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Antares Phar­ma wins FDA OK for oral testos­terone treat­ment; Eye-fo­cused biotech re­ports PhI­II da­ta for pupil di­la­tion drug

Antares Pharma has nabbed another FDA approval, and the company’s second involving testosterone.

The New Jersey pharma announced the company’s approval on Tuesday for Tlando, aka testosterone undecanoate, an oral treatment for testosterone replacement therapy. According to the pharma, the drug is indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism.

Af­ter CRL, CorMedix says new fil­ing has been ac­cept­ed by FDA; Spine Bio­Phar­ma nets a mod­est Se­ries B

After a manufacturing slip-up led to a CRL last year, a small biotech says its new approach is ready for the FDA.

NJ-based CorMedix refiled its application for its antibacterial and antifungal treatment to prevent bloodstream infections in patients undergoing chronic hemodialysis, the company announced Monday. The FDA has accepted the filing, considers it a “Class 2 response” and will look at it as part of a six-month review, CorMedix added.

EQRx links arms with In­sil­i­co on that two-let­ter buzz­word (AI); De­spite miss in pre­vi­ous­ly treat­ed pa­tients, Ri­bom­ic push­ing eye drug for­ward

Another deal has been inked in the artificial intelligence-based drug discovery landscape, and it’s one featuring a key player touting the two-letter buzzword frequently, teaming up with one of those biotechs claiming to be part of the next wave of developers of lower-cost drugs.

Insilico Medicine and EQRx will collaborate on up to three targets on de novo small molecule design. Deal terms were kept under the hood. The companies will use Insilico’s AI tools in the preclinical stages, and EQRx will handle clinical development. The AI player can invest at various points along the clinical stages, if Insilico so chooses, in return for more commercialization profits.

Bio­gen, Ei­sai un­veil new da­ta on lecanemab, but ques­tions linger on ARIA-E; Spa­tial bi­ol­o­gy out­fit grabs $33M round

Eisai and Biogen have released more data on lecanemab, another anti-Alzheimer’s drug in the partnership that spawned aducanumab. However, questions about the data remain when looking at ARIA-E events, with the typical caveat of cross-trial comparisons.

The data from lecanemab’s Phase IIb study were presented at the annual AD/PD meeting, and the ratio of ARIA-E — a type of amyloid-related imaging abnormalities resulting in brain bleeds — appeared higher than in Aduhelm studies when compared to placebo. Two trials on the highly controversial drug, ENGAGE and EMERGE, showed an ARIA-E rate of 41%, compared to 10% in the placebo arm. That was a 4:1 ratio.

Leg­end re­veals its hold stems from in­suf­fi­cient IND in­fo; Proven­tion re-files BLA af­ter Ju­ly CRL

In its fourth quarter and full year report, Legend Biotech went into a little more detail as to why the FDA slapped it with a clinical hold.

The biotech reported Friday afternoon that it was not allowed to start a Phase I study because its IND did not “contain sufficient information required by 21 CFR 312.23” to properly assess risks to patients. That law, 21 CFR 312.23, outlines how companies wishing to get a drug approved must submit their INDs.

Rin­voq nabs new ap­proval in sec­ond-line UC; Sen­so­ri­on says its failed drug now works in sub­set analy­sis

AbbVie’s Rinvoq racked up another approval late Wednesday afternoon.

The drug is now OK’d in adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers, AbbVie said in a press release. It’s the first approval for the drug in gastroenterology, the company added, with data stemming from three Phase III studies.

“There remains an unmet need for patients with moderately to severely active UC, who suffer from debilitating symptoms that are often unpredictable and burdensome,” said Thomas Hudson, AbbVie CSO. “With the approval of Rinvoq as a new treatment option, AbbVie continues our leadership in advancing research that can help impact the lives of people living with ulcerative colitis.”

Alec­tor presents PhII da­ta on lead de­men­tia drug; Chi­nese on­col­o­gy biotech nets mod­est Se­ries A+

Back in June, GSK paid Alector $700 million to kickstart an alliance for rights to two drugs targeting a range of neurological diseases.

The next month, Alector showed via early data that one of the drugs, antibody AL001 for a genetic and rapidly progressing form of dementia, brought levels of progranulin back to near-normal levels after six months in nine patients. Seven stayed at near-normal after a year.

Nat­era shares tum­ble af­ter short-sell­er al­leges de­cep­tive billing prac­tices — and pos­si­bly in­sur­ance fraud

Hindenburg Research — the short-seller firm that writes exposé reports every so often, as in the case of Sorrento Therapeutics in 2020 — went after genetics testing and DNA screening company Natera in its newest report. And the results are far from flattering.

The investment firm noted it wasn’t thrilled with the company from the get-go, and the title said it all with “Natera: Pioneers In Deceptive Medical Billing.” The report went into detail about what it alleged are shady billing practices, including charging both doctors and expectant mothers the full amount for a test and hiding their actions.

John Maraganore joins up with Pro­QR as strate­gic ad­vi­sor; Servi­er nabs pri­or­i­ty re­view for Tib­so­vo sN­DA

After a month-long break from advisory appointments, John Maraganore is once again being tapped to join another biotech.

The RNA-focused startup announced Maraganore’s appointment this morning, with the Alnylam founding CEO joining up as a strategic advisor to ProQR’s supervisory board.

Monday’s move comes a few weeks after the biotech’s lead candidate for the rare genetic eye disease, Leber congenital amaurosis, had shown no difference between placebo and any other efficacy measures. Maraganore said in a statement that he first met ProQR CEO Daniel de Boer more than a decade ago through former Genzyme CEO Henri Termeer, before his passing in 2017.

Egg al­ler­gy tri­als halt­ed by Aim­mune; At­las clos­es its 13th fund for $450M

A Phase II trial for Aimmune’s drug to treat children and young adults with egg allergies has been terminated.

The trial was terminated on Feb. 28, according to its site. In an emailed statement to Endpoints News, a company spokesperson said:

“Aimmune made the decision to terminate the study of AR201 in a characterized oral desensitization immunotherapy (CODIT™) regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive, based on difficulties in meeting enrollment goals, especially during the COVID-19 pandemic, and not for reasons relating to any concerns regarding quality, safety, or efficacy.”