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Take­da scores a win for a rare type of lung can­cer, gear­ing up for a show­down with J&J

Four months after J&J’s infused drug Rybrevant scored the industry’s first win in a rare type of non-small cell lung cancer (NSCLC), Takeda is following up with an oral option for the small but desperate patient population.

The FDA granted an accelerated approval to Takeda’s oral TKI inhibitor Exkivity (mobocertinib) in metastatic NSCLC patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, the company announced on Wednesday.

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Renée Aguiar-Lucander

Not so fast: FDA tacks 3 more months on­to de­ci­sion date for Cal­lid­i­tas' rare kid­ney dis­or­der drug

It looks like the FDA’s decision on Calliditas’ IgA nephropathy candidate Nefecon is going to take a few months longer than expected — allowing time for rivals like Martin Shkreli’s former company Travere Therapeutics to catch up.

Five months after granting Nefecon priority review, the FDA is extending its PDUFA date from Sept. 15 to Dec. 15, Calliditas announced on Tuesday. The Swiss biotech filed for accelerated approval back in March, based on data from 200 patients in the first part of the Phase III NefIgArd trial who showed a significant reduction in proteinuria, or excessive protein in the urine.

Josh Cohen (L) and Justin Klee (Amylyx)

Once held back, Amy­lyx ex­ecs say the FDA is now push­ing for an NDA on ALS drug

It turns out the FDA is willing to take a look at Amylyx Pharmaceuticals’ ALS drug after all.

Roughly five months after the FDA said it asked for a Phase III study to confirm last year’s positive Phase II results, the agency has apparently reversed course. Amylyx will be submitting its ALS drug for US approval after meeting with regulators last month, the company announced Wednesday.

The move comes on the heels of the FDA’s controversial decision to approve Biogen’s new Alzheimer’s drug in June, one potentially signifying officials’ growing willingness in rare neurological diseases to get medicines to patients more quickly. Amylyx had previously submitted its approval application in Canada, with further plans to do so in the EU by the end of the year, but the FDA remained a notable holdout.

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Andrew Crockett, KalVista CEO

UP­DAT­ED: Five months af­ter get­ting slapped with a clin­i­cal hold, KalVista gets the OK to restart oral HAE pro­gram

KalVista’s oral program for the prevention of hereditary angioedema (HAE) was only on hold for five months — but that was enough time for rival Pharvaris to close in with its own on-demand and prophylactic treatment. Now that KalVista has the FDA’s permission to continue dosing patients, it’s sprinting to take the lead in Phase II.

The FDA lifted a clinical hold on KalVista’s KVD824 program after reviewing the company’s responses to a request for more information and analysis related to certain preclinical trials, the company announced early Tuesday morning. The news sent the trans-Atlantic biotech’s stock $KALV up 6.25% in premarket trading.

Da­ta do not sup­port wide­spread Covid vac­cine boost­ers right now, out­go­ing FDA lead­ers write in the Lancet

Even with the Delta variant, vaccine efficacy against severe Covid-19 is so high that booster doses for the general population are not appropriate at this stage in the pandemic, the FDA’s two top vaccine leaders, who recently announced their upcoming retirements on the same day, wrote in the Lancet on Monday.

The viewpoint, which was also co-authored by WHO and other academic experts from around the world, comes as the FDA is considering authorizing the use of boosters, with an adcomm of outside experts due to weigh in on Friday (briefing docs coming Wednesday).

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Janet Woodcock, acting FDA commissioner (Bill Clark/CQ Roll Call via AP Images)

FDA head Janet Wood­cock rais­es patent-re­lat­ed con­cerns to PTO di­rec­tor

While matters of drug pricing may not fall squarely under the FDA’s purview, acting FDA commissioner Janet Woodcock made clear the agency’s concerns around patents and competition, according to a letter sent Friday to the US Patent and Trademark Office.

The letter, addressed to Andrew Hirshfield, under secretary of commerce for intellectual property and director of the US PTO, said the FDA is concerned that some companies are filing so-called “continuation” patent applications, which can allow a filer to pile on follow-on patents on one drug, creating a thicket of patents to block or intimidate the competition. While Woodcock did not mention AbbVie by name, the term patent thicket is often used in association with the company’s dozens of patents covering its blockbuster rheumatoid arthritis drug Humira.

Not just the ap­proved in­di­ca­tions: FDA to study DTC drug ads that in­clude sec­ondary end­point da­ta

While most of the world bans direct-to-consumer advertising for prescription drugs, the FDA said Friday that it’s launching a study into how people might perceive such ads that include information on secondary endpoints that are not part of an approved indication.

The online research will examine the impact of adding a disclosure about a secondary claim (i.e. clinical benefit information based on a secondary endpoint reported in a product’s approved labeling) in DTC and healthcare provider-directed online promotions.

Andrey Petrikovets

In a first, FDA warns a re­searcher for fail­ing to sub­mit da­ta 3 years af­ter tri­al com­ple­tion

For the first time ever, the FDA has threatened an individual clinical trial investigator with a fine after he failed to publish trial data on a government database. The warning is part of a wider attempt to hold researchers and companies accountable for submitting trial results after trials finish.

Andrey Petrikovets, a surgeon from Los Angeles, ran a study on pain drug regimens following vaginal pelvic floor reconstructive surgery, but failed to publish results on time, the FDA said in a warning letter posted this week.

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With in­dus­try's bless­ing, FDA launch­es nov­el ex­cip­i­ent re­view pi­lot pro­gram

The FDA on Tuesday launched a new pilot program that will initially review four novel excipients over two years, with an eye toward helping drug developers in situations where existing excipients may be difficult to employ.

The plan for such a pilot has been in the works since at least 2019, as the FDA does not currently review new excipients as part of an IND or a marketing application, although some novel excipients may provide public health benefits, such as improved drug delivery or potentially abuse-deterrent properties that could be key for new opioid formulations.

Dan Menichella (AP Photo/Andrew Harnik)

UP­DAT­ED: Food or drug? FDA blasts Flag­ship-backed mi­cro­bio­me play­er’s ‘non-IND’ Covid-19 tri­al

When Kaleido Biosciences unveiled results from a multi-center, open label, controlled clinical study testing its microbiome product in Covid-19 patients back in March, the biotech touted it as a “non-IND” trial that yielded positive results and paved the way for an IND.

But it turned out that the FDA was not impressed with that tactic.

The agency has issued a warning letter to Kaleido blasting its “failure to submit INDs for the conduct of clinical investigations with an investigational new drug” that falls under section 505 of the federal Food, Drug, and Cosmetic Act. Kaleido now has 15 days to explain itself or report the actions it’s taken to prevent similar violations — or else face regulatory action.