Af­ter talk­ing to Trump about top FDA job, Bal­a­ji Srini­vasan erased his barbed crit­i­cism of the drug agency

Bit­coin en­tre­pre­neur and close Pe­ter Thiel as­so­ciate Bal­a­ji Srini­vasan has long en­joyed tak­ing to Twit­ter to poke the FDA for be­ing too slow at ap­prov­ing new ther­a­pies. By his ac­count, the agency was guilty of con­sid­er­able harm. But late Fri­day night, af­ter news of his meet­ing on Thurs­day with Don­ald Trump for a top job at the agency spread like dig­i­tal wild­fire, his Twit­ter stream and FDA com­men­tary all dis­ap­peared in the blink of an eye.

Now there’s just one re­mark on dis­play.

 

You can still find sam­ples of his thoughts from re­porters pre­scient enough to grab them. Don­na Young at S&P Glob­al cit­ed these on Fri­day:

  • “For every thalido­mide though, many dead from slowed ap­provals.”
  • “Be­fore the FDA, sci­en­tists were able to take in­sulin from bench to bed­side in two years.”

This one could come­back to haunt him:

https://twit­ter.com/christapeter­so/sta­tus/820382547490193409

Srini­vasan may not have want­ed all of his tweets to come back for pub­lic dis­cus­sion if Trump breaks with tra­di­tion and goes with a new com­mis­sion­er who is not a doc­tor. Up to now, the smart mon­ey in bio­phar­ma cir­cles had fo­cused on Scott Got­tlieb, who is a physi­cian and has staked out an ac­tivist Re­pub­li­can per­spec­tive on Twit­ter and through nu­mer­ous op-ed pieces.

Srini­vasan is al­so close to Jim O’Neill, an­oth­er Thiel col­league and FDA con­tender who fa­mous­ly said at one time that the FDA should al­low drugs to be mar­ket­ed once they had es­tab­lished their safe­ty, let­ting ef­fi­ca­cy get worked out among the pa­tients. And Thiel him­self, as Young al­so re­port­ed, has been crit­i­cal of the FDA for not be­ing more en­cour­ag­ing to an­ti-ag­ing re­search.

All three, Srini­vasan, O’Neill and Thiel, have backed seast­eading, a fringe ef­fort aimed at sup­port­ing the de­vel­op­ment of in­de­pen­dent com­mu­ni­ties at sea — far from any gov­ern­ment over­sight and bu­reau­crat­ic en­tan­gle­ments.

One of them may get to see how the same at­ti­tude could play out with the au­thor­i­ty to run the FDA.

Trump him­self re­mains a reg­u­lar on Twit­ter, hap­py to stake out some con­tro­ver­sial po­si­tions. He’s al­ready made it clear that he in­tends to get drugs through the ap­proval process faster. And as of last week’s press con­fer­ence, you can add an out­spo­ken po­si­tion on us­ing the fed­er­al gov­ern­ment to rein in drug prices af­ter phar­ma com­pa­nies got “away with mur­der.”

With pos­i­tive topline PhII da­ta, NGM Bio takes a gi­ant leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution, and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50 companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115 mil­lion and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

No­var­tis gets a boost in block­buster mul­ti­ple scle­ro­sis race with Roche

In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

The drug, known as ofatumumab or Arzerra, has performed consistently well across late-stage trials in patients with the most common form of MS, including in head-to-head studies against Sanofi’s old blockbuster Aubagio. But, if the drug is approved, Novartis will find itself in a crosstown game of catch-up; since a 2017 approval, Roche’s Ocrevus has become the second best-selling MS drug on the market, nearly eclipsing Biogen’s Tecfidera last quarter with over a $1 billion in sales.

Tim Mayleben (file photo)

Es­pe­ri­on's goldilocks cho­les­terol fight­er wins FDA ap­proval — will its 'tra­di­tion­al' pric­ing ap­proach spur adop­tion?

It’s more effective than decades-old statins but not as good as the injectable PCSK9 — the goldilocks treatment for cholesterol-lowering, bempedoic acid, has secured FDA approval.

Its maker, Esperion Therapeutics, is betting that their pricing strategy — a planned list price of between $10 to $11 a day — will help it skirt the pushback the PCSK9 cholesterol fighters, Repatha and Praluent, got from payers for their high sticker prices.

The sky-high expectations for the pair of PCSK9 drugs that were first approved in 2015 quickly simmered — and despite a 60% price cut, coupled with data showing the therapies also significantly cut cardiovascular risk, sales have not really perked up.

Esperion is convinced that by virtue of being a cheaper oral therapy, bempedoic acid will hit that sweet spot in terms of adoption.

“We’re kind of like the old comfortable shoe,” Esperion’s chief commercial officer Mark Glickman remarked in an interview with Endpoints News ahead of the decision date. “It’s an oral product, once-daily and nontitratable — these are things that just resonate so true with patients and physicians and I think we’ve kind of forgotten about that.”

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Coro­n­avirus out­break threat­ens short­age of 150 drugs — re­port

American patients who suffer from conditions other than Covid-19 could feel the impact of the coronavirus due to shortage of drugs — as 150 prescription drugs are now reportedly on a list of at-risk therapies. The list spans “antibiotics, generics and some branded drugs without alternatives,” Axios reported citing sources familiar with the list. The FDA declined to comment.

Although factories in China are gradually reopening, restrictions in travel and disruptions at transit hubs are still slowing down production. An Indian company that relies on active pharmaceutical ingredients (API) from China told Bloomberg last week that it’s seeing prices of commonly used drugs jump by 40% to 70%.

Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.

Deborah Dunsire

The fourth CGRP mi­graine drug is here. Time for Lund­beck to prove it's worth $2B

They may be late, but Lundbeck is now officially in the game for preventing migraine with CGRP drugs.

The FDA has OK’d eptinezumab, the prize in Lundbeck’s $2 billion acquisition of Alder. Like rival offerings from Amgen/Novartis, Eli Lilly and Teva, the antibody blocks the calcitonin gene-related peptide, which is believed to dilate blood vessels in the brain and cause pain.

It will now be sold as Vyepti. The company has yet to announce a price. Amgen and Novartis had set the wholesale acquisition cost of their pioneering Aimovig at $6,900 for a year’s supply before raising it slightly this year; Lilly and Teva had followed suit with Emgality and Ajovy.

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