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.

The Busi­ness Stan­dard re­port notes that the warn­ing let­ter ob­serves that the com­pa­ny had dis­closed very lim­it­ed and re­strict­ed in­for­ma­tion. The let­ter al­so did not con­sid­er the ob­ser­va­tions from the FDA as se­ri­ous. SE­BI in turn has ad­vised the com­pa­ny to en­sure com­pli­ance with all ap­plic­a­ble pro­vi­sions of SE­BI’s reg­u­la­tions and to place this warn­ing let­ter be­fore its board of di­rec­tors.

Ac­cord­ing to an ar­ti­cle from The Eco­nom­ic Times, Au­robindo Phar­ma ac­knowl­edged that it did re­ceive the let­ter from SE­BI but of­fered no oth­er de­tails. In turn, Au­robindo did not re­spond to an in­quiry from End­points News.

Ini­tial­ly re­port­ed in Jan­u­ary, Au­robindo’s Unit 1 was slapped with a 483 fol­low­ing an Au­gust 2021 in­spec­tion. Ac­cord­ing to the 483, sev­en ob­ser­va­tions were made, in­clud­ing im­prop­er main­te­nance of equip­ment, sys­tems for eval­u­at­ing crit­i­cal ma­te­ri­als be­ing in­ad­e­quate and man­u­fac­tur­ing com­po­nents not be­ing test­ed and re­leased be­fore use, among oth­er in­frac­tions.

How­ev­er, this in­spec­tion at Unit 1 is not even the most re­cent time the FDA has writ­ten up the com­pa­ny. Ear­li­er this month, the FDA saw sev­er­al ob­ser­va­tions at Au­robindo’s Unit VII for­mu­la­tion plant in the vil­lage of Polepal­ly, In­dia dur­ing an in­spec­tion in ear­ly May.

There, in­ves­ti­ga­tors found an un­ex­plained dis­crep­an­cy and a fail­ure of a batch of its com­po­nents to meet any of its spec­i­fi­ca­tions, a lack of writ­ten pro­ce­dures for pro­duc­tion and process con­trols as well as batch pro­duc­tion and con­trol records not in­clud­ing com­plete in­for­ma­tion re­lat­ing to the pro­duc­tion and con­trol of each batch, among oth­er ob­ser­va­tions.

Over­all, the com­pa­ny has re­ceived a to­tal of 15 FDA 483s since 2016, with Unit 1 be­ing cit­ed twice.

The com­pa­ny has seen its stock on the In­di­an ex­change drop 29% over the past six months.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

FDA's vac­cine ad­comm to re­view first fe­cal trans­plant to treat C. dif­fi­cile in­fec­tions

Back in 2018, Swiss drugmaker Ferring Pharmaceuticals made a big bet on Minnesota-based Rebiotix, buying up the company for its experimental poop-based drug implant to treat an infection caused by C. difficile, a potentially dangerous bacteria, in a new way.

Four years later, Ferring’s fecal microbiota transplant, dubbed RBX2660 or Rebyota, will face the FDA’s adcomm of outside vaccine experts on Sept. 22, debating whether the agency should license the transplant as a treatment for adults following antibiotic treatment for recurrent C. difficile infection.