Missouri Court of Appeals, an intermediate state appellate court, last year ruled against J&J's bid to throw out the compensatory and punitive damages awarded to the plaintiffs but reduced the total to $2.12 billion from the $4.69 billion originally decided by a jury.

J&J has argued that a decision by a Missouri circuit court judge to consolidate disparate baby powder-related claims from the plaintiffs - including 17 women from outside the state - for a trial before a single jury violated the New Brunswick, New Jersey-based company's due process rights under the U.S. Constitution. J&J also has argued that the size of the jury's damages award violated its due process rights.

The Missouri Supreme Court, the state's highest court, in November declined to hear J&J's appeal of the Missouri Court of Appeals ruling, prompting the company to appeal to the U.S. Supreme Court.

J&J said in court papers that it faces more than 19,000 other cases that could be affected by the outcome of this litigation.

The plaintiffs, nine of whom have died and are now represented by their estates, have argued that Missouri courts have jurisdiction over out-of-state claims like those brought in this litigation. One of the products that the out-of-state plaintiffs said they had used was manufactured in Missouri.

Lawyers for the plaintiffs also have argued that the large punitive damages awarded by the jury in this case were justified by J&J's conduct. Lawyers for the plaintiffs said in court papers it is common practice for courts to consolidate cases at trial when the facts in each claim are essentially the same.

The Missouri Court of Appeals concluded that it was reasonable to infer from the evidence that J&J "disregarded the safety of consumers" in its drive for profit despite knowing its talc products caused ovarian cancer. It also found "significant reprehensibility" in J&J's conduct.

In addition to reducing the damages, the Missouri Court of Appeals dismissed two of the 17 out-of-state plaintiffs.

In court papers, J&J said the case followed a "winning formula" devised by plaintiffs' lawyers of bringing claims in jurisdictions where they can get dozens of out-of-state plaintiffs to testify in a single trial, prejudicing the jury and resulting in "outsized" damages awards.

In the Missouri trial, the company said, the jury awarded each plaintiff an identical punitive damages award of $25 million, regardless of the facts specific to each plaintiff or whether they were alive or dead. The company also said the jury awarded punitive damages much larger than the "already staggering" compensatory damages, which J&J has called a further violation of its due process rights.

Justice Samuel Alito did not participate in the Supreme Court's decision not to take up the appeal, likely because he owns J&J stock. Justice Brett Kavanaugh, whose father - now retired - was a longtime lobbyist for the toiletries industry, also did not take part. The justices do not explain why they step aside in certain cases.

A 2018 Reuters investigation https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer found that J&J knew for decades that asbestos, a carcinogen, was present in its talc products. Internal company records, trial testimony and other evidence showed that from at least 1971 to the early 2000s, J&J's raw talc and finished powders sometimes tested positive for small amounts of asbestos.

The company said in May 2020 https://www.reuters.com/article/us-johnson-johnson-babypowder/johnson-johnson-to-stop-selling-talc-baby-powder-in-u-s-and-canada-idUSKBN22V32U it would stop selling its baby powder talc in the United States and Canada, citing changes in consumer habits and what it called "misinformation" about the product's safety amid numerous legal challenges. In its statement https://www.jnj.com/our-company/johnson-johnson-consumer-health-announces-discontinuation-of-talc-based-johnsons-baby-powder-in-u-s-and-canada, J&J said it remained "steadfastly confident in the safety of talc-based Johnson's Baby Powder."

https://finance.yahoo.com/news/1-u-supreme-court-rebuffs-134526313.html

Moderna files for full U.S. approval of COVID-19 vaccine

 Moderna Inc on Tuesday filed for full U.S. approval of its COVID-19 vaccine, becoming the second drugmaker to do so after Pfizer Inc and its German partner BioNTech sought full clearance for their vaccine last month.

The U.S. Food and Drug Administration's emergency use approval allowed the health regulator to authorize the vaccines during the pandemic, based on a minimum number of COVID-19 infections among the trial population and two months of safety data for vaccine recipients.

Full approval for the COVID-19 vaccines, which will be based on six months of trial data, could be an important step in allaying vaccine hesitancy in the United States and other wealthy nations.

Moderna said it will continue to submit data to the FDA on a rolling basis over the coming weeks, with a request for a priority review. On completion of the submission, the agency will notify the company when it is formally accepted for review, Moderna added.

Cambridge, Massachusetts-based Moderna has an agreement with the U.S. government to supply 300 million doses of its COVID-19 vaccine, which is authorized or approved for use in more than 40 countries.

More than 151 million doses of Moderna's vaccine have been distributed around the United States, with roughly 124.5 million shots administered as of May 30, according to the U.S. Centers for Disease Control and Prevention.

Over 135 million people or nearly 41% of the total U.S. population has been fully vaccinated as of May 30, according to the CDC data.

Moderna said in April its vaccine showed strong protection against the coronavirus six months after people received their second shot, with efficacy of more than 90% against all cases of COVID-19 and more than 95% against severe COVID-19.

https://finance.yahoo.com/news/1-moderna-files-full-u-115154715.html

Biogen, Bio-Thera: Positive Results From Phase 3 Study

 The comparative study met its primary endpoints and showed equivalent efficacy and comparable safety profile in patients with moderate-to-severe rheumatoid arthritis

 Biogen Inc. (Nasdaq: BIIB) and Bio-Thera Solutions, Ltd. (688177.SH) today announced results from the Phase 3 study of BAT1806, a proposed biosimilar referencing ACTEMRA®/RoACTEMRA® (tocilizumab). The study met its primary endpoints, demonstrating equivalence to the reference medicine in patients with moderate to severe rheumatoid arthritis (RA) inadequately controlled by methotrexate therapy. The primary endpoint in the study was the American College of Rheumatology 20 percent response criteria (ACR20).

ACTEMRA/RoACTEMRA’s primary indication is for moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome. Biosimilars are products that demonstrate similar efficacy and safety to the originator’s reference product, with the advantage that they can be more affordable for patients and healthcare systems. In 2020 global sales of ACTEMRA were 2.8 billion CHF. Biogen has exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau and Taiwan).

https://finance.yahoo.com/news/biogen-bio-thera-announce-positive-113000165.html

Paratek: FDA Approves NUZYRA® (omadacycline) Oral Only Dosing

 Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and for other public health threats for civilian, government and military use, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for the oral-only dosing regimen of NUZYRA® for the treatment of adults with community-acquired bacterial pneumonia (CABP).

“The approval of an oral-only dose regimen for NUZYRA in pneumonia represents a significant opportunity to offer clinicians the ability to treat patients in either the outpatient or primary care setting. Treating in this way potentially reduces or eliminates hospitalizations and the associated risk and costs from a hospital stay,” said Adam Woodrow, President and Chief Commercial Officer of Paratek. “With the community expansion well under way we will broaden our promotional efforts to include this new dosing option and are particularly excited to bring primary care practitioners a new, safe and effective oral antibiotic in time for the upcoming pneumonia season."

Approved by the FDA on October 2, 2018, NUZYRA is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of CABP and acute bacterial skin and skin structure infections (ABSSSI). The recently approved oral-only dose for CABP has an initial dose of 300 mg twice on day one and 300 mg once daily thereafter for a total of 7 to 14 days. A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a broad spectrum of bacteria, including Gram-positive, Gram-negative, and atypicals including other drug-resistant strains.

Alkermes schizophrenia drug gets U.S. FDA approval

 Alkermes Plc said on Tuesday the U.S. Food and Drug Administration (FDA) had approved its treatment, Lybalvi, for schizophrenia and bipolar I disorder.

The company said it expects to commercially launch the drug in the fourth quarter.

The FDA in November had declined to approve the drug, citing concerns related to a tablet coating process at its manufacturing site.

Lybalvi is a once-daily, oral antipsychotic drug composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity, the company said.

Schizophrenia is a severe mental disorder and affects 20 million people worldwide, according to the World Health Organization.

The company also has FDA-approved antipsychotic and alcohol-dependence treatments in the market. 

https://finance.yahoo.com/news/1-alkermes-schizophrenia-drug-gets-112818741.html

Seres: FDA Clears IND for SER-155 Investigational Microbiome Therapeutic

  SER-155 aims to prevent mortality in immunocompromised patients due to gastrointestinal infections, bacteremia and GvHD 

– In collaboration with Memorial Sloan Kettering Cancer Center, Seres will now advance SER-155 into a Phase 1b clinical study 

https://finance.yahoo.com/news/seres-therapeutics-announces-fda-clearance-120000118.html

Immutep In New Collaboration With Merck KGaA LAG-3 Therapy, Efti

 

  • Collaboration with Merck KGaA, Darmstadt, Germany to evaluate eftilagimod alpha in combination with bintrafusp alfa

  • New investigator-initiated explorative, multi-centre, open-labelled Phase I/IIa trial in 12 previously treated patients with different solid tumours, called INSIGHT-005

  • First patient is expected to be enrolled and dosed in H2 of calendar year 2021