Rep. Carolyn Maloney (D-NY) (Bill Clark/CQ Roll Call via AP Images)

House, Sen­ate Dems in­tro­duce leg­is­la­tion to com­bat 'abu­sive' phar­ma busi­ness prac­tices

In the af­ter­math of Con­gress in­tro­duc­ing leg­is­la­tion al­low­ing Medicare to ne­go­ti­ate drug prices — which cur­rent­ly re­mains in lim­bo af­ter the failed pas­sage of the Build Back Bet­ter Act — some con­gres­sion­al Dems have shift­ed gears and have put their tar­gets on oth­er phar­ma busi­ness prac­tices.

Deb­bie Stabenow

House Over­sight Com­mit­tee Chair Car­olyn Mal­oney led a group of De­mo­c­rat col­leagues and in­tro­duced three bills on Thurs­day to tar­get “busi­ness prac­tices phar­ma­ceu­ti­cal com­pa­nies use to sup­press com­pe­ti­tion, main­tain mar­ket mo­nop­o­lies, and keep drug prices high,” a state­ment from the of­fi­cials said.

Sen. Deb­bie Stabenow, a Michi­gan De­mo­c­rat and chair of the Sen­ate’s fi­nance sub­com­mit­tee on health care, al­so in­tro­duced those same bills in the Sen­ate with Min­neso­ta Dem Tina Smith.

The three bills in­clude:

  • The Dis­count­ed Drugs for Clin­i­cal Tri­als Act, which would go af­ter brand name spon­sors who re­strict ac­cess to sam­ples of drugs nec­es­sary for bioe­quiv­a­lence test­ing. The bill would grant cer­tain re­searchers ac­cess to drugs or bi­o­log­ics for re­search pur­pos­es with a cer­tain price cap: a mak­er’s cost to man­u­fac­ture, max­i­mum.
  • The Phar­ma­ceu­ti­cal Re­search and Trans­paren­cy Act of 2022 would amend two cur­rent­ly-ex­ist­ing laws to have phar­ma com­pa­nies pub­licly dis­close their in­curred costs to con­duct clin­i­cal tri­als. The bill would cre­ate a pub­lic repos­i­to­ry of cost da­ta for drug clin­i­cal tri­als, would re­quire par­ties to sub­mit this cost da­ta with­in a year af­ter a tri­al is fin­ished to that repos­i­to­ry — plus re­port dis­ag­gre­gat­ed costs in their an­nu­al SEC fil­ings.
  • The Gener­ic Sub­sti­tu­tion Non-In­ter­fer­ence Act aims to block “Dis­pense-As-Writ­ten” cam­paigns, a type of cam­paign that the mem­bers of Con­gress called an­ti-com­pet­i­tive. It would make il­le­gal cer­tain prac­tices that would re­quire health care providers to write “dis­pense as writ­ten” on a pre­scrip­tion when a gener­ic or biosim­i­lar is avail­able.

“These three bills tar­get Big Phar­ma’s ma­nip­u­la­tive prac­tices in or­der to strength­en com­pe­ti­tion, pro­mote in­no­va­tion, and in­crease trans­paren­cy in­to re­search and de­vel­op­ment costs—all of which will help make drugs more af­ford­able,” Mal­oney said in a state­ment.

Mul­ti­ple non-prof­its and ad­vo­ca­cy groups an­nounced their sup­port for the bills.

Doc­tors With­out Bor­ders praised the in­tro­duc­tion of the clin­i­cal tri­al cost dis­clo­sure bill, while grass­roots ac­tivist group US PIRG (Pub­lic In­ter­est Re­search Group) health care cam­paign di­rec­tor Pa­tri­cia Kel­mar said that “these bills are a vi­tal start to pulling down the ob­sta­cles to com­pe­ti­tion and bring­ing about need­ed re­forms.”

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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