Eu­rope to sus­pend about 100 gener­ic drugs af­ter un­cov­er­ing da­ta 'ir­reg­u­lar­i­ties' at In­di­an CRO

The Eu­ro­pean Med­i­cines Agency is rec­om­mend­ing the sus­pen­sion of about 100 drugs af­ter find­ing da­ta in­tegri­ty is­sues at an In­dia-based CRO that ran tests for the gener­ic drugs.

The CRO in ques­tion, Syn­chron Re­search Ser­vices, isn’t the first to come un­der the mi­cro­scope for da­ta fail­ings. The FDA and EMA have raised sim­i­lar ques­tions in the past re­gard­ing da­ta find­ings from sev­er­al In­dia-based CROs, in­clud­ing Sem­ler Re­search and GVK Bio­sciences. In the case of Sem­ler, as in the case of Syn­chron, reg­u­la­tors are re­quir­ing the drug spon­sors to re­peat their bioe­quiv­a­lence/bioavail­abil­i­ty stud­ies at an ac­cept­able al­ter­nate study site.

Syn­chron al­so came un­der fire from FDA last Sep­tem­ber over sim­i­lar da­ta con­cerns.

“The rec­om­men­da­tion comes af­ter ir­reg­u­lar­i­ties were found in how the CRO car­ried out bioe­quiv­a­lence stud­ies, which raised se­ri­ous con­cerns about the com­pa­ny’s qual­i­ty man­age­ment sys­tem and the re­li­a­bil­i­ty of da­ta from that site,” the EMA said in a state­ment on Fri­day.

Com­pa­nies with af­fect­ed gener­ic drugs in­clude J&J, San­doz, Vi­a­tris, Te­va, Ju­bi­lant, Wock­hardt, Ac­cord Health­care, Au­ro­ra Bio­far­ma, Strides Phar­ma, Tillomed Phar­ma, Ori­farm Gener­ics, Sta­da, Brill­phar­ma, Mi­cro Labs, ra­tio­pharm, Ben­net Phar­ma­ceu­ti­ca, Med­icair Bio­science Lab­o­ra­to­ries, Pinewood Lab­o­ra­to­ries and more.

But the EMA warned mem­ber states that some of the drugs rec­om­mend­ed for sus­pen­sion “may be of crit­i­cal im­por­tance (e.g. due to lack of avail­able al­ter­na­tives) in a giv­en EU Mem­ber State. There­fore na­tion­al au­thor­i­ties can tem­porar­i­ly post­pone the sus­pen­sion in the in­ter­est of pa­tients. Mem­ber States should al­so de­cide whether re­calls of the af­fect­ed med­i­cines are need­ed in their ter­ri­to­ries.”

As far as what specif­i­cal­ly the reg­u­la­tors are con­cerned with, ac­cord­ing to the FDA’s un­ti­tled let­ter to Syn­chron last year, an in­spec­tion from 2019:

found un­usu­al and un­ex­plain­able study records demon­strat­ing that you en­gaged in prac­tices and process­es that un­der­mined the an­a­lyt­i­cal meth­ods used at your firm. Up­on close re­view of study records from your firm, we con­clude that those prac­tices and process­es re­sult­ed in the sub­mis­sion of fal­si­fied study da­ta to the FDA.

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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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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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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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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