As­traZeneca con­tin­ues to build out its pres­ence in Chi­na with new COPD drug man­u­fac­tur­ing site

As­traZeneca has been grow­ing its pres­ence in Chi­na over the past sev­er­al years, and the phar­ma’s lat­est ven­ture in the coun­try will see it es­tab­lish a man­u­fac­tur­ing process for COPD treat­ments.

Ac­cord­ing to a press re­lease, trans­lat­ed from Chi­nese, As­traZeneca of­fi­cial­ly an­nounced it will ex­pand its in­vest­ment in Chi­na and plans to spend some cash to con­struct a pro­duc­tion and sup­ply base as well, as a re­gion­al head­quar­ters in the port city of Qing­dao, Shan­dong in east­ern Chi­na. Qing­dao will al­so be home to an in­no­va­tion cen­ter fo­cused on rare dis­eases, a life sci­ence in­no­va­tion park and an in­dus­tri­al fund.

The com­pa­ny ad­di­tion­al­ly said that the planned man­u­fac­tur­ing and sup­ply base in Qing­dao will pro­duce the in­gre­di­ents for Breztri, a ther­a­peu­tic that treats COPD. As­traZeneca de­clined to com­ment on the cost, size or time­lines on the man­u­fac­tur­ing space and in­no­va­tion cen­ter.

“As­traZeneca’s in­vest­ment in the Qing­dao pro­duc­tion and sup­ply base aims to bet­ter meet the huge de­mand of pa­tients for Breztri in­hala­tion aerosols. To fur­ther pro­mote the de­vel­op­ment of Qing­dao’s bio­phar­ma­ceu­ti­cal in­dus­try and con­tribute to the Na­tion­al Health Vi­sion 2030, As­traZeneca will con­tin­ue to strength­en its con­fi­dence in in­creas­ing in­vest­ment in Chi­na,” said Wang Lei, the Chi­na pres­i­dent of As­traZeneca, in a state­ment.

Breztri, which gained ap­proval in Chi­na in 2019, had a rocky jour­ney with US reg­u­la­tors. In 2019, the triple-drug com­bi­na­tion treat­ment was orig­i­nal­ly shot down with a CRL, but it fi­nal­ly re­ceived the green light in 2020.

And while As­traZeneca has a sol­id pres­ence in Chi­na with sup­ply bases in Wuxi and Taizhou, Jiang­su, Chi­na, some staffers re­cent­ly found them­selves in trou­ble.

In Jan­u­ary, mul­ti­ple sus­pects were ar­rest­ed in con­nec­tion with an al­leged med­ical in­sur­ance fraud scheme or­ga­nized by As­traZeneca Chi­na em­ploy­ees, the coun­try’s Na­tion­al Health­care Se­cu­ri­ty Ad­min­is­tra­tion (NHSA) said. The ar­rests oc­curred af­ter an in­ves­ti­ga­tion found ev­i­dence that staff mem­bers tam­pered with the ge­net­ic test­ing re­sults of tu­mor pa­tients to de­fraud med­ical in­sur­ance funds.

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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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the 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 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.

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Merdad Parsey, Gilead CMO

Four months af­ter CRL due to con­t­a­m­i­nant wor­ries, Gilead re­turns to FDA for next-gen HIV drug

Just shy of four months ago, Gilead’s next-gen HIV drug candidate lenacapavir got hit with a CRL over CMC issues involving the type of vials planned for use. Now, the pharma is headed back to the FDA for round two.

Gilead announced Monday afternoon that it had refiled its NDA submission filled with new CMC data after the FDA essentially balked at borosilicate glass vials, originally used for the non-oral form of lenacapavir. The drug candidate, which recently won a positive opinion from Europe’s CHMP, is being developed for HIV-1 infection “in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.”

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.

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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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.

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.