No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Ear­li­er this year, No­var­tis tout­ed its ra­di­oli­gand as a ma­jor piece to counter com­pe­ti­tion in the can­cer space. How­ev­er, the phys­i­cal pro­duc­tion of its prod­ucts has had any­thing but a smooth ride.

In May, No­var­tis had to sus­pend pro­duc­tion of Lu­tathera and Plu­vic­to, its two pri­ma­ry ra­dio­ther­a­pies. Ac­cord­ing to the com­pa­ny, this was done out of an abun­dance of cau­tion as a re­sult of po­ten­tial qual­i­ty is­sues iden­ti­fied in its man­u­fac­tur­ing. The pro­duc­tion sus­pen­sion im­pacts the com­mer­cial and clin­i­cal tri­al sup­ply of the prod­ucts.

How­ev­er, No­var­tis has now restart­ed the pro­duc­tion of the two ther­a­pies at man­u­fac­tur­ing sites in Italy and New Jer­sey and re­sumed de­liv­ery of dos­es to pa­tients in a phased ap­proach, ahead of the ex­pect­ed six-week time­frame.

The com­pa­ny has re­port­ed­ly re­me­di­at­ed the is­sues that led to its sus­pen­sion and, ac­cord­ing to No­var­tis, these is­sues did not af­fect pa­tient safe­ty, and had no risk to pa­tients from the dos­es pre­vi­ous­ly pro­duced at these sites was iden­ti­fied.

“We rec­og­nize that this sit­u­a­tion has af­fect­ed — and is still af­fect­ing — pa­tients, their fam­i­lies and care teams. Prod­uct qual­i­ty and pa­tient safe­ty re­main the com­pa­ny’s top pri­or­i­ties. We ex­pect that prod­uct sup­ply may be ini­tial­ly lim­it­ed, and we are work­ing hard to re­sume full pro­duc­tion ca­pac­i­ty and meet pa­tient de­mand as quick­ly as pos­si­ble,” said the state­ment from No­var­tis.

No­var­tis is like­ly hap­py these ther­a­pies are back on the pro­duc­tion line as the com­pa­ny has sunk be­yond 10-fig­ures to pick them up.

Lu­tathera, an in­jec­tion for adults with gas­troen­teropan­cre­at­ic neu­roen­docrine tu­mors, came in­to the No­var­tis sta­ble af­ter a $4 bil­lion ac­qui­si­tion of Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions in 2018 and got a quick thumbs up from the FDA.

Plu­vic­to, a ther­a­py for adults with prostate-spe­cif­ic mem­brane anti­gen (PS­MA)-pos­i­tive metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer, was part of the $2.1 bil­lion ac­qui­si­tion of En­do­cyte back in 2018 and has been tout­ed by No­var­tis R&D for sev­er­al years.

This news al­so comes when No­var­tis is look­ing to axe 8,000 jobs out of its 108,000 glob­al staffers as part of a wider glob­al re­or­ga­ni­za­tion.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

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:

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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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.

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.

Anna Protopapas, Mersana CEO

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

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.”