Chi­na reg­u­la­tors of­fer VIP treat­ment for 48 over­seas drugs they're ready to hus­tle up with ac­cel­er­at­ed re­views

Chi­na wants nov­el drugs al­ready ap­proved over­seas to be avail­able in the coun­try faster. And in case some drug­mak­ers didn’t get the memo, it’s now come up with a di­rect ap­peal.

Eight months af­ter the Chi­nese drug ad­min­is­tra­tion rolled out its new pri­or­i­ty re­view path­way, its Cen­ter for Drug Eval­u­a­tion has un­veiled a list of 48 drugs (which you can see be­low) ap­proved in the US, EU or Japan that are ur­gent­ly need­ed in the clin­i­cal set­ting. As long as the com­pa­nies can pro­vide ev­i­dence that the drug works equal­ly well across races, they can im­me­di­ate­ly ap­ply for mar­ket­ing ap­proval with the da­ta they have and will be el­i­gi­ble for pri­or­i­ty re­view.

In a re­cent re­port, the CDE con­clud­ed that they took an av­er­age of 59 work­ing days to process an NDA once it’s ac­cept­ed for pri­or­i­ty re­view. That’s light­ning fast by EMA or FDA stan­dards — even for their break­through drug pro­grams.

Can­cer drugs make up a quar­ter of the group, with Roche/Chugai’s ALK in­hibitor alec­tinib hy­drochlo­ride (Ale­cen­sa) and Mer­ck’s PD-1 star pem­brolizum­ab (Keytru­da) top­ping the list. Am­gen’s deno­sum­ab, which was first OK’d in Eu­rope as Pro­lia in 2010, is the old­est drug in this sub­set; where­as enasi­denib me­sy­late (Id­hi­fa), a new AML ther­a­py de­vel­oped by Cel­gene and Agios, got its green­light on­ly a year ago.

When putting the list to­geth­er, reg­u­la­tors wrote, they gave spe­cial con­sid­er­a­tion to new treat­ments for rare con­di­tions, as well as drugs that tar­get se­ri­ous, life threat­en­ing dis­eases with no ef­fec­tive ther­a­pies cur­rent­ly avail­able.

Oth­er “want­ed” drugs in­clude Spark’s $ONCE gene ther­a­py Lux­tur­na, Bio­gen’s $BI­IB SMA drug Spin­raza, and Alex­ion’s $ALXN Soliris — all con­sid­ered ground­break­ing at the time of their first ap­proval. No­tably, Soliris, which treats the rare dis­or­der parox­ys­mal noc­tur­nal he­mo­glo­bin­uria, has been ap­proved in the US for more than 10 years.

The list marks an­oth­er move by an agency that’s pushed out re­form af­ter re­form in the past few years, in­clud­ing a de­ci­sion to ac­cept over­seas clin­i­cal da­ta in NDAs — sav­ing for­eign drug­mak­ers the headache of con­duct­ing tri­als in Chi­na.

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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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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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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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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Photo: Clara Bui for Endpoints News

#Can­nes­Lions2022: Phar­ma and health mar­keters lose spot­light at cre­ativ­i­ty ad fest, but does it mat­ter?

Pharma advertising has long been considered second-tier when compared to the rest of the advertising industry. And there are some legitimate reasons why. Nike sneakers and Coca-Cola soda ads will likely always be more entertaining or exciting than regulated campaigns for diabetes and heart disease.

Still, the Cannes Lions advertising festival of creativity was pharma and healthcare advertising’s annual chance to shine. For the past eight years, pharma agencies and clients stood side by side with consumer companies and agency hotshots on the biggest advertising award stage in the world at the Palais in Cannes, France.