Trump scolds phar­ma ex­ecs, de­mand­ing low­er prices, more US man­u­fac­tur­ing while promis­ing to slash FDA regs

Some of the top CEOs of the phar­ma in­dus­try got to­geth­er with Pres­i­dent Trump Tues­day morn­ing look­ing for com­mon ground. In­stead, they got an­oth­er lec­ture on drug pric­ing, a re­newed promise that the FDA will speed up new drug ap­provals with just a frac­tion of the old reg­u­la­tions in play, and as­sur­ances of an FDA pick wait­ing in the wings who will help put every­thing in or­der.

“We have to get the prices way down,” said Trump, flanked by Cel­gene CEO Bob Hug­in and Mer­ck CEO Ken Fra­zier. “The pric­ing has been as­tro­nom­i­cal for our coun­try.”

But there was a car­rot of­fered along with the stick, as Trump re­peat­ed­ly hit on his promise to slash drug reg­u­la­tions to help speed new drug ap­provals.

“We’re al­so go­ing to be stream­lin­ing the process,” he told the ex­ecs, “so that from your stand­point when you have a drug that you can ac­tu­al­ly get it ap­proved in­stead of wait­ing many, many years.”

“We’re go­ing to get the ap­proval process much faster,” he said. “We’re go­ing to be cut­ting reg­u­la­tions at a lev­el peo­ple have nev­er seen be­fore,” he added. Peo­ple can still be pro­tect­ed, he said, “but in­stead of 9,000 pages it can be 100 pages. And you don’t have to dou­ble up and quadru­ple up. We have com­pa­nies that have more peo­ple work­ing on reg­u­la­tions than they have work­ing at the com­pa­ny.”

To il­lus­trate his point, Trump came up with an anec­dote of a dy­ing pa­tient with just weeks to live, un­able to get an ex­per­i­men­tal ther­a­py. Those days, he vowed, are over. And he in­sist­ed that the com­pa­nies would be re­quired to do far more of their drug man­u­fac­tur­ing in­side the coun­try.

“You have to get your com­pa­nies back here,” he said, re­peat­ing a pledge to re­duce the reg­u­la­to­ry work­load need­ed to get a new plant ap­proved and in op­er­a­tion.

Trump signed a new ex­ec­u­tive or­der Mon­day or­der­ing that every gov­ern­ment agency would be re­quired to elim­i­nate two reg­u­la­tions on the books, for every one they want to add.

Said the pres­i­dent: “I’ll op­pose any­thing that makes it hard­er for small­er, younger com­pa­nies to take the risk of bring­ing a prod­uct to a vi­brant­ly com­pet­i­tive mar­ket. That in­cludes price fix­ing by the biggest dog in the mar­ket, Medicare, which is what’s hap­pen­ing. But we can in­crease com­pe­ti­tion and bid­ding wars big time.”

Trump al­so lev­eled a blast at the rest of the world, which have re­lied on high prices in the US to sub­si­dize their own dis­count­ed rates.

“We’re go­ing to end glob­al free­load­ing,” he pledged. “You’re go­ing to get your prod­ucts ei­ther ap­proved or not ap­proved, but its not go­ing to take 15 years,” he said, cit­ing av­er­age cost of drug de­vel­op­ment at $2.5 bil­lion. Both of those fig­ures are hot­ly de­bat­ed in bio­phar­ma, where poor R&D re­turns in Big Phar­ma have long in­flat­ed the cost and time it takes to get a new drug to mar­ket.

“We’re go­ing to be chang­ing a lot of the rules,” Trump not­ed about the FDA, adding that he has an FDA com­mis­sion­er who’s been picked out and will be named soon. He al­so seemed to ze­ro in on safe­ty as a key con­sid­er­a­tion of quick ap­provals, echo­ing a sug­ges­tion from Jim O’Neill, a Lib­er­tar­i­an close to Trump sup­port­er Pe­ter Thiel, who’s ad­vo­cat­ed ap­provals based on ev­i­dence of safe­ty alone. O’Neill is one of sev­er­al ru­mored can­di­dates for the top job at the FDA.

Along with Hug­in and Fra­zier, David Ricks at Eli Lil­ly, Joe Jimenez at No­var­tis and oth­ers joined the ses­sion.

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.