It’s late August. We’re in the dog days of summer. Seemingly everyone in biopharma has reported their first-half earnings and taken vacation, getting some R&R before things ramp back up following Labor Day.

But one of the more anticipated Q2 events will occur almost immediately after the holiday — the unusual second adcomm for Amylyx Pharmaceuticals’ experimental ALS drug. And at least one analyst appears to be foregoing time off (at least for now) to try and read the tea leaves ahead of the Sept. 7 hearing.

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In November of 1937, editors from JAMA magazine penned a scathing letter about the United States’ inability to protect patients from toxins that masquerade as therapeutics, saying the drug development process was in dire need of laws with “common scientific decency.” In the preceding months, the nation had been riveted by the sudden deaths of nearly 100 people after taking elixir sulfanilamide. According to a congressional report, the elixir had been given to patients despite having only been “tested for its flavor but not its effect on human life.” Up until this point, drug manufacturers were not required to test therapeutics before sending them to market.

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This is going to be a long weekend for us at Endpoints, thanks to Labor Day in the US, and it’s much needed. September is shaping up to be a busy month, with biopharma seemingly coming back from the summer and events kicking into gear. If you have any news to share, we always appreciate some lead time. For the daily readers — see you on Tuesday.

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Seven years ago, Jay Bradner left high-profile posts at Harvard Med and Dana-Farber and jumped to the leadership role at Novartis’ global research arm, the storied Novartis Institutes for BioMedical Research, where one of his first jobs was reorganizing the group and cutting staff. And today we learned that he’s wrapping up his stint at the pharma giant in the midst of a major shakeup that forced development chief John Tsai out.

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An administrative judge ruled Illumina’s $8 billion acquisition of cancer-testing company Grail didn’t violate antitrust law, Illumina said on Thursday.

A Federal Trade Commission lawsuit threatened to unwind Illumina’s acquisition of Grail, a blood testing company that screens for cancers at an early stage.

“As we’ve stated from the outset, this transaction is procompetitive, will advance innovation, lower healthcare costs and save lives,” Illumina general counsel Charles Dadswell said in a statement.

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The FDA’s briefing docs are in ahead of its unusual second adcomm for Amylyx Pharmaceuticals’ experimental ALS drug next week — and the agency’s opinion is largely negative.

While acknowledging that ALS treatments are “desperately needed” and providing an extensive history of their previous flexibility for the disease, FDA reviewers wrote that Amylyx’s submission of new analyses is “not independent data and is simply a new method for analyzing the same survival data presented in the original NDA submission.” The new data packages involve patients who switched over from treatment to placebo after the Phase II trial wrapped up, suggesting better survival results than the study originally indicated.

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The FDA on Friday expanded its approval of Vertex’s blockbuster cystic fibrosis pill Orkambi to include children between 12 and 24 months.

Orkambi first won approval in 2015 for ages 2 years and older with two copies of the F508del mutation, but Vertex went for the earlier age indication, as CMO Carmen Bozic said in a statement: “Treating children with cystic fibrosis as early in life as possible is critically important, because early treatment has the potential to slow the progression of this devastating disease.”

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Like a number of other conferences this year, ESMO — ​​the European Society for Medical Oncology — is returning as an in-person event in Paris next week. Just last week, Endpoints associate editor Kyle LaHucik was in Barcelona for ESC, reporting on the latest slate of cardiology drugs.

Already, companies are gearing up for the European cancer conference, touting their late-breaker acceptances and upcoming presentations. (Just yesterday, Amgen posted a Phase III win for its KRAS drug Lumakras in non-small cell lung cancer, for which it will be presenting data on the second to last day of the conference.) Ahead of ESMO, here’s some background on a few of the most anticipated readouts set to come:

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While Biocon continues to be one of the major players in the generics and biosimilars markets, several of the company’s manufacturing sites have ended up on the FDA’s radar.

In a letter submitted to the stock exchange of India, Biocon stated that the FDA inspected three manufacturing facilities in the city of Bengaluru, India, and Johor, Malaysia. According to the letter, the inspections started with the Bengaluru site on Aug. 11 and concluded in Malaysia on Aug. 31.

United Therapeutics claimed victory earlier this week in a patent battle against Liquidia Technologies, which won tentative FDA approval for its treprostinil inhalation powder, Yutrepia, to treat pulmonary arterial hypertension (PAH) and would compete directly with United’s soon-to-be blockbuster Tyvaso DPI.

The Delaware-based district court found that Liquidia failed to prove by “clear and convincing evidence” that certain claims on one of the patents are invalid. But both companies claimed victory over other parts of the decision, and when Yutrepia will launch is still up in the air.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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