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Boehringer In­gel­heim per­ma­nent­ly shelves pro­duc­tion of cloni­dine, cit­ing ear­li­er re­call and mar­ket com­peti­tors

One less version of clonidine, the decades-old blood pressure and ADHD drug, is now on the shelves.

Boehringer Ingelheim will discontinue its production of Catapres, telling the FDA the decision was due to both an October recall and a number of copycat drugs already on the market from other manufacturers.

BI, the German pharma giant, voluntarily recalled lots of three different doses of clonidine hydrochloride variant Catapres after an extraneous peak in a dissolution test, the company said at the time.

Re­call re­port: Fre­se­nius Kabi yanks in­flam­ma­to­ry med Ke­toro­lac af­ter find­ing par­tic­u­lates in vials

The FDA on Friday announced that Fresenius Kabi USA, based in Illinois, voluntarily recalled a single lot of Ketorolac Tromethamine Injection USP 30 mg/mL. Particulate matter was found in reserve sample vials of the drug, which is used as a short-term medication to manage severe acute pain which requires analgesia at the opioid level.

Fresenius Kabi USA has received no reports of negative side effects from the lot, the FDA said in a release.

FDA side­swipes Ne­oleukin with clin­i­cal hold on lead im­munother­a­py can­di­date, sends shares plum­met­ing

Natural killer and CD8 T cells for oncology have been a hotbed of investment in recent years, with some Big Pharma players dabbling in the effort. A smaller competitor, Seattle’s Neoleukin Therapeutics, hoped to give its IL-2 innovator a shot at boosting those cells without the toxicity concerns, but the FDA had other ideas.

The FDA has placed a clinical hold on Neoleukin’s IND application for NL-201, a de novo cytokine receptor agonist for IL-2 and IL-15, which it hoped to test in expanding CD8 T cells and natural killer cells for use in oncologic therapeutic areas, the company said Friday.

FDA of­fers first thoughts on neu­rode­gen­er­a­tive dis­ease gene ther­a­pies

The FDA has issued draft guidance on the development, testing, and trial design for human gene therapies for neurodegenerative diseases. The document, released on Tuesday, also highlights approval pathways for these novel products.

The draft guidance, which applies to products for both adult and pediatric populations, emphasizes the importance of early communication with FDA before the submission of an investigational new drug (IND) application. The agency pointed to INTERACT meetings, which can be used to discuss issues in a product’s early preclinical program, and pre-IND meetings, which occur later in development but prior to the submission of an application.

As­traZeneca's Farx­i­ga gets rough FDA re­view date for ground­break­ing move in­to chron­ic kid­ney dis­ease

AstraZeneca’s Farxiga broke ground last year with an FDA nod for heart failure patients with or without type 2 diabetes — a first-in-class approval. But Farxiga isn’t done innovating and is now looking at a approval in the coming months in another potential blockbuster indication.

The FDA will review AstraZeneca’s application to take SGLT2 inhibitor Farxiga into chronic kidney disease sometime in the second quarter after tagging the drug for priority review, the British drugmaker said Wednesday. CKD is believed to currently affect roughly 37 million US patients, AstraZeneca said.

'N of 1' ther­a­pies ad­dressed in draft FDA guid­ance

Recognizing the pace at which drug developers are moving ever further into individualized medicine, the FDA has issued a draft guidance addressing submission processes for some hyper-specialized treatments.

The new document, which gives high-level guidance for investigational new drug (IND) submissions of individualized anti-sense oligonucleotides (ASOs), takes into consideration that these “N of 1” therapies come with “a set of challenges and considerations not seen with the typical drug intervention,” according to a statement from Patrizia Cavazzoni, MD, the acting director of FDA’s Center for Drug Evaluation and Research (CDER).

Levi Garraway, Roche

Roche gets a leg up in the an­ti-TIG­IT race with first break­through des­ig­na­tion for PhII win­ner tiragolum­ab

In the race to usher in a next generation of immunotherapies, Roche’s Genentech has emerged from the pack, nabbing the first breakthrough designation for an anti-TIGIT drug.

The pharma giant’s tiragolumab plus Tecentriq landed a spot in the FDA’s expedited review program for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in those with high PD-L1 expression and no EGFR or ALK genomic tumor aberrations, Roche said Tuesday.

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Re­call re­port: Nos­trum ex­pands re­call of di­a­betes drug met­formin af­ter car­cino­gen con­cerns

Generic metformin has been a thorn in drugmakers’ sides for months after a probable human carcinogen was found in tested lots. Now, one of the companies is expanding its recall to another lot of the drug.

Nostrum Laboratories out of Kansas City, MO voluntarily recalled one lot of metformin HCl extended release tablets, USP 750 mg, a type 2 diabetes drug (the generic equivalent to Glucophage tablets) after testing discovered elevated levels of nitrosamine, the probable carcinogen.

Bris­tol My­ers Squibb walks on Op­di­vo's FDA nod for small-cell lung can­cer af­ter mid­dling OS da­ta could­n't back ap­proval

In a pitched battle against Merck’s Keytruda, Bristol Myers Squibb’s immunotherapy headliner Opdivo landed a major salvo with a groundbreaking FDA approval for certain lung cancer patients back in 2018. Since that nod, however, Opdivo has turned out clinical duds in that market, and now Bristol is cutting its losses.

Bristol has agreed to give up Opdivo’s third-line-or-later FDA approval for small-cell lung cancer after confirmatory trials for an accelerated nod in that indication back in 2018 failed to show benefit in extending patients’ lives, the drugmaker said Tuesday.

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As­traZeneca/Ox­ford score first vote of con­fi­dence as UK au­tho­rizes their Covid-19 vac­cine

AstraZeneca and Oxford have landed the first authorization for their Covid-19 vaccine. And with this particular shot, the UK may be much further ahead than the rest of the world.

The MHRA recommended an emergency OK to the UK government almost two months after it started a rolling review — although the developers only submitted the full application last week. Regulators have determined that “the vaccine has met its strict standards of safety, quality and effectiveness,” according to a statement, even though experts in other countries have raised questions.