Last month, In­di­an drug man­u­fac­tur­er Au­robindo Phar­ma let the na­tion­al stock ex­change know that they once again in­voked the ire of US reg­u­la­tors. Now the ‘Form 483’ shines a light on what ex­act­ly went wrong.

Ac­cord­ing to the form, sev­er­al ob­ser­va­tions were made at Au­robindo’s Unit VII for­mu­la­tion plant in the vil­lage of Polepal­ly, In­dia dur­ing an in­spec­tion in ear­ly May.

In­ves­ti­ga­tors found an un­ex­plained dis­crep­an­cy and a fail­ure of a batch of its com­po­nents to meet any of its spec­i­fi­ca­tions. The FDA found out spec­i­fi­ca­tion (OOS) as­say and dis­so­lu­tion re­sults had led to the re­jec­tions of four tablet batch­es which were iden­ti­fied by a lack of con­trol over com­pres­sion ma­chine set­tings.

Oth­er ob­ser­va­tions that were wit­nessed in­clud­ed there be­ing no 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. Al­so, the writ­ten sta­bil­i­ty test­ing pro­gram had not been fol­lowed.

The FDA al­so found con­trols not be­ing ex­er­cised over com­put­ers and equip­ment used in the man­u­fac­ture, pro­cess­ing, pack­ing, or hold­ing of drug prod­ucts not be­ing of ap­pro­pri­ate de­sign to fa­cil­i­tate op­er­a­tions for its in­tend­ed use.

This marks the 15th time that Au­robindo has got­ten the 483 slap since 2016 and the sec­ond time this site, in par­tic­u­lar, has been cit­ed. In 2019, the plant had sev­en ob­ser­va­tions in­clud­ing writ­ten pro­ce­dures not be­ing fol­lowed, un­clean ma­te­ri­als, qual­i­ty con­trol not be­ing fol­lowed and a fail­ure to re­view any dis­crep­an­cies, among oth­er warn­ings.

Up­on be­ing no­ti­fied back in May, the man­u­fac­tur­er no­ti­fied the Na­tion­al Stock Ex­change of In­dia in a let­ter that it had re­ceived the 483 and that “The Com­pa­ny will re­spond to the US FDA with­in the stip­u­lat­ed time­line and work close­ly with US FDA to close the ob­ser­va­tions,” the let­ter said.

De­spite the com­pa­ny be­ing one of the larg­er drug man­u­fac­tur­ers, this no­tice has not been a con­fi­dence boost­er to Au­robindo on the ex­change, as the com­pa­ny $AU­ROPHAR­MA has seen a 14% drop in its price over the past month and a 28% de­crease year to date.

Au­robindo’s woes al­so now ex­tend to a court in the US, as a group of plain­tiffs, in­clud­ing J&J’s Janssen unit and the Sloan Ket­ter­ing In­sti­tute for Can­cer Re­search, filed a law­suit against Au­robindo ac­cus­ing it of ap­ply­ing to mar­ket an Er­lea­da copy­cat be­fore five patents are up.

Just as scientific innovation is essential to advancing health, systemic healthcare innovation is required to tackle health disparities. Factors outside of science – such as racism, discrimination, and lack of access to quality health care – create barriers that prevent some people from benefiting from hard-won scientific advancements. Innovation must go beyond science to address disparities in cancer care.

The last few decades have been years of amazing progress in how we approach cancer care: emphasizing regular screenings, early diagnoses and treatment with targeted therapies that are helping many patients live longer and healthier than ever before. We in the oncology community are proud of the hope we’ve brought to people facing this disease. However, the pandemic brought to light how health disparities can set us back from achieving our ultimate goal of eliminating cancer as a cause of death.

The new GSK has a new look. In a blend of familiar and modern, its vibrant orange brand color remains, while the now three letter-only name has been reimagined in a curvy contemporary logo update.

While the logo is the most visible change, the new GSK brand debuting Thursday is more than just a makeover. It’s a wholesale change for the 300-year-old company that, for the first time in its history, is no longer in the consumer healthcare business. The biopharma-only GSK has adopted a new purpose “to unite science, technology and talent to get ahead of disease together” as well as a new strategy, ambitions and revamped brand identity.

Regenxbio is pushing deeper into the gene therapy space with the opening of a new facility at its campus in the Washington D.C., suburb of Rockville, MD.

Built in a year, the $65 million, 132,000-square-foot GMP facility will enable the company to boost its manufacturing of NAV Technology-based adeno-associated virus, or AAV, vectors at scales up to 2,000 liters. The facility will also implement Regenxbio’s platform suspension cell culture process.

Emma Walmsley’s bet on making GSK a pure play Big Pharma innovator just cleared a major milestone. But the GSK team is not home free yet.

The global player announced that its adult RSV vaccine cleared a Phase III trial — AReSVi 006 — offering “exceptional protection” to 25,000 enrollees over the age of 60, setting up a planned rollout with regulators. But while GSK cheered this as a clear success, and a landmark first, it’s keeping the key figure on efficacy in preventing severe infections under wraps for now, leaving the next big question of how this will look to regulators and industry rivals still unanswered.

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For the second straight day, the FDA’s Cellular, Tissue and Gene Therapies adcomm voted unanimously in favor of FDA approving a bluebird bio gene therapy, this time by a 13-0 vote in favor of beti-cel as a potential treatment for a blood disorder known as β-thalassemia for those who require regular blood transfusions.

The second straight unanimous thumbs up opens the potential for two FDA approvals later this summer for bluebird — although the agency on Friday raised some manufacturing concerns for both therapies.

The UK’s National Institute for Health and Care Excellence, or NICE, on Friday agreed to cover Amarin’s controversial cholesterol drug Vascepa, amidst turbulence for Amarin.

Amarin and NICE agreed to a price of £144.21 per 120 soft capsules (or $181 for 30-day supply), according to Amarin. Low-price generic versions of Vascepa, known as icosapent ethyl, cost about $100 in the US, according to GoodRx.

It’s been almost 10 months since the FDA granted Covis Pharma a hearing to review its controversial preterm birth drug Makena, which won an accelerated approval but failed its confirmatory trial, and still the company and FDA are wrangling over the details of that hearing.

In a letter dated Thursday, Covis lawyers from Sidley are now objecting to the hearing, including a publication that suggests a potential link between Makena and cancer in the offspring.

Add Canada to the list of countries where Biogen’s controversial Alzheimer’s drug Aduhelm isn’t wanted by health officials.

The biotech announced on Thursday that it’s pulling aducanumab’s new drug submission (NDS) in Canada after the country’s health agency indicated that “the data provided would not be sufficient to support a marketing authorization.”

The news comes just a couple of months after Biogen pulled aducanumab’s application in Europe, where regulators rejected it late last year — and almost a year to the date since the drug won its highly disputed accelerated approval in the US.

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