FDA com­pli­ance vet heads to In­dia-based Lupin af­ter long pub­lic ca­reer

In a rare move, a long-time vet­er­an of the FDA’s phar­ma qual­i­ty and com­pli­ance team is mov­ing over to an In­dia-based gener­ic drug­mak­er with a his­to­ry of non­com­pli­ance.

Di­ana Amador-Toro

Di­ana Amador-Toro, who spent al­most four decades with FDA in­clud­ing stints as a pro­gram di­rec­tor for the of­fice of phar­ma­ceu­ti­cal qual­i­ty op­er­a­tions, was hired in April by In­di­an gener­ic drug man­u­fac­tur­er Lupin as the com­pa­ny’s se­nior vice pres­i­dent of glob­al com­pli­ance, where she will be han­dling the com­pa­ny’s com­pli­ance func­tion in­clud­ing train­ing, in­ter­nal au­dits and in­ves­ti­ga­tions.

Ac­cord­ing to her LinkedIn, Amador-Toro has amassed well over 36 years of FDA field ex­pe­ri­ence in in­ves­ti­ga­tions and com­pli­ance ac­tiv­i­ties, con­tribut­ing to ICH and FDA guid­ance doc­u­ments as well as hav­ing con­duct­ed GMP and phar­ma­ceu­ti­cal qual­i­ty train­ing in Eu­rope and South Amer­i­ca. Be­fore serv­ing as a pro­gram di­rec­tor, she was re­spon­si­ble for over hun­dreds of field em­ploy­ees in sev­en dis­tricts and three lab­o­ra­to­ries in­clud­ing the ORA’s foren­sic chem­istry cen­ter.

While a few for­mer FDA em­ploy­ees have gone on to work for man­u­fac­tur­ers in the past, as In­dia’s CN­BC af­fil­i­ate high­light­ed, the fact that Lupin was able to net a com­pli­ance of­fi­cer is as ma­jor catch for the man­u­fac­tur­er. How­ev­er, Amador-Tor is join­ing a com­pa­ny that has run afoul with US reg­u­la­tors and has been cit­ed mul­ti­ple times.

In 2021, Lupin sub­sidiary Nov­el Lab­o­ra­to­ry’s fa­cil­i­ty in Som­er­set, New Jer­sey had GMP vi­o­la­tions such as an in­ad­e­quate clean­ing pro­ce­dure and qual­i­ty con­trol pro­ce­dures. Drug residue on tablet press­es and a fail­ure to val­i­date the man­u­fac­tur­ing process af­ter equip­ment changes were just some of the is­sues raised by an in­spec­tion.

And in April, Lupin was slapped with a Form 483 fol­low­ing an in­spec­tion car­ried out at their man­u­fac­tur­ing fa­cil­i­ty in Tara­pur, In­dia.

Amador-Toro did not im­me­di­ate­ly re­spond to a re­quest to com­ment on her new role.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.