FDA warns Span­ish drug and API man­u­fac­tur­er over mul­ti­ple pro­duc­tion line prob­lems

The FDA de­liv­ered a laun­dry list of cit­ed prob­lems to a Eu­ro­pean man­u­fac­tur­er with pro­duc­tion line is­sues that in­clud­ed mi­cro­bi­o­log­i­cal con­t­a­m­i­na­tion and im­prop­er clean­ing pro­ce­dures. The Form 483 was sent to Span­ish drug ma­te­ri­als man­u­fac­tur­er Bioiber­i­ca’s ma­te­ri­als man­u­fac­tur­ing plant in Palafolls, north of Barcelona.

In an in­spec­tion be­tween Jan. 31 and Feb. 4 this year the FDA found that clean­ing pro­ce­dures for the equip­ment used in the drug sub­stance man­u­fac­tur­ing were not val­i­dat­ed as nec­es­sary to en­sure ad­e­quate clean­ing and con­t­a­m­i­na­tion pre­ven­tion mea­sure. The FDA al­so found mi­cro­bi­o­log­i­cal con­t­a­m­i­na­tion and a lack of es­tab­lished con­trol pro­ce­dures to mon­i­tor the out­put man­u­fac­tur­ing process­es that could po­ten­tial­ly cause vari­abil­i­ty in the drug sub­stance.

The plant’s qual­i­ty con­trol unit al­so lacked the re­spon­si­bil­i­ty to ap­prove all pro­ce­dures or spec­i­fi­ca­tions around iden­ti­ty, strength, qual­i­ty and pu­ri­ty of sub­stances and had no writ­ten test­ing pro­gram to as­sess the sta­bil­i­ty char­ac­ter­is­tics.

The FDA found that writ­ten records of in­ves­ti­ga­tions in­to pre­vi­ous dis­crep­an­cies didn’t al­ways in­clude con­clu­sions and jus­ti­fied fol­low-ups. The in­spec­tors not­ed that was par­tic­u­lar­ly prob­lem­at­ic around in­ves­ti­ga­tions of mi­cro­bi­o­log­i­cal non-con­for­mi­ties for an un­named USP drug.

Bioiber­i­ca man­u­fac­tures a wide range of prod­ucts for an­i­mal, plant and hu­man health. For hu­mans, the com­pa­ny pro­duces Glu­cosamine API, sev­er­al he­parin com­pounds and Ten­dax­ion, among a slew of oth­er com­pounds.

This marks the first time the com­pa­ny has re­ceived a warn­ing from the FDA.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

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?”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als due to missed pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

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.