Trump tweets a new vow to spur com­pe­ti­tion in the phar­ma biz, slash­ing prices

Pres­i­dent Trump has a re­minder for the bio­phar­ma in­dus­try to­day: He hasn’t for­got­ten you or the con­tro­ver­sy over drug prices.

This lat­est tweet from the pres­i­dent of the Unit­ed States un­der­scores Trump’s re­peat­ed in­sis­tence that the fed­er­al gov­ern­ment can ratch­et down health­care prices by fos­ter­ing com­pe­ti­tion.

Trump proved that he can still send a jolt through in­dus­try shares. Both the IBB and XBI dropped more than a point on the tweet, then start­ed re­cov­er­ing some­what. The pres­i­dent’s so­cial me­dia pro­nounce­ments don’t have the same bite as we saw in the days af­ter his in­au­gu­ra­tion.

This lat­est tweet is al­so long on promise and short on de­tails. And it’s the de­tails — like Trump’s pick for FDA com­mis­sion­er — which peo­ple in the in­dus­try want to see now.

Trump’s brand of change may come through a re­formed FDA, where he’s in­sist­ed that dereg­u­la­tion can make a big dif­fer­ence in re­duc­ing the amount of time and mon­ey spent on drug de­vel­op­ment. Or Medicare could be re­jigged to al­low for price ne­go­ti­a­tions which have been barred by law.

Or all that and more could be in­clud­ed.

I’ve found many ex­ecs in bio­phar­ma be­lieve that the drug in­dus­try is plen­ty com­pet­i­tive as it stands. Al­so, there’s been lit­tle ev­i­dence that faster de­vel­op­ment will re­duce the cost of new drugs.

Umer Raf­fat at Ever­core ISI had this to say:

Ques­tion re­al­ly is:  what does that mean?  Re­call that Pres­i­dent Trump has pre­vi­ous­ly made ref­er­ences to “bid­ding”.

There are 2 types of com­pe­ti­tion:

1.   Brand vs gener­ic – this al­ready ex­ists (and in fact, mar­ket forces dri­ve gener­ics to have very fierce pric­ing wars)

2.   Brand vs brand – for this to hap­pen, you need in­ter­change­able brand­ed prod­ucts … e.g., just be­cause 2 drugs are ap­proved for same in­di­ca­tion doesn’t make them di­rect “com­pe­ti­tion”

o   For true “com­pe­ti­tion” among brands, you need:

§  Mul­ti­ple drugs in same class

§  Same in­di­ca­tion

§  Same route of ad­min­is­tra­tion

§  Sim­i­lar ef­fi­ca­cy

§  Sim­i­lar safe­ty

o   Some ther­a­peu­tic ar­eas have this … but not all

Most im­por­tant­ly, many ther­a­peu­tic ar­eas with gen­er­al­ly in­ter­change­able brand­ed prod­ucts are al­ready un­der Part D … and have for­mu­la­ry tiers etc. 

And that’s the ul­ti­mate ques­tion:  is the Pres­i­dent re­fer­ring more to Part B (where no for­mu­la­ries ex­ist cur­rent­ly)?  Re­al­i­ty is, we just don’t know un­til some­thing de­fin­i­tive is put out

Mean­while, phar­ma may have some ne­go­ti­at­ing lever­age with the Trump ad­min­is­tra­tion be­cause of the abil­i­ty to pitch a job-cre­ation plan … e.g., look at this tweet (al­so from to­day):

One sug­ges­tion from Jim O’Neill, a for­mer HHS of­fi­cial un­der Bush who is ev­i­dent­ly un­der con­sid­er­a­tion as the new head of the FDA, could have an im­pact on pric­ing. He has said in the past that drugs proven to be “safe” should be put on the mar­ket so that peo­ple can find out for them­selves how ef­fec­tive it may be.

A slew of new drugs hur­ried out un­der those stan­dards could start com­pet­ing with es­tab­lished drugs — we just won’t know if they’re worth any­thing at all.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Nurses star in J&J's campaign centered on the importance of nurses who are increasingly stressed, burnt out and quitting the profession (via Johnson & Johnson)

Thank­ful for nurs­es: J&J's new cam­paign aims to re­set pan­dem­ic clock back to grat­i­tude

In the early days of the pandemic, people cheered for nurses – delivering food, writing thank you notes and ringing bells nightly to show their appreciation. But something shifted this summer, and now Johnson & Johnson wants to remind people of the gratitude that nurses still deserve.

Call it politics or pandemic weariness or the result of almost two years of a deadly pandemic, but nurses today face threats and mistreatment from patients and their angry family members. And nurses are leaving the profession in record numbers.

Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Drug­mak­ers cut prices on av­er­age by more than 60% to get on Chi­na's 2022 NDRL list — re­port

China’s National Reimbursement Drug List (NRDL) is a crystal clear example of the country’s bargaining power in the biotech and pharma market, as more firms have reportedly agreed to cut their prices for 67 new medicines to be included in its national medical insurance coverage starting in January.

Being on the list is lucrative. Essentially, if a biotech or pharma company gets on this list, they’re covered by the biggest insurance network in the country. Given China’s vast population, the Chinese government has significant leverage to decide which medicines can make a profit. While domestic drugmakers are quite willing to play that game, cutting prices significantly in exchange for getting on the list, international companies don’t do it as often.