Ozempic, Mounjaro manufacturers sued over risk of stomach paralysis

 A Louisiana woman sued the manufacturers of popular weight loss drugs Ozempic and Mounjaro on Wednesday, alleging that the drug makers failed to warn patients about the risk of severe gastrointestinal problems.

The lawsuit claims that Novo Nordisk and Eli Lilly, the respective manufacturers of Ozempic and Mounjaro, “downplayed the severity of the gastrointestinal events” caused by their medications, such as gastroparesis, or stomach paralysis, and gastroenteritis, or stomach inflammation.

Jaclyn Bjorklund, 44, took Ozempic for more than a year before switching to Mounjaro in July and suffered from “severe gastrointestinal events,” including severe vomiting, stomach pain, gastrointestinal burning, hospitalization and the loss of teeth from excessive vomiting, according to the lawsuit. 

While the labels for both medications note that they delay gastric emptying and can cause a variety of stomach problems — including nausea, vomiting, diarrhea, abdominal pain and constipation — they do not explicitly warn of gastroparesis as a risk.

The lawsuit accuses Novo Nordisk and Eli Lilly of being aware of an association between medications like Ozempic and Mounjaro and severe gastrointestinal issues and choosing to ignore and not disclose this to patients.

As a result, the lawsuit alleged Bjorklund “was and still is caused to suffer from severe gastrointestinal issues, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain, and mental anguish.”

Ozempic and Mounjaro, which were developed to manage blood sugar levels in adults with Type 2 diabetes, have recently grown in popularity for their off-label use for weight loss.

A spokesperson for Novo Nordisk said in a statement that gastrointestinal events are “well-known side effects” of this class of medications, and the majority of Ozempic’s gastrointestinal side effects are “mild to moderate in severity and of short duration.”

“Patient safety is of utmost importance to Novo Nordisk,” the spokesperson said, adding, “We are continuously monitoring the safety profile of our products and collaborate closely with authorities to ensure patient safety, including adequate information on gastrointestinal side effects in the label.”

An Eli Lilly spokesperson similarly said in a statement that patient safety is the company’s “top priority,” noting that it “actively [engages] in monitoring, evaluating and reporting safety information” for all of its medicines.

https://thehill.com/policy/healthcare/4134614-ozempic-mounjaro-sued-stomach-paralysis/

Canada wildfire emissions more than double previous annual pollution record: Euro monitor

 Carbon emissions produced by Canadian wildfires this year have already more than doubled the annual record, according to data released Thursday by the European Union’s Copernicus Atmosphere Monitoring Service (CAMS).

Between the beginning of 2023 and the final day of July, emissions from the fires comprised 290 megatonnes, or about 290 million metric tons. This amount also accounted for 25 percent of the global total for the year, according to CAMS.

The northern wildfires have burned about 32 million acres this season, the most devastating in the country’s history — and earlier this summer caused clouds of smoke to choke the East Coast of the U.S. The previous full-year record for total area burned, which was about 17.55 million acres, was set in 1995. 

Copernicus said the atypical wildfire activity was largely the result of dryer and warmer weather, which climate change makes more likely, and El Niño conditions also playing a possible role.

“In recent years we have seen significant wildfires in the Northern Hemisphere, but this year’s fire activity in Canada is highly unusual,” CAMS Senior Scientist Mark Parrington said in a statement. “The weather has played a part, with warm and dry conditions increasing the flammability of vegetation and increasing the risk of large-scale fires. We support users in mitigating the impacts through monitoring the fire activity and intensity, and the emitted smoke.”

Meanwhile, the worst may be yet to come, as the northern hemisphere’s wildfire season typically peaks across July and August, according to CAMS. 

As of Thursday morning, Canada has had a total of 5,130 fires in 2023, including 1,039 that are currently active, according to the Canadian Interagency Forest Fire Center.

Of these, a majority, 660, are currently classified as out of control. The plurality of active fires, 348, are in British Columbia. 

https://thehill.com/policy/energy-environment/4135439-canada-wildfire-emissions-more-than-double-previous-annual-pollution-record/

'4 Pinocchios': WaPo Admits Biden Has Been Lying About Hunter Not Accepting Money From China

 by Jonathan Turley,

President Joe Biden has been a regular recipient of “Pinocchios” by the Washington Post for his false statements on subjects ranging from election laws to abortion protections to deficit reduction. 

Biden is undeterred and regularly repeats false stories from his life that have ranged from an invented arrest with Nelson Mandela to a zombie-like train conductor. Undeterred, this week he continued with the false claim about the “Joey, Baby” conductor.

Now, the President has a fresh set of “Four Pinocchios,” but the false claim is far more serious than inventing a conductor or rewriting the history of the Second Amendment. 

The Post is admitting that Biden has been lying about how his son Hunter never made money from China. It is the latest indication that the protective media wall surrounding Biden is beginning to crumble under the weight of new evidence in the corruption scandal.

Glenn Kessler wrote yesterday that Biden has repeatedly and categorically maintained that his son did not receive money from China.

“But now, nearly three years later, Biden’s assertions have been directly rebutted by Hunter himself. In court testimony last week, the younger Biden acknowledged that he in fact had been paid substantial sums in China — the first official confirmation that this was the case.”

What is curious is that Kessler and the Post waited for Hunter to effectively confess rather than take notice of money transfers and records released by House committees investigating the corruption scandal. The Post and most of the media have taken little observable journalistic interest in independently confirming such payments or benefits. Instead, the media has adopted a largely passive stance and waited for confessions rather than find confirmation.

Nevertheless, as with the laptop, there is some credit to be given for eventually confirming what has long been known.

Kessler noted that these dealings overlapped with the President’s travels and meetings:

“Twelve days after he flew to Beijing, Hunter Biden joined the board of a just-formed investment advisory firm known as BHR (Bohai, Harvest and Rosemont), whose partners included Chinese entities, including the man he introduced to his father. Separately, after Joe Biden left public office, Hunter Biden in 2017 inked a deal with CEFC China Energy, a Chinese energy conglomerate. The Washington Post reported last year that documents, including emails found on a Hunter Biden laptop that emerged during the final weeks of the 2020 presidential campaign, showed that over the course of 14 months, the CEFC and its executives paid $4.8 million to entities controlled by Hunter Biden and President Biden’s brother, James.”

Nevertheless, the Post emphasized that it “did not find evidence that Joe Biden personally benefited from or knew details about the transactions with CEFC.” Of course, the Post has not been known to be particularly active in independently trying to confirm such benefits . . . absent another Biden admission or confession.

As with the clearly false claims that he had no knowledge or involvement in these dealings, the question is now not whether Joe Biden has been lying but why he has been lying.

https://www.zerohedge.com/political/four-pinocchios-washington-post-admits-biden-has-been-lying-about-hunter-not-accepting

Allogene Q2 update

 

• Presented Long-Term Data for an Allogeneic CD19 CAR T Product Candidate in Relapsed/Refractory Large B Cell Lymphoma (LBCL) at the American Society of Clinical Oncology (ASCO) Annual Meeting and International Conference on Malignant Lymphoma (ICML) Lugano

  • ALLO-501/501A Demonstrated Rates of Durable Complete Responses Similar to Approved Autologous CAR T Therapies

• Enrollment Ongoing in the ALLO-501A ALPHA2 and EXPAND Phase 2 Trials in LBCL

  • ALPHA2 Trial Expected to Complete Enrollment in 1H 2024 with the First Data Readout Planned by Year-End 2024

• Ended Q2 2023 with $545 Million in Cash, Cash Equivalents and Investments

  • Includes Approximately $88 Million in Net Proceeds from At-the-Market (“ATM”) Equity Financing Facility During the Second Quarter; Cash Runway Now Projected to Extend into 2H 2025

• Conference Call and Webcast Scheduled for Wednesday at 2:00 PM PT/5:00 PM ET

2023 Financial Guidance

• As previously reported, the Company expects a decrease in cash, cash equivalents, and investments of approximately $230 million in 2023. GAAP Operating Expenses are expected to be approximately $340 million, including estimated non-cash stock-based compensation expense of approximately $80 million. These estimates exclude any impact from potential business development activities.
  

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company's website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days.

https://finance.yahoo.com/news/allogene-therapeutics-reports-second-quarter-200200930.html

Kymera Q2 update

 Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation (TPD) to deliver novel small molecule protein degrader medicines, today reported business highlights and financial results for the second quarter ended June 30, 2023.

“Kymera has made strong progress with our three proprietary clinical programs over the last quarter, including dosing our first patient in the KT-253 Phase 1 study and sharing data that both KT-333 and KT-413 reached degradation levels that were associated with anti-tumor activity in preclinical models. We believe these findings reinforce Kymera’s ability to translate our preclinical pharmacokinetic, pharmacodynamic and safety models to patients and provide a strong foundation as we expand our pipeline with potentially best-in-class, high-value programs. We expect to share updates on these programs later this year,” said Nello Mainolfi, Founder, President and CEO, Kymera Therapeutics. “Additionally, our partner Sanofi expects to initiate the first two Phase 2 clinical trials for KT-474 in the fourth quarter, moving us forward on our mission of building a fully-integrated global medicines company.”

To access the conference call via phone, please dial +1 (800) 715-9871 (US) or +1 (646) 307-1963 (International) and ask to join the Kymera Therapeutics call or provide Conference ID 7353312. A live webcast of the event will be available under Events and Presentations in the Investors section of the Company’s website at www.kymeratx.com. A replay of the webcast will be archived and available following the event.

https://finance.yahoo.com/news/kymera-therapeutics-announces-second-quarter-110000868.html

Fulcrum: Strong EPS Growth Despite Sales Disappointment

  Fulcrum Therapeutics exceeded expectations by reporting a loss of $(0.38) per share, surpassing the analyst consensus estimate of $(0.44) by an impressive 13.64%.

Sales: Unfortunately, the company fell short of projections with quarterly sales amounting to $880.00 thousand, missing the analyst consensus estimate of $1.60 million by a significant 45.00%.

Year-over-Year Comparison: Despite the sales disappointment, Fulcrum Therapeutics showcased promising growth in terms of EPS. The reported loss of $(0.38) per share signifies a remarkable 54.22% increase compared to the $(0.83) loss per share recorded during the same period last year. However, it’s worth noting that the sales figures of $880.00 thousand experienced a considerable 53.24% decline in comparison to the $1.88 million sales from the previous year.

https://beststocks.com/fulcrum-therapeutics-reports-strong-eps-growt/

Castle Bio revenue beats, guidance upped

Q2 2023 revenue increased 44% over Q2 2022 to $50 million

Q2 2023 total test reports increased 52% over Q2 2022

Raising full year 2023 revenue guidance to at least $180 million from $170-180 million

Conference call and webcast today at 4:30 p.m. ET

Cash, Cash Equivalents and Marketable Investment Securities

As of June 30, 2023, the Company’s cash, cash equivalents and marketable investment securities totaled $225.5 million.

2023 Outlook

Castle Biosciences is increasing its guidance for anticipated total revenue in 2023. The Company now anticipates generating at least $180 million in total revenue in 2023 compared to the previously provided guidance of $170-180 million.

Conference Call and Webcast Details

Castle Biosciences will hold a conference call on Wednesday, August 2, 2023, at 4:30 p.m. Eastern time to discuss its second quarter 2023 results and provide a corporate update.

A live webcast of the conference call can be accessed here: https://events.q4inc.com/attendee/543951973 or via the webcast link on the Investor Relations page of the Company’s website, https://ir.castlebiosciences.com/overview/default.aspx. Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until August 23, 2023.

To access the live conference call via phone, please dial 833 470 1428 from the United States, or +1 404 975 4839 internationally, at least 10 minutes prior to the start of the call, using the conference ID 967509.

There will be a brief Question & Answer session following management commentary.

https://finance.yahoo.com/news/castle-biosciences-reports-second-quarter-200500125.html