'ASCO 2024: FDA oncology head wants clinical trials to range beyond China alone'

 The Food and Drug Administration’s top oncologist reiterated that the agency doesn’t want drugmakers applying for approval with data from trials solely run in a single country such as China, but instead wants to see companies conducting studies across the world.

The comments by Richard Pazdur, director of the FDA’s Oncology Center of Excellence, came as more drugmakers report data from China, with Miami-based Summit Therapeutics earlier this week announcing that its investigational drug beat Merck’s blockbuster Keytruda in a head-to-head non-small cell lung cancer study in China.

https://www.statnews.com/2024/06/01/asco-fda-oncology-cancer-pazdur-trials-china/

Jazz: New HER2-Positive Biliary Tract Cancer Data at ASCO 2024

 Zanidatamab demonstrated a median overall survival (OS) of 15.5 months in patients with centrally confirmed immunohistochemistry (IHC) 2+ or 3+ and a median OS of 18.1 months in patients with IHC 3+ tumors

With approximately two years of median follow-up, as of July 28, 2023, median duration of response (DOR) increased by two months from initial analysis to 14.9 months

https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-presents-overall-survival-and-longer-follow-up-data-from-herizon-btc-01-trial-evaluating-zanidatamab-in-previously-treated-her2-positive-biliary-tract-cancer-at-asco-2024-302161115.html

Corbus: More ADC Safety, Efficacy Data at ASCO

 

• An additional 19 patients have been enrolled since January 2024 bringing the total to 37 of whom 25 were evaluable for efficacy
  
• SYS6002 (CRB-701) demonstrated 44% ORR and 78% DCR in mUC and 43% ORR and 86% DCR in cervical cancer to date at doses ≥ 1.2mg/Kg
• No dose limiting toxicities (DLTs) have been observed to date in doses up to and including 4.5 mg/Kg (cohort 7)
• Three cases of skin rash (including one grade 3) and one case of grade 1 neuropathy seen to date; all were resolved
• Early PK data demonstrate consistently lower levels of free MMAE than enfortumab vedotin across all doses in study including 4.5 mg/Kg

https://www.globenewswire.com/news-release/2024/06/01/2891822/0/en/SYS6002-CRB-701-A-Next-Generation-Nectin-4-Targeting-Antibody-Drug-Conjugate-Continues-to-Demonstrate-Encouraging-Safety-and-Efficacy-Observed-in-Patients-with-Nectin-4-Positive-Tu.html

Waste Management near $7 bln deal to buy Stericycle

 Waste Management Inc (NYSE:WM) is close to a deal to buy medical waste disposal firm Stericycle Inc (NASDAQ:SRCL) for about $7 billion including debt, The Wall Street Journal reported on Sunday.

A deal could be announced as soon as Monday, the report said.

The report comes just shortly after reports last week said that Stericycle was seeking a potential sale. The report saw the Bannockburn, Illinois-based firm’s shares jump over 13% on Friday.

Waste Management is one of the largest U.S. garbage collection and recycling companies, with the acquisition of Stericycle giving it exposure to the medical waste industry. Stericycle helps clinics, surgery centers and hospitals dispose of biohazardous and pharmaceutical waste.

https://finance.yahoo.com/news/waste-management-near-7-bln-192553288.html

Israel assessing alternatives to Hamas rule in Gaza, defence minister says

 Israel's defence minister said on Sunday that Israel would not accept Hamas continuing to rule Gaza at any stage during the process to wind down the war, and that it was examining alternatives to the Islamist group.

"While we conduct our important military actions, the defence establishment is simultaneously assessing a governing alternative to Hamas," Yoav Gallant said in a statement.

"We will isolate areas (in Gaza), remove Hamas operatives from these areas and introduce forces that will enable an alternative government to form – an alternative that threatens Hamas," Gallant said.

He did not elaborate on the possible alternatives.

Iran-backed Hamas, which is sworn to Israel's destruction, has ruled the Gaza Strip since 2007, a year after it won parliamentary elections and following a brief civil war with security forces from the Western-backed Palestinian Authority.

Israel's war cabinet, of which Gallant is a member, is expected to meet later in the day, Israeli media reported, after U.S. President Joe Biden presented a framework deal for winding down the Gaza war. Hamas has provisionally welcomed the initiative but has given no indication it might step aside or disarm voluntarily.

Gallant, in a statement from the IDF southern command headquarters, said that Israel's military operation, together with creating the potential for governing alternatives will allow the removal of Hamas' authority and the return of hostages.

"We will not accept the rule of Hamas in Gaza at any stage in any process aimed at ending the war," he said.

https://uk.news.yahoo.com/israel-assessing-alternatives-hamas-rule-151734948.html

Trump Campaign Raises Staggering $200 Million Since Thursday Conviction

If Democrats needed further confirmation that prosecuting Donald Trump on an obscure misdemeanor elevated to a felony just for him... (while the same DA reduced 60% of felonies to misdemeanors last year), the Trump campaign has raised over $200 million since Thursday's verdict in the former president's New York 'hush money' trial.

Of that, $70 million was from small donors, and 30% of the total were first-time donors to a political campaign, Eric Trump told Fox News' Maria Bartiromo on Sunday.

"I mean, these are Americans who are p*ssed off, said the younger Trump. "They're coming out of the woodwork and they want to support a guy that they just believe is getting bamboozled by a system.

"We saw it with Impeachment one, we saw it with Impeachment two, we see it where they weaponize every liberal DA and AG across the country with one intent: To take him down, to slander him, to ruin his reputation, to try and divide his family, to try and bankrupt him, to throw him in jail, to do whatever the hell they can do," he added.

"America sees through it. They know exactly what's going on."

As the Post Millennial notes further;

The $200 million was raised in a matter of just three days, which far surpasses any amount raised by President Biden's campaign in a similar time frame. Within 24 hours of President Trump's guilty verdict, the Trump campaign received $53 million in donations. The Biden campaign raised a total of $51 million for all of April.

According to a Friday statement by Trump campaign officials Susie Wiles and Chris LaCivita, "Biden and his Democrat allies have turned our legal system into a political tool, and Americans from every corner of the country have had enough," adding "This momentum is just getting started and together, as President Trump stated perfectly, Americans will render the real verdict on November 5."

https://www.zerohedge.com/political/trump-campaign-raises-staggering-200-million-thursday-conviction

Maldives will ban Israelis from entering country over the war in Gaza

 The Maldives government will ban Israelis from the Indian Ocean archipelago, known for luxury resorts, as public anger in the predominantly Muslim nation rises over the war in Gaza.

The president’s office said Sunday that the Cabinet decided to change laws to prevent Israeli passport holders from entering the country and to establish a subcommittee to oversee the process.

It said President Mohamed Muizu will appoint a special envoy to assess the Palestinian needs and to launch a fundraising campaign.

Due to the actions of Netanyahu’s government, Israelis will not be allowed to enter the Maldives.AP
Nearly 11,000 Israelis visited Maldives last year, which was 0.6% of the total tourist arrivals.

https://nypost.com/2024/06/02/world-news/maldives-will-ban-israelis-from-entering-country-over-the-war-in-gaza/