While most peo­ple think of glass as some­thing to drink from or look through, the ma­te­r­i­al al­so has many us­es in phar­ma.

Ger­man glass­mak­er Schott has been man­u­fac­tur­ing glass for a wide range of us­es for 138 years and has built up a ro­bust health­care di­vi­sion.

The com­pa­ny an­nounced on Mon­day that it’s es­tab­lish­ing a stand­alone com­pa­ny specif­i­cal­ly for its phar­ma busi­ness. Ac­cord­ing to Schott, its phar­ma di­vi­sion has grown faster than the mar­ket in re­cent years, war­rant­i­ng a stand­alone com­pa­ny. As part of the carve-out, the phar­ma side will op­er­ate un­der the new name of Schott Phar­ma AG & Co. KGaA. The move is ex­pect­ed to be com­plet­ed by the end of the year.

“By cre­at­ing a sep­a­rate le­gal en­ti­ty for our phar­ma busi­ness, we are gen­er­at­ing new op­por­tu­ni­ties to ex­pe­dite our prof­itable growth,” said Schott CEO Frank Hein­richt in a state­ment.

The spin­out will look at new fi­nanc­ing op­tions, in­clud­ing a pos­si­ble IPO for Schott Phar­ma, ac­cord­ing to CFO Jens Schulte, al­though no fur­ther de­tails were giv­en. The com­pa­ny did not re­spond to End­points News’ re­quest for fur­ther de­tails by press time.

While Schott’s phar­ma sec­tor pro­duces around 13 bil­lion prod­ucts an­nu­al­ly across a wide range of phar­ma man­u­fac­tur­ing us­es, net­ting €650 mil­lion in FY 2021, they are mak­ing more in­vest­ments in­to the phar­ma sec­tor.

Schott has been mak­ing prod­ucts for use in bio­pro­cess­ing, in­jecta­bles, drug con­tain­ment and drug de­liv­ery.

The com­pa­ny said it’s in­vest­ing a triple-dig­it mil­lion eu­ro fig­ure to meet greater de­mand. That in­cludes a new pro­duc­tion fa­cil­i­ty for pre-fil­l­able poly­mer sy­ringes in Ger­many which is al­ready un­der­way. The com­pa­ny is al­so build­ing a new plant for glass sy­ringes in Hun­gary and broke ground on new pro­duc­tion build­ings in Chi­na even as it looks to triple its ca­pac­i­ty for ster­ile vials in the US.

The spin­out from Schott comes as oth­er ma­jor cor­po­ra­tions are spin­ning out their health man­u­fac­tur­ing-re­lat­ed di­vi­sions in­to sep­a­rate com­pa­nies. Man­u­fac­tur­er 3M re­cent­ly an­nounced its plans to spin out its health man­u­fac­tur­ing di­vi­sion in­to a sep­a­rate com­pa­ny, and Lab­corp an­nounced last week its CRO busi­ness will be on its own.

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:

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.”

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.