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.”

BMS brought in more than $9 bil­lion in sales from its an­ti­co­ag­u­lant Eliquis in 2020, and it con­tin­ues to see growth with more than $8 bil­lion in sales in the first nine months of 2021 (near­ly $4.5 bil­lion of which went to Pfiz­er in 2021 as part of their part­ner­ship).

And while the ex­clu­sion that be­gan last Jan­u­ary raised a furor among pa­tients who lost ac­cess to their blood thin­ner, BMS said 95% of Eliquis pa­tients na­tion­al­ly were not af­fect­ed by the ini­tial for­mu­la­ry ex­clu­sion from CVS.

“The Bris­tol My­ers Squibb-Pfiz­er Al­liance is pleased with the de­ci­sion to add Eliquis (apix­a­ban) back to pre­ferred sta­tus on se­lect for­mu­la­ries (stan­dard/ad­vanced con­trol) with­in CVS Health Com­mer­cial, Zinc Health Ser­vices (GPO), ef­fec­tive Ju­ly 1, 2022,” a BMS spokesper­son said in a state­ment. “Eliquis has been as­so­ci­at­ed with a more fa­vor­able safe­ty pro­file than al­ter­nate ther­a­pies, in­clud­ing few­er bleed­ing events, as sug­gest­ed by clin­i­cal tri­al da­ta and fur­ther com­ple­ment­ed by re­al-world ev­i­dence gen­er­at­ed by mul­ti­ple ob­ser­va­tion­al stud­ies.”

The shift from CVS al­so fol­lows a let­ter sent ear­li­er this month by De­moc­rats Sen. Amy Klobuchar (MN) and Rep. Katie Porter (CA) to the De­part­ment of Jus­tice and Fed­er­al Trade Com­mis­sion not­ing that prices for Eliquis and its com­peti­tor Xarel­to “have risen every year since they en­tered the mar­ket at a rate far out­pac­ing in­fla­tion, with­out any mean­ing­ful im­prove­ments to the med­ica­tions or any ap­par­ent in­crease in pro­duc­tion costs.”

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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.”