Judge cuts Bayer $2.25 billion Roundup verdict to $400 million

 A Pennsylvania judge on Tuesday slashed a $2.25 billion U.S. verdict against Bayer to $400 million for a Pennsylvania man who said he developed cancer from exposure to the company's Roundup weedkiller.

A jury in the Philadelphia Court of Common Pleas found that John McKivison's non-Hodgkins lymphoma was the result of using Roundup for yard work at his house for several years, and it ordered Bayer to pay $250 million in compensatory damages and $2 billion in punitive damages.

Judge Susan Schulman granted some of Bayer's post-trial motions challenging that verdict, reducing compensatory damages to $50 million and punitive damages to $350 million.

Bayer said it would continue to appeal to the Superior Court of Pennsylvania, challenging the trial court's decision to allow the jury to hear what it called misleading and "inflammatory" testimony.

"While the court's decision reduces the unconstitutionally excessive damage award, we still disagree with the ruling on the liability verdict, as the trial was marred by significant and reversible errors," a Bayer spokesperson said Tuesday.

Bayer also called for U.S. legislative reform to protect companies whose products comply with federal labeling requirements.

Bayer has said that decades of studies have shown Roundup and its active ingredient, glyphosate, are safe for human use.

Roundup is among the most widely used weedkillers in the United States, though the company phased out its sales for home use last year.

But the company has taken a string of losses in Roundup trials in late 2023 and early 2024, resulting in more than $4.25 billion in verdicts. Some of those verdicts, like McKivison's, were later reduced, but the cases ended a nine-trial winning streak for Bayer and shattered investor and company hopes that the worst of the Roundup litigation was over.

Around 165,000 claims have been made in the U.S. against the company for personal injuries allegedly caused by Roundup, which Bayer acquired as part of its $63 billion purchase of U.S. agrochemical company Monsanto in 2018. Most plaintiffs, like McKivison, allege that the product caused non-Hodgkins lymphoma.

In 2020, Bayer settled most of the then-pending Roundup cases for up to $9.6 billion but failed to get a settlement covering future cases. More than 50,000 claims remain pending.

https://www.yahoo.com/news/judge-cuts-bayer-2-25-224952938.html

Britain considers offering Lilly weight-loss drug on better terms than Wegovy

 Britain's medical costs regulator on Tuesday recommended Eli Lilly's weight-loss drug Mounjaro for some patients with obesity and suggested not placing a time limit on the medicine's use as it had for rival Novo Nordisk's Wegovy.

Once approved, the draft recommendations from the National Institute for Health and Care Excellence (NICE) would provide a roadmap under which Britain's National Health Service (NHS) could offer Mounjaro as an alternative to Wegovy.

In its draft roadmap for Mounjaro, known chemically as tirzepatide and sold in the U.S. for weight loss as Zepbound, NICE said the drug could be used in patients with a body mass index (BMI) of at least 35 and at least one weight-related co-morbidity, such as type 2 diabetes or heart disease.

The regulator last year recommended Wegovy for the same patient population but said it could only be taken "for a maximum of two years" through the NHS's specialist weight management scheme - matching the length patients were on the drug in Novo's pivotal clinical trial.

NICE's committee found it "was not appropriate to include a long-term stopping rule for tirzepatide," although it recommended considering stopping treatment if patients lose less than 5% of their initial weight after 6 months, according to the document.

Lilly and Novo are vying to make their drugs more easily accessible to patient populations globally as they ramp up production to meet soaring demand and compete in a market that many analysts now expect to reach $150 billion by the early 2030s.

Both Mounjaro and Wegovy are already available privately in the UK for patients with a BMI of 30 or over and patients with a BMI of 27 or more who also have another weight-related health problem such as high blood pressure.

Outside the U.S., Lilly has launched Mounjaro for obesity in Britain, Germany, Poland, Saudi Arabia and the United Arab Emirates, according to the company.

The U.S. Food and Drug Administration reported that two doses of Mounjaro and Zepbound are now available that were expected to be in limited supply through the second quarter of this year.

NICE also recommended use of Mounjaro for patients with a lower BMI from several ethnic backgrounds including Black African and South Asian.

The regulator said it expected to finalize the roadmap on Oct. 30 after a public comment period.

https://www.yahoo.com/news/britain-considers-offering-lilly-weight-165907007.html

Hamas wants Israel to commit to permanent ceasefire, full withdrawal from Gaza

 Hamas cannot agree to any deal unless Israel makes a "clear" commitment to a permanent ceasefire and a complete withdrawal from the Gaza Strip, a senior official from the Palestinian militant group said on Tuesday.

Qatar, which alongside the United States and Egypt has been mediating talks between Hamas and Israel, has also urged Israel to provide a clear position that has the backing of its entire government to reach a deal.

"We cannot agree to an agreement that doesn't secure, guarantee, and ensure a permanent ceasefire, a complete withdrawal from the Gaza Strip and completing a real serious swap deal accordingly," Osama Hamdan, a Hamas official, told a televised press conference.

A three-phase proposal presented by U.S. President Joe Biden on Friday involved in its first phase a six-week ceasefire when Israeli forces would withdraw from "all populated areas" of Gaza and some hostages - including the elderly and women - would be freed in exchange for hundreds of Palestinian prisoners.

Under that plan, Hamas and Israel would negotiate in the same phase a permanent ceasefire that Biden said would last "as long as Hamas lives up to its commitments."

In the second phase, Biden said there would be an exchange for all remaining living hostages, including male soldiers, Israeli forces would withdraw from Gaza and the permanent ceasefire would begin.

Hamdan said: "Israel only wants one phase where it takes all its hostages, then it resumes its aggression and war on our people."

"We ask mediators to get a clear position from the Israeli occupation to commit to a permanent ceasefire and a complete withdrawal," he added.

Hamas has previously said it viewed the contents of the proposal positively.

The United States said on Sunday that if Hamas accepted the proposed plan it expected Israel to follow suit.

The third phase in the proposal would include a major reconstruction plan for the enclave, which has been devastated by eight months of war, and the return of the remains of dead hostages to their families.

https://www.yahoo.com/news/hamas-wants-israel-commit-permanent-183340561.html

AdComm to Review IceCure De Novo Marketing Request for ProSense, Decision Expected Early 2025

 

• Demonstrates public health importance of assessing ProSense®'s potential to offer optimal treatment that benefits women with early-stage breast cancer
• Patients, patient advocacy groups, doctors, and the general public will be welcome to participate and comment in the open public hearing
• IceCure welcomes a transparent public forum to share ICE3 study results and show how ProSense® cryoablation could potentially offer a minimally invasive alternative treatment to women diagnosed with early-stage breast cancer estimated at 65,000 in the U.S. annually
• ProSense® is already approved for the treatment of early-stage breast cancer in numerous European countries, as well as Brazil, India, and China 

https://www.biospace.com/article/releases/fda-to-convene-advisory-panel-for-review-of-icecure-s-de-novo-marketing-clearance-request-for-prosense-decision-expected-early-2025-aligns-with-commercial-readiness-plan/

Maia Data Show THIO’s Strong Efficacy in Non-Small Cell Lung Cancer

  MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced new efficacy data from its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens. Updated results show a favorable overall response rate (ORR) of 38% and a disease control rate (DCR) of 85% from THIO + CPI in third-line treatment. The new data was presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on June 3, 2024.

The primary objectives of THIO-101 Phase 2 trial are to examine the safety and tolerability of THIO as an anticancer drug and as an immune system primer, and to examine the clinical efficacy of THIO in the form of ORR. At the time of the most recent data cut-off (April 30, 2024), all evaluable patients had completed ≥1 post-baseline assessment.

https://www.biospace.com/article/releases/maia-biotechnology-reveals-new-clinical-data-showing-thio-s-strong-efficacy-in-non-small-cell-lung-cancer/

Capricor Positive 3-Year Efficacy Results from Open Label Extension Study in Duchenne

 --Results in Performance of the Upper Limb (PUL 2.0) Continue to Show Benefits in Skeletal Muscle Function After 3 Years of CAP-1002 Treatment (p< 0.001)--

--Stabilization in Left Ventricular Ejection Fraction (LVEF) Suggests Preservation of Cardiac Function--

--Results Recently Shared with FDA at Type-B Meeting Held in May 2024--

https://www.biospace.com/article/releases/capricor-therapeutics-announces-positive-3-year-efficacy-results-from-hope-2-open-label-extension-study-of-cap-1002-in-duchenne-muscular-dystrophy/

Illumina’s Board Votes to Spin Off Grail Instead of Selling Cancer Testing Firm

 DNA sequencing company Illumina announced Monday that its board of directors has approved the spinoff of cancer diagnostics firm Grail.

The spinoff process will be completed on June 24, 2024, and Grail will be listed on the Nasdaq with the ticker symbol GRAL. Grail is also anticipated to start stock trades toward the end of June.

Illumina will retain a minority share of 14.5% of Grail. Shareholders also net one share of Grail’s common stock for every six Illumina shares they hold. No other details on the spinout were immediately available.

Monday’s announcement was a bit of a surprise as Illumina seemed to be on the path to selling Grail, as the European Commission approved Illumina’s “restorative measures” to Grail’s independence in April 2024. However, at the time, no specific plans were disclosed by Illumina.

“Today’s announcement marks a milestone for Illumina and signals an important step forward for the company since the divestiture of Grail is one of our 2024 priorities,” CEO Jacob Thaysen said in a statement. “As we prepare to lead the next era of genomics innovation, we believe Grail will play an important role in advancing the industry and improving human health.”

Illumina’s saga with Grail started with an $8 billion acquisition offer back in 2020. However, the deal was put under the regulatory microscope in the U.S. by the Federal Trade Commission and the E.U., with the European Commission putting a pause on the agreement during its investigation. In 2023, the Securities and Exchange Commission also started looking into the deal and requested documents and communications related to the acquisition.

Eventually, Illumina threw in the towel and agreed to divest from Grail after a U.S. Fifth Circuit Court of Appeals decision  ruled that the acquisition was anti-competitive.

During the divestiture process, activist investor Carl Icahn launched several campaigns to remove members of Illumina’s board of directors and replace them with his own people. CEO Francis DeSouza also stepped down in 2023 amid the attacks.

https://www.biospace.com/article/illumina-s-board-votes-to-spin-off-grail-instead-of-selling-cancer-testing-firm/